中國生物制藥報(bào)告

1、1 biopharmaceutical industry mar. 2009 oci in china and world wide briefs: nbiopharmaceutical enjoy a high growth rate world widely nbiotech is essential for drug innovation nchina has established favorable environment for biopharma firms nwith a solid and rapid progress chinas biofirms have prepare

2、d for making blockbusters 2 index nglobal biopharmaceutical status: market capacity and growth innovations, development cycle m&a deals nchina biopharmaceutical conditions: structure market capacity and growth driving forces & environment advancement weakness and opportunities nappendix 3 biotech gr

3、owth is much higher than traditional pharmaceuticals revenue: billion usd % growth global biotech sales and growth( us$) source: ims health, midas, mat dec 2007 global biotech market reached $75bn in 2007 4 number of nmes* first launched worldwide 1990-2006 source: cmr international nmes total biolo

4、gical nme is crucial for drug innovations *new molecular entities (nmes) 5 biotechnology approach target discovery and early validation lead discovery lead optimization transition to development development = 3- -5 years in discovery 3 years in development pharmacology biology chemistry traditional

5、approach development target discovery target validation lead discovery lead optimization transition to development 12 years13 years0.51 year24 years12 years = 612 years in discovery 3- -4 years in development nbiopharmaceutical ntraditional pharmaceutical biotechnology reduces drug discovery circle

6、time 6 autoimmune disorders blood disorders cancer/related conditions cardiovascular disease diabetes/related conditions digestive disorders eye conditions genetic disorders growth disorders hiv/aids infection/ related conditions infectious diseases neurologic disorders respiratory disorders skin di

7、sorders transplantation other biotechnology medicines trends in development (usa)* *some medicine are listed in more than one category by therapeutic category*by product category* total 633 biopharmaceuticals under clinical trail or wait for fda approval in year 2008 sources: phrma 2009 7 biotech do

8、minates 2008 pharma m&a deal making ntotal 150 deals announced worth usd 93.7 billion world wide in 2008 8 biopharmaceutical industry in china 9 chinas pharmaceutical industry source: datamonitor (% share, by value)share of biopharmaceutical in asia pacific 2007 10 china biopharma market value 2003-

9、2007 source: datamonitor revenue: million usd cagr:18.2% the market of chinas biopharmaceutical industry is gradually expanding duo to chinas rapid economic growth, peoples higher income, increasing understanding and demand of biopharmaceutical. growth % 11 china biotech industry in 2008 12 china bi

10、opharma market value forecast: 2007-2012 cagr:24.7% nanticipated cagr of 24.7% for the five-year period 2007-2012 source:datamonitor revenue: million usd growth % 13 driving forces for chinese biopharma industry nbig and profitable market more than 400 biogeneric manufacturers over 300 biopharmaceut

11、ical innovation firms chinese biotherapeutics enjoy a growth rate of 30% with high margin exported $ 478 million per year at a growth rate of 54% ngovernment encourages biologic innovator products biopharmaceutics has been included in priority list for national economic development chinas “863” and

12、other program funding promising r & d projects build biological high-tech park ip rights protection has been strengthened ncapital infusion the industry is witnessing a surge of mergers, acquisitions and partnerships between domestic and multinational big pharmas and small biopharmas. 14 advancement

13、 of chinese biotech firms the earliest traditional vaccine provider (cnbg) 1919 in 1989 china marketed its first genetically engineered drug: recombinant human interferon alpha 1b the first to complete clinical trail for a vaccine for sars and avain flu. commercialized the first gene therapy product

14、: rh- adeno p53 in 2004 has developed 30 biotech drugs, more than 150 biopharmaceuticals in pipeline include 35 innovative products at clinical trail stage launched the worlds first rh-endosatin (endu) for treatment of non-small-cell lung cancer over 40 new “class 1” biopharmaceuticals are expected

15、to complete clinical trails ntraditional vaccine & blood products: nfollow-on generics nr&d oriented: ndomestic blockbuster: ninternational blockbusters? 15 16 company namepipeline products tianjin fusogen pharma sifuvirtide, fusolin (hbv inhibitor), fusopin (hcv inhibitor) sinovac biotech. ltd. sar

16、s vaccine, pandemic influenza vaccine (human-used avian flu vaccine) shanghai sunway biotechh102,h103 beijing biotech pharma regf-p64k/mont vaccine, humanized anti- cd6 monoclonal antibody beijing sl pharmarh parathyroid hormone for injection wuhan institute of biological products monoclonal antibod

17、y against hemorrhagic fever for injection xiamen pku bioway biotechhwap-1, dx-hemoglobin guangzhou doublle bioproduct, inc. recombinant human endostatin adenovirus injection changchun bcht pharmaaids vaccine anhui gloden sun biochemtumor vaccine suzhou landing biopharma recombinant human pro-urokina

18、se for injection sample of innovative products in china biofirms pipeline 17 nsize: nfinancing: nr&d: nproduction: nmanagement and weakness of chinese biotfirms chinese biotech firms need to overcome many weaknesses: in general, chinese biotech firms are small most companies dont have sufficient fun

19、ds to foster intensive r&d and facility upgrades 90% of these firms focus on the development and production of follow-on biologics so far, no chinese biopharma has managed to obtain western gmp certifications or who prequalification many companies do not have managers with international managerial o

20、r marketing experience. marketing: 18 china biofirms collaborations and partnerships n2008年有限公司與賽富亞洲投資基金等共同向翰宇首期投入 深圳翰宇藥業(yè)深圳翰宇藥業(yè)1500 萬美元 從事多肽藥物的研究與開發(fā) 深圳翰宇正與teva、hospira、apotex、biocon、chemo、dksh 等知名 藥企展開合作 n2006年南京先聲南京先聲出資2億購買天津麥德津80%的股權(quán) 擁有了抗腫瘤i類生物藥 “恩度” 的專利權(quán) “恩度”2006年上市，07年銷售額超過2個(gè)億，08年估計(jì)6個(gè)億 （”恩度” 200

21、5年拿到生產(chǎn)許可證，南京先聲購買天津麥德津是在2006年接 觸到談判僅用了半年多，競標(biāo)企業(yè)估計(jì)50多個(gè)，包括淡馬錫） n2007年綠葉制藥綠葉制藥9940萬元收購維信北京大學(xué)生物科技公司43% 股權(quán) n2008年gsk出資3133萬美元與海王英特龍海王英特龍成立合資公司 從事創(chuàng)新疫苗的開發(fā) 19 appendix： nmajor biogenerics in china (table a b) ntop ten biofirms ntop ten biotherapeutic areas ntop ten bio-medicines nsample of newly approved inno

22、vative bio-medicine in year 2007 20 biogenericsindicationsmanufacturer(s) ifn-1b hepatitis b, hepatitis c shenzhen kexing shanghai institute of biological products beijing tri-prime ifn-1b(eye drop) viral keratitischangchun institute of biological products ifn-1a hepatitis b, hepatitis c changchun i

23、nstitute of biological products changsheng gene pharma sunshine pharma sundiro pharma liaoning satellite shanghai wanxing ifn- 2a(suppository) gynecological diseases whhan tianao changchun changsheng ifn-2b hepatitis b, hepatitis c anke hansheng huaxin dingli yuance hualida neptunus interlong reahar

24、 changchun institute of biological products ifn-2b(gel)herpeshefei zhaofeng ifnrheumatoid shanghai institute ofbiological products shanghai clone livzon pharma interleukin-2(il-2) adjunctive therapy for cancer four-rings huaxin changchun institute of biological products sunshine pharma changsheng ge

25、ne-science ruide jinsili kangli biogenericsindicationsmanufacturer(s) 125 il-2 adjunctive therapy for cancer beijing sl pharma 125ser il-2 adjunctive therapy for cancer shandong quangang liaoning satellite g-csfleukopenia hangzhou jiuyuan gene eng. beijing sl changchun genescience suzhou zhongkai sh

26、anghai sunway beihai fangzhou amoytop shangdong kexing xinpeng geneleuk lilu chengdu rongsheng reahar north china pharma gm-csfleukopenia xiamen amoytop north china pharma beijing medical iniv.pharma reahar hainan huakang gene-science shanghai huaxin liaoning satellite erythropoietin(ep o) renal ane

27、mia sunshine pharma huaxin shandong kexing shanghai clone chengdu diao shangdong ahua four-rings biologicals north china pharma hepatitis b vaccine(yeast) prevention of hepatitis b shenzhen kangtai beijing institute of biological products table a. major biogenerics in chinatable b. major biogenerics

28、 in china 21 全球十大生物制藥企業(yè)全球十大生物制藥企業(yè) 前十企業(yè)前十企業(yè) 2007 2007 市場規(guī)市場規(guī) 模（億美模（億美 元）元） 市場分額市場分額 （%） 增長率增長率 （% ） 復(fù)合年均增長復(fù)合年均增長 率（率（%，02-06 年）年） 全球生物技術(shù)市場全球生物技術(shù)市場 751.210012.518.8 1 安進(jìn)公司（amgen） 159.6421.3 -0.527 2 羅氏/基因技術(shù)（roche/genentech） 154.6920.620.433.5 3 強(qiáng)生公司（johnson & johnson） 62.858.4-3.43 4 諾和諾德公司（novo nordi

29、sk） 58.97.813.717.6 5 禮來公司（lilly） 39.31 6 賽諾菲-安萬特公司（sanofi-aventis） 32.014.333.337.7 7 雅培公司（abbott） 31.454.2 39.2119.1 8 德國默克公司（merck kgaa） 27.343.613.517.9 9 先靈葆雅公司（schering plough） 25.7 10 惠氏公司（wyeth） 22.543 1838.4 前十合計(jì)前十合計(jì) 614.5181.810.520.3 http:/ 22 全球十大生物醫(yī)藥治療領(lǐng)域全球十大生物醫(yī)藥治療領(lǐng)域

30、前十治療領(lǐng)域前十治療領(lǐng)域 20072007銷售收銷售收 入（億美元）入（億美元） 市場分額市場分額 （% %） 增長率增長率 （% %） 復(fù)合年均增長率復(fù)合年均增長率 （% %，02-0602-06年）年） 全球生物醫(yī)藥市場全球生物醫(yī)藥市場 751.210012.518.8 1促紅細(xì)胞生成素(epo) 128.7217.1-911.9 2抗腫瘤藥 (anticancer)113.65 3抗糖尿病藥 (diabetes)102.3113.614.615.4 4自身免疫藥 (auto-immune)83.5711.124.559 5干擾素 (interferon)66.79

31、 6immunostim ag ex intfron 60.058517.3 7免疫抑制劑 (immue depression)45.2619.621.7 8生長激素 (somatotrophin)26.273.5129.7 9血液凝結(jié)劑(coagulation)24.333.29.617.4 10疫苗 (vaccine)20.992.8172.42.8 前十合計(jì)前十合計(jì) 671.8989.411.419.2 http:/ 23 前十產(chǎn)品前十產(chǎn)品 2007 2007 銷售收銷售收 入入 （億美元）（億美元） 市場分額市場分額 （%） 增長率增長率 （%） 復(fù)合年均增長率復(fù)合年均增長率 （%，02-06年）年） 全球生物醫(yī)藥市場全球生物醫(yī)藥市場751.210012.518.8 1enbrel (amg/wye/tak) 52.9715.547.4 2aranes