港股异动 | 映恩生物-B(09606)再涨超8% DB-1418获FDA授予快速通道资格 同时在中国获批临床

智通财经
Nov 13, 2025

智通财经APP获悉,映恩生物-B(09606)再涨超8%,截至发稿,涨7.36%,报329.6港元,成交额6.58亿港元。

消息面上,11月11日,映恩生物宣布DB-1418获美国FDA授予快速通道资格,针对不可切除的局部晚期或转移性非小细胞肺癌(NSCLC)患者的治疗适应症。11月12日,中国国家药监局药品审评中心(CDE)官网公示,映恩生物1类新药注射用DB-1418获批临床,拟开发治疗晚期/转移性恶性实体瘤。

公开资料显示,今年1月,映恩生物与Avenzo Therapeutics就双特异性ADC产品AVZO-1418/DB-1418达成全球开发合作。DB-1418/AVZO-1418是映恩生物开发的EGFR/HER3双特异性ADC。根据协议,映恩生物将获得5000万美元的首付款,并有资格获得高达11.5亿美元的开发、注册及商业化里程碑付款。同时,映恩生物还有资格获得Avenzo在其区域内的销售收入分成。

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