沃森生物(300142.SZ):二價HPV疫苗收到註冊現場核查通知
格隆匯 12 月 31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的全資子公司玉溪澤潤生物技術有限公司(“玉溪澤潤”)申請上市許可的“重組人乳頭瘤病毒雙價(16/18型)疫苗(酵母)”(“二價HPV疫苗”或“本疫苗”)於2020年12月31日收到國家藥品監督管理局藥品審評中心發來的《藥審中心關於啟動重組人乳頭瘤病毒雙價(16/18型)疫苗(酵母)註冊現場核查的通知》。根據《藥品註冊管理辦法》有關規定,藥審中心需對玉溪澤潤申報註冊的二價HPV疫苗(受理號:CXSS2000024、CXSS2000025)啟動藥品註冊核查(藥學)。
公司子公司研發的二價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。
玉溪澤潤收到二價HPV疫苗《註冊現場核查通知》,表明本疫苗的藥品注冊上市許可申請工作取得了重要進展,即將開始註冊現場核查。在通過國家藥品監督管理局的審評審批後,本疫苗方可取得藥品註冊批件。
玉溪澤潤收到二價HPV疫苗《註冊現場核查通知》對公司近期業績不會產生重大影響。本疫苗藥品註冊批件的最終審批結果和審批完成時間具有一定的不確定性。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.