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榮昌生物-B(09995.HK):注射用維迪西妥單抗(商品名:愛地希®)獲得NMPA在中國附條件上市批准
格隆匯 06-09 21:23

格隆匯6月9日丨榮昌生物-B(09995.HK)發佈公吿,公司自主研發的新型靶向HER2抗體偶聯物(ADC)注射用維迪西妥單抗(RC48,商品名:愛地®)於2021年6月9日正式獲得中國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)(GC)。

注射用維迪西妥單抗(RC48,商品名:愛地希®)是集團在繼今年3月份獲得注射用泰它西普獲准在國內上市後的第二款獲批上市產品,亦是集團的一項重大里程碑,體現了集團在腫瘤治療領域的成就,也彰顯了我們在生物藥領域的強大的自主研發能力,尤其是開發ADC產品的能力。

應公司要求,股份已於2021年6月9日下午3時14分於聯交所短暫停止買賣,以待刊發該公吿。公司已向聯交所申請股份自2021 年6月10日上午9時正起於聯交所恢復買賣。 

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