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四環醫藥(00460.HK):惠升生物研發的重磅產品德谷門冬雙胰島素注射液惠優加®獲國家藥監局批准上市
格隆匯 08-06 12:07

格隆匯8月6日丨四環醫藥(00460.HK)宣佈,集團旗下非全資附屬公司惠升生物製藥股份有限公司("惠升生物")研發的德谷門冬雙胰島素注射液(商品名:惠優加®,"該產品")已獲中國國家藥監局批准上市,用於治療成人2型糖尿病。是繼原研諾和諾德後國產首個獲批上市的德谷門冬雙胰島素注射液生物類似藥。

德谷門冬雙胰島素作為新一代胰島素製劑,具有控制血糖更優,糖化血紅素達標率更高,低血糖風險更小的優點。該產品由70%德谷胰島素與30%門冬胰島素組合而成,是全球首個長效與速效胰島素類似物組合而成的可溶性雙胰島素製劑,相比較傳統預混胰島素製劑,兩種組分在製劑中獨立存在,注射前無需混勻操作,大大簡化用法,改善了用藥不均一的問題。該產品僅單次注射即可模擬接近生理性胰島素分泌,德谷胰島素形成多六聚體長鏈,持續覆蓋24小時,平穩控制空腹血糖;門冬胰島素迅速解離成單體,迅速降低餐後血糖,兩種生物活性物質以固定比例組合成澄清溶液,在體內保持各自的藥物動力學特點,優勢互補,同時減少了傳統預混胰島素製劑中不同成分所產生的效應疊加,會更有效地幫助患者降低低血糖風險,減少注射次數和心理負擔。多項臨牀研究結果顯示,無論是起始治療還是強化治療,與其他胰島素治療相比,德谷門冬雙胰島素在達到有效降糖的同時,低血糖發生的機會更少,提高了胰島素治療的安全性。德谷門冬雙胰島素是國家醫保乙類品種,因其卓越的療效、安全性和經濟性,備受指南青睞,目前已獲得大量國內外指南╱共識的推薦和認可和高度肯定,在二型糖尿病全程均可使用。

據IDF最新報吿,2021年中國糖尿病患者約1.4億人,預計2045年將增至1.744億人。據諾和諾德年報數據,2023年,諾和諾德的德谷胰島素及其複方製劑全球銷售額超20億美元(年報顯示2023年銷售額約21.6億美元),其中德谷門冬雙胰島素注射液在大中華區的收入約2.88億美元,較2022年同比增長61.3%。據公開數據中康開思系統數據顯示,在2023年國內眾多胰島素銷售額不斷下滑時,德谷門冬雙胰島素以57.8%的同比增長率拿下全國等級醫院胰島素市場第三名。

糖尿病領域為惠升生物重點佈局領域,本次德谷門冬雙胰島素注射液獲國家藥監局批准上市,將能夠為廣大醫生患者提供更優化的控糖藥物,惠及更多中國患者,同時,也為集團及惠升生物的糖尿病藥物管線再添一重磅品種,該產品未來上市後將為集團和惠升生物的業績和增長帶來巨大新動能。

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