恒瑞ADC新药拟纳入突破性疗法|华东医药自研ADC新药两项适应症获FDA孤儿药资格认定

中国医药创新促...
Dec 22, 2025

新药审批华东医药 注射用HDM201212月15日,华东医药子公司中美华东自主研发的ADC创新药注射用HDM2012的胃癌和胃食管交界癌、胰腺癌两项适应症获得美国食品药品监督管理局(FDA)孤儿药资格认定。海思科HSK45019片 HSK50042片 注射用HSK5571812月15日,HSK45019片、HSK50042片获批临床,适应症分别为拟开发治疗炎症性肠病(包括溃疡性结肠炎和克罗恩病)和...

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