中国生物制药贝莫苏拜单抗注射液新增适应症上市申请获CDE书面同意
财中社12月19日电中国生物制药（01177）发布公告，宣布其自主研发的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国家药品监督管理局（NMPA）药品审评中心（CDE）申请新增晚期腺泡状软组织肉瘤（ASPS）适应症的上市申请，并获得CDE书面同意。此次申请将为ASPS患者提供新的治疗选择，ASPS是一种极为罕见且恶性程度较高的软组织肉瘤，全球发病率低于1/100万，现有治疗手段非常有限，5年总生存率仅为20%~46%。
安罗替尼将成为针对ASPS的第12个适用药物，而贝莫苏拜单抗则是其第5个适用药物。公司将持续推进贝莫苏拜单抗和安罗替尼的开发，旨在为更多患者带来新的治疗选择。
（文章来源：财中社）
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