由啟明創(chuàng)投投資企業(yè)康希諾生物研制的擁有自主知識產權的一類新藥“重組肺炎球菌蛋白疫苗”（PBPV, Protein BasedPneumococcal Vaccine）日前獲得國家食品藥品監(jiān)督管理總局新藥臨床試驗批準。這是繼埃博拉病毒病疫苗獲得中國新藥證書以及肺結核疫苗在加拿大進入臨床試驗之后，康希諾生物開發(fā)的第三個全球創(chuàng)新疫苗進入臨床研究階段。
該疫苗屬于第三代肺炎疫苗。相較于第一代肺炎多糖疫苗和第二代肺炎多糖蛋白結合疫苗，重組肺炎球菌蛋白疫苗具有覆蓋率高，不受血清型的限制和易于生產等獨特優(yōu)勢。眾所周知，肺炎球菌有90多個血清型, 康希諾生物研發(fā)的“重組肺炎球菌蛋白疫苗”采用了多種蛋白作為疫苗的抗原成份，其保護力不受限于肺炎鏈球菌的血清型，同時可以產生很好的免疫記憶，適用于嬰兒及老年人；該疫苗蛋白抗原生產工藝清晰可控，更便于產能擴大及廣泛推廣使用。肺炎蛋白疫苗也是跨國疫苗公司多年來的重要研究方向。
肺炎球菌是革蘭氏陽性、帶莢膜的雙球菌。肺炎球菌感染可引發(fā)腦膜炎、菌血癥、肺炎，中耳炎等嚴重疾病。世界衛(wèi)生組織（WHO）報告顯示，全球每年約 47.6 萬人死于肺炎球菌感染。發(fā)展中國家肺炎球菌感染的發(fā)病率和死亡率均遠高于發(fā)達國家。嬰幼兒和老人是肺炎球菌的主要侵襲對象， WHO建議全球各國均應將肺炎疫苗納入本國兒童免疫接種規(guī)劃，特別是那些兒童死亡率高的國家，應將引進多抗原肺炎球菌疫苗作為國家免疫規(guī)劃中的優(yōu)先項目。肺炎疫苗的市場潛力巨大?？迪ＶZ生物研發(fā)的這款全球創(chuàng)新肺炎疫苗，有望進一步對預防肺炎球菌感染做出巨大貢獻。
康希諾生物股份公司于2009年注冊于天津濱海新區(qū)，注冊資本1.61億元，創(chuàng)始人團隊由四位曾擔任北美跨國制藥企業(yè)的高管組成，管理團隊具有多年國際和中國本土疫苗行業(yè)的豐富經驗，是國家級高新技術企業(yè)?？迪ＶZ已經建立了基于腺病毒載體疫苗技術、蛋白結構設計和重組技術、結合技術、制劑技術等四大核心技術平臺，擁有多項疫苗核心知識產權及專有技術；創(chuàng)立了十余個新型疫苗組成的研發(fā)管線，涵蓋了對肺炎、結核病、埃博拉病毒病、腦膜炎、百白破等一系列疾病的預防?？迪ＶZ生物以在世界范圍內提供預防傳染病和感染病的解決方案為己任，專業(yè)從事高質量人用疫苗的研發(fā)、生產和商業(yè)化，是國內領先的高科技生物制藥企業(yè)。
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.
