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海創藥業(688302.SH):口服PROTAC藥物HP568片用於治療ER+/HER2-晚期乳腺癌的臨牀試驗申請獲得美國FDA批准
格隆匯 12-30 15:42

格隆匯12月30日丨海創藥業(688302.SH)公佈,收到美國食品藥品監督管理局(簡稱“FDA”)的臨牀研究繼續進行通知書(StudyMayProceedNotification),公司自主研發的HP568片用於治療雌激素受體(EstrogenReceptor,ER)陽性和人表皮生長因子受體2(HumanEpidermalGrowthFactorReceptor,HER2)陰性的晚期乳腺癌(ER+/HER2-晚期乳腺癌)的臨牀試驗申請正式獲得FDA批准。此前,HP568片中國同適應症的臨牀試驗申請已於2024年10月獲得中國國家藥品監督管理局批准。經查詢,截至本公吿披露日,國內外無同類PROTAC產品獲批上市。

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