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榮昌生物-B(09995.HK):國家藥監局(NMPA)受理注射用維迪西妥單抗用於治療HER2表達局部晚期或轉移性尿路上皮癌新藥上市申請
格隆匯 07-14 21:19

格隆匯7月14日丨榮昌生物-B(09995.HK)公吿,公司自主研發的抗HER2抗體-藥物偶聯物(ADC)注射用維迪西妥單抗(RC48,商品名:愛地希®)用於治療HER2表達局部晚期或轉移性尿路上皮癌的新藥上市申請已正式獲得國家藥品監督管理局(NMPA)受理。

這是繼注射用維迪西妥單抗(RC48,商品名:愛地希®)於2021年6月9日成功獲得國家藥品監督管理局(NMPA)在中國的附條件上市批准,用於治療局部晚期或轉移性胃癌(包括胃食管結合部腺癌(GEJ))後該藥品在中國的第二個新藥上市申請(NDA)。

這也是第一個由國內公司自主研發的在中國遞交新藥上市申請的ADC產品,用於治療HER2表達局部晚期或轉移性尿路上皮癌。

注射用維迪西妥單抗(RC48)是一款抗HER2的抗體-藥物偶聯物,針對具有大量未被滿足醫療需求的常見癌症,且是在中國第一個獲批上市的由國內公司自主研發的ADC產品。該產品已於2021年6月9日正式獲得國家藥品監督管理局(NMPA)在中國的附條件上市的批准,用於治療局部晚期或轉移性胃癌(包括胃食管結合部腺癌(GEJ))。

公司就維迪西妥單抗正在針對目前尚缺乏治療的常見HER2表達適應症實施差異化開發和商業策略,包括(i)胃癌(GC),(ii)尿路上皮癌(UC)和(iii)乳腺癌(BC),以及(iv)HER2表達的其他癌症適應症。這些治療領域的臨牀需求未被滿足,可大幅擴大維迪西妥單抗適用的患者人羣。

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