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中國生物製藥(01177.HK):"甲磺酸艾立布林注射液"獲批上市

格隆匯12月11日丨中國生物製藥(01177.HK)宣佈,集團開發的"甲磺酸艾立布林注射液"(商品名:艾樂林)已獲得中國國家藥品監督管理局的上市批准,用於治療既往接受過至少兩種化療方案(含蒽環類和紫杉烷類藥物)的局部晚期或轉移性乳腺癌患者。這是國內前三款獲批上市的甲磺酸艾立布林注射液。

艾立布林為人工合成的軟海綿素B結構類似物,是一種新型非紫杉烷類微管蛋白抑制劑,因其作用機制與傳統的微管抑制劑紫杉烷類不同,因此對紫杉醇耐藥後的患者仍然有效。目前,艾立布林已被納入國內外多個權威指南推薦,《中國臨牀腫瘤學會(CSCO)乳腺癌診療指南(2023版)》將艾立布林作為紫杉類治療失敗的三陰性晚期乳腺癌的單藥I級推薦,《美國國家綜合癌症網絡(NCCN)臨牀實踐指南:乳腺癌(2023V4)》認可艾立布林作為HER2陰性晚期乳腺癌的優選方案。

艾立布林分子結構的手性中心多,合成步驟長,是迄今為止醫藥工業中採用純化學合成方法生產的、結構最為複雜的非肽類藥物之一。集團憑藉深厚的研發實力和生產經驗,通過嚴謹的實驗設計、先進的製造技術和嚴格的生產控制策略,進一步提高了工藝的可控性和藥品質量的穩定性,以滿足患者對高質量藥品的需求。

在乳腺癌領域,集團已有曲妥珠單抗、哌柏西利、氟維司羣、多西他賽等多款產品獲批上市。此外,集團還有多款重磅在研創新藥,包括:TQB3616(CDK2/4/6抑制劑)已向中國國家藥品監督管理局藥品審評中心遞交上市申請,TQB2102(HER2雙抗ADC)位臨牀III期,TQB2930(HER2雙抗)位臨牀II期。集團將加速產品研發,力爭為乳腺癌患者提供更多優質的治療選擇。

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