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四環醫藥(00460.HK):第四代胰島素類似物德谷胰島素注射液新藥上市申請獲國家藥監局受理
格隆匯 07-18 12:15

格隆匯7月18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”)研發的第四代胰島素類似物德谷胰島素注射液(“該產品”)的新藥上市申請(NDA)已獲得中國國家藥監局受理,是繼原研產品諾和達®後第一個在國內進行新藥上市申請並獲得受理的國產第四代胰島素類似物德谷胰島素。

德谷胰島素是新一代長效基礎胰島素類似物,長效機制獨特,降糖效果優,具有血糖濃度平穩、低血糖風險低、安全性高、效果持久等特點。其半衰期可達約25小時,持續作用時間可長達約42小時,得益於更長的半衰期及持續作用時間,德谷胰島素的注射時間更為靈活,患者依從性更高,是第一種使糖尿病患者可在一天中任意時間(間隔8小時)注射的胰島素。臨牀數據顯示,惠升生物研發的德谷胰島素藥代動力學和藥效學與原研相似,III期對比研究主要終點糖化血紅蛋白達到預期,與原研藥臨牀效果相當。

根據IQVIA數據顯示,2021年中國胰島素市場規模達到近人民幣200億元。其中,德谷胰島素在中國的銷售額在2018至2021年間快速增長,年均複合增長率高達903.8%。

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,惠升生物的德谷胰島素上市後,有望實現快速放量,快速搶佔市場份額,潛力巨大。同時,該產品還可以與惠升生物產品管線中其他產品形成德谷╱門冬雙胰島素、德谷胰島素╱利拉魯肽複方製劑的組合拳,這也將有助於集團加快開闢糖尿病產品管線,並有望進一步促進銷量增長,提高集團綜合實力,大幅增強集團的核心競爭力。

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