華潤雙鶴(600062.SH):子公司甲硝唑氯化鈉注射液通過仿製藥質量和療效一致性評價
格隆匯1月21日丨華潤雙鶴(600062.SH)公佈,近日,華潤雙鶴藥業股份有限公司全資子公司安徽雙鶴藥業有限責任公司(“安徽雙鶴”)收到了國家藥品監督管理局頒發的甲硝唑氯化鈉注射液(100ml)(“該藥品”)《藥品補充申請批准通知書》(通知書編號:2022B00015),該藥品通過仿製藥質量和療效一致性評價。
甲硝唑為硝基咪唑衍生物,主要用於治療敏感厭氧菌引起的腹腔內感染、皮膚和軟組織感染、婦科感染、下呼吸道感染等嚴重感染以及預防擇期結直腸手術的術後厭氧菌感染。截至公吿日,安徽雙鶴就該藥品開展一致性評價累計研發投入為人民幣534萬元(未經審計)。
根據國家藥品監督管理局信息顯示,中國大陸境內已批准上市的100ml規格甲硝唑氯化鈉注射液生產企業110家,其中通過一致性評價的生產企業有5家(含安徽雙鶴)。根據米內網數據顯示,2020年國內醫療市場甲硝唑氯化鈉注射液銷售總額(終端價)為2.85億元人民幣。
安徽雙鶴2021年甲硝唑氯化鈉注射液的銷售額為1705萬元。
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