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恒瑞医药回应“双艾”组合再次延迟批准上市:未涉及产品安全性及有效性

恒瑞医药公告公司收到美国食品药品监督管理局关于注射用卡瑞利珠单抗联合甲磺酸阿帕替尼片用于不可切除或转移性肝细胞癌患者的一线治疗的生物制品许可申请的完整回复信。这也���“双艾”组合第三次被FDA延迟批准上市。对此,恒瑞医药回应称,“稳步推进国际化是公司的长期发展战略,公司多项创新药的海外研发进程均按计划持续推进中。此次CRL未涉及对产品临床研究数据、安全性及有效性方面的问题。公司将积极与FDA及合…

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