智通财经APP获悉,12月16日,信达生物(01801)和礼来共同宣布,就礼来非共价(可逆)BTK抑制剂捷帕力®(匹妥布替尼100毫克和50毫克片剂)在中国内地的权益达成以下合作协议:信达生物将负责捷帕力的进口、销售、推广和分销工作;礼来将负责捷帕力的研发和上市后医学事务相关工作。
匹妥布替尼片是一种高选择性布鲁顿酪氨酸激酶(BTK)抑制剂,采用新型非共价结合机制,可以在既往接受过共价BTK抑制剂治疗的套细胞淋巴瘤(MCL)患者中重新建立 BTK 抑制作用,并持续获益,有效解决这部分患者未被满足的临床需求。
匹妥布替尼于2023年1月获得美国FDA批准,并于2024年10月获得中国NMPA批准,单药适用于既往接受过至少两种系统性治疗(含BTK抑制剂)的复发或难治性套细胞淋巴瘤(MCL)成人患者。
礼来正在全球(包括中国)开展多项匹妥布替尼的3期临床研究,包括初治及复发/难治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)的和未经BTK抑制剂治疗的复发/难治MCL等,探索单药或联合治疗的潜力。
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