智通财经APP讯,联邦制药(03933)发布公告,公司全资附属公司珠海联邦生物医药有限公司申报的利拉鲁肽注射液(规格:3ml:18mg(预填充))通过中国国家药品监督管理局药品注册审批,药品批准文号 S20250014。
利拉鲁肽注射液是一种重组人胰高血糖素样肽-1(GLP-1)类似物,适用于成人 2 型糖尿病患者控制血糖;及单用二甲双胍或磺脲类药物最大可耐受剂量治疗后血糖仍控制不佳的患者,与二甲双胍或磺脲类药物联合应用。一天注射一次即可满足患者的降糖需求。
于2024年12月,珠海联邦生物医药有限公司及其申报的利拉鲁肽注射液、德谷胰岛素注射液及司美格鲁肽注射液经中国国家药品监督管理局批复,成为广东省第一批生物制品分段生产企业和试点品种。通过创新生产模式,提升生产效率及产品质量,保障市场稳定供应,同时惠及广大患者。
围绕 GLP-1 靶点,公司已布局创新药和生物类似药相结合的差异化产品管线,有助于提升公司于生物医药领域市场竞争力。未来,公司将持续致力于新产品研发,预期将为公司及其股东创造更大收益。
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