中國生物製藥(01177.HK)"鹽酸安羅替尼膠囊"、"TQB2916(CD40激動劑)"共5項研究數據將在2024AACR公佈
格隆匯3月11日丨中國生物製藥(01177.HK)公吿,集團附屬公司正大天晴藥業集團股份有限公司("正大天晴")開發的兩款創新藥"鹽酸安羅替尼膠囊"、"TQB2916(CD40激動劑)"將在2024年美國癌症協會年會("AACR")公佈5項研究成果。
安羅替尼是正大天晴自主研發的一款口服新型小分子多靶點受體酪氨酸激酶抑制劑(TKI),能有效抑制VEGFR1-3、PDGFRα/β、FGFR1-4、c-Kit等激酶,通過調控腫瘤微環境重編程達到抑制腫瘤血管新生、抑制腫瘤生長、調控免疫微環境的作用。
2018年5月,鹽酸安羅替尼膠囊獲中國國家藥品監督管理局("NMPA")批准上市,是中國首個獲批用於晚期非小細胞肺癌三線治療的藥物。鹽酸安羅替尼膠囊已在國內獲批五個適應症:三線非小細胞肺癌、三線小細胞肺癌、軟組織肉瘤、甲狀腺髓樣癌和分化型甲狀腺癌。2023年1月,鹽酸安羅替尼膠囊的第六個適應症的上市申請獲中國國家藥品監督管理局藥品審評中心("CDE")正式受理,用於聯合貝莫蘇拜單抗"TQB2450(PD-L1抑制劑)"和化療一線治療小細胞肺癌。2024年2月,鹽酸安羅替尼膠囊的第七個適應症的上市申請獲CDE正式受理,用於聯合貝莫蘇拜單抗治療複發性或轉移性子宮內膜癌。
CD40激動劑主要通過激活抗原提呈細胞(APC)促進免疫細胞的活化發揮腫瘤抑制作用。TQB2916是靶向CD40的激動型全人源IgG2單抗。體外藥效學結果顯示TQB2916可激活B細胞和樹突狀細胞,進而激活T細胞分泌IFN-γ。臨牀前體內藥效學結果顯示TQB2916可顯著抑制動物模型的腫瘤生長。目前全球尚無CD40激動劑獲批上市,同類產品在胰腺癌、軟組織肉瘤、黑色素瘤、食管癌等領域展現出有潛力的開發前景。
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