智通财经APP讯，石药集团(01093)发布公告，公司附属公司石药集团巨石生物制药有限公司开发的治疗用生物制品3.3类注射用奥马珠单抗(商品名：恩益坦®)(该产品)用于治疗中至重度持续性过敏性哮喘的新适应症已获得中华人民共和国国家药品监督管理局上市许可批准。这是恩益坦®在中国获批的第二个适应症。
恩益坦®是集团开发的人免疫球蛋白E(IgE)人源化单克隆抗体，为茁乐®的生物类似药。该产品遵循生物类似药相关的研究指南，通过药学、非临床、并且采用“头对头”的药代动力学比对和慢性自发性荨麻疹患者人群的临床等效性试验等一系列逐步递进的研究，科学、严谨、全面、系统地确证了恩益坦®与原研药(茁乐®)在品质、安全性和有效性方面的高度相似性。
恩益坦®是国内首个以生物制品3.3类注册分类获批上市的奥马珠单抗生物类似药。先前已获批的适应症为用于治疗采用H1抗组胺药治疗后仍有症状的成人和青少年(12岁及以上)慢性自发性荨麻疹患者。
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