羅欣藥業(002793.SZ):注射用福沙匹坦雙葡甲胺獲得藥品註冊證書
格隆匯6月10日丨羅欣藥業(002793.SZ)公佈,公司下屬子公司山東羅欣藥業集團股份有限公司(“山東羅欣”)於近日收到國家藥品監督管理局核准簽發的注射用福沙匹坦雙葡甲胺《藥品註冊證書》。
注射用福沙匹坦雙葡甲胺是一種神經激肽1(NK1)受體拮抗劑,是阿瑞匹坦的前藥,該產品為注射用凍乾粉針劑,相較於口服阿瑞匹坦,對於一些有與疾病相關噁心無法接受口服給藥的患者,使用注射給藥能夠提供更大的靈活性和便利性。該產品與其他止吐藥物聯合給藥,適用於成年患者預防高度致吐化療藥物(HEC)初次和重複治療過程中出現的急性和遲發性噁心和嘔吐。
注射用福沙匹坦雙葡甲胺最早是由MERCK AND CO INC開發,於2008年1月先後在歐洲和美國上市,原研製劑未在國內上市。
福沙匹坦雙葡甲胺於2019年10月被列入中國《第一批鼓勵仿製藥品目錄》。山東羅欣於2015年9月14日獲得注射用福沙匹坦雙葡甲胺的藥物臨牀試驗批件,2018年10月完成臨牀試驗,於2019年11月向國家藥品監督管理局藥品審評中心申報生產並獲得受理。
根據IQVIA數據,2021年度注射用福沙匹坦雙葡甲胺的全球市場規模為1.58億美元(以出廠價計算);根據IQVIA及米內網數據,2021年度注射用福沙匹坦雙葡甲胺的國內市場規模為5.06億人民幣(以招標價計算)。
注射用福沙匹坦雙葡甲胺獲得藥品註冊證書,視同通過一致性評價,將提高公司在抗腫瘤領域的市場競爭力,進一步豐富了公司的產品線,有利於提升公司的市場競爭力,對公司產生積極影響。公司將根據市場需求情況,着手安排生產銷售。
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