四環醫藥(00460.HK)首個自主研發治療糖尿病創新專利藥加格列淨新藥上市申請獲國家藥監局受理
格隆匯3月2日丨四環醫藥(00460.HK)發佈公吿,集團旗下非全資附屬公司吉林惠升生物製藥有限公司的加格列淨新藥上市申請(NDA)已獲得中國國家藥品監督管理局受理,是第二個在國內進行上市申請並獲得受理的國產1 類創新藥SGLT-2抑制劑。
根據披露,加格列淨是鈉-葡萄糖協同轉運蛋白2(SGLT-2)抑制劑,其通過抑制SGLT-2,減少腎小管對於葡萄糖的重吸收,從而增加尿糖排泄,達到降低血糖水平的作用。SGLT-2抑制劑是目前國際上極受推薦的治療2型糖尿病患者的新型口服降糖藥物。
加格列淨作為集團自主研發並達到III期臨牀終點的1類降糖創新藥,擁有全球權益,包括中國、美國、歐洲、日本和韓國的專利權。本次加格列淨上市申請獲得受理標誌着集團在治療糖尿病領域原研創新藥方面獲得突破性進展,充分證明了集團強大的創新藥自主研發能力與實力。隨着SGLT-2抑制劑類降糖藥物治療地位的不斷提升,市場應用不斷擴容,同時藉助集團傑出的營銷能力,預期惠升生物的加格列淨成功上市後,潛力巨大,可實現快速放量。這也將有助於集團加快實現在糖尿病產品管線的產業化發展,進一步提高集團的競爭力和綜合實力。
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