The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of Hangzhou Sciwind Biosciences Co., Ltd.* 杭州先為達生物科技股份有限公司 (A joint stock company incorporated in the People's Republi ...

Core Insights - Structure Therapeutics Inc. announced positive topline data from the ACCESS clinical program for aleniglipron, an oral small molecule therapeutic for obesity, showing significant weight loss and favorable tolerability [2][6] Efficacy Data - In the Phase 2 ACCESS II study, aleniglipron achieved a placebo-adjusted mean weight loss of 16.3% (39 lbs) at 180 mg and 16.0% (37 lbs) at 240 mg over 44 weeks, with no evidence of a weight loss plateau [3][9] - Continued weight loss of 16.2% (40.5 lbs) was observed with a 120 mg dose in the ACCESS Open Label Extension study at 56 weeks [3][12] Tolerability and Safety - Aleniglipron demonstrated a tolerability profile consistent with GLP-1 receptor agonists, with a low adverse event-related discontinuation rate of 2.0% to 3.4% across studies [4][5] - The most common adverse events were gastrointestinal-related, primarily nausea and vomiting, which are typical for this drug class [9][14] Phase 3 Development - The company is preparing for a Phase 3 clinical development, with an End-of-Phase 2 meeting with the FDA scheduled for Q2 2026 and Phase 3 initiation expected in the second half of 2026 [6][16] Study Design - The ACCESS II study involved 85 adult participants with obesity or overweight, evaluating doses up to 240 mg over 44 weeks [8] - A body composition study assessed the effects of a lower starting dose of 2.5 mg, showing improved tolerability and weight loss of 6.8% after 20 weeks [10][11] Company Overview - Structure Therapeutics focuses on developing innovative oral small molecule treatments for chronic metabolic conditions, aiming to provide accessible options for obesity management [18][19]

Core Insights - Biomea Fusion, Inc. has initiated a Phase I clinical trial for BMF-650, a next-generation oral small molecule GLP-1 receptor agonist aimed at treating obesity [1][4] - BMF-650 is designed to enhance oral bioavailability and reduce pharmacokinetic variability, potentially leading to better weight reduction outcomes for patients [2][5] Company Overview - Biomea Fusion is focused on developing oral small molecule therapies for diabetes and obesity, with BMF-650 being a key candidate [11] - The company aims to improve the lives of patients suffering from metabolic diseases through innovative treatments [11] Product Details - BMF-650 has shown promising results in preclinical studies, demonstrating dose-dependent reductions in food intake and significant weight loss in obese cynomolgus monkeys [3][6] - In these studies, animals receiving 10 mg/kg and 30 mg/kg doses experienced average body weight reductions of approximately 12% and 15% respectively [3] - The drug has a favorable pharmacokinetic profile, with higher bioavailability and less inter-individual variability compared to other oral GLP-1 receptor agonists [6] Clinical Development - The Phase I trial will evaluate the safety, tolerability, and preliminary efficacy of BMF-650 in healthy overweight or obese participants, with results expected in the first half of 2026 [4] - Initial data from the trial will focus on 28-day weight loss outcomes at the highest dose [4] Market Context - Obesity is a chronic disease affecting over 40% of adults in the United States, leading to various health complications and a significant public health burden [8] - GLP-1 receptor agonists are recognized for their role in improving glycemic control and promoting weight loss in individuals with type 2 diabetes and obesity [10]

The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Application Proof, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Application Proof. Application Proof of Eccogene Inc. 誠益生物開曼有限公司 * (the "Company") (Incorporated in the Cayman Islands with limited liability) This Applica ...