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司太立(603520.SH):子公司申報的碘帕醇注射液已獲審批通過
格隆匯 05-14 19:08

格隆匯5月14日丨司太立(603520.SH)在股票交易異常波動公告中稱,2020年5月14日,國家藥品監督管理局網站發佈通知,公司下屬全資子公司上海司太立製藥有限公司申報的碘帕醇注射液已獲審批通過,目前尚未收到註冊批件,公司將積極關注後續進展並及時履行信息披露業務。

經公司核實,因前述公司與恆瑞醫藥簽訂藥品合作協議事項,近日出現部分與此相關的媒體報道,可能對公司股價造成一定影響。除此之外,公司未發現其他可能導致公司股價產生較大波動的市場傳聞、熱點概念等。

公司與恆瑞醫藥簽署的協議涉及的合作產品碘帕醇注射液已獲得審批通過,處於待制證狀態,碘海醇注射液的註冊申請尚處於受理待批階段,由於醫藥產品具有高科技、高風險、高附加值的特點,容易受到一些不確定性因素的影響,存在一定的不確定性,能否順利獲得藥監部門藥品註冊批件尚存在不確定性。協議雖約定合作產品的定價機制及利潤分配,但後續合作產品獲批後,恆瑞醫將根據商業化推廣的情況向公司提供具體的採購訂單以及公司根據合作產品的製造成本,最終確定合作產品的具體的採購價格及數量,並根據商業化推廣的實際銷售情況來確定具體的收益情況,因此該協議對公司業績的影響存在不確定性。

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