信达生物和 HUTCMED 的呋喹替尼和信迪利单抗治疗晚期子宫内膜癌的 NDA 在中国获得优先审评。 Innovent and HUTCHMED's NDA for fruquintinib and sintilimab to treat advanced endometrial cancer receives priority review in China.
信达生物制药与 HUTCMED 在中国联合开发的呋喹替尼和信迪利单抗治疗晚期子宫内膜癌新药上市申请已获得国家药品监督管理局(NMPA)的优先审评资格。 Innovent Biologics and HUTCHMED's joint NDA for fruquintinib and sintilimab to treat advanced endometrial cancer in China has received priority review status from the National Medical Products Administration (NMPA). 该组合旨在解决不适合接受根治性手术或放射治疗且先前全身治疗失败的患者。 The combination aims to tackle patients not eligible for curative surgery or radiation and who have failed prior systemic therapy. 该应用程序得到了 FRUSICA-1 第 2 阶段研究数据的支持。 The application is supported by data from a Phase 2 FRUSICA-1 study.