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          沃森生物13價肺炎結合疫苗進入優先審評通道

                 肺炎球菌感染引起的疾病包括肺炎、腦膜炎、菌血癥、中耳炎、鼻竇炎和氣管炎等,肺炎球菌疾病是對人類健康的重大威脅。根據WHO的數據,全球每年有160萬人死于肺炎球菌疾病,包括70-100萬5歲以下的兒童。我國每年死于肺炎球菌疾病的5歲以下嬰幼兒每年高達3萬名,肺炎球菌疾病是我國5歲以下嬰幼兒面臨的重大威脅。
                  云南沃森生物技術股份有限公司(以下簡稱“公司”或 “沃森生物”) 自主知識產權研發的13 價肺炎球菌多糖結合疫苗 (以下簡稱“ 13 價肺炎結合疫苗”或“本疫苗”) 申請新藥生產于 2018 年 2 月 1 日 獲得國家食品藥品監督管理總局(以下簡稱 “CFDA” )出具的《受理通知書》,受理號: CXSS1800003 國。 公司根據《總局關于鼓勵藥品創新實行優先審評審批的意見》的有關程序,申請將本疫苗納入優先審評審批。 2018 年 3 月 28 日 , CFDA 藥品審評中心官網公示了擬納入優先審評品種(第二十七批),本疫苗在該批公示名單中。 2018 年 4 月 9 日, 根據 CFDA 藥品審評中心官網信息顯示, 公司 13 價肺炎結合疫苗已正式被納入優先審評品種。 根據國家優先審評審批的規定, CFDA 藥品審評中心對列入優先審評審批的藥品注冊申請,將優先配置資源進行審評。
                  本次沃森生物的13價肺炎結合疫苗納入優先審評程序,將有利于國產13價肺炎結合疫苗迅速上市,打破國外疫苗公司在嬰幼兒肺炎結合疫苗領域的壟斷局面,并將對我國乃至全球的嬰幼兒肺炎球菌疾病預防產生深遠的影響。目 前,公司 13 價肺炎結合疫苗正在 CFDA 藥品審評中心進行技術審評,后續還需經過臨床試驗注冊現場檢查、生產現場檢查等程序,在獲得 CFDA 頒發的藥品注冊批件并通過 GMP 認證后即能組織產品生產,產品獲得批簽發合格證后即可上市銷售。
                  據了解,13價肺炎結合疫苗是全球銷售額最大的疫苗品種,2016年銷售額接近58億美元,目前僅有美國輝瑞公司獨家生產銷售。沃森生物13價肺炎結合疫苗的成功上市,將打破國外疫苗巨頭在嬰幼兒肺炎疫苗領域的壟斷,對中國、對世界均具有里程碑的意義。現如今,中美貿易戰烽煙乍起,國產產品無論是從推崇度還是性價比都愈將凸顯。在WHO大宗采購的疫苗目錄中,肺炎球菌結合疫苗位居最高優先級,是全球急需的疫苗品種,據預測僅GAVI大宗采購的需求即達到2億劑/年,其中供應缺口高達1億劑/年。沃森生物13價肺炎結合疫苗上市后,沃森生物將成為全球唯一同時具有23價肺炎球菌多糖疫苗與13價肺炎球菌結合疫苗上市的企業,將極大地改變全球肺炎疫苗市場的競爭格局。
                  沃森生物的13價肺炎結合疫苗的研發歷經十余年,該疫苗是在國家科技部“十一五”國家科技支撐計劃課題“細菌多糖-蛋白質結合關鍵技術及其應用研究”及國家科技部“艾滋病和病毒性肝炎等重大傳染病防治專項”課題“細菌多糖結合疫苗平臺技術的研發”支持下取得的重大自主創新科技成果,也是國家發改委“2012年蛋白類生物藥和疫苗發展專項” 項目“系列重大傳染病預防用疫苗新產品產業化能力建設” 支持產業化的重大產品。在該疫苗研發過程中,沃森生物已獲得多項13價肺炎結合疫苗核心發明專利授權,沃森生物的13價肺炎結合疫苗是具有完全自主知識產權的創新產品。同時沃森生物已建成13價肺炎結合疫苗生產車間,年產能可達千萬劑以上。在13價肺炎結合疫苗獲得生產注冊批件,生產車間通過GMP認證后即可投入生產,將極大地緩解國內13價肺炎結合疫苗的供應不足的現狀,保障我國肺炎球菌疾病預防用疫苗的供應安全。
                  沃森生物13價肺炎結合疫苗上市后,有望快速搶占國內市場并將成為國內銷售額最大的疫苗品種。一方面,其媲美輝瑞產品的國際一流產品質量與全面達到國際標準的生產質量管理體系將推動沃森生物迅速敲開國際市場的大門。供不應求的市場穩助公司擴充產能,在實現快速放量的同時大大加快云南省生物醫藥產業轉型升級,不斷將現有資源轉化為產業優勢和經濟優勢,為公司未來的盈利增長提供無限的想象空間,為云南健康產品品牌的打造,云南省生物醫藥與大健康產業的發展貢獻一己之力。另一方面,13價肺炎結合疫苗的上市,將為降低5歲以下兒童死亡率及提升人民健康水平的健康中國2030偉大目標提供助力。


                  未來,沃森生物必將始終秉承“讓人人生而健康”的企業使命,義不容辭地參與到健康事業中,不斷利用現有資源,不斷提高科技創新能力,不斷為大眾謀福祉,不斷為健康事業的發展貢獻沃森生物力量。

          股份公司品牌管理部 供稿

          凤凰彩票

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