速递｜口服GLP-1三靶点减肥药明年递交IND，对标诺和诺德和礼来！

Core Viewpoint - Protagonist Therapeutics has selected PN-477 as its primary development candidate for obesity treatment, which is a triple agonist peptide targeting GLP-1, GIP, and glucagon (GCG) receptors, offering both efficacy and convenience through oral or subcutaneous administration [2][4]. Group 1: Drug Development and Efficacy - PN-477 has completed extensive preclinical evaluations, demonstrating positive effects in various animal models of obesity and blood glucose control, including diet-induced obese mice, normal dogs, and crab-eating macaques [4]. - The drug exhibits strong activation of GLP-1, GIP, and GCG receptors in vitro, indicating its potential effectiveness [4]. - PN-477's pharmacodynamic properties and overall performance make it suitable for parallel development as both a daily oral medication (PN-477o) and a weekly injection (PN-477sc) [4]. Group 2: Clinical Trials and Future Plans - The Investigational New Drug (IND) application is currently underway, with the first phase of clinical trials expected to start in the second quarter of 2026 [4]. - Protagonist Therapeutics plans to submit a New Drug Application (NDA) for its other candidates in 2025, indicating a robust pipeline [6][7]. Group 3: Market Position and Competitive Advantage - Despite the dominance of GLP-1 receptor agonists in the market, there is room for improvement, and a triple agonist like PN-477 could provide a significant breakthrough in obesity treatment by offering an oral option alongside injectable therapies [6]. - PN-477 is anticipated to reduce fat mass while preserving lean body mass and improving tolerability and comorbidities, positioning it as a potential blockbuster product for the company [6]. Group 4: Company Overview - Protagonist Therapeutics is an integrated biopharmaceutical company focused on drug discovery and late-stage development, with two novel candidates in Phase III clinical trials and plans for NDA submissions in 2025 [6][7]. - The company is also advancing several preclinical peptide drug development projects, including PN-881 and oral hepcidin [7].