复宏汉霖-B(02696.HK):HLX15用于多发性骨髓瘤治疗的临试申请获国药监局受理
格隆汇 11 月 12日丨复宏汉霖-B(02696.HK)宣布,近日,公司研制的用于多发性骨髓瘤("MM")治疗的重组抗CD38全人单克隆抗体注射液HLX15("HLX15")的临床试验申请获国家药监局受理。
公告称公司自主研发的HLX15是达雷妥尤单抗注射液(中文商品名:兆珂®)的生物类似药,拟用于MM的治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体,其可与肿瘤细胞表面表达的CD38结合,通过补体依赖的细胞毒作用(CDC)、抗体依赖性细胞介导的细胞毒作用(ADCC)和抗体依赖性细胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外,达雷妥尤单抗还可通过降低髓源性抑制细胞和消耗CD38表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作用。达雷妥尤单抗于2015年11月获美国食品药品管理局(FDA)批准上市,用于MM的治疗,其皮下注射制剂於2020年5月获批上市。2019年7月,国家药监局批准达雷妥尤单抗注射液上市,用于单药治疗复发和难治性MM成人患者。根据《生物类似药研发与评价技术指导原则(试行)》,公司对HLX15与原研药达雷妥尤单抗注射液进行了药学和体内外药理学全面的头对头比较研究。研究结果表明,HLX15与达雷妥尤单抗注射液高度相似。
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