華森製藥(002907.SZ):“注射用甲磺酸加貝酯”首家通過仿製藥一致性評價
格隆匯8月12日丨華森製藥(002907.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的關於“注射用甲磺酸加貝酯”的《藥品補充申請批准通知書》(通知書編號:2022B03222)。
注射用甲磺酸加貝酯為急性胰腺炎急搶救用藥,臨牀必需;為國家醫保目錄產品,獲多國指南推薦;是唯一醫保報銷不受限的蛋白酶抑制劑。
公司目前是首家且唯一一家注射用甲磺酸加貝酯通過一致性評價的廠家。公司自產該品種原料藥,為原料藥製劑一體化品種,原料藥質量及供應得到保障,並且自產原料藥可以有效控制生產成本,使本品在未來集採中更具優勢。根據藥智網數據顯示,2021年注射用甲磺酸加貝酯整體市場份額為1.31億元。
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