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(shí)產(chǎn)權(quán)的一類(lèi)新藥“重組肺炎球菌蛋白疫苗”（PBPV, Protein BasedPneumococcal Vaccine）日前獲得國(guó)家食品藥品監(jiān)督管理總局新藥臨床試驗(yàn)批準(zhǔn)。這是繼埃博拉病毒病疫苗獲得中國(guó)新藥證書(shū)以及肺結(jié)核疫苗在加拿大進(jìn)入臨床試驗(yàn)之后，康希諾生物開(kāi)發(fā)的第三個(gè)全球創(chuàng)新疫苗進(jìn)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(jié)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(chǎn)等獨(dú)特優(yōu)勢(shì)。眾所周知，肺炎球菌有90多個(gè)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(hù)力不受限于肺炎鏈球菌的血清型，同時(shí)可以產(chǎn)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(chǎn)工藝清晰可控，更便于產(chǎn)能擴(kuò)大及廣泛推廣使用。肺炎蛋白疫苗也是跨國(guó)疫苗公司多年來(lái)的重要研究方向。
肺炎球菌是革蘭氏陽(yáng)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(yán)重疾病。世界衛(wèi)生組織（WHO）報(bào)告顯示，全球每年約 47.6 萬(wàn)人死于肺炎球菌感染。發(fā)展中國(guó)家肺炎球菌感染的發(fā)病率和死亡率均遠(yuǎn)高于發(fā)達(dá)國(guó)家。嬰幼兒和老人是肺炎球菌的主要侵襲對(duì)象， WHO建議全球各國(guó)均應(yīng)將肺炎疫苗納入本國(guó)兒童免疫接種規(guī)劃，特別是那些兒童死亡率高的國(guó)家，應(yīng)將引進(jìn)多抗原肺炎球菌疫苗作為國(guó)家免疫規(guī)劃中的優(yōu)先項(xiàng)目。肺炎疫苗的市場(chǎng)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(jìn)一步對(duì)預(yù)防肺炎球菌感染做出巨大貢獻(xiàn)。
康希諾生物股份公司于2009年注冊(cè)于天津?yàn)I海新區(qū)，注冊(cè)資本1.61億元，創(chuàng)始人團(tuán)隊(duì)由四位曾擔(dān)任北美跨國(guó)制藥企業(yè)的高管組成，管理團(tuán)隊(duì)具有多年國(guó)際和中國(guó)本土疫苗行業(yè)的豐富經(jīng)驗(yàn)，是國(guó)家級(jí)高新技術(shù)企業(yè)?？迪ＶZ已經(jīng)建立了基于腺病毒載體疫苗技術(shù)、蛋白結(jié)構(gòu)設(shè)計(jì)和重組技術(shù)、結(jié)合技術(shù)、制劑技術(shù)等四大核心技術(shù)平臺(tái)，擁有多項(xiàng)疫苗核心知識(shí)產(chǎn)權(quán)及專(zhuān)有技術(shù)；創(chuàng)立了十余個(gè)新型疫苗組成的研發(fā)管線，涵蓋了對(duì)肺炎、結(jié)核病、埃博拉病毒病、腦膜炎、百白破等一系列疾病的預(yù)防?？迪ＶZ生物以在世界范圍內(nèi)提供預(yù)防傳染病和感染病的解決方案為己任，專(zhuān)業(yè)從事高質(zhì)量人用疫苗的研發(fā)、生產(chǎn)和商業(yè)化，是國(guó)內(nèi)領(lǐng)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.
