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東陽光藥(01558.HK):遞交門冬胰島素30注射液境內生產註冊獲受理
格隆匯 02-19 19:12

格隆匯 2 月 19日丨東陽光藥(01558.HK)公吿,公司已經獲得國家藥品監督管理局關於門冬胰島素30注射液("該產品")境內生產註冊的受理通知書,該產品受理號為CXSS2100019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30注射液獲國家藥品監督管理局批准上市。門冬胰島素30注射液是一款預混胰島素,品含30%可溶性門冬胰島素和70%精蛋白門冬胰島素。

門冬胰島素30注射液適用於糖尿病的治療,可臨餐注射,其糖化血紅蛋白(HbA1c)達標率更高,可更好地控制餐後血糖。此外,門冬胰島素30注射液在改善血糖控制、減少低血糖風險、提高依從性以及節約醫療成方面優勢明顯,更適合低血糖感知受損(IAH)高危患者。

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%。根據艾美仕數據,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。

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