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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的首個減重適應症新藥上市申請

INNOVENT BIO: VOLUNTARY ANNOUNCEMENT - THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION ACCEPTED THE FIRST NEW DRUG APPLICATION FOR MAZDUTIDE FOR CHRONIC WEIGHT MANAGEMENT

香港交易所 ·  Feb 7 03:30
Summary by Moomoo AI
信達生物製藥有限公司宣佈，其研發的新藥瑪仕度肽（IBI-362）已於2024年2月獲得中國國家藥品監督管理局（NMPA）的新藥上市申請（NDA）受理，用於治療成人肥胖或超重，以實現長期體重控制。瑪仕度肽是一種GLP-1R/GCGR雙重激動劑，旨在通過促進胰島素分泌、降低血糖和減輕體重，同時增加能量消耗和改善肝臟脂肪代謝。該藥物在中國進行的III期臨床研究GLORY-1已於2024年1月達成主要研究終點和所有關鍵次要終點，顯示出與安慰劑組相比，瑪仕度肽能顯著改善體重和心血管代謝指標。公司計劃在2024年的學術大會和學術期刊上公佈更詳細的研究數據。信達生物製藥將與禮來製藥共同推進瑪仕度肽的開發，並積極配合監管部門，期待為中國肥胖和超重人群提供一種有效且安全的治療方案。
信達生物製藥有限公司宣佈，其研發的新藥瑪仕度肽（IBI-362）已於2024年2月獲得中國國家藥品監督管理局（NMPA）的新藥上市申請（NDA）受理，用於治療成人肥胖或超重，以實現長期體重控制。瑪仕度肽是一種GLP-1R/GCGR雙重激動劑，旨在通過促進胰島素分泌、降低血糖和減輕體重，同時增加能量消耗和改善肝臟脂肪代謝。該藥物在中國進行的III期臨床研究GLORY-1已於2024年1月達成主要研究終點和所有關鍵次要終點，顯示出與安慰劑組相比，瑪仕度肽能顯著改善體重和心血管代謝指標。公司計劃在2024年的學術大會和學術期刊上公佈更詳細的研究數據。信達生物製藥將與禮來製藥共同推進瑪仕度肽的開發，並積極配合監管部門，期待為中國肥胖和超重人群提供一種有效且安全的治療方案。
SINDA BIOPHARMACEUTICAL CO., LTD. ANNOUNCED THAT ITS DEVELOPED NEW DRUG MESIDEPEPTIDE (IBI-362) WAS ACCEPTED IN FEBRUARY 2024 FOR A NEW DRUG LISTING APPLICATION (NDA) FROM THE NATIONAL MEDICINES REGULATORY AUTHORITY (NMPA) OF CHINA FOR THE TREATMENT OF OBESITY OR OVERWEIGHT IN ADULTS TO ACHIEVE LONG-TERM WEIGHT CONTROL. MARSETOPEPTIDE IS A GLP-1R/GCGR DUAL STIMULANT DESIGNED TO INCREASE ENERGY CONSUMPTION AND IMPROVE LIVER FAT METABOLISM BY PROMOTING INSULIN SECRETION, LOWERING BLOOD SUGAR, AND LOSING WEIGHT. GLORY-1, A Phase III clinical trial of the drug in China, reached the main study endpoint and all key secondary endpoints in January 2024, showing that methylated peptide significantly improved body weight and cardiovascular metabolism indicators compared to the placebo group. The company plans to publish more detailed research data in academic conferences and academic journals in 2024. Sinda Biopharmaceuticals will jointly promote the development of mastidine and actively work with regulatory authorities to provide an effective and safe treatment for the obese and overweight population in China.
SINDA BIOPHARMACEUTICAL CO., LTD. ANNOUNCED THAT ITS DEVELOPED NEW DRUG MESIDEPEPTIDE (IBI-362) WAS ACCEPTED IN FEBRUARY 2024 FOR A NEW DRUG LISTING APPLICATION (NDA) FROM THE NATIONAL MEDICINES REGULATORY AUTHORITY (NMPA) OF CHINA FOR THE TREATMENT OF OBESITY OR OVERWEIGHT IN ADULTS TO ACHIEVE LONG-TERM WEIGHT CONTROL. MARSETOPEPTIDE IS A GLP-1R/GCGR DUAL STIMULANT DESIGNED TO INCREASE ENERGY CONSUMPTION AND IMPROVE LIVER FAT METABOLISM BY PROMOTING INSULIN SECRETION, LOWERING BLOOD SUGAR, AND LOSING WEIGHT. GLORY-1, A Phase III clinical trial of the drug in China, reached the main study endpoint and all key secondary endpoints in January 2024, showing that methylated peptide significantly improved body weight and cardiovascular metabolism indicators compared to the placebo group. The company plans to publish more detailed research data in academic conferences and academic journals in 2024. Sinda Biopharmaceuticals will jointly promote the development of mastidine and actively work with regulatory authorities to provide an effective and safe treatment for the obese and overweight population in China.
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