羅欣藥業(002793.SZ):依達拉奉注射液通過仿製藥質量和療效一致性評價
格隆匯2月9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依達拉奉注射液《藥品補充申請批准通知書》。
依達拉奉注射液是一種腦保護劑(自由基清除劑),用於改善急性腦梗死所致的神經症狀、日常生活活動能力和功能障礙,抑制肌萎縮側索硬化(ALS)所致功能障礙的進展。
依達拉奉注射液最早由日本田邊三菱製藥株式會社開發,商品名為RADICUT®,規格為20ml:30mg,於2001年06月01日在日本上市,目前原研製劑未在國內上市。山東羅欣研製的依達拉奉注射液於2018年06月首次獲准上市,批准文號:國藥準字H20183191。
根據IQVIA數據,依達拉奉注射液2020年度全球市場規模為3.0億美元(以出廠價計算);根據IQVIA及米內網數據,依達拉奉注射液2020年度國內市場規模為10.7億人民幣(以招標價計算)。
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