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Thursday, October 15, 2026

再多一款新藥在「1+」機制下獲批註冊

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政府表示,再有一款新藥在「1+」藥物審批機制下獲批註冊,用於轉移型激素敏感型前列腺癌,令機制下獲批註冊新藥增加至23款。

發言人說,有關新藥已獲中國內地的藥物監管機構批核,並在「1+」機制下提交註冊申請。香港藥劑業及毒藥管理局轄下的註冊委員會,在對申請人提交的臨床數據及相關資料作出審評及經徵詢本地專家意見後,認為該款新藥符合相關安全、效能及素質標準,批准在香港註冊。衞生署已通知申請人有關審批結果。

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