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速递|信达生物:小分子GLP-1申报临床
GLP1减重宝典· 2025-07-21 12:01
Core Viewpoint - The article highlights the advancements in the development of GLP-1 receptor agonists by Innovent Biologics, particularly focusing on the new drug IBI3032 and its potential impact on weight management and blood sugar control [2][3][4][5]. Group 1: Drug Development Progress - IBI3032, an oral GLP-1 small molecule candidate, has shown a bioavailability 5 to 10 times higher than similar products in preclinical studies and is preparing for clinical trial applications, with plans to initiate Phase I trials in China and the US in 2025 [3][4]. - The drug IBI3012, a dual receptor agonist, is expected to offer a longer dosing interval of over four weeks, with an IND application planned for late 2025 to early 2026 [4]. - IBI3030, a triple receptor agonist targeting GLP-1, GCG, and GIP, has demonstrated significant effects on blood sugar and lipid regulation in preclinical studies and may further reduce fat accumulation through PCSK9 inhibition [4]. Group 2: Market Impact and Clinical Trials - The approval of the injection formulation of Ma Shidu Peptide for long-term weight management in adults marks a significant advancement in the weight loss treatment field, being the first and only approved GCG/GLP-1 dual receptor agonist [5]. - Currently, seven Phase III clinical trials are underway in China for Ma Shidu Peptide, including studies focusing on obesity and type 2 diabetes, as well as its effects on patients with obstructive sleep apnea [5]. - A high-dose version of Ma Shidu Peptide (15mg) is also being compared with Tirzepatide in an ongoing I/II phase study [5].
Innovent to Present Multiple R&D Results of General Biomedicine Pipeline at the ADA's 85th Scientific Sessions
Prnewswire· 2025-06-13 01:00
Core Viewpoint - Innovent Biologics is set to present multiple clinical study results of mazdutide at the American Diabetes Association's 85th Scientific Sessions, highlighting its potential as a next-generation treatment for Type 2 Diabetes (T2D) and other metabolic diseases [1] Group 1: Clinical Studies and Presentations - The first Phase 3 study of mazdutide in Chinese adults with T2D (DREAMS-1) will be presented orally [1] - Multiple exploratory mechanism of action (MoA) analyses of mazdutide and a preclinical study of IBI3030 will be showcased in poster presentations [1] - The presentations include various studies on mazdutide's effects on liver fat accumulation, hyperuricemia, and cardiovascular risk markers [1][1][1] Group 2: Product Development and Regulatory Status - Mazdutide is currently under review with two New Drug Applications (NDAs) accepted by the National Medical Products Administration (NMPA) [4] - The drug is being evaluated in six Phase 3 clinical studies, with GLORY-1, DREAMS-1, and DREAMS-2 having met their primary endpoints [4] - Innovent has plans for several new clinical studies involving mazdutide, targeting conditions such as metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF) [7] Group 3: Company Overview and Partnerships - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including oncology and metabolic disorders [4] - The company has launched 15 products and has 3 new drug applications under regulatory review, with 4 assets in Phase III trials and 15 molecules in early clinical stages [4] - Innovent collaborates with over 30 global healthcare companies, including Eli Lilly, to enhance its product offerings and market reach [4]