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復宏漢霖-B(02696.HK):HLX15用於多發性骨髓瘤治療的臨試申請獲國藥監局受理
格隆匯 11-12 17:54

格隆匯 11 月 12日丨復宏漢霖-B(02696.HK)宣佈,近日,公司研製的用於多發性骨髓瘤("MM")治療的重組抗CD38全人單克隆抗體注射液HLX15("HLX15")的臨牀試驗申請獲國家藥監局受理。

公告稱公司自主研發的HLX15是達雷妥尤單抗注射液(中文商品名:兆珂®)的生物類似藥,擬用於MM的治療。達雷妥尤單抗是一種人源化的抗CD38的IgG1κ單克隆抗體,其可與腫瘤細胞表面表達的CD38結合,通過補體依賴的細胞毒作用(CDC)、抗體依賴性細胞介導的細胞毒作用(ADCC)和抗體依賴性細胞吞噬作用(ADCP)、以及Fcγ受體等多種免疫相關機制誘導腫瘤細胞凋亡。除此之外,達雷妥尤單抗還可通過降低髓源性抑制細胞和消耗CD38表達陽性的免疫調節性T、B細胞來達到減少MM細胞的作用。達雷妥尤單抗於2015年11月獲美國食品藥品管理局(FDA)批准上市,用於MM的治療,其皮下注射製劑於2020年5月獲批上市。2019年7月,國家藥監局批准達雷妥尤單抗注射液上市,用於單藥治療復發和難治性MM成人患者。根據《生物類似藥研發與評價技術指導原則(試行)》,公司對HLX15與原研藥達雷妥尤單抗注射液進行了藥學和體內外藥理學全面的頭對頭比較研究。研究結果表明,HLX15與達雷妥尤單抗注射液高度相似。

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