由启明创投投资企业康希诺生物研制的拥有自主知识产权的一类新药“重组肺炎球菌蛋白疫苗”（PBPV, Protein BasedPneumococcal Vaccine）日前获得国家食品药品监督管理总局新药临床试验批准。这是继埃博拉病毒病疫苗获得中国新药证书以及肺结核疫苗在加拿大进入临床试验之后，康希诺生物开发的第三个全球创新疫苗进入临床研究阶段。
该疫苗属于第三代肺炎疫苗。相较于第一代肺炎多糖疫苗和第二代肺炎多糖蛋白结合疫苗，重组肺炎球菌蛋白疫苗具有覆盖率高，不受血清型的限制和易于生产等独特优势。众所周知，肺炎球菌有90多个血清型, 康希诺生物研发的“重组肺炎球菌蛋白疫苗”采用了多种蛋白作为疫苗的抗原成份，其保护力不受限于肺炎链球菌的血清型，同时可以产生很好的免疫记忆，适用于婴儿及老年人；该疫苗蛋白抗原生产工艺清晰可控，更便于产能扩大及广泛推广使用。肺炎蛋白疫苗也是跨国疫苗公司多年来的重要研究方向。
肺炎球菌是革兰氏阳性、带荚膜的双球菌。肺炎球菌感染可引发脑膜炎、菌血症、肺炎，中耳炎等严重疾病。世界卫生组织（WHO）报告显示，全球每年约 47.6 万人死于肺炎球菌感染。发展中国家肺炎球菌感染的发病率和死亡率均远高于发达国家。婴幼儿和老人是肺炎球菌的主要侵袭对象， WHO建议全球各国均应将肺炎疫苗纳入本国儿童免疫接种规划，特别是那些儿童死亡率高的国家，应将引进多抗原肺炎球菌疫苗作为国家免疫规划中的优先项目。肺炎疫苗的市场潜力巨大。康希诺生物研发的这款全球创新肺炎疫苗，有望进一步对预防肺炎球菌感染做出巨大贡献。
康希诺生物股份公司于2009年注册于天津滨海新区，注册资本1.61亿元，创始人团队由四位曾担任北美跨国制药企业的高管组成，管理团队具有多年国际和中国本土疫苗行业的丰富经验，是国家级高新技术企业。康希诺已经建立了基于腺病毒载体疫苗技术、蛋白结构设计和重组技术、结合技术、制剂技术等四大核心技术平台，拥有多项疫苗核心知识产权及专有技术；创立了十余个新型疫苗组成的研发管线，涵盖了对肺炎、结核病、埃博拉病毒病、脑膜炎、百白破等一系列疾病的预防。康希诺生物以在世界范围内提供预防传染病和感染病的解决方案为己任，专业从事高质量人用疫苗的研发、生产和商业化，是国内领先的高科技生物制药企业。
CanSinoBIO’s Protein-based Pneumococcal Vaccine Candidate Received Clinical Approval from Chinese Regulatory Agency NMPA
CanSino Biologics Inc. announced that the company’s innovative vaccine candidate “Protein-based Pneumococcal Vaccine” (PBPV) obtained approval for clinical trials from the Center for Drug Evaluation (CDE) of National Medical Product Agency (NMPA) in China. This is CanSinoBIO’s third globally innovative vaccine candidate that has moved into the clinical trial stage. The other two are Ebola virus disease vaccine (Ad5-EBOV) which was approved by NMPA of China as a new drug for emergency use and stockpile, the TB Booster vaccine which is currently in phase Ib clinical trial in Canada.
The PBPV is a third-generation pneumococcal vaccine. Compared with the first generation of pneumococcal polysaccharide vaccine (PCV23) and the second generation of pneumococcal polysaccharide conjugate vaccine ( PCV13), PBPV has unique advantages such as serotype-independent, broader coverage and easy to scale up. Pneumococci containmore than 90 serotypes. CanSinoBIO’s PBPV vaccine candidate uses several proteins as antigen components, which provide protection independent to the serotypes of pneumococcal bacteria. PBPV is able to stimulate both humoral and cellular immune responses and could be suitable for both infants and the elderly.The production process is expected to have good quality control and can be further scaled up. Protein-based pneumococcal vaccine has been important research direction for global vaccine industry.
Streptococcus pneumoniae is gram-positive, diplococcus with capsule. Pneumococcal infections can cause meningitis, bacteremia, pneumonia, otitis media and other serious diseases. According to WHO report, pneumococcal infection leads to approximately 476,000 deaths globally each year. The incidence rates of pneumococcal diseases in developing countries are much higher than that in industrialized countries. The infants and the elderly are the main target of Streptococcus pneumoniae. WHO recommends the inclusion of PCVs in childhood immunization programs worldwide. In particular, countries with high childhood mortality should make the introduction of these multicomponent PCVs a high priority. The market potential for pneumococcal vaccines is enormous. Once CanSino’s newly developed PBPV candidate succeeds, it can make great contributions to the prevention of pneumococcal infections.
CANSINOBIOLOGICS INC. (CanSinoBIO) is China’s dynamic biotech leader blazing new paths in R&D, manufacturing and commercialisation of vaccine products for human use. Founded in the Tianjin Economic and Technological Development Area (TEDA)in 2009, CanSinoBIO’s founders formed a superb team of scientists and managers who had previously held senior management and technical positions at many of the world’s leading pharmaceutical companies. Equipped with the latest cutting-edge scientific know-how and technology, CanSinoBio has established a robust vaccine pipeline, and is one of the leading vaccine companies in China.
