全球重组蛋白疫苗研发态势简析

Worldwide Status of Research and Development of Recombinant Protein Vaccine

目的分析全球重组蛋白疫苗的研发态势。方法采用计算机检索Cortellis数据库中全球已上市、处于注册或预注册状态、已启动Ⅲ期临床试验的重组蛋白疫苗,检索时间为自建库起至2021年9月1日。分别从原研单位国家分布、首次上市/Ⅲ期临床试验启动时间、适应证等方面分析其全球研发概况。结果全球重组蛋白疫苗有74个已上市或处于注册、预注册状态,有29个处于Ⅲ期临床试验阶段。从原研单位国家来看,中国已上市或处于注册、预注册状态/进入Ⅲ期临床试验阶段的产品均最多(21个/12个);美国、英国、古巴、法国分别有15个/7个、11个/0个、5个/0个、4个/1个,位居前列。1986年至1997年、1998年至2009年、2010年至2021年分别上市9个、29个、36个产品,2016年至2021年启动Ⅲ期临床试验的产品有23个。适应证涵盖乙型病毒性肝炎病毒感染,百日咳、白喉、破伤风(简称百白破),流行性感冒(简称流感)嗜血杆菌感染,流感病毒感染,脑膜炎奈瑟球菌感染,脊髓灰质炎病毒感染的产品分别有30个、18个、12个、11个、6个、6个;以预防人乳头状瘤病毒(HPV)感染、非HPV感染引起的肿瘤、肺炎链球菌感染为适应证的处于Ⅲ期临床试验阶段的产品分别有5个、4个、3个,且均超过对应的已上市产品数。结论全球重组蛋白疫苗研发成果丰富,上市产品数量逐渐增加,获批适应证从百白破、流感、脑膜炎等逐渐扩展至其他传染病和肿瘤。中国已上市产品数和Ⅲ期临床试验在研数量均全球领先。

Objective To analyze the worldwide status of research and development(R&D)of recombinant protein vaccine.Methods The information of the recombinant protein vaccine in the world that had been marketed,were in the registration or preregistration status and had started the phaseⅢclinical trials in the Cortellis database from the inception to September 1,2021 were searched by the computer.The worldwide R&D status of recombinant protein vaccine was analyzed from the distribution of countries where institutions researching the products located,time to market for the first time/time to start the phaseⅢclinical trial,indications and other aspects.Results There were 74 recombinant protein vaccine in the world had been marketed or were in the registration or pre-registration status,and 29 products were in the phaseⅢclinical trials.In terms of countries where institutions researching the products located,China had the most products that had been marketed or were in the registration or preregistration status(21 products)/were in the phaseⅢclinical trials(12 products),followed by the United States(fifteen products/seven products),the United Kingdom(eleven products/zero product),Cuba(five products/zero product)and France(four products/one product),ranking in the forefront.Nine products were marketed from 1986 to 1997,29 products were marketed from 1998 to 2009,36 products were marketed from 2010 to 2021,and 23 products were in the phaseⅢclinical trials from 2016 to 2021.There were thirty,eighteen,twelve,eleven,six and six products with indications of hepatitis B virus(HBV)infection,diphtheria,tetanus,pertussis(DTaP),the Haemophilus influenzae infection,influenza virus infection,Neisseria meningitidis infection and poliovirus infection,respectively.There were five,four and three products in the phaseⅢclinical trials for the prevention of human papillomavirus(HPV)infection,tumors caused by the non-HPV infection and Streptococcus pneumoniae infection,respectively,more than the corresponding marketed products.Conclusion The R&D achievements of recombinant protein vaccine in the world are rich,the number of marketed products is gradually increasing,and the approved indications have expanded from DTaP,influenza and meningitis to other infectious diseases and tumors.China leads the world in both the number of products that have been marketed and the number of products in the phaseⅢclinical trials.