東陽光(600673.SH):門冬胰島素注射液的藥品註冊申請獲受理
格隆匯 3 月 1日丨東陽光(600673.SH)公佈,近日,公司控股子公司宜昌東陽光長江藥業股份有限公司(“東陽光藥”)收到了國家藥品監督管理局(“藥監局”)簽發的《受理通知書》(受理號:CXSS2100025國),該產品名稱為門冬胰島素注射液。
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。目前,門冬胰島素注射液的生產企業主要有諾和諾德(中國)製藥有限公司和甘李藥業股份有限公司等。
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。
截至目前,東陽光藥門冬胰島素注射液已累計研發投入約人民幣6861.8萬元。
此次申請藥品註冊的門冬胰島素注射液為公司在糖尿病治療領域的佈局產品,未來該產品如順利通過上市審評審批,將有利於拓展公司內分泌及代謝治療領域業務,進一步豐富公司的產品組合。本次獲藥品註冊申請受理不會對公司現階段業績產生重大影響。
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