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和黃醫藥(00013.HK)與信達生物宣佈呋喹替尼聯合信迪利單抗用於治療晚期腎細胞癌的中國新藥上市申請獲受理

格隆匯6月5日丨和黃醫藥(00013.HK)和信達生物聯合宣佈呋喹替尼(fruquintinib)和信迪利單抗(sintilimab)聯合療法用於治療既往接受過一種酪氨酸激酶抑制劑治療失敗的局部晚期或轉移性的腎細胞癌患者的新藥上市申請已獲中國國家藥品監督管理局(“國家藥監局”)受理。

和黃醫藥研發負責人兼首席醫學官石明博士表示:“腎癌在中國仍是一項重大挑戰,對於一線治療失敗的患者而言,治療選擇十分有限。此次提交呋喹替尼聯合信迪利單抗用於晚期腎細胞癌的新藥上市申請,是我們解決這一未被滿足醫療需求的重要一步。我們致力推動這一聯合療法惠及腎細胞癌患者。與此同時,我們將持續研究以挖掘該聯合療法更大的潛力,並推進我們管線中其他產品在多個癌症領域的應用,爲更多患者帶來創新且有效的治療選擇。”

信達生物高級副總裁周輝博士表示:“很高興看到信迪利單抗聯合呋喹替尼的第二項新藥上市申請獲受理,有望爲中國晚期腎細胞癌患者提供更有效二線治療選擇。這也是信迪利單抗(達伯舒®)的第10項受理的新藥上市申請,進一步鞏固了其作爲免疫腫瘤(IO)治療的基石藥物的領先地位,同時也是信達生物對於該品種在生命週期管理和最大化其臨牀價值方面的重要里程碑。”

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