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Biopharmaceuticals China News


                                       Vol.1 Issue 1. 2010




    Copyright © CCM International Limited
Biopharmaceuticals China News
                                    Vol. 1 Issue 1. 2010           Publication date: 4 May, 2010


                                       CONTENTS

 Investment Focus
 1     Potential investment opportunity in China’s vaccine industry
 2     Resources (holding) integrates Beijing Pharmaceutical Group

 Govermental Policies
 3     Updated Pricing Drug List by NDRC comes into force
 3     Procurement and Distribution Rules of Essential Drugs to issue in 2010

 Market Dynamics
 4	    Hualan’s	net	profit	soars	229.10%	in	2009
 5     Huge potential in China’s diabetes treatment market
 7     China Securities Pharmaceutical Index hits record high
 7	    Total	output	of	Ceftriaxone	Sodium	hit	a	record	high	in	2009
 9	    Beijing	OriGene	won	USD16	million	venture	capital
 9	    Lilly’s	Multi-Drug	Resistant	Tuberculosis	Plan	in	China
 10	   Hepalink	ratified	to	be	listed	

 Technology	&	New	Product
 11	 Cephalosporin	Oxazine	Amidine	produced	by	Baiyunshan	Pharmaceutical	obtains	USP

 News	in	Brief
 12	   Sanofi	-	Aventis	builds	research	center	in	China
 12	   Novartis	(China)	publicizes	diabetes	treatment	breakthrough	
 12	   Fosun’s	net	profit	up	91.3%	in	Q1	2010
 12    Bayer Schering Pharma (China) upgrades
 12    Biopharmaceutical output value in Jiangsu to exceed USD73 billion in 2012




     Welcome	 to	 the	 April	 issue	             vaccine producer in China, achieved net
     of Biopharmaceuticals China                 profit	growth	of	USD89.1	million,	up	
     News,	specially	published	by	               229.40%	year	on	year.	
     CCM International.                          In order to guide health and sustainable
                                                 development of China’s pharmaceutical
     Despite	of	global	financial	crisis	         industry, Chinese government successively
     which	resulted	in	negative	                 issued related policies, such as Pricing
     effect on most industries in the            Drug List by National Development and
     world,	China’s	pharmaceutical	              Reform Commission, Procurement and
     industry	witnessed	sound	                   Distribution Rules of Essential Drugs,
     development	in	2009,	thanks	to	             etc. These policies are bound to facilitate
     implementation	of	nationwide	               the progress of pharmaceutical industry,
     Health Care Reform. Some                    especially biopharmaceutical industry.
     biopharmaceutical enterprises               China’s	pharmaceutical	industry	will	
     achieved splendid performance               continue its development momentum and
     in	2009,	such	as	Hualan	                    boom	in	the	following	several	years.	
     Biological Engineering Inc.,
     the largest blood product and
Biopharmaceuticals China News
                                          Vol. 1 Issue 1. 2010              Publication date: 4 May, 2010


                  Biopharmaceutical	China	News	at	a	glance
■ The	confidence	bankruptcy	toward	China’s	vaccine	safety	after	a	series	of	incidents	broke	out	in	
recent months provided great potential investment opportunity for foreign pharmaceutical companies
in China’s vaccine industry.
■ Cooperated	 with	 Beijing	 government,	 Recources(holding)	 integrated	 pharmaceutical	 asset	 of	
Beijing	Pharmaceutical	Group	Co.,	Ltd.	on	Apr.	2nd,	2010.
■ The	updated	Pricing	Drug	List	by	Development	and	Reform	Commission	came	into	force	on	Apr.	
1st , 2010.
■ Stipulations	for	Procurement	and	Distribution	of	Essential	Drugs	in	China	will	be	issued	in	2010.

■ Hualan	realized	net	profit	growth	of	229.40%	in	2009,	mainly	aided	by	increased	plasma	dosage	in	
blood	products	and	rising	demand	for	vaccine	in	Q3	2009.
■ Huge potential market exists in China’s diabetes treatment market as China has the largest
numbers	of	diabetes	patients	throughout	the	world.
■ Aided	by	excellent	performance	of	biopharmaceutical	companies,	China	Securities	Pharmaceutical	
Index,	on	Apr.	12th,	2010,	hit	record	high,	close	to	6125.0.
■ Export	 quantity	 and	 price	 of	 Ceftriaxone	 Sodium	 has	 hit	 a	 record	 high	 since	 2008,	 thanks	 to	
thriving clinical demand, improving of total CS output and intensifying the efforts on oversea markets
exploitation.
■ On	 Mar.	 17th,	 2010,	 Beijing	 OriGene	 won	 USD16	 million	 venture	 capital	 for	 its	 TrueMABTM	
project.
■ Cooperating	with	Zhejiang	Hisun,	Lilly	started	to	implement	its	global	MDR-TB	plan	in	China	on	
Mar. 23rd, 2010.
■ In	 Apr.	 2010,	 Hepalink	 has	 been	 formally	 ratified	 to	 be	 listed	 by	 China	 Securities	 Regulatory	
Commission.
■ On	Apr.	11th,	2010,	Cephalosporin	Oxazine	Amidine	developed	by	Baiyunshan	Pharmaceutical	
successfully obtained USP.


                        Main companies mentioned in this issue
Biopharmaceuticals	China	News                                                                                                        Vol. 1 Issue 1. 2010




 Investment Focus                                                              In	Nov.	2009,	Novartis	Pharmacy	Ltd.,	the	second	largest	flu	
                                                                               vaccine	 producer	 in	 the	 world,	 also	 entered	 Chinese	 vaccine	
                                                                               industry	 by	 expending	 USD124.63	 million	 to	 purchase	 85	
Potential investment opportunity                                               %	 stocks	 of	 Zhejiang	 Tianyuan	 Bio	 Pharmaceutical	 Co.,	 Ltd.	
in China’s vaccine industry                                                    (Tianyuan), the second largest flu vaccine supplier in China. ’
                                                                               At	present,	China	is	the	third	largest	pharmaceutical	market	in	
                                                                               the	world.	In	the	future,	Novartis	will	provide	Tianyuan	vaccine	
The	confidence	bankruptcy	toward	China’s	vaccine	                              technology	 including	 technology	 of	 influenza	 vaccine,	 rabies	
safety after a series of incidents broke out in recent                         vaccine, etc., for the purpose of Novartis’s vaccine production
months provided great potential investment                                     localization,	and	Novartis’s	strategic	target	is	to	become	a	leader	
opportunity for foreign pharmaceutical companies                               in	the	fast-growing	vaccine	industry	in	China.’	said	Mr.	Vasella,	
in China’s vaccine industry. For instance, nearly                              CEO	of	Novartis	in	Nov.	2009.
100 children in Shanxi Province died from the
unqualified vaccine injected; another case is that                             The	above-mentioned	facts	indicate	that	investment	restriction	
unqualified vaccine produced by Jiangsu Ealong                                 for foreign pharmaceutical companies in China’s vaccine
Biotech. Co., Ltd., the first vaccine producer in                              industry have been gradually relaxed, and policy barriers
Jiangsu Province, flooded in Jiangsu’s vaccine                                 restraining foreign pharmaceutical companies to enter China’s
market.                                                                        vaccine	industry	will	be	eliminated	step	by	step.					

These incidents result in the absence confidence                               Notes:
of	 Chinese	 people	 towards	 homemade	 vaccine	                               Vaccine basics refer to vaccines supplied by Chinese
safety and governmental credibility, and quality                               government for free, including:
assured vaccines are urgently needed in China.                                 1.Vaccines belong to the catalogue of National Immunization
Thus,	 foreign	 pharmaceutical	 companies,	 with	                              Program.
the	 advantage	 of	 superior	 technology,	 won	 the	                           2.Extra vaccines when provinces, autonomous regions and
potential investment opportunities in China’s                                  municipalities implement the National Immunization Program.
vaccine industry, such as exporting qualified                                  3.Vaccines used for emergent vaccination or mass preventive
vaccines	 to	 China,	 cooperating	 with	 domestic	                             vaccination organized by government at or above the county
pharmaceutical producers by providing                                          level or relevant administrative department in charge of
technology, etc.                                                               health.

In	 the	 future,	 vaccine	 basics	 market	 which	 was	
monopolized	 by	 state-owned	 enterprises	 is	
likely	to	be	co-shared	by	foreign	pharmaceutical	
companies, such as some foreign pharmaceutical
companies have invested into BCG vaccine and
Polio	vaccine	which	belong	to	catalogue	of	China’s	
immunization	programs,	according	to	the	revised	
industrial Catalog Guiding Foreign Investment in
2007.                                                                             Related Market Report this Month:
C h i n e s e 	 g o v e r n m e n t 	 h a s 	 a l l o w e d 	 f o r e i g n	
                                                                                  Future of Red Biotechnology in
pharmaceutical	 companies	 to	 co-invest	 with	
                                                                                  China
domestic vaccine producers in China’s vaccine
industry.	 In	 Sep.	 2009,	 Glaxo	 Smith	 Kline,	 the	
second largest pharmaceutical company in                                          A	comprehensive	industry	report	with	178	
the	 world,	 cooperated	 with	 Jiangsu	 Watoson	                                  pages, please click the title to see the main
Biotechnology	 Ltd.	 which	 focuses	 on	 human	                                   content and sample pages.
vaccine R&D, production and sales in China, to
have	invested	USD53.97	million	in	China’s	children	                               To purchase or need more details, please
vaccine industry and established a joint venture in                               contact us at econtact@cnchemicals.com
China,	with	Glaxo	Smith	Kline	holding	65%	stocks.	
According	to	the	investment	plan,	the	plant	will	
manufacture	 measles-rubella-mumps	 combined	
vaccines,	a	kind	of	children	vaccine,	which	fall	into	
the catalogue of National Vaccination Program, as
well	as	other	children’s	vaccine.	




CCM International Limited                                                           1                                              www.cnchemicals.com
Biopharmaceuticals	China	News                                                                                      Vol. 1 Issue 1. 2010




            Resources (holding) integrates Beijing Pharmaceutical Group

         On	 Apr.	 2nd,	 2010,	 cooperated	 with	 the	 Beijing	       Resources Medications’s target of this integration is to
         government, China Resources (holding) Co., Ltd.              set up platform for pharmaceutical enterprises under
         Resources(holding), one of the leading conglomerates         direct	jurisdiction	of	central	government.	And	after	this	
         in	 Hong	 Kong	 and	 Chinese	 Mainland,	 integrated	         asset	reorganization,	Beijing	Pharmaceutical	Group	will	
         pharmaceutical assets of Beijing Pharmaceutical Group        get listed in overall.
         Co., Ltd.( Beijing Pharmaceutical Group) (PICTURE 1).
                                                                      Resources	Medications	will	form	a	complete	industry	
         The	integration	will	be	implemented	by	China	Resources	      chain of pharmaceutical industry covering Chinese
         Medications Group Co., Ltd. (Resources Medications), a       medicine, chemical medicine, biopharmaceutical,
         subsidiary	of	Resources	(holding).	After	the	integration,	   medical	equipment	and	pharmaceutical	business,	which	
         Beijing	 government	 will	 hold	 30%	 stocks	 of	 the	       will	 largely	 heighten	 its	 position	 in	 pharmaceutical	
         integrated	 company,	 and	 Resources	 (holding)	 will	       industry. Resources Medications has achieved total
         relocate the headquarter of Resources Medications,           revenue	 of	 USD4.94	 billion	 in	 2009,	 and	 become	 the	
         used	to	be	in	Shenzhen,	to	Beijing.	                         second largest pharmaceutical company in China.

         Resources (holding) and Beijing government signed a          Resources Medications is a wholly-owned subsidiary of
         strategic	cooperation	framework	agreement	regarding	         Resources (holding), engaged in Resources (holding)’s
         pharmaceutical	and	microelectronics	sectors.	According	      domestic pharmaceutical business, with total assets
         to this agreement, Resources (holding)’s investment into     of around USD3.81 billion and turnover of USD3.96
         pharmaceutical	industry	in	Beijing	will	be	encouraged	       billion in 2009. Beijing Pharmaceutical Group, with
         and supported by Beijing government, such as enjoying        total turnover of USD3.9 billion in 2009, is a wholly-
         reduction	and	exemption	of	taxes,	financial	assistance,	     owned company of Beijing government. It has about
         etc.,	 and	 Beijing	 government	 will	 also	 facilitate	     20 subsidiaries, among which Wandong Medical
         Resources (holding)’s integration of biopharmaceutical       Equipment and Beijing Double-Crane Pharmaceutical
         resources in order to found a leading pharmaceutical         are listed in Shanghai and Shenzhen Stock Exchange.
         enterprise	 in	 Beijing.	 Through	 cooperation	 with	
         Resources	 (holding),	 Beijing	 government	 will	 further	
         promote the development of pharmaceutical industry.”
         said Mr. Guo Jinlong, Mayor of Beijing on the signing
         ceremony.




                                        PICTURE 1: Signing ceremony of Beijing government
                                                     and Resources (holding)




                             Source: http://info.crc.com.cn/internet/news/xwfbny/201004/
                            t20100403_111966.htm




CCM International Limited                                         2                                              www.cnchemicals.com
Biopharmaceuticals	China	News                                                                                                              Vol. 1 Issue 1. 2010




Govermental Policies                                                            referential price. That is to say, in the reimbursement of
                                                                                drugs, the price of prescription drugs was constituted by
                                                                                the National Development and Reform Commission, and
Updated Pricing Drug List by                                                    drugs with government referential price were referred to
                                                                                retail price by local government, according to actual local
NDRC comes into force                                                           condition. To OTC drugs, local government constitute
                                                                                retail price, according to actual local condition.


The updated Pricing Drug List by National Development and
Reform	Commission	NDRC		came	into	force	on	Apr.	1st,	2010,	
indicating	 that	 Chinese	 government	 will	 further	 strengthen	
management and supervision of prescription drugs prices and
decentralize	more	pricing	power	to	local	government,	in	order	
to	achieve	standardization	in	drugs	market	and	rational	pricing	
authority division.
                                                                                Procurement and Distribution Rules
                                                                                of Essential Drugs to issue in 2010
According	to	the	new	List,	all	prescription	drugs	in	the	Socialized	
Medicine	Catalog	published	in	2009	and	all	national	essential	
                                                                                        On	Apr.	8th,	2010,	the	forum	on	how	to	actively	
drugs are added into Pricing Drug List. Besides, prices of
                                                                                        manage the procurement and distribution of
narcotic drugs and psychotropic substances in Pricing Drug List
                                                                                        essential drugs after the issuance of National
are	guided	by	with	the	highest	ex-factory	price	and	their	highest	
                                                                                        Basic	Medicine	System	was	held	in	Beijing,	in	
retail price, instead of government referential price in previous
                                                                                        which	rule	for	procurement	and	distribution	of	
time.
                                                                                        essential drugs in China to be issued in 2010
                                                                                        was	informed,	indicating	that	as	some	relative	
Under	the	background	of	publishment	of	On	Establishment	of	
                                                                                        policies and stipulations perfect, production
Implementation	 Advices	 of	 National	 Essential	 Drugs	 System	
                                                                                        and	 supply	 of	 basic	 drugs	 will	 be	 more	
in	Aug.	2009,	NDRC	upgrades	the	Pricing	Drug	List	issued	in	
                                                                                        reasonable	and	scientific	under	governmental	
2005.	The	new	List	will	exert	influence	on	drug	pricing,	market	
                                                                                        management.
behavior, etc. of related pharmaceutical enterprises. Some
experts	air	their	own	opinions	on	this	upgraded	List.		
                                                                                        A c c o r d i n g 	 t o 	 M r . 	 Z h e n g , 	 D i r e c t o r 	 o f	
                                                                                        Department of Essential Drug of the Ministry
“Though	 main	 prescription	 drugs	 with	 patent	 protection	
                                                                                        of Health, by the end of Feb. 2010, there have
belong to multinational companies, their patent protection
                                                                                        been	 about	 30%	 primary	 care	 institutions	
will	 have	 expired	 one	 after	 another	 by	 2013,	 which	 will	 leave	
                                                                                        implementing National Basic Medicine
great development opportunity for domestic prescription
                                                                                        System, and the proportion is expected to
drugs producers. Thus, in order to effectively guide China’s
                                                                                        climb	to	more	than	60%	in	2010.	During	the	
pharmaceutical industry’s health development, NDRC upgrades
                                                                                        implementation of National Basic Medicine
Pricing Drug List.” disclosed by a director from a multinational
                                                                                        System for about one year, various defects like
enterprise in Shanghai.
                                                                                        skimble	-	scamble	price	of	drugs,	commercial	
                                                                                        bribe, etc., have been exposed. Thus, it is
“In	 the	 light	 of	 this	 policy,	 there	 are	 556	 kinds	 of	 over-the-
                                                                                        necessary and urgent to constitute a unified
counter drugs priced by provinces, autonomous regions and
                                                                                        standard for procurement and distribution of
municipalities pricing departments, implying that Chinese
                                                                                        essential drugs
government	 will	 decentralize	 more	 pricing	 power	 to	 local	
government.”	disclosed	by	an	insider	in	Apr.	2010.
                                                                                        Regarding	 how	 to	 effectively	 implement	 the	
                                                                                        rule,	 some	 experts	 air	 their	 views	 on	 this	
Wangming,	 Manager	 of	 Guangzhou	 Pharmaceutical	 Holdings	
                                                                                        forum. Mr. Liao, Deputy Director of Health
Ltd.	said	“After	the	updated	Pricing	Drug	List	came	into	force,	
                                                                                        Department of Sichuan Province, said, “In poor
pharmaceutical	companies	may	show	more	concern	on	how	to	
                                                                                        regions like Sichuan Province, government
win	a	preponderant	price	in	the	process	of	drug	tender.	“	
                                                                                        should	permit	relevant	qualified	companies	to	
                                                                                        participate in distribution, in order to ensure
Note:
                                                                                        availability of essential drugs.”
The Pricing Drug List issued in 2005 by National Development
and Reform Commission showed that the pricing drugs were
divided into following two categories: part of drugs are
priced by the government; the rest are guided by government




CCM International Limited                                                   3                                                           www.cnchemicals.com
Biopharmaceuticals	China	News                                                                                          Vol. 1 Issue 1. 2010




       Mr.	Niu	Zhengqian,	Deputy	Secretary	of	Chinese	Medicine	Entrepreneur	Association,	viewed	“We	should	take	market	
       mechanism into full play; and let hospitals, manufacturers and distribution companies be engaged in free competition; only
       by	this	way	can	the	rule	of	procurement	and	distribution	of	essential	drugs	take	greater	effect	and	bring	more	benefits.”.	

       “After	the	National	Basic	Medicine	System	has	been	implemented,	government	should	constitute	a	national	unified	standard	
       for procurement and distribution of essential drugs, in order to avoid the commercial bribe in the tender process.” said Li
       Zhenjiang,	Chairman	of	Shineway	Pharmaceutical	Group,	the	largest	manufacturer	of	modern	Chinese	medicine	injections,	
       soft capsules and granules.

       Regarding	how	to	carry	out	this	rule,	CCM	also	put	forward	some	suggestions.	Firstly,	there	should	be	a	complete,	objective	
       and fair standard system for drugs tender; secondly, government should establish reasonable entrance thresholds for
       pharmaceutical industry in order to guarantee drugs quality; thirdly, as for pricing, combination of market mechanism and
       governmental	supervision	should	be	made	in	the	whole	tender	process	and	enterprises	should	be	given	more	rights,	such	as	
       how	to	distribute	drugs,	etc.	




                                                                   doses vaccine for national H1N1 storage task, among
  Market Dynamics                                                  which	29.46	million	have	been	shipped	to	the	locations	
                                                                   designated	by	government,	and	the	rest	will	be	released	
                                                                   before	the	end	of	this	year.	In	the	future,	it	will	accelerate	
Hualan’s	net	profit	soars	229.10%	                                 the process of overseas registration for H1N1 bacteria and
in	2009                                                            seasonal	influenza	vaccines	so	as	to	further	enhance	its	
                                                                   vaccine	business	(TABLE	1).
                                                                   Development of blood products business also contributed
 According	to	annual	report	for	fiscal	year	2009	on	Mar.	          to	the	net	profit	growth.	The	company	achieved	revenue	
 9th,	2009,	Hualan	Biological	Engineering	Inc.	(Hualan),	          of	 USD74.19	 million	 from	 blood	 products,	 with	 gross	
 the largest blood product and vaccine producer in China           profit	rate	of	63.63%	in	2009,	respectively	up	26.09%	and	
 with	capacity	of	1,500t/a	for	plasma	processing	and	29.74	        4.88%	 against	 2008.	 Revenues	 from	 human	 albumin,	
 million doses per year for vaccine, achieved net profit           intravenous immunoglobulin (IVIG) and other blood
 growth	 of	 229.40%,	 thanks	 to	 significantly	 increased	
 plasma dosage in blood products, and rising demand for
 vaccine	in	Q3	2009.
                                                                           TABLE	1:	Hualan’s	business	situation,	2008	&	2009
 Though	under	the	context	of	global	financial	crisis,	Hualan	                                          2009                    2008
 still	made	considerable	achievements	in	2009.	
                                                                                            Value,                       Value,
 .                                                                                          million       Up YOY,        million      Up
 The	achievement	firstly	sourced	from	vaccine,	which	was	                   Item             USD             %            USD        YOY, %
 needed	 with	 large	 numbers	 when	 influenza	 suddenly	           Revenue                  178.00           160.39       68.00      48.25
 happened	 in	 Q3	 2009.	 Revenue	 from	 vaccine	 realized	
                                                                    Net profit                 89.00          229.40       27.00      70.35
 USD104.52	 million	 in	 2009,	 up	 887.84%	 over	 2008.	
 Besides, the company is responsible for 52.25 million             Source: Annual report of Hualan in 2009




CCM International Limited                                         4                                                 www.cnchemicals.com
Biopharmaceuticals	China	News                                                                                                Vol. 1 Issue 1. 2010




products	reached	USD38.56	million,	USD21.11	million,	
USD14.51	 million,	 up	 15.53%,	 10.74%	 and	 127.27%	           FIGURE	1:	Hualan’s	stock	performance,	Jan.	2006	~	Apr.	2010
separately	over	2008.	Taking	the	rising	market	demand	
for IVIG into consideration, the National Development
and Reform Commission raised IVIG price, thus revenue
from IVIG increased, and revenue proportion of human
serum albumin declined accordingly in blood products.
This	structure	optimization	is	helpful	for	improvement	
of	plasma	utilization	rate	and	gross	profit	rate	of	blood	
products (FIGURE 1).

Hualan is estimated to get sound development in 2010,
as	a	series	of	vaccines	such	as	seasonal	influenza	vaccine,	     �
hansenula	 hepatitis	 B	 vaccine,	 etc.	 will	 be	 put	 into	
market	this	year.	Additionally,	aided	 by	the	 increased	
plasma	dosage,	couple	with	the	price	increase	of	IVIG	
from	 USD60.41/dose	 to	 USD87.97/dose	 in	 Shanghai,	
which	is	also	likely	to	increase	in	other	regions	of	China,	
the	company’s	net	profit	is	estimated	to	rise	by	30%~50%	
year on year. The company’s much better performance in
stock market is a strong proof for its fastest development
in recent years.

                                                                 Source: google finance
                                                                 Note: SCI refers to Shanghai Composite Index




Huge potential in China’s diabetes
treatment market

China,	with	more	than	92	million	adult	diabetes	and	about	150	               diabetes market, Novo Nordisk, the largest human insulin
million potential diabetes, has the largest numbers of diabetes              producer	 in	 the	 world,	 input	 USD381	 million	 to	 establish	 the	
patients	 in	 the	 world,	 according	 to	 New	 England	 Journal	 of	         world’s	largest	insulin	preparation	and	bottling	plant	in	China	at	
Medicine	in	Mar.	2010,	in	which	new	medical	research	findings,	              the	end	of	2008,	which	is	the	largest	investment	for	the	company	
review	articles,	and	editorial	opinion	on	a	wide	variety	of	topics	          after	its	foundation	for	80	years.	At	present,	Novo	Nordisk	seizes	
of importance to biomedical science and clinical practice are                above	60%	market	share	of	human	insulin	in	China.	
published. Besides, total direct medical expenditure of diabetes
(male	and	female	diabetes	patients	with	age	of	over	20	in	China)	            Another	case	is	Sanofi-Aventis,	a	diversified	healthcare	company	
and	 its	 complications	 has	 reached	 USD2.8	 billion	 and	 it	 will	       in	 the	 world.	 To	 further	 enlarge	 its	 market	 share	 in	 China,	 it	
witness	uptrend	in	the	future,	disclosed	in	the	High	Blood	Sugar	            announced	in	Apr.	2009	that	it	would	invest	USD87.9	million	to	
Diabetes	Forum	sponsored	by	USA	Abbott	Laboratories	in	Apr.	                 expand	its	Lantus	pre-filling	production	line	in	its	insulin	factory	
2010.                                                                        in	Beijing	Economic	and	Technological	Development	Zone,	which	
                                                                             is expected to be launched in 2012. By then the company’s Lantus
This	shows	that	huge	potential	exists	in	China’s	diabetes	treatment	         capacity	will	reach	50	million	units	per	year.	
market. Some multinational pharmaceutical enterprises, like
Novo	Nordisk,	Eli	Lilly	and	Sanofi-Avetis	have	captured	about	               At	 present,	 domestic	 approved	 antidiabetic	 drugs	 mainly	 refer	
90%	market	share	of	China’s	diabetes	treatment	market	of	top	                to	 insulin	 secretion	 (glinides	 and	 sulphonylurea),	 non-insulin	
first	class	hospitals.	And	they	have	enlarged	or	will	enlarge	their	         secretion	 (biguanides,	 α-glucosidase	 inhibitor	 and	 glitazones)	
investments	in	this	field	in	China.	                                         and human insulin. What is the situation of prescription status of
For instance, in order to consolidate its leadership in China’s              patients	with	diabetes	in	main	hospitals	of	China’s	medium	and	




CCM International Limited                                                5                                                 www.cnchemicals.com
Biopharmaceuticals	China	News                                                                                                Vol. 1 Issue 1. 2010




large cities? (FIGURE 2)                                                      Medicines.
                                                                              However,	 in	 the	 class	 of	 α-glucosidase	 inhibitor,	 Acarbose	
In the light of a market research study, surveying diabetes                   produced	 by	 Germany	 Bayer	 Group	 captures	 about	 30%	
prescription status in main hospitals of China’s medium and                   prescription share, aided by its being under patent protection
large	 cities	 with	 4500	 prescriptions	 of	 patients	 with	 diabetes	       status	and	successful	promotion	in	diabetes	treatment	field.	
by Cegedim Strategic Data, a leading market research company
dedicated	to	the	healthcare	industry,	in	Mar.	2010,	in	the	field	of	          In the field of injective drugs treating diabetes, human insulin
oral drugs treating diabetes, the class of Biguanide, accounting for          occupies	about	38.6%	prescription	share.	Key	products	of	Novolin	
37.6%	prescription	share,	is	still	the	most	widely	used	antidiabetic	         30R	 of	 Novo	 Nordisk	 in	 Demark	 takes	 up	 12.3%	 prescription	
drug	for	diabetes	treatment,	and	recommended	as	first-line	drug	              share.
for diabetes treatment and listed in Catalogue of National Basic




                  FIGURE	2:	Structure	of	prescription	share	by	different	classes	and	brands	of	diabetes	drugs	in	2009


                         Biguanide    α-glucosidase inhibitor
                                                  Sulphonylurea

                           Others
                           4.90%          Others
                                          1.10%
                                                                                                       Premix human insulin
                                                     Others
                                                     8.10%
                                                                                           Intermediate-efficacy
                                                                                                human insulin
                                                   Glimepiride
                          Metformin                   4.50%                                                        Others
                           22.50%                                                                                  5.80%  Long-
              Glinides
                                         Acarbose                                      Short-acting                       acting
                                                  Diamicron
                                          29.40%                                      human insulin                       human
                                                   8.30% Glitazones                                          Humulin70/30
                                                                                                                          insulin
                                                                                                                6.10%
                                                                          Glinides and
            Others1.50%                                                   Biguanides
                                             Glipizide
             Repaglinide Metformin                      Others          Others
                                              9.30%                               Others Novolin 30R
               7.50% Hydrochloride                      6.10%           2.40%                        Others
                                                                                  1.50%    12.30%
                          10.20%                                                                      0.40%
                                   Kaboping Gliquidone Avandia         Novolin R Novolin N           Lantus
             Nateglinide
                                    4.10%     3.50%     4.10% Avandamet 3.80%     3.30%              2.90%
               3.40%
                                                                0.20%
            Distribution of prescription share
               12.4%     37.6%            34.6%      33.7%       10.2%         0.2%        6.4%       4.8%     24.1%          3.3%

                                     s
           Source: Cegedim Strategic Data




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Biopharmaceuticals	China	News                                                                                                       Vol. 1 Issue 1. 2010




 China Securities Pharmaceutical
 Index hits record high

A i d e d 	 b y 	 e x c e l l e n t 	 p e r f o r m a n c e 	 o f	
biopharmaceutical companies, China Securities                        Figure:	CSPI	and	SSECI	performance,	Jan.	2009	~	Apr.	2010
Pharmaceutical	 Index	 (CSPI,	 399933)	 has	 been	
performing strongly since early 2010, and hit
record	high	of	6125.0	on	Apr.	12th,	2010.

As	 of	 Apr.	7th,	2010,	88	BC	 have	 released	their	
fiscal	 2009	 annual	 reports	 in	 succession,	 and	
achieved	 total	 net	 profit	 of	 USD231.95	 million,	
up	67.58%	compared	with	2008,	mainly	thanks	
to sound development and promising prosperity
in this industry, reform of Health Care system,
issuance of the Catalog of National Basic Drugs,
reorganized	assets	of	BC,	etc.	

It is aided by the excellent performance of
biopharmaceutical companies that CSPI has
become the strongest securities industry index in                    Source: Baidu Finance
China.	 On	 Apr.	 12th,	 Shanghai	 Stock	 Exchange	
Composite	Index	(SSECI)	performed	downtrend,	
while	 CSPI	 hit	 the	 historically	 high	 level	 and	
closed	 at	 points	 of	 6125.0.	 As	 of	 that	 day,	 CSPI	
has continuously advanced for 11 market days,
reflecting	the	promising	prosperity	in	this	industry	
(FIGURE 3).                                                          Total output of Ceftriaxone Sodium
When CSPI reached record high, many
                                                                     hit	a	record	high	in	2009
pharmaceutical stocks’ price also jumped to a
new	 high	 point.	 Apart	 from	 the	 pharmaceutical	                 Total output of Ceftriaxone Sodium, the third generation cephalosporin
stocks listed this year, 45 pharmaceutical stocks                    and	 a	 broad-spectrum	 cephalosporin	 with	 a	 long	 plasma	 elimination	
have hit record high since early 2010, accounting                    half-life	 of	 approximately	 8	 hours	 in	 normal	 adults,	 hit	 a	 record	 high	
for	32.85%	of	the	total	comparable	stocks.	And	12	                   in	2009	reaching	3768	tonnes	in	2009,	up	29%	year	on	year,	thanks	to	
pharmaceutical stocks have achieved the highest                      thriving clinical demand, significantly increasing number of producers
since	Apr.	2010,	such	as	Shanghai	RAAS,	Jiangsu	                     of Ceftriaxone Sodium and their efforts to intensify exploitation of
Yuyue,	Pkucare	Southwest	Pharmaceuticals,	etc.	                      overseas market. Besides, the export price of Ceftriaxone Sodium reached
                                                                     USD127.3/kg	in	Feb.	2010,	up	35.8%	compared	with	that	in	May.	2009.	
Eyeing this excellent performance of BC,
institutional	investors	significantly	increased	their	               Clinical	 demand	 of	 Ceftriaxone	 Sodium	 is	 growing	 steadily	 along	with	
BC	 stocks.	 As	 of	 Q4	 2009,	 their	 total	 BC	 stocks	            the	development	of	primary	care.	According	to	a	report	issued	by	China	
reached	3.20	billion	shares,	 up	70.6%	over	 that	                   Association	 of	 Pharmaceutical	 Commerce	 (CAPC)	 in	 Apr.	 2010,	 the	
as	of	Q3	2009,	indicating	their	optimism	towards	                    expenditure of Ceftriaxone Sodium in hospitals of 22 major cities in
biopharmaceutical industry.                                          China	was	USD39	million,	up	35.1%	compared	with	that	in	2007,	and	its	
                                                                     market	share	has	achieved	42%	in	China’s	cephalosporin	market	in	2009,	
Notes:                                                               up	11.5%	compared	with	that	in	2004.	Besides,	as	to	the	annual	growth	
CSPI is an index to reflect the overall performance                  rate	over	the	past	few	years,	only	Ceftriaxone	Sodium	has	achieved	106%	
of biopharmaceutical stocks in Shanghai and                          compared	with	other	cephalosporins	like	Cefazolin	Sodium,	Cefotaxime	
Shenzhen stock markets, which is indexed with                        Sodium,	 Cefoperazone	 Sodium,	 Cefurozime	 Sodium.	 As	 an	 act	 of	 the	
all biopharmaceutical shares by China Securities                     reform	of	health-care	in	2009,	Chinese	government	will	invest	USD124.6	
Index Co., Ltd., a professional company                              billion to improve primary care over the next three years. Therefore, it is
specializing in creation and management of                           expected	that	the	clinical	demand	of	Ceftriaxone	Sodium	will	continue	this	
indices and index-related services.                                  uptrend in the future.




CCM International Limited                                                        7                                                www.cnchemicals.com
Biopharmaceuticals	China	News                                                                                              Vol. 1 Issue 1. 2010




    In	 the	 past	 few	 years,	 total	 number	 of	 Ceftriaxone	 Sodium	         a	total	value	of	USD236	million	to	Russia	and	Belarus,	whose	
    producers	 significantly	 increased.	 According	 to	 a	 report	             cephalosporin production technology lags behind (FIGURE 4).
    issued	by	CAPC	in	Apr.	2010,	the	number	of	total	producers	
    of	Ceftriaxone	Sodium	was	3	in	the	early	stage	but	reached	                 However,	there	are	some	uncertainties	for	Ceftriaxone	Sodium	
    36	at	end	of	2009.	Meanwhile,	main	producers	like	Shanxi	                   exports	in	the	future.	In	Oct.	2008,	the	Ministry	of	Commerce	
    Weiqida	 Pharmaceutical	 Co.,	 Ltd.,	 Shanghai	 Asia	 Pioneer	              and Industry of India formally determined that the export of
    Pharmaceutical	 Co.,	 Ltd.,	 etc.,	 captured	 about	 80%	 total	            Ceftriaxone	Sodium	to	India	from	China	was	dumping,	and	the	
    capacity of Ceftriaxone Sodium in China.                                    Indian	government	levied	108%~120%	anti-dumping	duties	
                                                                                on Ceftriaxone Sodium imported from China. Thus, many
    Ceftriaxone Sodium producers have been intensifying                         Chinese	Ceftriaxone	Sodium	exporters	are	forced	to	withdraw	
    exploitation	 of	 overseas	 market.	 In	 the	 past	 few	 years,	            form Indian market. Besides, some member countries in
    the export of Ceftriaxone Sodium has been amounted to                       European Commission like Italy and Spain begin to investigate
    30%~40%	of	its	total	capacity,	which	achieved	899	tonnes	in	                the dumping cases of Chinese Ceftriaxone Sodium, disclosed
    2009,	up	14.1%	year	on	year.	India,	South	Korea,	Europe,	and	               by some insiders in China.
    Southeast	Asia	are	the	major	export	destinations.	Since	2007,	
    Ceftriaxone Sodium producers has exported cephalosporin
    including	Ceftriaxone	Sodium,	cefoperazone,	etc.,	achieving	




                          FIGURE	4:	Export	volume	and	export	growth	rate	of	Ceftriaxone	Sodium,	2007~2009

                                      1,000                                                                  25.00%
                                                                                                 899
                                       900
                                                                            788
                                       800            19.33%                   19.76%                        20.00%
                                       700         658

                                       600                                                                   15.00%
                                                                                                    14.09%
                              tonne




                                       500
                                       400                                                                   10.00%
                                       300
                                       200                                                                   5.00%
                                       100
                                          -                                                                  0.00%
                                                   2007                     2008                2009

                                                          Export Quantity          Export Grow th Rate

                             Source: China Customs




CCM International Limited                                                   8                                            www.cnchemicals.com
Biopharmaceuticals	China	News                                                                                    Vol. 1 Issue 1. 2010




Beijing	 OriGene	 won	 USD16	                                   Beijing OriGene Technologies, Inc. is a gene centric life
                                                                sciences tool company dedicated to support academic,
million venture capital                                         pharmaceutical and biotech companies in their research
                                                                of gene functions and drug discovery. OriGene’s novel
   On	Mar.	17th,	2010,	Beijing	OriGene	Technologies,	           product line includes the world’s largest cDNA and shRNA
   Inc.(Beijing	 OriGene)	 announced	 it	 has	 won	             clone collection, over 5,000 purified human proteins, high
   USD16	million	Series	B	venture	capital	from	IDG-             quality monoclonal antibodies, 100,000 highly validated
   Accel,	 SBI	 &	 TH	 Venture	 Capital	 Management	            human tissues, and Lumines Multiplex Assay products.
   Co.,	 Ltd.,	 and	 Zero2IPO	 Capital,	 and	 its	 previous	    OriGene also provides a broad range of antibody validation
   investors, Morningside Venture Investments and               products including genome-wide tagged antigen standards
   President International Development Corp. also               and extensive IHC slides derived from the company’s tissue
   participated.	The	venture	capital	will	be	mainly	used	       collection.
   to continuously build the largest collection of next
   generation	 monoclonal	 antibodies	 (TrueMABTM)	
   covering the majority of human proteome in the
   world.

   “This	 capital	 will	 facilitate	 the	 accomplishment	 of	
   building the largest monoclonal antibody collection
   in	the	world	covering	the	entire	human	genome	of	
   approximately 20,000 genes.” said Mr. He, Beijing
                                                                L i l l y ’ s 	 M u l t i - D r u g 	 R e s i s t a n t	
   OriGene’s	Chairman	and	CEO.                                  Tuberculosis Plan in China
    Beijing	 OriGene	has	 dedicated	 to	 build	 the	 largest	   Cooperating	 with	 Zhejiang	 Hisun	 Pharmaceutical	 Co.,	
    collection	of	human	full-length	cDNA	clones	since	          Ltd.	 (Zhejiang	 Hisun),	 a	 well-known	 anti-infection	
    last	decade.	The	project	will	be	developed	with	the	        pharmaceutical enterprise in China, Eli Lilly Company (Lilly)
    most	 up-to-date	 antibody	 technologies	 and	 will	        in	 the	 US,	 a	 global	 R&D-based	 pharmaceutical	 company,	
    be	 using	 authentic	 human	 full-length	 proteins	 as	     started	 to	 implement	 its	 global	 multi-drug	 resistant	
    immunogens during the manufacturering process.              tuberculosis	plan	(MDR-TB)	in	China	on	Mar.	23rd,	2010.	

    TrueMABTM	 monoclonal	 antibodies	 are	 currently	          This	 MDR-TB	 project	 exists	 to	 save	 lives	 by	 preventing	
    available	 in	 the	 market	 and	 will	 be	 utilized	 by	    and	 treating	 MDR-TB	 –	 a	 terrible	 disease	 that	 afflicts	
    commercial partners for various applications                millions of people in some poor regions throughout the
    like	 flow	 cytometry	 and	 Multiples	 enzyme-linked	       world.	According	to	Mr.	Lai,	Lilly’s	CEO	in	China,	Lily	has	
    immunosorbent assays.	 It	 was	 estimated	 by	 some	        cooperated	with	Zhejiang	Hisun	by	transferring	technology	
    insiders	that	as	of	2020,	there	will	be	about	3,000	        of capreomycin for free, training relevant technicians, as
    kinds	of	new	drugs	produced	by	biopharmaceutical	           well	as	proving	ample	funds,	besides,	in	order	to	effectively	
    technology, and gross output value of drugs produced        control	the	spread	of	MDR-TB,	the	company	will	also	carry	
    by	 biotechnology	 will	 reach	 USD396	 billion,	           out a series of health education, such as training medical
    disclosed by Liu Yanhua, Undersecretary of Ministry         personnel,	popularizing	prevention	knowledge,	etc.	
    of Science and Technology in Jun. 2007. Therefore,
    the promising prospect of biopharmaceutical                 Lily has successfully transferred a series of production
    industry attracts venture investors’ capital.               technology	of	capreomycin	to	Hisun	till	now,	and	Hisun	has	
                                                                launched	capreomycin	production	line	for	this	project	with	
    According	to	statistic	from	Zero2IPO,	an	information	       total	capacity	of	5	million	doses/year.
    and consultation for venture capital (VC) and private
    equity	(PE),	in	2009,	there	were	total	49	cases	of	VC	      By	 far,	 Lilly	 has	 invested	 USD135	 million	 for	 this	 MDR-
    and PE to have been invested in the pharmaceutical          TB project. In Jan. 2010, contributed by this project,
    industry	with	total	investment	of	USD320	million,	          Lilly	 won	 “2009	 Multinational	 Corporations	 in	 China	
    among	which	31	cases	are	invested	into	development	         Contribution	Award	“.	“This	award	future	indicates	the	long-
    and expansion of pharmaceutical companies. “It              term commitment for preventing and treating tuberculosis
    is estimated that in 2010, investors of VC and PE           in	 China,	 especially	 for	 MDR-TB,”	 said	 Mr.	 Eric	 Baclet,	
    will	be	 further	 active	in	 pharmaceutical	 industry.”	    Regional	CEO	of	Lilly	in	China	in	Jan.	2010.
    said	Zhengyufen,	senior	project	manager	of	medical	
    health	department	in	Zero2IPO.                              MDR-TB	 prevention	 and	 treatment	 is	 austere	 in	 China.	
                                                                According	to	a	report	issued	by	Chinese	Ministry	of	Health,	
    Note:




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Biopharmaceuticals	China	News                                                                                                           Vol. 1 Issue 1. 2010




    there	were	about	4.5	million	patients	with	active	tuberculosis	in	China	as	of	Mar.	2009,	80%	of	which	were	in	rural	areas.	Besides,	
    according	to	a	WHO	research	in	2006,	about	130,000	new	MDR-TB	patients	increase	annually	in	China,	accounting	for	28%	of	the	
    world’s	total	newly	MDR-TB	patients.	At	the	same	time,	high	treatment	expenditure	for	MDR-TB,	usually	100	times	higher	than	
    that for normal tuberculosis, also restricts patients’ treatment.

    Great	concern	for	treatment	of	MDR-TB	has	been	shown	in	China,	where	symptoms	suspicious	of	tuberculosis	are	checked,	and	a	
    unified	free	treatment	for	free	program	for	patients	diagnosed	is	also	provided.	During	the	year	2001	to	2008,	there	were	642,000	
    MDR-TB	patients	healed.	

    Capreomycin	is	mainly	applied	for	mycobacterium-caused	tuberculosis	patients	who	aren’t	healed	with	first-line	anti-drugs	such	as	
    streptomycin,	isoniazid,	rifampicin	and	ethambuto,	etc.,	and	for	the	patients	who	are	not	applicable	to	the	above	mentioned	first-
    line	anti-drugs,	attributed	to	toxicity	or	bacteria	resistance.	It	will	be	acquired	bacterial	resistance	when	used	separately,	thus	only	
    with	combination	of	antibacterial	drugs	can	it	cure	TB.	




                                                                superiority	 in	R&D	 and	production.	At	present,	 it	 has	 become	 the	largest	 heparins	
Hepalink	ratified	to	be	                                        sodium’s	API	production	and	sale	enterprise	in	the	world.	According	to	statistics	from	
listed                                                          China	 Customs	 in	 2009,	 Jan.	 2009	 ~	 Sep.	 2009,	 Hepalink’s	 export	 value	 reached	
                                                                USD175.8	million,	accounting	for	39.5%	of	national	total	export	value	of	this	product.		
 In	 Apr.	 2010,	 Shenzhen	 Hepalink	
 Pharmaceutical Co., Ltd. (Hepalink),                           Currently,	 supply	 of	 heparins	 sodium’s	 API	 falls	 short	 of	 demand	 and	 inadequate	
 the biggest supplier of heparins                               capacity has become the bottleneck for its further development in future. The launch of
 s o d i u m ’ s 	 A c t i v e 	 P h a r m a c e u t i c a l	   this	new	production	line	will	effectively	solve	this	problem,	disclosed	by	insider	in	Apr.	
 Ingredients	 API	 in	 the	 world,	 has	                        2010.
 been formally ratified to be listed in
 Shenzhen	 Stock	 Exchange	 by	 China	                          After	it	is	listed	in	Shengzhen	Stock	Exchange,	stock	holder	of	the	company	will	benefit	
 Securities Regulatory commission.                              a	lot.	Lili	and	Litan	couple,	Hepalink’s	facto	controller	holding	288.0	million	Hepalink’s	
                                                                stock	 shares,	 will	 become	 the	 richest	 person	 in	 Chinese	 mainland	 valuing	 USD6.3	
 The	 company	 will	 issue	 40.1	 million	                      billion.	And	stock	value	of	Goldman	Sachs,	a	full-service	global	investment	banking	and	
 stocks,	with	about	USD21.7	per	share,	                         securities	firm,	who	invested	USD	4.9	million	to	Hepalink	in	2007,	and	holding	12.5%	
 to	 raise	 about	 USD869.5	 million,	                          stocks	of	the	company,	will	reach	USD966.2	million,	93	times	of	its	initial	investment.	
 among	 which	 about	 USD70.8	 million	
 will	 be	 used	 for	 its	 new	 heparins	                       According	to	Hapalin’s	Prospectus	issued	in	Apr.	2010,	it	is	estimated	that	as	of	2010,	
 sodium’s	 API	 production	 lines	 with	                        demand	for	heparins	sodium’s	API	will	reach	6142	tonnes,	achieving	a	CAGR	of	10.2%	
 capacity	of	830t/a,	and	about	USD56.2	                         year on year.
 million	will	be	used	as	floating	capital	
 of	this	project.	The	products	of	this	new	                     However,	 Hepalink	 may	 also	 face	 some	 uncertainties	 in	 future.	 Its	 profit	 margin	
 production	line	are	in	accordance	with	                        will	 decline	 in	 the	 future,	 since	 the	 production	 cost	 of	 raw	 material	 of	 heparins	
 authentication standards of U.S. Food                          sodium’s	API,	which	accounts	for	85%	production	cost,	may	increase	in	the	future,	
 and	 Drug	 Administration	 (FDA)	 and	                         while	heparins	sodium’s	API	price	will	decline	due	to	the	expanded	capacity	of	other	
 Certificate of Suitability for European                        companies	in	recent	years	(TABLE	2).	
 Pharmacopeia (CEP).

 Hepalink has been developing rapidly
 since	 2007.	 In	 2009,	 its	 revenue	 and	                      TABLE	2:	Hepalink’s	heparins	sodium’s	API	export	value,	Jan.	2006~Sep.	2009
 net	 profit	 reached	 USD32.8	 million	
                                                                                                                  Hepalink’s export
 and	 USD11.9	 million,	 respectively	 up	                              Year              Total export value            value              Market share
 411.2%	 and	 387.8%	 year	 on	 year.	 Its	                                                 (million USD)          (million USD)               (%)
 revenue and net profit respectively                            Jan. 2009~Sep. 2009
                                                                                                444.2                   175.8                   39.5
 realized	a	CAGR	of	172.6%	and	244.5%	
 from	2007	to	2009.	                                                    2008                    226.1                    63.5                   28.1
                                                                        2007                    137.5                    27.6                   20.1
 The company’s rapid achievement
                                                                        2006                    103.3                    29.4                   28.5
 is mainly thanks to its technical
                                                                               Market	share=Hepalin’s	export	value/total	export	value
                                                                Source: Hapalin’s Prospectus issued in Apr. 2010




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Biopharmaceuticals	China	News                                                                                Vol. 1 Issue 1. 2010




                                                            of	 Cephalosporin	 Oxazine	 Amidine	 can	 further	 enhance	
 Technology	&	New	Product                                   the	 company’s	 hi-tech	 innovation	 capability,	 which	 is	 in	
                                                            accordance	 with	 its	 strategy	 –	 patent	 first,	 distribution	
Cephalosporin	 Oxazine	 Amidine	                            follows	in	overseas	market.	Through	this	way,	Baiyunshan	
                                                            Pharmaceutical’s	 COA	 will	 participate	 in	 international	
produced by Baiyunshan                                      competition.”
Pharmaceutical obtains USP
                                                            With	accession	to	WTO,	Chinese	government	has	issued	a	
On	Apr.	11th,	2010,	Cephalosporin	Oxazine	Amidine	          series	of	policies	such	as	Measures	for	the	Administration	
developed	by	Guangzhou	Baiyunshan	Pharmaceutical	           of	Drug	Registration,	to	support	R&D	of	new	drugs	with	
Co., Ltd.( Baiyunshan Pharmaceutical) successfully          independent intellectual property rights. Mr. Liu Xuebin,
achieved the US Patent(USP), and Baiyunshan                 one	 of	 the	 key	 researchers	 for	 Cephalosporin	 Oxazine	
Pharmaceutical	 will	 cooperate	 with	 the	 South	          Amidine,	 said	 ”Aided	 by	 relative	 supporting	 policies	 of	
China	Center	for	Innovative	Pharmaceutical,	a	non-          government, pharmaceutical companies have changed the
business	 scientific	 organization	 engaged	 in	 new	       disjunction of drugs R&D and market demand, and have
pharmaceuticals creation and public services, to            been	 taking	 more	 important	 role	 in	 innovation	 of	 new	
develop	this	new	drug,	revealed	Mr.	Chen,	General	          drugs as they are fully informed of market demand. ”
Manager	of	Guangzhou	Baiyunshan	Pharmaceutical	
Co., Ltd. (000522, one of the leading pharmaceutical         Mr.	 Chen	 also	 showed	 his	 confidence	 in	 the	 market	
manufacturer in Guangdong Province).                         prospect	 of	 this	 new	 drug.	 According	 to	 statistics	 from	
                                                             Chinese	Pharmaceutical	Association,	national	organization	
The	newly	developed	drug	enjoys	good	antibacterial	          of pharmaceutical professionals, total consumers of
activity	to	gram-positive	bacteria.	Mr.	Zhu,	Deputy	         cephalosporin in 22 major cities in China have reached
Director of Baiyunshan Pharmaceutical, said                  USD101.5	million	in	2008,	up	27.0%	compared	with	2007.	
”Cephalosporin	 Oxazine	 Amidine	 has	 an	 entirely	         Besides,	exemplified	by	cefathiamidine,	with	sales	revenue	
new	chemical	structure	which	is	obtained	through	            of	USD44.0	million	in	2009,	coupled	with	rich	experience	
molecular modification of cefathiamidine, and has            for	promotion	of	products,	Cephalosporin	Oxazine	Amidine	
shorter	half-life	and	less	toxicity	than	cefathiamidine,	    is	bound	to	win	good	prosperous	market	in	the	future.	
thus it enjoys good application prospect.”

Baiyunshan	 Pharmaceutical	 has	 been	 always	
attaching great importance to independent R&D
of	 drugs.	 Mr.	 Chen	 also	 viewed	 ”Independent	
intellectual property can strengthen company’s
core-competitiveness,	especially	for	pharmaceutical	
companies. Thus, the achievement of obtaining USP




CCM International Limited                                   11                                             www.cnchemicals.com
Biopharmaceuticals	China	News                                                                                            Vol. 1 Issue 1. 2010




 News	in	Brief

Sanofi	 -	 Aventis	 builds	 research	                                       Bayer Schering Pharma (China)
center in China                                                             upgrades
On	 April	 6th,	 Sanofi	 -	 Aventis	 Group	 (Sanofi	 -	 Aventis),	          Since this year, Bayer Schering Pharma (China) upgraded
the largest drug manufacturer in Europe, announced that                     to be a separate district and reported directly to
it	 would	 set	 up	 its	 R	 &	 D	 centers	 of	 Asia	 Pacific	 in	 China	    headquarters.	It	will	invest	USD132.92	million	to	global	R	
to accelerate the development of drugs and therapies                        &	D	center	in	Beijing	in	next	5	years	and	launch	four	new	
innovation.	The	R&D	will	radiate	regions	including	Japan,	                  varieties to speed up the exploitation of Chinese market. It
Russia and India.                                                           achieved USD704.53 million sales revenue last year, up by
                                                                            28%	year	on	year.

N o v a r t i s 	 ( C h i n a ) 	 p u b l i c i z e s	
diabetes treatment breakthrough                                             Biopharmaceutical output value
                                                                            in Jiangsu to exceed USD73
On	April	21st,	Novartis	(China)	and	the	Ministry	of	Health	                 billion in 2012
joined hands to issue the largest diabetes treatment
breakthrough	 on	 "Second	 Sino-US	 high-level	 exchange	 of	               Recently, Science and Technology Department of
Cardiovascular Summit" held in Shanghai. The breakthrough                   Jiangsu Province published Development Plan of
of	NAVIGATOR	attract	great	concern	from	cardiovascular	                     New	 Biotechnology	 and	 Pharmaceutical	 Industry	 in	
experts,	since	it	showed	that	RAS	inhibitors	Valsartan	can	                 Jiangsu	 Province	 (2009	 ~	 2012).	 The	 plan	 shows	 that	
effectively	prevent	diabetes	occurrence	for	pre-diabetes.                   Biopharmaceutical	 output	 value	 in	 Jiangsu	 will	 exceed	
                                                                            USD73	 billion	 in	 2012	 compared	 with	 USD29	 billion	

Fosun’s	net	profit	up	91.3%	in	Q1	                                          currently	and	it	will	push	Jiangsu	to	be	the	most	active	area	
                                                                            of	new	biotechnology	and	pharmaceutical	industry	all	over	
2010                                                                        the	world.

On	April	29th,	Fosun	Pharmaceutical	(Fosun)	announced	its	
first	Quarter	Report	in	2010,	according	to	which	its	revenue	
increased	 by	 27.34%	 and	 net	 profit	 by	 91.3%	 aided	 by	
excellent performance of key pharmaceutical business, and
benefit	from	stock	transfer.	




CCM International Limited                                                  12                                           www.cnchemicals.com
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Biopharmaceuticals China News Sample - Published by CCM International Ltd

  • 1. Biopharmaceuticals China News Vol.1 Issue 1. 2010 Copyright © CCM International Limited
  • 2. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 Publication date: 4 May, 2010 CONTENTS Investment Focus 1 Potential investment opportunity in China’s vaccine industry 2 Resources (holding) integrates Beijing Pharmaceutical Group Govermental Policies 3 Updated Pricing Drug List by NDRC comes into force 3 Procurement and Distribution Rules of Essential Drugs to issue in 2010 Market Dynamics 4 Hualan’s net profit soars 229.10% in 2009 5 Huge potential in China’s diabetes treatment market 7 China Securities Pharmaceutical Index hits record high 7 Total output of Ceftriaxone Sodium hit a record high in 2009 9 Beijing OriGene won USD16 million venture capital 9 Lilly’s Multi-Drug Resistant Tuberculosis Plan in China 10 Hepalink ratified to be listed Technology & New Product 11 Cephalosporin Oxazine Amidine produced by Baiyunshan Pharmaceutical obtains USP News in Brief 12 Sanofi - Aventis builds research center in China 12 Novartis (China) publicizes diabetes treatment breakthrough 12 Fosun’s net profit up 91.3% in Q1 2010 12 Bayer Schering Pharma (China) upgrades 12 Biopharmaceutical output value in Jiangsu to exceed USD73 billion in 2012 Welcome to the April issue vaccine producer in China, achieved net of Biopharmaceuticals China profit growth of USD89.1 million, up News, specially published by 229.40% year on year. CCM International. In order to guide health and sustainable development of China’s pharmaceutical Despite of global financial crisis industry, Chinese government successively which resulted in negative issued related policies, such as Pricing effect on most industries in the Drug List by National Development and world, China’s pharmaceutical Reform Commission, Procurement and industry witnessed sound Distribution Rules of Essential Drugs, development in 2009, thanks to etc. These policies are bound to facilitate implementation of nationwide the progress of pharmaceutical industry, Health Care Reform. Some especially biopharmaceutical industry. biopharmaceutical enterprises China’s pharmaceutical industry will achieved splendid performance continue its development momentum and in 2009, such as Hualan boom in the following several years. Biological Engineering Inc., the largest blood product and
  • 3. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 Publication date: 4 May, 2010 Biopharmaceutical China News at a glance ■ The confidence bankruptcy toward China’s vaccine safety after a series of incidents broke out in recent months provided great potential investment opportunity for foreign pharmaceutical companies in China’s vaccine industry. ■ Cooperated with Beijing government, Recources(holding) integrated pharmaceutical asset of Beijing Pharmaceutical Group Co., Ltd. on Apr. 2nd, 2010. ■ The updated Pricing Drug List by Development and Reform Commission came into force on Apr. 1st , 2010. ■ Stipulations for Procurement and Distribution of Essential Drugs in China will be issued in 2010. ■ Hualan realized net profit growth of 229.40% in 2009, mainly aided by increased plasma dosage in blood products and rising demand for vaccine in Q3 2009. ■ Huge potential market exists in China’s diabetes treatment market as China has the largest numbers of diabetes patients throughout the world. ■ Aided by excellent performance of biopharmaceutical companies, China Securities Pharmaceutical Index, on Apr. 12th, 2010, hit record high, close to 6125.0. ■ Export quantity and price of Ceftriaxone Sodium has hit a record high since 2008, thanks to thriving clinical demand, improving of total CS output and intensifying the efforts on oversea markets exploitation. ■ On Mar. 17th, 2010, Beijing OriGene won USD16 million venture capital for its TrueMABTM project. ■ Cooperating with Zhejiang Hisun, Lilly started to implement its global MDR-TB plan in China on Mar. 23rd, 2010. ■ In Apr. 2010, Hepalink has been formally ratified to be listed by China Securities Regulatory Commission. ■ On Apr. 11th, 2010, Cephalosporin Oxazine Amidine developed by Baiyunshan Pharmaceutical successfully obtained USP. Main companies mentioned in this issue
  • 4. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 Investment Focus In Nov. 2009, Novartis Pharmacy Ltd., the second largest flu vaccine producer in the world, also entered Chinese vaccine industry by expending USD124.63 million to purchase 85 Potential investment opportunity % stocks of Zhejiang Tianyuan Bio Pharmaceutical Co., Ltd. in China’s vaccine industry (Tianyuan), the second largest flu vaccine supplier in China. ’ At present, China is the third largest pharmaceutical market in the world. In the future, Novartis will provide Tianyuan vaccine The confidence bankruptcy toward China’s vaccine technology including technology of influenza vaccine, rabies safety after a series of incidents broke out in recent vaccine, etc., for the purpose of Novartis’s vaccine production months provided great potential investment localization, and Novartis’s strategic target is to become a leader opportunity for foreign pharmaceutical companies in the fast-growing vaccine industry in China.’ said Mr. Vasella, in China’s vaccine industry. For instance, nearly CEO of Novartis in Nov. 2009. 100 children in Shanxi Province died from the unqualified vaccine injected; another case is that The above-mentioned facts indicate that investment restriction unqualified vaccine produced by Jiangsu Ealong for foreign pharmaceutical companies in China’s vaccine Biotech. Co., Ltd., the first vaccine producer in industry have been gradually relaxed, and policy barriers Jiangsu Province, flooded in Jiangsu’s vaccine restraining foreign pharmaceutical companies to enter China’s market. vaccine industry will be eliminated step by step. These incidents result in the absence confidence Notes: of Chinese people towards homemade vaccine Vaccine basics refer to vaccines supplied by Chinese safety and governmental credibility, and quality government for free, including: assured vaccines are urgently needed in China. 1.Vaccines belong to the catalogue of National Immunization Thus, foreign pharmaceutical companies, with Program. the advantage of superior technology, won the 2.Extra vaccines when provinces, autonomous regions and potential investment opportunities in China’s municipalities implement the National Immunization Program. vaccine industry, such as exporting qualified 3.Vaccines used for emergent vaccination or mass preventive vaccines to China, cooperating with domestic vaccination organized by government at or above the county pharmaceutical producers by providing level or relevant administrative department in charge of technology, etc. health. In the future, vaccine basics market which was monopolized by state-owned enterprises is likely to be co-shared by foreign pharmaceutical companies, such as some foreign pharmaceutical companies have invested into BCG vaccine and Polio vaccine which belong to catalogue of China’s immunization programs, according to the revised industrial Catalog Guiding Foreign Investment in 2007. Related Market Report this Month: C h i n e s e g o v e r n m e n t h a s a l l o w e d f o r e i g n Future of Red Biotechnology in pharmaceutical companies to co-invest with China domestic vaccine producers in China’s vaccine industry. In Sep. 2009, Glaxo Smith Kline, the second largest pharmaceutical company in A comprehensive industry report with 178 the world, cooperated with Jiangsu Watoson pages, please click the title to see the main Biotechnology Ltd. which focuses on human content and sample pages. vaccine R&D, production and sales in China, to have invested USD53.97 million in China’s children To purchase or need more details, please vaccine industry and established a joint venture in contact us at econtact@cnchemicals.com China, with Glaxo Smith Kline holding 65% stocks. According to the investment plan, the plant will manufacture measles-rubella-mumps combined vaccines, a kind of children vaccine, which fall into the catalogue of National Vaccination Program, as well as other children’s vaccine. CCM International Limited 1 www.cnchemicals.com
  • 5. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 Resources (holding) integrates Beijing Pharmaceutical Group On Apr. 2nd, 2010, cooperated with the Beijing Resources Medications’s target of this integration is to government, China Resources (holding) Co., Ltd. set up platform for pharmaceutical enterprises under Resources(holding), one of the leading conglomerates direct jurisdiction of central government. And after this in Hong Kong and Chinese Mainland, integrated asset reorganization, Beijing Pharmaceutical Group will pharmaceutical assets of Beijing Pharmaceutical Group get listed in overall. Co., Ltd.( Beijing Pharmaceutical Group) (PICTURE 1). Resources Medications will form a complete industry The integration will be implemented by China Resources chain of pharmaceutical industry covering Chinese Medications Group Co., Ltd. (Resources Medications), a medicine, chemical medicine, biopharmaceutical, subsidiary of Resources (holding). After the integration, medical equipment and pharmaceutical business, which Beijing government will hold 30% stocks of the will largely heighten its position in pharmaceutical integrated company, and Resources (holding) will industry. Resources Medications has achieved total relocate the headquarter of Resources Medications, revenue of USD4.94 billion in 2009, and become the used to be in Shenzhen, to Beijing. second largest pharmaceutical company in China. Resources (holding) and Beijing government signed a Resources Medications is a wholly-owned subsidiary of strategic cooperation framework agreement regarding Resources (holding), engaged in Resources (holding)’s pharmaceutical and microelectronics sectors. According domestic pharmaceutical business, with total assets to this agreement, Resources (holding)’s investment into of around USD3.81 billion and turnover of USD3.96 pharmaceutical industry in Beijing will be encouraged billion in 2009. Beijing Pharmaceutical Group, with and supported by Beijing government, such as enjoying total turnover of USD3.9 billion in 2009, is a wholly- reduction and exemption of taxes, financial assistance, owned company of Beijing government. It has about etc., and Beijing government will also facilitate 20 subsidiaries, among which Wandong Medical Resources (holding)’s integration of biopharmaceutical Equipment and Beijing Double-Crane Pharmaceutical resources in order to found a leading pharmaceutical are listed in Shanghai and Shenzhen Stock Exchange. enterprise in Beijing. Through cooperation with Resources (holding), Beijing government will further promote the development of pharmaceutical industry.” said Mr. Guo Jinlong, Mayor of Beijing on the signing ceremony. PICTURE 1: Signing ceremony of Beijing government and Resources (holding) Source: http://info.crc.com.cn/internet/news/xwfbny/201004/ t20100403_111966.htm CCM International Limited 2 www.cnchemicals.com
  • 6. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 Govermental Policies referential price. That is to say, in the reimbursement of drugs, the price of prescription drugs was constituted by the National Development and Reform Commission, and Updated Pricing Drug List by drugs with government referential price were referred to retail price by local government, according to actual local NDRC comes into force condition. To OTC drugs, local government constitute retail price, according to actual local condition. The updated Pricing Drug List by National Development and Reform Commission NDRC came into force on Apr. 1st, 2010, indicating that Chinese government will further strengthen management and supervision of prescription drugs prices and decentralize more pricing power to local government, in order to achieve standardization in drugs market and rational pricing authority division. Procurement and Distribution Rules of Essential Drugs to issue in 2010 According to the new List, all prescription drugs in the Socialized Medicine Catalog published in 2009 and all national essential On Apr. 8th, 2010, the forum on how to actively drugs are added into Pricing Drug List. Besides, prices of manage the procurement and distribution of narcotic drugs and psychotropic substances in Pricing Drug List essential drugs after the issuance of National are guided by with the highest ex-factory price and their highest Basic Medicine System was held in Beijing, in retail price, instead of government referential price in previous which rule for procurement and distribution of time. essential drugs in China to be issued in 2010 was informed, indicating that as some relative Under the background of publishment of On Establishment of policies and stipulations perfect, production Implementation Advices of National Essential Drugs System and supply of basic drugs will be more in Aug. 2009, NDRC upgrades the Pricing Drug List issued in reasonable and scientific under governmental 2005. The new List will exert influence on drug pricing, market management. behavior, etc. of related pharmaceutical enterprises. Some experts air their own opinions on this upgraded List. A c c o r d i n g t o M r . Z h e n g , D i r e c t o r o f Department of Essential Drug of the Ministry “Though main prescription drugs with patent protection of Health, by the end of Feb. 2010, there have belong to multinational companies, their patent protection been about 30% primary care institutions will have expired one after another by 2013, which will leave implementing National Basic Medicine great development opportunity for domestic prescription System, and the proportion is expected to drugs producers. Thus, in order to effectively guide China’s climb to more than 60% in 2010. During the pharmaceutical industry’s health development, NDRC upgrades implementation of National Basic Medicine Pricing Drug List.” disclosed by a director from a multinational System for about one year, various defects like enterprise in Shanghai. skimble - scamble price of drugs, commercial bribe, etc., have been exposed. Thus, it is “In the light of this policy, there are 556 kinds of over-the- necessary and urgent to constitute a unified counter drugs priced by provinces, autonomous regions and standard for procurement and distribution of municipalities pricing departments, implying that Chinese essential drugs government will decentralize more pricing power to local government.” disclosed by an insider in Apr. 2010. Regarding how to effectively implement the rule, some experts air their views on this Wangming, Manager of Guangzhou Pharmaceutical Holdings forum. Mr. Liao, Deputy Director of Health Ltd. said “After the updated Pricing Drug List came into force, Department of Sichuan Province, said, “In poor pharmaceutical companies may show more concern on how to regions like Sichuan Province, government win a preponderant price in the process of drug tender. “ should permit relevant qualified companies to participate in distribution, in order to ensure Note: availability of essential drugs.” The Pricing Drug List issued in 2005 by National Development and Reform Commission showed that the pricing drugs were divided into following two categories: part of drugs are priced by the government; the rest are guided by government CCM International Limited 3 www.cnchemicals.com
  • 7. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 Mr. Niu Zhengqian, Deputy Secretary of Chinese Medicine Entrepreneur Association, viewed “We should take market mechanism into full play; and let hospitals, manufacturers and distribution companies be engaged in free competition; only by this way can the rule of procurement and distribution of essential drugs take greater effect and bring more benefits.”. “After the National Basic Medicine System has been implemented, government should constitute a national unified standard for procurement and distribution of essential drugs, in order to avoid the commercial bribe in the tender process.” said Li Zhenjiang, Chairman of Shineway Pharmaceutical Group, the largest manufacturer of modern Chinese medicine injections, soft capsules and granules. Regarding how to carry out this rule, CCM also put forward some suggestions. Firstly, there should be a complete, objective and fair standard system for drugs tender; secondly, government should establish reasonable entrance thresholds for pharmaceutical industry in order to guarantee drugs quality; thirdly, as for pricing, combination of market mechanism and governmental supervision should be made in the whole tender process and enterprises should be given more rights, such as how to distribute drugs, etc. doses vaccine for national H1N1 storage task, among Market Dynamics which 29.46 million have been shipped to the locations designated by government, and the rest will be released before the end of this year. In the future, it will accelerate Hualan’s net profit soars 229.10% the process of overseas registration for H1N1 bacteria and in 2009 seasonal influenza vaccines so as to further enhance its vaccine business (TABLE 1). Development of blood products business also contributed According to annual report for fiscal year 2009 on Mar. to the net profit growth. The company achieved revenue 9th, 2009, Hualan Biological Engineering Inc. (Hualan), of USD74.19 million from blood products, with gross the largest blood product and vaccine producer in China profit rate of 63.63% in 2009, respectively up 26.09% and with capacity of 1,500t/a for plasma processing and 29.74 4.88% against 2008. Revenues from human albumin, million doses per year for vaccine, achieved net profit intravenous immunoglobulin (IVIG) and other blood growth of 229.40%, thanks to significantly increased plasma dosage in blood products, and rising demand for vaccine in Q3 2009. TABLE 1: Hualan’s business situation, 2008 & 2009 Though under the context of global financial crisis, Hualan 2009 2008 still made considerable achievements in 2009. Value, Value, . million Up YOY, million Up The achievement firstly sourced from vaccine, which was Item USD % USD YOY, % needed with large numbers when influenza suddenly Revenue 178.00 160.39 68.00 48.25 happened in Q3 2009. Revenue from vaccine realized Net profit 89.00 229.40 27.00 70.35 USD104.52 million in 2009, up 887.84% over 2008. Besides, the company is responsible for 52.25 million Source: Annual report of Hualan in 2009 CCM International Limited 4 www.cnchemicals.com
  • 8. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 products reached USD38.56 million, USD21.11 million, USD14.51 million, up 15.53%, 10.74% and 127.27% FIGURE 1: Hualan’s stock performance, Jan. 2006 ~ Apr. 2010 separately over 2008. Taking the rising market demand for IVIG into consideration, the National Development and Reform Commission raised IVIG price, thus revenue from IVIG increased, and revenue proportion of human serum albumin declined accordingly in blood products. This structure optimization is helpful for improvement of plasma utilization rate and gross profit rate of blood products (FIGURE 1). Hualan is estimated to get sound development in 2010, as a series of vaccines such as seasonal influenza vaccine, � hansenula hepatitis B vaccine, etc. will be put into market this year. Additionally, aided by the increased plasma dosage, couple with the price increase of IVIG from USD60.41/dose to USD87.97/dose in Shanghai, which is also likely to increase in other regions of China, the company’s net profit is estimated to rise by 30%~50% year on year. The company’s much better performance in stock market is a strong proof for its fastest development in recent years. Source: google finance Note: SCI refers to Shanghai Composite Index Huge potential in China’s diabetes treatment market China, with more than 92 million adult diabetes and about 150 diabetes market, Novo Nordisk, the largest human insulin million potential diabetes, has the largest numbers of diabetes producer in the world, input USD381 million to establish the patients in the world, according to New England Journal of world’s largest insulin preparation and bottling plant in China at Medicine in Mar. 2010, in which new medical research findings, the end of 2008, which is the largest investment for the company review articles, and editorial opinion on a wide variety of topics after its foundation for 80 years. At present, Novo Nordisk seizes of importance to biomedical science and clinical practice are above 60% market share of human insulin in China. published. Besides, total direct medical expenditure of diabetes (male and female diabetes patients with age of over 20 in China) Another case is Sanofi-Aventis, a diversified healthcare company and its complications has reached USD2.8 billion and it will in the world. To further enlarge its market share in China, it witness uptrend in the future, disclosed in the High Blood Sugar announced in Apr. 2009 that it would invest USD87.9 million to Diabetes Forum sponsored by USA Abbott Laboratories in Apr. expand its Lantus pre-filling production line in its insulin factory 2010. in Beijing Economic and Technological Development Zone, which is expected to be launched in 2012. By then the company’s Lantus This shows that huge potential exists in China’s diabetes treatment capacity will reach 50 million units per year. market. Some multinational pharmaceutical enterprises, like Novo Nordisk, Eli Lilly and Sanofi-Avetis have captured about At present, domestic approved antidiabetic drugs mainly refer 90% market share of China’s diabetes treatment market of top to insulin secretion (glinides and sulphonylurea), non-insulin first class hospitals. And they have enlarged or will enlarge their secretion (biguanides, α-glucosidase inhibitor and glitazones) investments in this field in China. and human insulin. What is the situation of prescription status of For instance, in order to consolidate its leadership in China’s patients with diabetes in main hospitals of China’s medium and CCM International Limited 5 www.cnchemicals.com
  • 9. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 large cities? (FIGURE 2) Medicines. However, in the class of α-glucosidase inhibitor, Acarbose In the light of a market research study, surveying diabetes produced by Germany Bayer Group captures about 30% prescription status in main hospitals of China’s medium and prescription share, aided by its being under patent protection large cities with 4500 prescriptions of patients with diabetes status and successful promotion in diabetes treatment field. by Cegedim Strategic Data, a leading market research company dedicated to the healthcare industry, in Mar. 2010, in the field of In the field of injective drugs treating diabetes, human insulin oral drugs treating diabetes, the class of Biguanide, accounting for occupies about 38.6% prescription share. Key products of Novolin 37.6% prescription share, is still the most widely used antidiabetic 30R of Novo Nordisk in Demark takes up 12.3% prescription drug for diabetes treatment, and recommended as first-line drug share. for diabetes treatment and listed in Catalogue of National Basic FIGURE 2: Structure of prescription share by different classes and brands of diabetes drugs in 2009 Biguanide α-glucosidase inhibitor Sulphonylurea Others 4.90% Others 1.10% Premix human insulin Others 8.10% Intermediate-efficacy human insulin Glimepiride Metformin 4.50% Others 22.50% 5.80% Long- Glinides Acarbose Short-acting acting Diamicron 29.40% human insulin human 8.30% Glitazones Humulin70/30 insulin 6.10% Glinides and Others1.50% Biguanides Glipizide Repaglinide Metformin Others Others 9.30% Others Novolin 30R 7.50% Hydrochloride 6.10% 2.40% Others 1.50% 12.30% 10.20% 0.40% Kaboping Gliquidone Avandia Novolin R Novolin N Lantus Nateglinide 4.10% 3.50% 4.10% Avandamet 3.80% 3.30% 2.90% 3.40% 0.20% Distribution of prescription share 12.4% 37.6% 34.6% 33.7% 10.2% 0.2% 6.4% 4.8% 24.1% 3.3% s Source: Cegedim Strategic Data CCM International Limited 6 www.cnchemicals.com
  • 10. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 China Securities Pharmaceutical Index hits record high A i d e d b y e x c e l l e n t p e r f o r m a n c e o f biopharmaceutical companies, China Securities Figure: CSPI and SSECI performance, Jan. 2009 ~ Apr. 2010 Pharmaceutical Index (CSPI, 399933) has been performing strongly since early 2010, and hit record high of 6125.0 on Apr. 12th, 2010. As of Apr. 7th, 2010, 88 BC have released their fiscal 2009 annual reports in succession, and achieved total net profit of USD231.95 million, up 67.58% compared with 2008, mainly thanks to sound development and promising prosperity in this industry, reform of Health Care system, issuance of the Catalog of National Basic Drugs, reorganized assets of BC, etc. It is aided by the excellent performance of biopharmaceutical companies that CSPI has become the strongest securities industry index in Source: Baidu Finance China. On Apr. 12th, Shanghai Stock Exchange Composite Index (SSECI) performed downtrend, while CSPI hit the historically high level and closed at points of 6125.0. As of that day, CSPI has continuously advanced for 11 market days, reflecting the promising prosperity in this industry (FIGURE 3). Total output of Ceftriaxone Sodium When CSPI reached record high, many hit a record high in 2009 pharmaceutical stocks’ price also jumped to a new high point. Apart from the pharmaceutical Total output of Ceftriaxone Sodium, the third generation cephalosporin stocks listed this year, 45 pharmaceutical stocks and a broad-spectrum cephalosporin with a long plasma elimination have hit record high since early 2010, accounting half-life of approximately 8 hours in normal adults, hit a record high for 32.85% of the total comparable stocks. And 12 in 2009 reaching 3768 tonnes in 2009, up 29% year on year, thanks to pharmaceutical stocks have achieved the highest thriving clinical demand, significantly increasing number of producers since Apr. 2010, such as Shanghai RAAS, Jiangsu of Ceftriaxone Sodium and their efforts to intensify exploitation of Yuyue, Pkucare Southwest Pharmaceuticals, etc. overseas market. Besides, the export price of Ceftriaxone Sodium reached USD127.3/kg in Feb. 2010, up 35.8% compared with that in May. 2009. Eyeing this excellent performance of BC, institutional investors significantly increased their Clinical demand of Ceftriaxone Sodium is growing steadily along with BC stocks. As of Q4 2009, their total BC stocks the development of primary care. According to a report issued by China reached 3.20 billion shares, up 70.6% over that Association of Pharmaceutical Commerce (CAPC) in Apr. 2010, the as of Q3 2009, indicating their optimism towards expenditure of Ceftriaxone Sodium in hospitals of 22 major cities in biopharmaceutical industry. China was USD39 million, up 35.1% compared with that in 2007, and its market share has achieved 42% in China’s cephalosporin market in 2009, Notes: up 11.5% compared with that in 2004. Besides, as to the annual growth CSPI is an index to reflect the overall performance rate over the past few years, only Ceftriaxone Sodium has achieved 106% of biopharmaceutical stocks in Shanghai and compared with other cephalosporins like Cefazolin Sodium, Cefotaxime Shenzhen stock markets, which is indexed with Sodium, Cefoperazone Sodium, Cefurozime Sodium. As an act of the all biopharmaceutical shares by China Securities reform of health-care in 2009, Chinese government will invest USD124.6 Index Co., Ltd., a professional company billion to improve primary care over the next three years. Therefore, it is specializing in creation and management of expected that the clinical demand of Ceftriaxone Sodium will continue this indices and index-related services. uptrend in the future. CCM International Limited 7 www.cnchemicals.com
  • 11. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 In the past few years, total number of Ceftriaxone Sodium a total value of USD236 million to Russia and Belarus, whose producers significantly increased. According to a report cephalosporin production technology lags behind (FIGURE 4). issued by CAPC in Apr. 2010, the number of total producers of Ceftriaxone Sodium was 3 in the early stage but reached However, there are some uncertainties for Ceftriaxone Sodium 36 at end of 2009. Meanwhile, main producers like Shanxi exports in the future. In Oct. 2008, the Ministry of Commerce Weiqida Pharmaceutical Co., Ltd., Shanghai Asia Pioneer and Industry of India formally determined that the export of Pharmaceutical Co., Ltd., etc., captured about 80% total Ceftriaxone Sodium to India from China was dumping, and the capacity of Ceftriaxone Sodium in China. Indian government levied 108%~120% anti-dumping duties on Ceftriaxone Sodium imported from China. Thus, many Ceftriaxone Sodium producers have been intensifying Chinese Ceftriaxone Sodium exporters are forced to withdraw exploitation of overseas market. In the past few years, form Indian market. Besides, some member countries in the export of Ceftriaxone Sodium has been amounted to European Commission like Italy and Spain begin to investigate 30%~40% of its total capacity, which achieved 899 tonnes in the dumping cases of Chinese Ceftriaxone Sodium, disclosed 2009, up 14.1% year on year. India, South Korea, Europe, and by some insiders in China. Southeast Asia are the major export destinations. Since 2007, Ceftriaxone Sodium producers has exported cephalosporin including Ceftriaxone Sodium, cefoperazone, etc., achieving FIGURE 4: Export volume and export growth rate of Ceftriaxone Sodium, 2007~2009 1,000 25.00% 899 900 788 800 19.33% 19.76% 20.00% 700 658 600 15.00% 14.09% tonne 500 400 10.00% 300 200 5.00% 100 - 0.00% 2007 2008 2009 Export Quantity Export Grow th Rate Source: China Customs CCM International Limited 8 www.cnchemicals.com
  • 12. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 Beijing OriGene won USD16 Beijing OriGene Technologies, Inc. is a gene centric life sciences tool company dedicated to support academic, million venture capital pharmaceutical and biotech companies in their research of gene functions and drug discovery. OriGene’s novel On Mar. 17th, 2010, Beijing OriGene Technologies, product line includes the world’s largest cDNA and shRNA Inc.(Beijing OriGene) announced it has won clone collection, over 5,000 purified human proteins, high USD16 million Series B venture capital from IDG- quality monoclonal antibodies, 100,000 highly validated Accel, SBI & TH Venture Capital Management human tissues, and Lumines Multiplex Assay products. Co., Ltd., and Zero2IPO Capital, and its previous OriGene also provides a broad range of antibody validation investors, Morningside Venture Investments and products including genome-wide tagged antigen standards President International Development Corp. also and extensive IHC slides derived from the company’s tissue participated. The venture capital will be mainly used collection. to continuously build the largest collection of next generation monoclonal antibodies (TrueMABTM) covering the majority of human proteome in the world. “This capital will facilitate the accomplishment of building the largest monoclonal antibody collection in the world covering the entire human genome of approximately 20,000 genes.” said Mr. He, Beijing L i l l y ’ s M u l t i - D r u g R e s i s t a n t OriGene’s Chairman and CEO. Tuberculosis Plan in China Beijing OriGene has dedicated to build the largest Cooperating with Zhejiang Hisun Pharmaceutical Co., collection of human full-length cDNA clones since Ltd. (Zhejiang Hisun), a well-known anti-infection last decade. The project will be developed with the pharmaceutical enterprise in China, Eli Lilly Company (Lilly) most up-to-date antibody technologies and will in the US, a global R&D-based pharmaceutical company, be using authentic human full-length proteins as started to implement its global multi-drug resistant immunogens during the manufacturering process. tuberculosis plan (MDR-TB) in China on Mar. 23rd, 2010. TrueMABTM monoclonal antibodies are currently This MDR-TB project exists to save lives by preventing available in the market and will be utilized by and treating MDR-TB – a terrible disease that afflicts commercial partners for various applications millions of people in some poor regions throughout the like flow cytometry and Multiples enzyme-linked world. According to Mr. Lai, Lilly’s CEO in China, Lily has immunosorbent assays. It was estimated by some cooperated with Zhejiang Hisun by transferring technology insiders that as of 2020, there will be about 3,000 of capreomycin for free, training relevant technicians, as kinds of new drugs produced by biopharmaceutical well as proving ample funds, besides, in order to effectively technology, and gross output value of drugs produced control the spread of MDR-TB, the company will also carry by biotechnology will reach USD396 billion, out a series of health education, such as training medical disclosed by Liu Yanhua, Undersecretary of Ministry personnel, popularizing prevention knowledge, etc. of Science and Technology in Jun. 2007. Therefore, the promising prospect of biopharmaceutical Lily has successfully transferred a series of production industry attracts venture investors’ capital. technology of capreomycin to Hisun till now, and Hisun has launched capreomycin production line for this project with According to statistic from Zero2IPO, an information total capacity of 5 million doses/year. and consultation for venture capital (VC) and private equity (PE), in 2009, there were total 49 cases of VC By far, Lilly has invested USD135 million for this MDR- and PE to have been invested in the pharmaceutical TB project. In Jan. 2010, contributed by this project, industry with total investment of USD320 million, Lilly won “2009 Multinational Corporations in China among which 31 cases are invested into development Contribution Award “. “This award future indicates the long- and expansion of pharmaceutical companies. “It term commitment for preventing and treating tuberculosis is estimated that in 2010, investors of VC and PE in China, especially for MDR-TB,” said Mr. Eric Baclet, will be further active in pharmaceutical industry.” Regional CEO of Lilly in China in Jan. 2010. said Zhengyufen, senior project manager of medical health department in Zero2IPO. MDR-TB prevention and treatment is austere in China. According to a report issued by Chinese Ministry of Health, Note: CCM International Limited 9 www.cnchemicals.com
  • 13. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 there were about 4.5 million patients with active tuberculosis in China as of Mar. 2009, 80% of which were in rural areas. Besides, according to a WHO research in 2006, about 130,000 new MDR-TB patients increase annually in China, accounting for 28% of the world’s total newly MDR-TB patients. At the same time, high treatment expenditure for MDR-TB, usually 100 times higher than that for normal tuberculosis, also restricts patients’ treatment. Great concern for treatment of MDR-TB has been shown in China, where symptoms suspicious of tuberculosis are checked, and a unified free treatment for free program for patients diagnosed is also provided. During the year 2001 to 2008, there were 642,000 MDR-TB patients healed. Capreomycin is mainly applied for mycobacterium-caused tuberculosis patients who aren’t healed with first-line anti-drugs such as streptomycin, isoniazid, rifampicin and ethambuto, etc., and for the patients who are not applicable to the above mentioned first- line anti-drugs, attributed to toxicity or bacteria resistance. It will be acquired bacterial resistance when used separately, thus only with combination of antibacterial drugs can it cure TB. superiority in R&D and production. At present, it has become the largest heparins Hepalink ratified to be sodium’s API production and sale enterprise in the world. According to statistics from listed China Customs in 2009, Jan. 2009 ~ Sep. 2009, Hepalink’s export value reached USD175.8 million, accounting for 39.5% of national total export value of this product. In Apr. 2010, Shenzhen Hepalink Pharmaceutical Co., Ltd. (Hepalink), Currently, supply of heparins sodium’s API falls short of demand and inadequate the biggest supplier of heparins capacity has become the bottleneck for its further development in future. The launch of s o d i u m ’ s A c t i v e P h a r m a c e u t i c a l this new production line will effectively solve this problem, disclosed by insider in Apr. Ingredients API in the world, has 2010. been formally ratified to be listed in Shenzhen Stock Exchange by China After it is listed in Shengzhen Stock Exchange, stock holder of the company will benefit Securities Regulatory commission. a lot. Lili and Litan couple, Hepalink’s facto controller holding 288.0 million Hepalink’s stock shares, will become the richest person in Chinese mainland valuing USD6.3 The company will issue 40.1 million billion. And stock value of Goldman Sachs, a full-service global investment banking and stocks, with about USD21.7 per share, securities firm, who invested USD 4.9 million to Hepalink in 2007, and holding 12.5% to raise about USD869.5 million, stocks of the company, will reach USD966.2 million, 93 times of its initial investment. among which about USD70.8 million will be used for its new heparins According to Hapalin’s Prospectus issued in Apr. 2010, it is estimated that as of 2010, sodium’s API production lines with demand for heparins sodium’s API will reach 6142 tonnes, achieving a CAGR of 10.2% capacity of 830t/a, and about USD56.2 year on year. million will be used as floating capital of this project. The products of this new However, Hepalink may also face some uncertainties in future. Its profit margin production line are in accordance with will decline in the future, since the production cost of raw material of heparins authentication standards of U.S. Food sodium’s API, which accounts for 85% production cost, may increase in the future, and Drug Administration (FDA) and while heparins sodium’s API price will decline due to the expanded capacity of other Certificate of Suitability for European companies in recent years (TABLE 2). Pharmacopeia (CEP). Hepalink has been developing rapidly since 2007. In 2009, its revenue and TABLE 2: Hepalink’s heparins sodium’s API export value, Jan. 2006~Sep. 2009 net profit reached USD32.8 million Hepalink’s export and USD11.9 million, respectively up Year Total export value value Market share 411.2% and 387.8% year on year. Its   (million USD) (million USD) (%) revenue and net profit respectively Jan. 2009~Sep. 2009   444.2 175.8 39.5 realized a CAGR of 172.6% and 244.5% from 2007 to 2009. 2008 226.1 63.5 28.1 2007 137.5 27.6 20.1 The company’s rapid achievement 2006 103.3 29.4 28.5 is mainly thanks to its technical Market share=Hepalin’s export value/total export value Source: Hapalin’s Prospectus issued in Apr. 2010 CCM International Limited 10 www.cnchemicals.com
  • 14. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 of Cephalosporin Oxazine Amidine can further enhance Technology & New Product the company’s hi-tech innovation capability, which is in accordance with its strategy – patent first, distribution Cephalosporin Oxazine Amidine follows in overseas market. Through this way, Baiyunshan Pharmaceutical’s COA will participate in international produced by Baiyunshan competition.” Pharmaceutical obtains USP With accession to WTO, Chinese government has issued a On Apr. 11th, 2010, Cephalosporin Oxazine Amidine series of policies such as Measures for the Administration developed by Guangzhou Baiyunshan Pharmaceutical of Drug Registration, to support R&D of new drugs with Co., Ltd.( Baiyunshan Pharmaceutical) successfully independent intellectual property rights. Mr. Liu Xuebin, achieved the US Patent(USP), and Baiyunshan one of the key researchers for Cephalosporin Oxazine Pharmaceutical will cooperate with the South Amidine, said ”Aided by relative supporting policies of China Center for Innovative Pharmaceutical, a non- government, pharmaceutical companies have changed the business scientific organization engaged in new disjunction of drugs R&D and market demand, and have pharmaceuticals creation and public services, to been taking more important role in innovation of new develop this new drug, revealed Mr. Chen, General drugs as they are fully informed of market demand. ” Manager of Guangzhou Baiyunshan Pharmaceutical Co., Ltd. (000522, one of the leading pharmaceutical Mr. Chen also showed his confidence in the market manufacturer in Guangdong Province). prospect of this new drug. According to statistics from Chinese Pharmaceutical Association, national organization The newly developed drug enjoys good antibacterial of pharmaceutical professionals, total consumers of activity to gram-positive bacteria. Mr. Zhu, Deputy cephalosporin in 22 major cities in China have reached Director of Baiyunshan Pharmaceutical, said USD101.5 million in 2008, up 27.0% compared with 2007. ”Cephalosporin Oxazine Amidine has an entirely Besides, exemplified by cefathiamidine, with sales revenue new chemical structure which is obtained through of USD44.0 million in 2009, coupled with rich experience molecular modification of cefathiamidine, and has for promotion of products, Cephalosporin Oxazine Amidine shorter half-life and less toxicity than cefathiamidine, is bound to win good prosperous market in the future. thus it enjoys good application prospect.” Baiyunshan Pharmaceutical has been always attaching great importance to independent R&D of drugs. Mr. Chen also viewed ”Independent intellectual property can strengthen company’s core-competitiveness, especially for pharmaceutical companies. Thus, the achievement of obtaining USP CCM International Limited 11 www.cnchemicals.com
  • 15. Biopharmaceuticals China News Vol. 1 Issue 1. 2010 News in Brief Sanofi - Aventis builds research Bayer Schering Pharma (China) center in China upgrades On April 6th, Sanofi - Aventis Group (Sanofi - Aventis), Since this year, Bayer Schering Pharma (China) upgraded the largest drug manufacturer in Europe, announced that to be a separate district and reported directly to it would set up its R & D centers of Asia Pacific in China headquarters. It will invest USD132.92 million to global R to accelerate the development of drugs and therapies & D center in Beijing in next 5 years and launch four new innovation. The R&D will radiate regions including Japan, varieties to speed up the exploitation of Chinese market. It Russia and India. achieved USD704.53 million sales revenue last year, up by 28% year on year. N o v a r t i s ( C h i n a ) p u b l i c i z e s diabetes treatment breakthrough Biopharmaceutical output value in Jiangsu to exceed USD73 On April 21st, Novartis (China) and the Ministry of Health billion in 2012 joined hands to issue the largest diabetes treatment breakthrough on "Second Sino-US high-level exchange of Recently, Science and Technology Department of Cardiovascular Summit" held in Shanghai. The breakthrough Jiangsu Province published Development Plan of of NAVIGATOR attract great concern from cardiovascular New Biotechnology and Pharmaceutical Industry in experts, since it showed that RAS inhibitors Valsartan can Jiangsu Province (2009 ~ 2012). The plan shows that effectively prevent diabetes occurrence for pre-diabetes. Biopharmaceutical output value in Jiangsu will exceed USD73 billion in 2012 compared with USD29 billion Fosun’s net profit up 91.3% in Q1 currently and it will push Jiangsu to be the most active area of new biotechnology and pharmaceutical industry all over 2010 the world. On April 29th, Fosun Pharmaceutical (Fosun) announced its first Quarter Report in 2010, according to which its revenue increased by 27.34% and net profit by 91.3% aided by excellent performance of key pharmaceutical business, and benefit from stock transfer. CCM International Limited 12 www.cnchemicals.com
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