INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 信達生物製藥 自願公告 瑪仕度肽高劑量9mg上市申請 獲國家藥品監督管理局受理 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣布，信爾美® （瑪仕度肽注射液，胰高血糖素 「GCG」╱胰高血糖素樣肽-1「GLP-1」雙受體激動劑）高劑量9mg用於成人中重度 肥胖患者長期體重控制的上市申請已獲中國國家藥品監督管理局（「NMPA」）藥品 審評中心（「CDE」）受理。瑪仕度肽有望在減重手術之外，為中國中重度肥胖人群 提供一個強效、安全的新治療選擇。 本次上市申請基於瑪仕度肽9mg在中國中重度肥胖人群中開展的III期註冊臨床研 究GLORY-2(NCT06164873)的卓越結果。該研究近期達成了 ...

Core Viewpoint - The article highlights the significance of the GLORY-1 clinical trial for the innovative weight-loss drug, Ma Shidu Tie (IBI362), which is a dual receptor agonist targeting glucagon (GCG) and glucagon-like peptide-1 (GLP-1). This trial is notable for being the first of its kind to be published in a prestigious medical journal, the New England Journal of Medicine, despite not being the first dual-target GLP-1 drug to undergo clinical research globally [1][2][3]. Group 1: Clinical Research and Results - The GLORY-1 study involved 610 participants and demonstrated that Ma Shidu Tie significantly reduced body weight compared to a placebo, with 73.9% and 82.0% of participants in the 4mg and 6mg groups, respectively, achieving a weight loss of ≥5% by week 32, compared to only 10.5% in the placebo group [4]. - By week 48, the proportions of participants achieving a weight loss of ≥15% were 35.7% and 49.5% for the 4mg and 6mg groups, respectively, versus 2.0% for the placebo group [4]. - The study also found that Ma Shidu Tie significantly lowered cardiovascular metabolic indicators, including blood pressure, blood lipids (triglycerides, total cholesterol, and low-density lipoprotein cholesterol), uric acid levels, and liver enzyme levels, while also reducing liver fat content in patients with fatty liver disease [4]. Group 2: Market Context and Competition - Ma Shidu Tie is being developed and commercialized in China by Innovent Biologics, having obtained rights from Eli Lilly, which also developed the first approved dual-target GLP-1 drug, Tirzepatide, that was launched in China earlier this year [2][3]. - The competitive landscape indicates that both Ma Shidu Tie and Tirzepatide will be vying for market share in the weight-loss drug segment in China, with Ma Shidu Tie expected to be approved for sale by 2025 [5]. - The pricing of Tirzepatide has been noted, with costs ranging from approximately 2,180 yuan to 4,980 yuan per box, which is significantly higher than Novo Nordisk's single-target GLP-1 agonist, Semaglutide, suggesting a differentiated marketing strategy focusing on fat reduction [6].