信达生物(01801)癌症新药拟纳入突破性治疗品种

智通财经
23 Mar

智通财经APP获悉,3月21日,中国国家药监局药品审评中心(CDE)官网最新公示,信达生物(01801)申报的1类新药IBI363拟纳入突破性治疗品种,用于既往未经过系统性治疗的不可切除局部晚期或转移性肢端型及黏膜型恶性黑色素瘤。

IBI363是信达生物在研的一款PD-1/IL-2α-bias双特异性抗体融合蛋白。针对本次拟纳入突破性治疗品种的适应症,信达生物已经于今年3月初启动IBI363的关键注册研究,同时这也是IBI363的首个关键注册临床研究。

IBI363是由信达生物自主研发的PD-1/IL-2α-bias双特异性抗体融合蛋白,同时具有阻断PD-1/PD-L1通路和激活IL-2通路两项功能。

根据信达生物此前新闻稿,IBI363在前期研究中已在未经免疫治疗的黑色素瘤上展现出了突破性疗效信号。

公开资料显示,黑色素瘤病死率高,发病率也在逐年增加。既往未接受免疫治疗的黑色素瘤患者生存期较短,存在较大未满足的临床需求。非皮肤型黑色素瘤(尤其是黏膜型)是对免疫治疗不敏感的“冷肿瘤”,临床获益更加有限,亟待更加有效的治疗手段。

IBI363通过PD-1与IL-2的双重机制,将“冷肿瘤”转化为“热肿瘤”,且在1a/1b期和2期研究中已展现出令人鼓舞的疗效和良好的耐受性,有望成为针对恶性黑色素瘤的新型免疫疗法。

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