四環醫藥(00460.HK)：糖尿病創新藥德谷門冬雙胰島素注射液獲批國內首個生物類似物臨牀試驗
格隆匯6月7日丨四環醫藥(00460.HK)宣佈，集團旗下非全資附屬公司(間接持股約82.68%)吉林惠升生物開發的治療糖尿病藥物德谷門冬雙胰島素注射液已成功獲得國家藥監局頒發的藥物臨牀試驗批件，研發進展在生物類似物中處於國內首位，除已上市的諾和諾德公司原研產品諾和佳外，尚無其他公司產品獲得國內註冊臨牀試驗批准。該產品已正式被納入醫保，用於其他胰島素或口服藥難以控制的II型糖尿病患者。
該產品是一種可溶性雙胰島素製劑，由70%的德谷胰島素和30%的門冬胰島素組成，特點為集基礎胰島素和餐時胰島素於一身，一次注射便能同時滿足基礎和餐時胰島素需求，能夠快速控制空腹和餐後血糖。與使用甘精胰島素加門冬胰島素相比，該產品夜間確證性低血糖風險顯著更低，更利於糖尿病患者的血糖調控。該產品作為非共結晶的複合製劑，無需混勻即可使用，提高了產品便捷性，也避免了混合製劑的注射風險。該產品可減少治療方案中注射次數。對於一般II型糖尿病患者或者生活規律I型患者，通常可比基礎和餐時胰島素方案減少注射次數，從而有助於提高患者依從性，降低醫療負擔，並有望提高患者預期壽命。
中國是糖尿病大國，國際糖尿病聯盟(IDF)的數據顯示，中國糖尿病患病人數超過一億，高居全球首位。隨着II型糖尿病進展，糖尿病患者需要補充外源性胰島素治療。在中國的II型糖尿病患者中，約三分之一的患者使用胰島素製劑，其中約三分之二的患者使用預混胰島素製劑，這與中國高碳水化合物的飲食習慣，糖尿病患者餐後血糖偏高的臨牀特點有關。
據IQVIA預測，中國新型胰島素德谷門冬雙胰島素在國內的銷售額增長快速，預計到2025年將增長到30億元的市場規模。預期集團的德谷門冬雙胰島素獲批上市後年銷售額也有望依勢增長，潛力巨大。這也有助於集團加快開闢糖尿病產品線，提高集團綜合實力，大幅增強集團的核心競爭力。
公吿顯示，吉林惠升生物是專注於糖尿病及併發症全面解決方案的生物製藥公司，是國內為數不多的佈局了糖尿病及併發症領域全產品覆蓋的領先企業，擁有數十款優質糖尿病及併發症研發產品管線。吉林惠升生物擬建立獨立高效的市場營銷網絡，以便迅速推進產品的商業化。
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