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信達生物：自願公告 - 國家藥品監督管理局受理瑪仕度肽治療2型糖尿病的新藥上市申請

INNOVENT BIO: VOLUNTARY ANNOUNCEMENT - THE NATIONAL MEDICAL PRODUCTS ADMINISTRATIONACCEPTED THE NEW DRUG APPLICATION OF MAZDUTIDEFOR TYPE 2 DIABETES

HKEX ·  Aug 1 16:30
Summary by Futu AI
信達生物製藥有限公司宣布，其開發的新藥瑪仕度肽（IBI362），一種用於治療2型糖尿病的GLP-1R/GCGR雙重激動劑，已獲中國國家藥品監督管理局（NMPA）正式受理新藥上市申請（NDA）。該申請基於兩項III期臨床研究結果，證明瑪仕度肽在血糖控制和減重方面的優效，並可改善心血管、肝臟和腎臟相關指標，未發現新的安全性風險。瑪仕度肽是首個在中國T2D III期臨床取得成功的GLP-1R/GCGR雙重激動劑，有望為中國超過1.4億糖尿病患者提供更有效的疾病管理。信達生物將與監管部門緊密合作，期待早日將此藥物推向市場。
信達生物製藥有限公司宣布，其開發的新藥瑪仕度肽（IBI362），一種用於治療2型糖尿病的GLP-1R/GCGR雙重激動劑，已獲中國國家藥品監督管理局（NMPA）正式受理新藥上市申請（NDA）。該申請基於兩項III期臨床研究結果，證明瑪仕度肽在血糖控制和減重方面的優效，並可改善心血管、肝臟和腎臟相關指標，未發現新的安全性風險。瑪仕度肽是首個在中國T2D III期臨床取得成功的GLP-1R/GCGR雙重激動劑，有望為中國超過1.4億糖尿病患者提供更有效的疾病管理。信達生物將與監管部門緊密合作，期待早日將此藥物推向市場。
Innovent bio pharmaceutical announced that its newly developed drug, Marcytepa (IBI362), a GLP-1R/GCGR dual agonist for the treatment of type 2 diabetes, has officially received new drug application acceptance (NDA) from China's National Medical Products Administration (NMPA). The application is based on the results of two Phase III clinical studies that demonstrate Marcytepa's superior effects in blood glucose control and weight loss, and can improve cardiovascular, hepatic, and renal indicators without finding new safety risks. Marcytepa is the first GLP-1R/GCGR dual agonist for T2D Phase III clinical trials in China and is expected to provide more effective disease management for more than 0.14 billion diabetic patients in China. Innovent bio will closely collaborate with regulatory agencies and expects to launch this drug to the market soon.
Innovent bio pharmaceutical announced that its newly developed drug, Marcytepa (IBI362), a GLP-1R/GCGR dual agonist for the treatment of type 2 diabetes, has officially received new drug application acceptance (NDA) from China's National Medical Products Administration (NMPA). The application is based on the results of two Phase III clinical studies that demonstrate Marcytepa's superior effects in blood glucose control and weight loss, and can improve cardiovascular, hepatic, and renal indicators without finding new safety risks. Marcytepa is the first GLP-1R/GCGR dual agonist for T2D Phase III clinical trials in China and is expected to provide more effective disease management for more than 0.14 billion diabetic patients in China. Innovent bio will closely collaborate with regulatory agencies and expects to launch this drug to the market soon.
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