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Build Effective Vaccine R&D Capabilities with Chinese Characteristics

Build Effective Vaccine R&D Capabilities with Chinese Characteristics. 建立有中国特色的疫苗研发体系 Sean Du, Ph.D. , Executive Director, Vaccine Research 报告人：杜笑 寒 博士，疫苗研究部执行总监 Shanghai, China, 2010.09.15. Global Vaccine Market 世界疫苗市场概况.

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Build Effective Vaccine R&D Capabilities with Chinese Characteristics

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  1. Build Effective Vaccine R&D Capabilities with Chinese Characteristics 建立有中国特色的疫苗研发体系 Sean Du, Ph.D. , Executive Director, Vaccine Research 报告人：杜笑寒 博士，疫苗研究部执行总监 Shanghai, China, 2010.09.15

  2. Global Vaccine Market 世界疫苗市场概况 • The worldwide market for vaccines has more than doubled from 2005 to 2008, having grown at a compound annual rate of 32%. From year 2008 to 2009, vaccine sales was up a another 16% and hit $22.1 billion in 2009. 世界疫苗市场从2005年到2008年，翻了一番，年增长32％。从2008到2009，又增加了16％，达到2009年的221亿美金。 • Five vaccines with over $1B in annual sales. 五个疫苗年销售额达到$10亿美金 • Wyeth Prevnar (pneumococcus) 惠氏公司脑炎疫苗用以预防侵袭性肺炎球菌疾病 • MerckGardasil (HPV) 默克公司子宫颈癌疫苗用以预防人类乳头状瘤病毒 • MerckZostavax (shingles) 默克公司水痘疫苗用以预防带状疱疹 • MerckRotaTeq (rotavirus) 默克公司轮状病毒疫苗 • GSK RotaRix (rotavirus) 葛兰素史克公司轮状病毒疫苗 • Vaccine sales will continue to rise annually at a rate of 9.7% for the next five years, which could push annual sales as high as $35 billion by 2015. 全球疫苗的销售在近五年会继续以9.7％增长，并于2015年达到$350亿美金.

  3. Global Vaccine Leaders 世界疫苗的竞争格局 • The top 5 players accounting for around 80% of the total market • 全球前五大疫苗企业占了全球疫苗市场的80% • 2005, 3 out of the world top10 pharmas involved in vaccine business • 2010, 9out of the world top10 pharmas involved in vaccine business • 2005年，世界十大制药企业只有三家有疫苗；目前十家里九家有疫苗产业 澳洲英联邦血液实验室 Merck默沙东 (2009.9.3 Flu vaccine) 百特 AstraZeneca 阿斯利康 (2007.06, $15.6B) 赛诺菲－巴斯德 苏威 Abbott雅培(2010.02, EU4.5B) 博尔纳 Crucell科伯纳 (2005.12.8, $450M) Sanofi Pasteur (2008.07, $546M) 赛诺菲－巴斯德 2005 凯龙 Novartis 诺华(2006, $5.5B) 惠氏 Pfizer 辉瑞 (2009.10.15, $68B) 葛兰素－史克 Johnson & Johnson 强生 (2009.09, EU302M=18%stock) 默沙东

  4. Major Vaccines in Development全球现处临床开发阶段的主要疫苗 4 “Nice Shot - Why vaccines are pharma’s Next Big Thing. ”By Megan Scudellari, The Scientist 2009 24:32

  5. Domestic Vaccine Market 中国疫苗市场 • World’s largest population; 17 million newborn babies each year. 世界1/4人口；每年的一千五到七百万新生儿。 • The largest vaccine manufacturer by dose; the fourth largest vaccine market. 世界上最大的疫苗生产国；世界第四大疫苗市场. • Over 30 manufacturers producing ~40 vaccines against over 20 diseases 共有疫苗生产企业30多家，可以生产预防20多种传染病的40多种疫苗 • The growth rate for the past has been ~15%, exceeding5 billion RMB on 2009. 中国的疫苗市场过去几年的增速大约是15% ,2009年超过RMB￥50亿元， • The best selling vaccines (by sales) are Rabies and Influenza vaccines. 以狂犬病疫苗和流感疫苗销售最高。 • The growth rate for next few years over 20%, reaching8 billion RMB by 2012. 未来几年的增速有望达到25%；到2012年，市场的容量将达到RMB￥80亿元。 • Only 1/25th of the world vaccine market. 占全球疫苗市场的25-30分之一

  6. Room for Growth: Vaccine Supply vs. Demand 成长空间：中国疫苗产能 • For many vaccines, current domestic production capabilities can’t meet demand. Most production processes need a major upgrade. 中国许多疫苗品种的产能严重不足，生产技术急需提升

  7. Room for Growth: Process Improvement Needed成长空间：国内疫苗需要提升的生产工艺

  8. Pros and Cons of Chinese R&D Environment中国疫苗研发环境的优缺点比较

  9. Pros and Cons of Chinese R&D Environment中国疫苗研发环境的优缺点比较

  10. R&D Strategy of A Typical Vaccine Manufacturer 国内私营疫苗企业的研发策略 Most products have been developed through collaborations or tech transfer 新产品开发主要采用联合开发或转让的方式 Basic research activities are often carried out by academic collaborators 基础研究由科研机构完成 R&D ＝ Tech Transfer and Process Adaptation R&D team takes over each project at pilot stage, often with established process 研发团队在中试阶段进入 This way, the R&D team can focus its limited resources mostly on industrialization 研发团队集中有限力量进行产业化研究

  11. Success Example：Recombinant HEV Vaccine 成功范例：基因工程戊肝疫苗 • Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Currently there is no HEV vaccine. • 血清学数据表面全球有三分之一人口曾感染过戊型肝炎病毒。国内外尚无疫苗。 • Through a long term collaboration among Dr. Ning-Shao Xia at National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Beijing Wantai Biological Pharmacy, and Xiamen Innovax Biotech, a major breakthrough has been made in HEV vaccine development. The vaccine, HEV 239, has just passed a Phase III efficacy trial with 97356 participants, and is on SFDA’s fast approval track. The results were published in Lancet 2010. • 由厦门大学国家传染病诊断试剂与疫苗工程技术研究中心夏宁邵博士、北京养生堂万泰生物药业股份有限公司、厦门万泰沧海生物技术有限公司等单位联合研制的戊型肝炎疫苗取得重大突破，由97356人参加的三期临床研究证实戊肝疫苗安全有效，等待药监部门批准后即可迅速上市。相关研究成果近日在《柳叶刀》发表。 • Four international patents on the vaccine have been granted. • 迄今已取得4项国内外授权发明专利，是我国少见的高度原创性生物药物之一。 Zhu, F-C, et al. 2010. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. The Lancet, 376 (9744):895 - 902,

  12. 401(K) Management vs. China Vaccine R&D Strategy 类比退休基金管理和中国疫苗研发策略

  13. Innovation Drives Growth创新刺激增长 Simcere R&D Strategy: Increasing focus on innovation 先声研发策略：逐渐增加对创新的药和候选物的重视 2005 2006 2007 2008

  14. SimcereSnapshot　先声药业集团简介 • A NYSE company, with highest standard of corporate compliance and transparency • About 3000 sales reps and 1,500 distributors, covering over 3,000 hospitals and • 70,000 retail pharmacies • 8 GMP facilities supporting small molecule and biologics manufacturing • China-leading R&D capabilities 中国领先的研发能力 14 14

  15. A Leader in China’s Pharmaceutical Industry中国医药业的领袖 Revenue (M, RMB) Ranking(排行): #21 in Net Profit in China healthcare industry* 中国医疗业总利润排名第21名 #7 among the Top 20 most competitive public listed healthcare companies in China 中国最具竞争力的前20家医疗业上市企业中排第7名 CAGR=33% * 2009 Chinese Medical Statistical Yearbook by Ministry of Industry and Information Technology of PRC

  16. Differentiated Products with Market Leadership in Oncology and CNS差别性产品和聚焦医疗领域

  17. Simcere Biologics Capabilities先声生物制品 Biopharmaceuticals Simcere R&D Center 100% 52.5% 35% Institute of Biologics Research 生物制品所 Department of Vaccine Research 疫苗研究部 Shandong Simcere Medgenn Bio-Pharmaceutical Co. Ltd. 山东先声麦得津生物制药 Jiangsu Yanshen Biological Technology Stock Co. Ltd. 江苏延申生物 Shanghai Celgen Bio-Pharmaceutical Co. Ltd. 上海赛金生物制药 Humanized Rabbit MAbs Co-development with Epitomics on humanized RabMab® antibody therapeutics for multiple tumors Vaccine Research Endu (Endostatin) Innovative anti-cancer drug with sales of RMB124m in 2009 Vaccines Manufacturer of Influenza vaccine (to be marketed on 2011) R&D pipeline with Hep A and Rabies vaccine candidates, etc Etanercept Drug to treat auto-immune diseases. Completed clinical trials and awaiting SFDA approval Platforms　平台 MAbs　单克隆抗体 Mammalian cells　哺乳细胞表达 Pilot under construction 中试在建 New-type vaccine research planned　新型疫苗研究在计划中 Platforms　平台 Recombinant protein　重组蛋白 E. coli Expression　大肠杆菌表达 Yeast Expression 酵母表达 Pilot& GMP 中试和GMP生产 Platforms　平台 Egg-based split vaccine Cell-based inactivated vaccine－　 鸡胚裂解疫苗和细胞灭活疫苗 Pilot& GMP 中试和GMP生产 Platforms　平台 MAbs　单克隆抗体 Mammalian cells　哺乳细胞表达 Pilot& GMP 中试和GMP生产

  18. New Vaccine Facilities and Products 新厂址和产品 • Build on a 19.5 acres land. 占地130亩. • R&D pilot plant has been used to develop Rabies vaccine based on a bioreactor technology.目前研发中试车间已经用于生物反应器狂犬疫苗的开发 • Hep A and Flu vaccine facilities, Fill & Finish, as well as new QC lab, will be completed this year　甲肝、流感、分包装车间和新的QC实验室于今年完工

  19. Simcere Vaccine Strategy　先声疫苗战略 • Enter Chinese vaccine market through acquisitionof Jiangsu Yanshen 通过兼并疫苗企业进入中国疫苗市场 • Ensure progress of the current product pipelines in Jiangsu Yanshen 确保目前江苏延申生物的产品线的进程 • Establish Vaccine Research Department in Simcere R&D Center, with both upstream discovery and downstream development capabilities, as well as a rich pipeline balancing short-, mid-, and long-term goals 在先声研发中心成立先声疫苗研究部，建立上游发现和下游攻关相结合的、短中长相匹配的、管线丰富的研发体系 • Seek technology transfer and in-license opportunities for established vaccine processes and products to enrich Simcere current product portfolio 寻找机会，对成熟的工艺和产品进行技术转让或项目引进以丰富先声疫苗产品 • Seek collaboration opportunities for clinical- and/or pre-clinical stage vaccine candidates both internationally and domestically 寻求对处于临床和临产前阶段的疫苗候选物的合作机会，放眼国际也关注国内

  20. Simcere Vaccine Strategy先声疫苗战略 • Enter Chinese vaccine market through acquisitionof Jiangsu Yanshen 通过兼并疫苗企业进入中国疫苗市场 • Ensure progress of the current product pipelines in Jiangsu Yanshen 确保目前江苏延申生物的产品线的进程 • Establish Vaccine Research Department in Simcere R&D Center, with both upstream discovery and downstream development capabilities, as well as a rich pipeline balancing short-, mid-, and long-term goals 在先声研发中心成立先声疫苗研究部，建立上游发现和下游攻关相结合的、短中长相匹配的、管线丰富的研发体系 • Seek technology transfer and in-license opportunities for established vaccine processes and products to enrich Simcere current product portfolio 寻找机会，对成熟的工艺和产品进行技术转让或项目引进以丰富先声疫苗产品 • Seek collaboration opportunities for clinical- and/or pre-clinical stage vaccine candidates both internationally and domestically 寻求对处于临床和临产前阶段的疫苗候选物的合作机会，放眼国际也关注国内 Simcere is the partner of choice for a number of multinational companies 先声是各大跨国企业的首选合作伙伴

  21. Continuous Improvement不断改进 We know we are not there yet. But we are fully committed to continuously improve ourselves. And we welcome all the helps and collaboration opportunities to reach this goal. 我们知道离目标还有差距，但我们承诺不断地改进自己. 我们欢迎所有能够帮助我们实现这个目标的合作伙伴和机遇。 Global Vaccine Leaders China Vaccine Manufacturers Thank you!

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