1、Build Effective Vaccine R&D Capabilities with Chinese Characteristics 建立有中国特色的疫苗研发体系建立有中国特色的疫苗研发体系 Sean Du,Ph.D.,Executive Director,Sean Du,Ph.D.,Executive Director,Vaccine ResearchVaccine Research 报告人：杜笑寒报告人：杜笑寒 博士，疫苗研究部执行总监博士，疫苗研究部执行总监 Shanghai,China,2022.09.15Shanghai,China,2022.09.15 Global Vacc
2、ine Market 世界疫苗市场概况 The worldwide market for vaccines has more than doubled from 2022 to 2022,having grown at a compound annual rate of 32%.From year 2022 to 2022,vaccine sales was up a another 16%and hit$22.1 billion in 2022.世界疫苗市场从2022年到2022年，翻了一番，年增长32。从2022到2022，又增加了16，到达2022年的221亿美金。Five vaccin
3、es with over$1B in annual sales.五个疫苗年销售额到达$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 Merck Gardasil(HPV)默克公司子宫颈癌疫苗用以预防人类乳头状瘤病毒 Merck Zostavax(shingles)默克公司水痘疫苗用以预防带状疱疹 Merck RotaTeq(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
4、a rate of 9.7%for the next five years,which could push annual sales as high as$35 billion by 2022.全球疫苗的销售在近五年会继续以9.7增长，并于2022年到达$350亿美金.2 Global Vaccine Leaders 世界疫苗的竞争格局 Sanofi Pasteur 26%GSK 23%Merck 16%Wyeth 12%Chiron 5%Acambis 2%Berna 2%Solvay 1%MedImmune 1%Baxter 1%CSL 1%Other 10%The top 5 play
5、ers 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%2022,3 out of the world top 10 pharmas involved in vaccine business 2022,9 out of the world top10 pharmas involved in vaccine business 2022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 2022 百特 澳洲英联邦血液实验室 凯龙 惠氏 Sanofi Pasteur (2022.07,$546M)赛诺菲巴斯
6、德 Novartis 诺华(2022,$5.5B)AstraZeneca 阿斯利康(2022.06,$15.6B)博尔纳 Crucell 科伯纳(2022.12.8,$450M)Pfizer 辉瑞(2022.10.15,$68B)Johnson&Johnson 强生(2022.09,EU302M=18%stock)苏威 Abbott 雅培(2022.02,EU4.5B)Merck 默沙东(2022.9.3 Flu vaccine)默沙东 葛兰素史克 赛诺菲巴斯德 Major Vaccines in Development 全球现处临床开发阶段的主要疫苗 4 Infectious Disease
7、s 传染病传染病 Manufacturer 生产厂家生产厂家 Vaccine 疫苗名称疫苗名称 Development 临床开发阶段临床开发阶段 Notes 备注备注 Travelers diarrhea 旅行者腹泻 Intercell N/A Phase II Tuberculosis 结核菌 GSK N/A Phase II Intercell N/A Phase I With Sanofi-Aventis RSV 呼吸道合胞病毒 MedImmune Motavizumab Phase III HIV/AIDS 艾滋病病毒 Novavax N/A Preclinical Sanofi-Av
8、entis N/A Phase III HSV-2 2型单纯疱疹病毒 GSK Simplirix Phase III Formally Herpevac Dengue fever 登革热病毒 GSK N/A Phase II West Nile virus 西尼罗河脑炎病毒 Sanofi-Aventis ChimeriVax-WN02 Phase II Malaria 疟疾 GSK RTS,S Phase III GSK Mosquirix Phase II EBV 艾普斯登-巴尔病毒 GSK N/A Phase II From MedImmune Typhoid 伤寒菌 Norvatis N
9、/A Preclinical With Wellcome Trust CMV 细胞巨大型病毒 GSK N/A Phase I Staph.aureus 金黄色葡萄球菌 Merck V710 Phase II With Intercell“Nice Shot-Why vaccines are pharmas Next Big Thing.By Megan Scudellari,The Scientist 2022 24:32 Domestic Vaccine Market 中国疫苗市场 Worlds largest population;17 million newborn babies eac
10、h 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%,exceeding 5 billion RMB on 20
11、22.中国的疫苗市场过去几年的增速大约是15%,2022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%,reaching 8 billion RMB by 2022.未来几年的增速有望到达25%；到2022年，市场的容量将到达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 5 Ro
12、om for Growth:Vaccine Supply vs.Demand 成长空间：中国疫苗产能 For many vaccines,current domestic production capabilities cant meet demand.Most production processes need a major upgrade.中国许多疫苗品种的产能严重缺乏，生产技术急需提升 6 311530642020010203040506070MMR 麻腮风Varicella 水痘Hep A 甲肝DTP 白百破Rabies 狂犬Influenza 流感Demand 需求Supply 供
13、应Room for Growth:Process Improvement Needed 成长空间：国内疫苗需要提升的生产工艺 7 Areas need future improvement 生产工艺需要提升的疫苗领域生产工艺需要提升的疫苗领域 Large scale production technologies for mammalian cells and several viral vaccines 病毒型疫苗及其宿主细胞的大规模培养技术，包括流感裂解疫苗，轮状病毒疫苗和水痘疫苗 Effective yeast expression platform and HPV vaccine 酵母
14、高效表达平台，及酵母表达的HPV疫苗 Effective insect expression platform and HPV vaccine 昆虫细胞高效表达平台，及昆虫细胞HPV疫苗 Recombinant vaccine development 各种新型基因工程构建的亚单位疫苗 Large scale production and process upgrade for several vaccines newly added to the National Immunization Plan 扩大免疫计划疫苗的规模化生产和升级换代，包括脊髓灰质炎疫苗；无细胞百白破疫苗；麻腮风三联减毒活
15、疫苗；甲肝疫苗 Scale-up production and QC techniques for Pneumococcal 23-valent polysaccharide vaccine 23价肺炎疫苗的规模化生产和质控关键技术 Highly efficient expression and purification of carrier proteins for conjugate vaccines 结合疫苗载体蛋白的高效表达技术和分离纯化技术 Conjugate vaccine technologies,including activation of polysaccharide,co
16、njugation,purification,QC,and evaluation of conjugation efficiency,etc.细菌多糖蛋白结合疫苗技术，包括多糖活化，结合条件和纯化条件的优化；质量分析标准的研究；疫苗结合效果的评估。涉及疫苗包括肺炎，流脑，Hib，伤寒，副伤寒，痢疾，及大肠杆菌疫苗 Pros and Cons of Chinese R&D Environment 中国疫苗研发环境的优缺点比较 8 Pros 优点 Affordable HR cost(1/7 of USA HR cost)容易负担的人力资源 Strong government supports on land and infrastructure 强大的政府支持力度 High quality hardware(GMP plant,instrument)高质量的硬件系统 Good working ethics 优良的职业道德 Strong wills to learn new technologies 强烈的求知欲望 Vaccine R&D budget can be relatively