珍寶島(603567.SH):鹽酸克林黴素膠囊(0.15g)已通過一致性評價
格隆匯8月24日丨珍寶島(603567.SH)公佈,近日,公司全資子公司哈爾濱珍寶製藥有限公司(“哈珍寶”)通過國家藥品監督管理局藥品評審中心(“CDE”)網站獲悉,鹽酸克林黴素膠囊(0.15g)已通過仿製藥質量和療效一致性評價。
鹽酸克林黴素膠囊為抗感染類藥物,主要用於由鏈球菌屬、葡萄球菌屬及厭氧菌等敏感菌株所致的感染性疾病。該品種已列入2018年國家基藥和2019年醫保甲類目錄。
鹽酸克林黴素屬於細菌蛋白合成抑制劑林可酰胺類抗生素,具有抗厭氧菌和抗革蘭氏陽性菌的雙重作用,抗菌活性強,具有不被胃酸破壞,胃腸道迅速吸收的治療特點,臨牀廣泛應用於下呼吸道、皮膚、軟組織、婦產科及腹腔等感染,被《中國成人社區獲得性肺炎診斷和治療(2016年版)》、《抗菌藥物臨牀應用指導原則(2015年版)》、《創傷後抗菌藥物預防性應用專家共識(2016)》等權威指南和共識廣泛推薦。
CDE網站顯示,目前鹽酸克林黴素膠囊(0.15g)通過一致性評價的還有四川科倫藥業股份有限公司、重慶藥友製藥有限責任公司、宜昌人福藥業有限責任公司等3家公司。克林黴素製劑2016-2018年國內市場規模分別約為30.48億元、33.16億元和33.19億元(數據來源:米內網)。
該項目截至目前累計研發投入約854萬元。
哈爾濱珍寶製藥有限公司生產的鹽酸克林黴素膠囊(0.15g)通過一致性評價,是公司首個通過一致性評價的品種,是公司向化藥、生物藥領域拓展邁出積極的一步,是公司仿製藥一致性評價工作取得成果的良好開端。該產品通過一致性評價,有利於豐富公司產品線,擴大藥品的市場份額,提升公司行業競爭力。
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