中國(guó)生物制藥報(bào)告

1 Biopharmaceutical Industry Mar. 2009 OCI In china and world wide Briefs: Biopharmaceutical enjoy a high growth rate world widely Biotech is essential for drug innovation China has established favorable environment for biopharma firms With a solid and rapid progress Chinas biofirms have prepared for making blockbusters 2 Index Global biopharmaceutical status: Market capacity and growth Innovations, development cycle M&A deals China biopharmaceutical conditions: Structure Market capacity and growth Driving forces & environment Advancement Weakness and opportunities Appendix 3 Biotech growth is much higher than traditional pharmaceuticals 010203040506070801998 1999 2000 2001 2002 2003 2004 2005 2006 20070%5%10%15%20%25%30%35%G l o b a l b i o t e c h s a l e sBi o t e c h g ro w t hRevenue: billion USD % GROWTH Global Biotech Sales and Growth( US$) Source: IMS Health, MIDAS, MAT Dec 2007 Global Biotech Market Reached $75Bn in 2007 4 17 657 6510 9411246 6 735443738353430412732282026 22 182218201020304050601990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006Bi o l o g i c a l sNumber of NMEs* first launched worldwide 1990-2006 Source: CMR international NMEs Total Biological 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 approach Development Target discovery Target validation Lead discovery Lead optimization Transition to development 12 years 13 years 0.51 year 24 years 12 years = 612 years in discovery 3-4 years in development Biopharmaceutical Traditional pharmaceutical Biotechnology Reduces Drug Discovery Circle Time 6 59202542519158115341621827191035Autoimmune 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 Disorders Transplantation Other Biotechnology Medicines Trends In Development (USA)* *Some medicine are listed in more than one category 162338516101926622344A n t i s e n s eC e l l T h e r a p yG e n e T h e r a p yG r o w t h F a c t o r sI n t e r f e r o n sI n t e r l e u k i n sM o n o c l o n a l A n t i b o d i e s ( m A b )R e c o m b i n a n t H o r m o n e s / P r o t e i n sV a c c i n e sO t h e r sBy Therapeutic Category* By Product Category* Total 633 biopharmaceuticals under clinical trail or wait for FDA approval in year 2008 Sources: PhRMA 2009 7 Biotech Dominates 2008 Pharma M&A Deal making Total 150 Deals Announced worth USD 93.7 Billion world wide in 2008 8 Biopharmaceutical Industry in China 9 Chinas Pharmaceutical Industry S t r u c t u r e o f C h i n a s p h a r m a c e u t i c a l i n d u s t r y3 4 . 6 %2 6 . 6 %8 . 7 %8 . 9 %1 7 . 9 %3 . 3 %C h e m i c a l p re p a ra t i o nC h e m i c a l b u l k p h a rm a c e u t i c a l sM e d i c a l i n s t ru m e n t sBi o l o g i c a l p h a rm a c e u t i c a l sPre p a re d C h i n e s e m e d i c i n eO t h e rs C h i n a1 4 . 9 0 %Ja p a n4 6 . 8 0 %R e s t o f A s i a -Pa ci f i c3 8 . 3 0 %Source: Datamonitor (% share, by value) Share of biopharmaceutical in Asia Pacific 2007 10 01 , 0 0 02 , 0 0 03 , 0 0 04 , 0 0 05 , 0 0 06 , 0 0 02003 2004 2005 2006 20070 . 0 %5 . 0 %1 0 . 0 %1 5 . 0 %2 0 . 0 %2 5 . 0 %3 0 . 0 %$ m i l l i o n G ro w t h %China Biopharma Market Value 2003-2007 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 05 , 0 0 01 0 , 0 0 01 5 , 0 0 02 0 , 0 0 02007 2008 2009 2010 2011 20122 3 . 5 %2 4 . 0 %2 4 . 5 %2 5 . 0 %2 5 . 5 %2 6 . 0 %$ m i l l i o n G ro w t h %China Biopharma Market Value Forecast: 2007-2012 CAGR:24.7% anticipated CAGR of 24.7% for the five-year period 2007-2012 Source:Datamonitor Revenue: million USD Growth % 13 Driving forces for Chinese biopharma industry Big and profitable market More than 400 biogeneric manufacturers Over 300 biopharmaceutical innovation firms Chinese biotherapeutics enjoy a growth rate of 30% with high margin Exported $ 478 million per year at a growth rate of 54% Government encourages biologic innovator products Biopharmaceutics has been included in Priority list for National Economic Development Chinas “863” and other program funding promising R & D projects Build biological high-tech park IP rights protection has been strengthened Capital infusion The industry is witnessing a surge of mergers, acquisitions and partnerships between domestic and multinational big pharmas and small biopharmas. 14 Advancement 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: 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 to complete clinical trails Traditional vaccine & blood products: Follow-on generics R&D oriented: Domestic Blockbuster: International Blockbusters? 15 16 Company Name Pipeline products Tianjin Fusogen Pharma Sifuvirtide, Fusolin (HBV inhibitor), Fusopin (HCV inhibitor) Sinovac Biotech. Ltd. SARS Vaccine, Pandemic Influenza Vaccine (Human-used Avian Flu Vaccine) Shanghai Sunway Biotech H102,H103 Beijing Biotech Pharma rEGF-P64k/Mont vaccine, Humanized Anti-CD6 Monoclonal Antibody Beijing SL Pharma rh Parathyroid Hormone for Injection Wuhan Institute of Biological Products Monoclonal antibody against hemorrhagic fever for injection Xiamen PKU Bioway Biotech HWAP-1, Dx-Hemoglobin Guangzhou Doublle Bioproduct, Inc. Recombinant human endostatin adenovirus injection Changchun BCHT Pharma AIDS vaccine Anhui Gloden Sun Biochem Tumor vaccine Suzhou landing Biopharma Recombinant human pro-urokinase for injection Sample of innovative products in China Biofirms Pipeline 17 Size: Financing: R&D: Production: Management 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 funds 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 or marketing experience. Marketing: 18 China biofirms Collaborations and Partnerships 2008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) 1500 萬(wàn)美元 從事多肽藥物的研究與開(kāi)發(fā) 深圳翰宇正與 Teva、 Hospira、 Apotex、 Biocon、 Chemo、 DKSH 等知名藥企展開(kāi)合作 2006年 南京先聲 出資 2億購(gòu)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(guò) 2個(gè)億， 08年估計(jì) 6個(gè)億 （”恩度” 2005年拿到生產(chǎn)許可證，南京先聲購(gòu)買天津麥德津是在 2006年接觸到談判僅用了半年多，競(jìng)標(biāo)企業(yè)估計(jì) 50多個(gè)，包括淡馬錫） 2007年 綠葉制藥 9940萬(wàn)元收購(gòu)維信北京大學(xué)生物科技公司 43%股權(quán) 2008年 GSK出資 3133萬(wàn)美元與 海王英特龍 成立合資公司 從事創(chuàng)新疫苗的開(kāi)發(fā) 19 Appendix： Major biogenerics in China (Table A B) Top ten biofirms Top ten biotherapeutic areas Top ten bio-medicines Sample of newly approved innovative bio-medicine in year 2007 20 Biogenerics Indications Manufacturer(s) IFN-1b Hepatitis B, hepatitis C Shenzhen Kexing Shanghai Institute of Biological Products Beijing Tri-prime IFN-1b(eye drop) Viral keratitis Changchun Institute of Biological Products IFN-1a Hepatitis B, hepatitis C Changchun Institute 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 Changchun Institute of Biological Products IFN-2b(gel) Herpes Hefei Zhaofeng IFN Rheumatoid 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 Gene-Science Ruide Jinsili Kangli Biogenerics Indications Manufacturer(s) 125 IL-2 Adjunctive therapy for cancer Beijing SL Pharma 125Ser IL-2 Adjunctive therapy for cancer Shandong Quangang Liaoning Satellite G-CSF Leukopenia Hangzhou Jiuyuan Gene Eng. Beijing SL Changchun GeneScience Suzhou Zhongkai Shanghai Sunway Beihai Fangzhou Amoytop Shangdong Kexing Xinpeng GeneLeuk Lilu Chengdu Rongsheng Reahar North China Pharma GM-CSF Leukopenia Xiamen Amoytop North China Pharma Beijing Medical Iniv.Pharma Reahar Hainan Huakang Gene-Science Shanghai Huaxin Liaoning Satellite Erythropoietin(EPO) Renal anemia 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 China Table B. Major biogenerics in China 21 全球十大生物制藥企業(yè) 前十企業(yè) 2007 市場(chǎng)規(guī)模（億美元） 市場(chǎng)分額（ %） 增長(zhǎng)率（ % ） 復(fù)合年均增長(zhǎng)率（ %， 02-06年） 全球生物技術(shù)市場(chǎng) 751.2 100 12.5 18.8 1 安進(jìn)公司（ Amgen） 159.64 21.3 -0.5 27 2 羅氏 /基因技術(shù)（ Roche/Genentech） 154.69 20.6 20.4 33.5 3 強(qiáng)生公司（ Johnson & Johnson） 62.85 8.4 -3.4 3 4 諾和諾德公司（ Novo Nordisk） 58.9 7.8 13.7 17.6 5 禮來(lái)公司（ Lilly） 39.31 5.2 7.1 4.7 6 賽諾菲 -安萬(wàn)特公司（ Sanofi-Aventis） 32.01 4.3 33.3 37.7 7 雅培公司（ Abbott） 31.45 4.2 39.2 119.1 8 德國(guó)默克公司（ Merck KGaA） 27.34 3.6 13.5 17.9 9 先靈葆雅公司（ Schering Plough） 25.77 3.4 5.8 1.4 10 惠氏公司（ Wyeth） 22.54 3 18 38.4 前十合計(jì) 614.51 81.8 10.5 20.3 /Htmls/GenMarkeIntelligence/080709/15433.html 22 全球十大生物醫(yī)藥治療領(lǐng)域 前十治療領(lǐng)域 2007銷售收入（億美元） 市場(chǎng)分額 （ %） 增長(zhǎng)率 （ %） 復(fù)合年均增長(zhǎng)率 （ %， 02-06年） 全球生物醫(yī)藥市場(chǎng) 751.2 100 12.5 18.8 1 促紅細(xì)胞生成素 (EPO) 128.72 17.1 -9 11.9 2 抗腫瘤藥 (Anticancer) 113.65 15.1 24.2 45.9 3 抗糖尿病藥 (Diabetes) 102.31 13.6 14.6 15.4 4 自身免疫藥 (Auto-immune) 83.57 11.1 24.5 59 5 干擾素 (Interferon) 66.79 8.9 2.3 9.8 6 Immunostim Ag Ex Intfron 60.05 8 5 17.3 7 免疫抑制劑 (Immue depression) 45.2 6 19.6 21.7 8 生長(zhǎng)激素 (Somatotrophin) 26.27 3.5 12 9.7 9 血液凝結(jié)劑 (Coagulation) 24.33 3.2 9.6 17.4 10 疫苗 (Vaccine) 20.99 2.8 172.4 2.8 前十合計(jì) 671.89 89.4 11.4 19.2 /Htmls/GenMarkeIntelligence/080709/15433.html 23 前十產(chǎn)