恆瑞醫藥(600276.SH):碘克沙醇注射液通過一致性評價
格隆匯5月11日丨恆瑞醫藥(600276.SH)宣佈,公司近日收到國家藥監局核准簽發的關於碘克沙醇注射液的《藥品補充申請批准通知書》,公司碘克沙醇注射液通過仿製藥質量和療效一致性評價。
碘克沙醇注射液為X-線對比劑,適用於成人的心血管造影、腦血管造影、外周動脈造影、腹部血管造影、尿路造影以及CT增強檢查;兒童心血管造影、尿路造影和CT增強檢查。
碘克沙醇注射液最初由挪威奈科明製藥有限公司開發,1996年經美國食品藥品監督管理局批准在美國上市。2001年,碘克沙醇注射液(商品名:威視派克)經國家藥監局批准進口上市。除公司外,國內已有揚子江藥業、南京正大天晴、北京北陸藥業等多家企業獲批生產,其中揚子江藥業、正大天晴藥業、上海司太立3家通過(或視同於通過)仿製藥一致性評價。
經查詢,2019年碘克沙醇注射劑全球銷售額約為6.88億美元,暫未查到2020年度銷售數據。截至目前,碘克沙醇注射液(規格:100ml:27g(I))在仿製藥一致性評價項目上累計研發投入857萬元。
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