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中国生物制药(01177.HK):抗肿瘤药“注射用硼替佐米”获通过一致性评价
格隆汇 01-22 17:07

格隆汇 1 月 22日丨中国生物制药(01177.HK)发布公告,集团的抗肿瘤药“注射用硼替佐米”(商品名:千平)(规格:1.0mg和3.5mg)已获中国国家药品监督管理局颁发药品补充申请批准通知书,通过了仿制药质量和疗效一致性评价。

硼替佐米是一种蛋白酶体抑制剂,具靶向性抗肿瘤作用,适用于治疗多发性骨髓瘤(MM)及套细胞淋巴瘤(MCL)。硼替佐米是骨髓瘤治疗的基石药物,以硼替佐米为基础的联合方案在骨髓瘤治疗的一线地位不可撼动,尤其对于高危及肾功能不全患者。硼替佐米适用于多发性骨髓瘤的各种人群及各个治疗阶段,在延长骨髓瘤患者生存率方面有显着疗效。

目前原研进口的硼替佐米价格高昂,一定程度上限制了国内患者的使用。集团的千平获通过一致性评价,可成为进口制剂的替代产品,为临床医生提供治疗骨髓瘤和套细胞淋巴瘤又一重要选择,并大幅降低患者的治疗费用。

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