中国生物制药(01177.HK):"注射用盐酸苯达莫司汀"获药品注册批件
格隆汇12月11日丨中国生物制药(01177.HK)公告,公司附属公司正大天晴药业集团股份有限公司开发的抗肿瘤药"注射用盐酸苯达莫司汀",已获中华人民共和国国家药品监督管理局颁发药品注册批件。该产品适用于治疗利妥昔单抗或含利妥昔单抗方案治疗过程中或者治疗后病情进展的惰性B细胞非霍奇金淋巴瘤。该产品是按照化药新3类申报,视同通过仿制药质量和疗效一致性评价,国内首仿获批。这一重磅产品获批上市,将进一步丰富和完善本集团血液肿瘤产品线布局。
盐酸苯达莫司汀是一种双功能基烷化剂,具有抗肿瘤和杀细胞作用。作为新一代抗癌药物,盐酸苯达莫司汀具有毒性低,活性高,抗瘤谱广,患者易耐受、可长期使用的特点。盐酸苯达莫司汀单药或联合治疗方案已被欧美临床指南指定为多种血液系统恶性肿瘤的一线或二线治疗选择。目前国内只有进口注射用盐酸苯达莫司汀上市。
集团开发的注射用盐酸苯达莫司汀,处方组成与原研产品相同,疗效与原研产品相当;日后上市,将可降低患者治疗成本,减轻其用药的经济压力。
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