恒瑞医药(600276.SH)：舒地胰岛素注射液获批上市该产品是中国首个自主研发的长效胰岛素类似物

智通财经07-29 20:14

智通财经APP讯，恒瑞医药(600276.SH)发布公告，公司近日，公司收到国家药品监督管理局的通知，批准公司自主研发的1类治疗用生物制品舒地胰岛素注射液上市，用于治疗成人2型糖尿病(T2DM)。该产品是中国首个自主研发的长效胰岛素类似物。

舒地胰岛素注射液是公司自主研发的基础长效胰岛素，具备起效平稳、药效维持时间长和产生夜间性低血糖风险低等优点。本次获批主要基于舒地胰岛素(研发代号：INS068)治疗成人T2DM患者的两项关键Ⅲ期临床试验：INS068-301研究和INS068-302研究。结果显示：在两种不同治疗背景(基础胰岛素或口服降糖药血糖控制不佳)的中国T2DM患者中，舒地胰岛素在血糖控制方面均显示出与甘精胰岛素整体相当的疗效，且夜间低血糖风险低于甘精胰岛素。

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恒瑞医药(600276.SH)：舒地胰岛素注射液获批上市 该产品是中国首个自主研发的长效胰岛素类似物

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恒瑞医药(600276.SH)：舒地胰岛素注射液获批上市该产品是中国首个自主研发的长效胰岛素类似物