復宏漢霖(02696.HK)創新型單抗H藥漢斯狀®獲批治療鱗狀非小細胞肺癌
2022年11月1日,上海——復宏漢霖(2696.HK)宣佈,旗下首款自主研發的創新生物藥抗PD-1單抗H藥——漢斯狀®(通用名:斯魯利單抗注射液)新適應症上市申請獲得國家藥品監督管理局(NMPA)批准,聯合卡鉑和白蛋白紫杉醇用於一線治療不可手術切除的局部晚期或轉移性鱗狀非小細胞肺癌(sqNSCLC)新適應症,為肺鱗癌患者提供了用藥新選擇。此前,H藥已獲批治療微衞星高度不穩定 (MSI-H) 實體瘤,廣泛的適應症佈局推動更多患者獲益。
肺癌是全球最常見癌症之一,是中國發病率和死亡率最高的惡性腫瘤。近年來,免疫檢查點抑制劑在臨牀治療中取得了諸多突破,在NSCLC方面也獲得了長足的發展,尤其是抗PD-1單抗聯合卡鉑+白蛋白紫杉醇治療晚期或轉移性sqNSCLC已獲得NCCN、CSCO等國內外權威指南推薦,並推動晚期NSCLC進入免疫治療時代。H藥的獲批將為該病理亞型帶來新的用藥選擇,促進免疫治療在肺癌臨牀治療中更廣泛的應用,也進一步助力肺癌治療創新發展。
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