山東新華製藥股份(00719.HK):克林黴素磷酸酯注射液通過仿製藥一致性
格隆匯10月13日丨山東新華製藥股份(00719.HK)發佈公吿,近日,公司收到國家藥品監督管理局核准簽發的克林黴素磷酸酯注射液(2ml:0.3g和4ml:0.6g)《藥品補充申請批准通知書》,該產品通過仿製藥質量和療效一致性評價(“仿製藥一致性評價”)。
根據披露,克林黴素磷酸酯注射液由美國PHARMACIA AND DUPJOHN CO公司開發並在美國上市,商品名為Cleocin Phosphate® 。該產品主要用於革蘭氏陽性菌和厭氧菌引起的各種感染性疾病,具有抗菌譜廣、副作用較小、抗菌活性強等的臨牀優勢,臨牀需求巨大。經查詢數據庫,2020年克林黴素在中國城市公立及縣級公立醫療機構銷售金額為14.79億元。截至該公吿日,公司針對克林黴素磷酸酯注射液的一致性評價已投入研發費用約人民幣948 萬元。
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