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恒瑞醫藥(600276.SH):與印度瑞迪博士實驗室簽署馬來酸吡咯替尼片授權許可協議
格隆匯 10-08 15:54

格隆匯10月8日丨恒瑞醫藥(600276.SH)公佈,公司)與印度瑞迪博士實驗室(簡稱“Dr.Reddy's”)達成協議,將具有自主知識產權的靶向藥物馬來酸吡咯替尼片項目有償許可給Dr.Reddy's。Dr.Reddy's將向恒瑞支付累計不超過1.525億美元的銷售里程碑款。Dr.Reddy's將向恒瑞支付達到實際年淨銷售額兩位數比例的銷售提成。

吡咯替尼(商品名艾瑞妮)是恒瑞自主研發並擁有知識產權的口服HER1、HER2、HER4酪氨酸激酶抑制劑,是中國首個自主研發的抗HER1/HER2/HER4靶向藥。2018年,吡咯替尼憑藉Ⅱ期臨牀研究獲國家藥品監督管理局附條件批准上市,是實體瘤領域中國首個憑藉Ⅱ期臨牀研究獲附條件批准上市的創新藥。2019年,吡咯替尼被納入國家醫保目錄;2020年,吡咯替尼憑藉兩項重要Ⅲ期研究(PHENIX、PHOEBE)結果獲得完全批准上市,聯合卡培他濱用於治療HER2陽性、接受過曲妥珠單抗治療的復發或轉移性乳腺癌患者。2022年,吡咯替尼獲批第二個適應症,聯合曲妥珠單抗和多西他賽用於HER2陽性早期或局部晚期乳腺癌患者的新輔助治療。2023年,吡咯替尼獲批第三個適應症,與曲妥珠單抗和多西他賽聯合,適用於治療HER2陽性、晚期階段未接受過抗HER2治療的復發或轉移性乳腺癌患者。

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