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恆瑞醫藥(600276.SH):SHR8058滴眼液獲批開展臨牀試驗
格隆匯 12-07 17:47

格隆匯 12 月 7日丨恆瑞醫藥(600276.SH)公佈,公司及eVENUS PHARMACEUTICAL LABORATORIES INC.近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。

根據《中華人民共和國藥品管理法》及有關規定,經審查,2020923日受理的SHR8058滴眼液符合藥品註冊的有關要求,同意開展瞼板腺功能障礙相關乾眼病的臨牀試驗。

SHR8058滴眼液是公司從Novaliq GmbH 公司 (“Novaliq 公司”)引進的NOV03(全氟己基辛烷),詳見公司於201911月披露的《恆瑞醫藥關於引進德國Novaliq公司產品的公告》SHR8058滴眼液通過在眼表面形成穩定包膜、防止淚液過強蒸發,治療與瞼板腺功能障礙相關蒸發過強型乾眼症。經查詢,除德國Novaliq公司的NovaTears在歐盟和澳大利亞已作為醫療器械上市外,目前無同機制產品上市。

截至目前,該產品累計已投入研發費用約2816萬元。

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