石药集团生物制品获批新适应症
财中社2月10日电石药集团（01093）发布公告，公司的附属公司石药集团巨石生物制药有限公司开发的生物制品恩益坦®（注射用奥马珠单抗）已获得中华人民共和国国家药品监督管理局的上市许可批准，用于治疗中至重度持续性过敏性哮喘的新适应症。这是恩益坦®在中国获得的第二个适应症，标志着公司在生物类似药领域的进一步发展。
恩益坦®是一种人免疫球蛋白E(IgE)人源化单克隆抗体，属于生物类似药，其研发遵循相关研究指南，通过一系列严格的药学、非临床及临床等效性试验，证实了其与原研药茁乐®在品质、安全性和有效性方面的高度相似性。值得注意的是，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，进一步增强了公司的市场竞争力。
（文章来源：财中社）
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