華領醫藥(02552.HK)公佈2021年中期業績 全球首創新藥dorzagliatin NDA獲NMPA受理
格隆匯8月19日丨華領醫藥-B(02552.HK)公佈2021年中期業績,報吿期內,公司開支總額約為1.65億元,其中研發開支約為9800萬元。截至2021年6月30日,公司銀行結餘及現金約為8.47億元,推動dorzagliatin藥品上市和創新領域的新藥研發項目。
報吿期內,全球首創新藥葡萄糖激酶激活劑(GKA)dorzagliatin的新藥上市申請(NDA)已獲國家藥品監督管理局(NMPA)藥品審評中心(CDE)受理,成為全球範圍內首個遞交NDA的GKA類糖尿病治療藥物。
下半年,公司將開展dorzagliatin與現有糖尿病藥物的聯合用藥研究,包括dorzagliatin分別與達格列淨、胰島素和GLP-1的聯合用藥研究,探索在糖尿病腎病、代謝綜合症型糖尿病、晚期糖尿病,以及糖尿病認知障礙等領域的創新機遇。公司還將在美國開展針對1型糖尿病患者的臨牀研究,此外公司還將在上海臨港新片區設立華領醫藥製藥公司,確保dorzagliatin充足的商業供應。
未來,公司計劃進一步推進開發dorzagliatin用於糖尿病及其相關疾病治療的固定複方製劑產品管線。
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