港股異動 | 歌禮制藥漲12% 晚期實體瘤抑制劑ASC61臨牀試驗申請獲批
格隆匯2月7日丨歌禮制藥(1672.HK)盤中漲12.02%,報4.28港元,總市值48億港元。歌禮制藥-B2月6日公佈,歌禮完全自主研發的口服PD-L1小分子抑制劑ASC61獲美國食品藥品監督管理局(FDA)批准,開展用於治療晚期實體瘤的臨牀試驗。這是歌禮繼ASC22(恩沃利單抗)獲批開展用於慢性乙型肝炎功能性治癒的美國臨牀試驗後,在2022年獲批開展的第二個美國臨牀試驗。ASC61是一款強效、高選擇性的口服PD-L1小分子抑制劑,通過誘導PD-L1二聚體的形成和內吞,從而阻斷PD-1/PD-L1的相互作用。ASC61單藥在人源化小鼠模型等多種動物模型中表現出顯著的抗腫瘤療效。臨牀前研究顯示,ASC61在動物模型中有良好的安全性和藥代動力學特徵。

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