中生制药(01177.HK)将为创新药递交ASPS适应症上市申请

阿斯达克财经

2024-12-19

中生制药(01177.HK) 公布，集团自主研发的1类创新药贝莫苏拜单抗注射液联合盐酸安罗替尼胶囊，已向中国药监局(NMPA)药品审评中心(CDE)就新增晚期腺泡状软组织肉瘤(ASPS)适应症的上市申请进行沟通，并获得CDE书面同意提交上市申请。集团将于近期递交上市申请。
ASPS是安罗替尼即将申报上市的第12个适应症、贝莫苏拜单抗即将申报上市的第5个适应症，有望为ASPS患者带来新的治疗选择。
贝莫苏拜单抗联合安罗替尼有望成为中国首个获批用于ASPS的PD-L1抑制剂与小分子抗血管生成药物联合疗法。(sl/da)(港股报价延迟最少十五分钟。沽空资料截至 2024-12-19 16:25。)

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