康恩貝(600572.SH):複方磺胺甲噁唑片通過仿製藥一致性評價
格隆匯 6 月 23日丨康恩貝(600572.SH)公佈,近日,公司控股子公司浙江金華康恩貝生物製藥有限公司(“金華康恩貝”)收到國家藥品監督管理局(“國家藥監局”)頒發的關於複方磺胺甲噁唑片的《藥品補充申請批件》,該藥品通過仿製藥一致性評價。
複方磺胺甲噁唑片為磺胺類抗菌藥,是磺胺甲噁唑(SMZ)與甲氧苄啶(TMP)的複方製劑,已列入《國家醫保目錄(2019年版)》,類別為甲類藥品。主要用於預防或治療敏感菌株所致的感染。磺胺甲噁唑與甲氧苄啶複方製劑最初由Sun Pharm INDs公司開發,於1973年經FDA批准在美國上市,劑型為片劑,包括400mg:80mg和800mg:160mg兩種規格。1996年金華康恩貝研製的複方磺胺甲噁唑片獲批上市,2018年金華康恩貝開始選取國家局公佈的參比製劑對其進行仿製藥質量和療效一致性評價研究。
截至公告披露日,金華康恩貝是國內首家通過國家藥監局一致性評價的複方磺胺甲噁唑片生產廠家。
米內網數據顯示:相應國內藥品終端市場2019年複方磺胺甲噁唑片銷售額2,946萬元。因產品原料供應、銷售價格等原因,金華康恩貝該藥品近三年未產生銷售。
截至公告披露日,金華康恩貝針對該藥品一致性評價已投入研發費用約人民幣552.71萬元。
根據國家相關政策,通過一致性評價的藥品品種在醫保支付及醫療機構採購等領域將獲得更大的支持力度。因此金華康恩貝的複方磺胺甲噁唑片通過仿製藥一致性評價,有利於該藥品開拓市場,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。
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