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科濟藥業-B(02171.HK):FDA授予CT041再生醫學先進療法(RMAT)資格用於治療CLDN18.2陽性晚期胃癌╱食管胃結合部腺癌
格隆匯 01-10 08:09

格隆匯1月10日丨科濟藥業-B(02171.HK)發佈公吿,美國食品藥品監督管理局(FDA)授予CT041再生醫學先進療法(RMAT)資格,用於治療CLDN18.2陽性的晚期胃癌╱食管胃結合部腺癌。

根據披露,CT041是一種潛在全球同類首創的、靶向CLDN18.2蛋白質的自體CAR T細胞候選產品。CT041用於治療CLDN18.2陽性實體瘤,主要治療胃癌╱食管胃結合部腺癌及胰腺癌。CT041在正在進行的臨牀試驗中表現出前景光明的治療效果及良好的安全性。公司認為,CT041有潛力成為胃癌╱食管胃結合部腺癌和胰腺癌的骨幹療法並惠及全球大量患者羣體。

RMAT資格計劃旨在幫助FDA應對滿足(1)符合RMAT資格(界定為細胞療法、組織工程治療產品、人類細胞及組織產品或使用相關療法或產品的任何聯合產品);(2)目的為治療、調節、逆轉或治癒嚴重或威脅生命的疾病或症狀;且(3)初步臨牀證據表明藥品有潛力解決有關疾病或症狀的未被滿足醫療需求的任何藥物的高效開發計劃提供協助。

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