Core Viewpoint - The completion of subject enrollment in the Phase IIa study for ASC30, a novel GLP-1 receptor agonist for obesity treatment, marks a significant milestone in the development of this innovative therapy [1] Company Summary - Songlei Pharmaceutical-B (01672.HK) has announced the completion of subject enrollment for its monthly subcutaneous depot formulation of the small molecule GLP-1 receptor agonist ASC30 in the United States [1] - The study involved 65 participants, all of whom are either obese or overweight individuals with at least one weight-related comorbidity [1] - The CEO of Songlei, Dr. Wu Jinzi, highlighted the importance of this milestone, indicating substantial progress in the development of ASC30 [1] Product Summary - ASC30 is the first and only small molecule GLP-1 receptor agonist that can be administered either orally once daily or via subcutaneous injection once a month to once a quarter [1] - The product is designed for both weight loss treatment and weight maintenance therapy, aimed at long-term weight management [1] - ASC30 features a prolonged apparent half-life of 46 days and a superior peak-to-trough ratio of approximately 1.5, positioning it as a promising monthly treatment option for obesity [1] - Topline data from the Phase IIa study is expected to be available in the first quarter of 2026 [1]

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 5% in early trading, driven by the announcement of a voluntary lock-up commitment from the controlling shareholder, which will prevent the sale of shares until key clinical data is released [1] Group 1: Clinical Trials and Data - Gilead Sciences announced that the controlling shareholder will not sell any company shares before the release of three key clinical data points: 1. Top-line data from the U.S. Phase I clinical trial of ASC47 combined with semaglutide in obese subjects, expected by the end of September 2025 2. Top-line data from the U.S. 13-week Phase IIa clinical trial of ASC30 oral tablets in obese or overweight subjects, expected by December 2025 3. Top-line data from the U.S. Phase I single ascending dose study of ASC50 in healthy subjects, expected by December 2025 [1][1][1] Group 2: Drug Development and Potential - The company recently announced that the small molecule GLP-1R agonist ASC30 demonstrated an apparent half-life of 75 days in obese subjects, indicating the potential for developing a long-term weight management solution with quarterly dosing [1][1] - ASC30 is developed using Gilead's Ultra-Long-Acting Drug Development Platform (ULAP), and the company has multiple pipelines relying on this platform to develop long-acting formulations, which may meet various clinical needs [1][1]

Core Viewpoint - The company is set to present clinical data for ASC30, an oral small molecule GLP-1 receptor agonist, at the 61st European Association for the Study of Diabetes (EASD) annual meeting in Vienna, Austria, highlighting its potential as a differentiated treatment for obesity [1] Group 1: Clinical Research and Development - ASC30 is currently undergoing a 28-day multiple ascending dose study (NCT06680440) [1] - The drug is characterized as a new chemical entity (NCE) with unique properties that allow for both oral and subcutaneous administration [1] - The compound is protected by patents in the U.S. and globally, with patent protection lasting until 2044, excluding any extensions [1] Group 2: Company Leadership and Vision - Dr. Wu Jinzi, the founder, chairman, and CEO of the company, expressed confidence that the efficacy and safety data presented will position ASC30 as a promising option for obesity treatment [1]

Core Viewpoint - Songlei Pharmaceutical-B has announced the completion of the Phase IIa study for its small molecule oral GLP-1R agonist ASC30, targeting obesity or overweight subjects, indicating rapid clinical advancement in a competitive market [1][2]. Group 1: Clinical Progress - ASC30 is the first and only small molecule GLP-1R agonist developed by the company that can be administered either orally once daily or via subcutaneous injection once monthly. The company initiated the Phase IIa clinical trial in early July and enrolled 125 subjects in just over a month, showcasing high efficiency. The treatment period lasts for 13 weeks, with top-line data expected in Q4 2025. Currently, the fastest progress in the global small molecule GLP-1 development pipeline is by Eli Lilly with Orforglipron, which has submitted an FDA application, while Pfizer has abandoned its small molecule GLP-1 pipeline, placing ASC30 in a competitive catch-up position [1]. Group 2: Potential and Safety Profile - ASC30 demonstrates potential to become a Best in Class (BIC) treatment due to its safety profile and rapid weight loss capabilities. According to data presented at the ADA conference from the Phase I MAD study, the average weight loss after four weeks was 6.4%. No severe adverse reactions, such as hepatotoxicity, were observed, and treatment-emergent adverse events (TEAEs) were mild, with no vomiting reported at doses of 2mg and 5mg. This positions ASC30 favorably in the market [1]. Group 3: ASC47 Development - ASC47, another small molecule THRβ agonist developed by the company, is designed for monthly injection and is currently in clinical trials in combination with semaglutide for treating obesity. ASC47 targets adipose tissue and is expected to provide synergistic effects when used with GLP-1, helping to reduce muscle loss while enhancing weight loss efficacy. The design of ASC47 allows for convenient monthly administration alongside GLP-1 [2]. Group 4: Financial Forecast - The company anticipates increased overseas clinical investment, projecting R&D expenses of 415 million, 487 million, and 540 million yuan for 2025, 2026, and 2027, respectively. The net profit attributable to the parent company is forecasted to be -372 million, -467 million, and -562 million yuan for the same years. Given the rapid clinical progress of ASC30 and ASC47, the company is positioned to achieve Best in Class potential in the small molecule weight loss drug development space, leading to a "Buy" investment rating [2].