四環醫藥(00460.HK)：三款門冬胰島素注射液產品新藥上市申請獲國家藥監局受理
格隆匯1月27日丨四環醫藥(00460.HK)宣佈，集團旗下非全資附屬公司吉林惠升生物製藥有限公司(”惠升生物“)研發的門冬胰島素注射液、門冬胰島素30注射液及門冬胰島素50注射液的新藥上市申請(BLA)已獲得國家藥監局受理。惠升生物是目前國內唯一一家全品類門冬胰島素同步進行上市申請並被受理的公司，充分體現了公司研發策略的全面性和完整性，滿足糖尿病患者不同胰島素治療方案的臨牀需求。
門冬胰島素注射液屬於速效胰島素類似物，比人胰島素起效更迅速，更好控制餐後血糖，降低低血糖發生風險，同時注射時間更靈活；門冬胰島素30/50注射液是由30%/50%可溶性門冬胰島素和70%/50%精蛋白門冬胰島素組成的雙時相胰島素，相比人胰島素，能同時更好的控制空腹和餐後血糖，降低低血糖發生風險，減少注射次數，從而提高患者治療依從性。門冬胰島素注射液、門冬胰島素30注射液及門冬胰島素50注射液均屬於國家醫保乙類(2021年版)。
中國是糖尿病大國，根據流調資料顯示，2020年中國糖尿病患病人數達到1.298億，患病率高達12.8%。糖尿病作為一種慢性疾病需終生使用降糖藥物，胰島素及其類似物產品在糖尿病治療中具有重要地位，整體市場具有巨大的需求量，目前佔有超過50%的市場份額。
門冬胰島素系列產品是目前國內應用最廣泛的用於治療糖尿病的速效及預混胰島素類似物產品。根據諾和諾德年報資料，2020年門冬胰島素注射液與預混門冬胰島素注射液在中國市場收入分別為人民幣22億元與人民幣50億元，同比分別增長21.7%和15%。據IQVIA數據，2020年，門冬胰島素注射液、門冬胰島素30注射液、門冬胰島素50注射液國內銷售額分別為人民幣16.97億元、人民幣33.65億元、人民幣2.17億元，同比上一年分別增長11.13%、8.27%、13.61%。
隨着胰島素類似物進一步替代人胰島素市場以及類似物市場的不斷下沉，同時藉助集團突出的營銷能力，惠升生物的門冬胰島素注射液、門冬胰島素30注射液及門冬胰島素50注射液上市後，有望快速放量，快速搶佔市場份額，潛力巨大。這也將有助於集團加快開闢糖尿病產品管線，提高集團綜合實力，大幅增強集團的核心競爭力。
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