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東陽光藥(01558.HK):遞交門冬胰島素注射液境內生產註冊獲受理
格隆匯 03-01 16:44

格隆匯 3 月 1日丨東陽光藥(01558.HK)宣佈,公司已經獲得國家藥品監督管理局關於門冬胰島素注射液境內生產註冊的受理通知書,該產品受理號為CXSS2100025國,是公司自主研究及開發的產品。目前,中國已有兩家企業生產的門冬胰島素注射液獲國家藥品監督管理局批准上市。

門冬胰島素屬於人胰島素類似物。與可溶性人胰島素相比,門冬胰島素經皮下注射後起效更快,作用持續時間更短,能更好的模擬餐後生理性胰島素分泌模式,從而更好的改善餐後血糖。糖尿病患者使用門冬胰島素更加便捷,是當前糖尿病治療中尤為重要的餐時胰島素。

根據國際糖尿病聯盟2019年報吿數據,中國大陸糖尿病患者數量約為1.16億,20–79歲人羣中發病率約為10.4%。根據艾昆緯數據,2019年中國糖尿病領域藥物銷售金額約為39.21億美元,較2018年增長率約為8.97%,其中2019年國內胰島素及其類似物類藥物銷售金額的份額約為42.52%,具有可觀的市場潛力。

公司在糖尿病治療領域擁有全面規劃,佈局了完整的產品線。此前披露有關公司產品重組人胰島素注射液已獲批准上市,目前已展開對該品種的市場推廣工作;及有關公司產品甘精胰島素注射液及門冬胰島素30注射液境內生產註冊獲受理。未來該產品如順利通過國家藥品監督管理局的上市審評審批,將進一步豐富公司糖尿病治療領域的產品組合。

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