中國生物製藥(01177.HK)：貝莫蘇拜單抗注射液聯合鹽酸安羅替尼膠囊治療子宮內膜癌適應症獲批上市
格隆匯11月27日丨中國生物製藥(01177.HK)宣佈，集團自主研發的1類創新藥貝莫蘇拜單抗注射液聯合鹽酸安羅替尼膠囊已獲得中國國家藥品監督管理局批准用於既往系統性抗腫瘤失敗且不適合進行根治性手術治療或根治性放療的非微衞星高度不穩定(非MSI-H)或非錯配修復基因缺陷(非dMMR)的複發性或轉移性子宮內膜癌的治療。這是貝莫蘇拜單抗注射液在中國獲批的第二個適應症，是鹽酸安羅替尼膠囊在中國獲批的第七個適應症。
2024年國際婦科腫瘤學會(IGCS)年會上公佈了貝莫蘇拜單抗注射液聯合鹽酸安羅替尼膠囊治療複發性或轉移性子宮內膜癌的II期研究(ETER200/ NCTO4574284)的部分數據：截至2024年5月9日，該研究隊列一共入組85例患者，客觀緩解率(ORR)為34.1%，其中2例患者實現完全緩解(CR)，27例患者實現部分緩解(PR)，37例患者病情穩定(SD)，疾病控制率(DCR)為77.7%，mPFS為8.8個月，mOS為21.8個月。該結果表明，貝莫蘇拜單抗注射液聯合鹽酸安羅替尼膠囊對子宮內膜癌具有良好的抗腫瘤效果。
子宮內膜癌是女性常見的惡性腫瘤，其發病率位居中國女性生殖系統惡性腫瘤的第二位，在發達國家居首位。隨着高脂、高熱飲食模式的日益普遍，不健康的生活方式逐步蔓延，子宮內膜癌的發病率不斷上升，尤其在中國呈明顯年輕化趨勢。2016年，中國子宮內膜癌新發病例數超過7萬。目前，國內子宮內膜癌的一線治療方案為含鉑化療，然而，對於一線治療後進展的患者，臨牀尚無標準治療方案，患者的治療選擇有限，預後較差，亟需有效的治療手段。
除獲批適應症外，貝莫蘇拜單抗注射液與鹽酸安羅替尼膠囊的聯合療法正在開展多項III期臨牀試驗，涵蓋一線非小細胞肺癌、非小細胞肺癌放化療後維持、一線腎癌等多個重要領域。集團將繼續大力推進創新產品的開發，充分挖掘產品潛力，力爭為更多患者提供更優的治療方案。
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