沃森生物(300142.SZ):子公司二價HPV疫苗申請新藥生產的藥品註冊申請獲受理
格隆匯 6 月 15日丨沃森生物(300142.SZ)公佈,公司控股子公司上海澤潤生物科技有限公司(“上海澤潤”)擁有自主知識產權研發的“重組人乳頭瘤病毒雙價(16/18型)疫苗(酵母)”(“二價HPV疫苗”)於2020年4月完成了Ⅲ期臨牀研究並獲得了《臨牀試驗報告》(詳見公司於2020年5月1日在巨潮資訊網披露的2020-046號公告)。該疫苗將由上海澤潤全資子公司玉溪澤潤生物技術有限公司(“玉溪澤潤”)進行產業化生產,根據《疫苗管理法》等相關法律法規的規定,玉溪澤潤向國家藥品監督管理局提交了該疫苗的新藥生產申請並於2020年6月15日收到國家藥品監督管理局出具的《受理通知書》,受理號:CXSS2000024國和CXSS2000025國(西林瓶和預灌封兩個劑型)。
上海澤潤研發的二價HPV疫苗用於預防由HPV16型和18型病毒感染導致的子宮頸癌。目前,全球已上市銷售的HPV疫苗包括英國葛蘭素史克公司(GSK)的二價HPV疫苗、美國默沙東公司的四價HPV疫苗和九價HPV疫苗以及我國廈門萬泰滄海生物技術有限公司的二價HPV疫苗。根據GSK和默沙東兩家公司的年報,2019年HPV系列疫苗全球銷售額合計約38億美元。
根據國家藥品註冊管理相關法規,玉溪澤潤二價HPV疫苗申請新藥生產獲得受理後,還需經過技術審評、藥品註冊核查、藥品註冊檢驗等程序。該疫苗申請新藥生產獲得受理通知書對公司近期業績不會產生重大影響。該疫苗後續藥品註冊申請審評審批的進展和時間具有一定的不確定性。公司對該疫苗申請新藥生產的後續進展將嚴格按規定及時履行信息披露義務。敬請廣大投資者謹慎決策,注意投資風險。
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