FDA再次推迟恒瑞医药PD-1组合上市批准

华尔街见闻
21 Mar

作为中国创新药领域的先锋,恒瑞医药近年来在国际市场的拓展步伐备受瞩目。其自主研发的“双艾”产品——卡瑞利珠单抗(PD-1抑制剂)联合阿帕替尼(VEGFR抑制剂)——旨在为不可切除或转移性肝细胞癌(HCC)患者提供一线治疗方案。然而,该产品在美国市场的上市之路却一波三折。继2024年5月首次收到美国食品药品监督管理局(FDA)的完整回复函(CRL)后,恒瑞医药在今年再次收到CRL,今天恒瑞合作伙伴...

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