Core Insights - Ascletis Pharma Inc. presented promising data from Phase Ib studies of its obesity treatment candidates, ASC30 and the combination of ASC31 and ASC47, at ObesityWeek 2025, highlighting their efficacy and safety profiles [4][15]. Group 1: ASC30 Oral Tablet - The Phase Ib study of ASC30 oral tablet demonstrated a placebo-adjusted mean body weight reduction of up to 6.5% after 28 days of treatment, with the highest dose (60 mg) showing a maximum reduction of 9.3% [1][8]. - The study reported mild-to-moderate gastrointestinal adverse events (AEs), with no serious adverse events (SAEs) observed across all cohorts [7][8]. - The safety profile of ASC30 was consistent with or better than that of the GLP-1R agonist class, indicating it is safe and well tolerated [8]. Group 2: ASC30 Subcutaneous Injection - The Phase Ib study of ASC30 subcutaneous injection revealed an observed half-life of 46 days for the treatment formulation and 75 days for the maintenance formulation, supporting once-monthly and once-quarterly dosing [2][10]. - Similar to the oral tablet, the subcutaneous formulations were well tolerated, with only mild-to-moderate treatment-emergent adverse events reported [11][9]. - No serious adverse events or significant safety signals were detected, reinforcing the safety of ASC30 formulations [9][10]. Group 3: Combination of ASC31 and ASC47 - The combination of ASC31 and ASC47 significantly outperformed both tirzepatide and ASC31 monotherapy in weight loss, achieving a 44.8% reduction in weight compared to 19.1% for ASC31 alone, representing a 134% greater reduction [12][13]. - The combination also demonstrated superior results in body fat loss and muscle preservation, restoring the body composition of obese mice to that of healthy non-obese mice [13]. - ASC31 is a dual GLP-1R and GIPR peptide agonist, while ASC47 is designed for targeted delivery to adipose tissue, showcasing Ascletis' innovative approach in obesity treatment [12][13].

Core Insights - Ascletis Pharma Inc. has selected ASC36 as a clinical development candidate for obesity treatment, with an Investigational New Drug Application (IND) submission expected in Q2 2026 [3][4][7] Group 1: Drug Development and Efficacy - ASC36 is a once-monthly, subcutaneously administered amylin receptor agonist, demonstrating a half-life of approximately 15 days in non-human primate studies, which is three times longer than petrelintide [1][4] - In a diet-induced obese rat study, ASC36 achieved a body weight reduction of 10.01%, compared to 5.25% for petrelintide, indicating a 91% greater relative efficacy [5][6] - The drug's formulation allows for co-formulation with other peptides, such as ASC35, enhancing its therapeutic potential [2][7] Group 2: Technological Advancements - ASC36 was developed using Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, which facilitate the design of ultra-long-acting peptides [4][9] - The engineered properties of ASC36 support scalability advantages in manufacturing, contributing to its potential as a best-in-class treatment for obesity [5][7] Group 3: Company Strategy and Future Plans - Ascletis aims to develop ASC36 as a cornerstone therapy for cardio-metabolic diseases, with plans for combination therapies involving ASC35 [8] - A conference call is scheduled for October 30, 2025, to discuss further developments [10]

Core Insights - Ascletis Pharma Inc. is presenting multiple posters on its obesity treatment programs, including ASC30, at ObesityWeek 2025 in Atlanta, Georgia, highlighting advancements in its obesity portfolio [1][2]. Group 1: Product Details - ASC30 is an investigational GLP-1 receptor biased small molecule agonist, designed for both oral and subcutaneous administration, with patent protection until 2044 [3]. - ASC31 is a novel peptide agonist targeting GLP-1R and GIPR, showing favorable pharmacokinetics and efficacy in diet-induced obese mice [4]. - ASC47 is a once-monthly subcutaneous injected small molecule agonist targeting thyroid hormone receptor beta, designed for adipose tissue targeting [5]. Group 2: Event Information - ObesityWeek 2025 will take place from November 4 to 7, 2025, featuring the latest developments in obesity research and treatment [7]. - Presentations at the event include a full analysis of a 28-day study of ASC30 and comparisons of ASC31 and ASC47 against existing treatments [2]. Group 3: Company Overview - Ascletis Pharma Inc. focuses on developing best-in-class therapeutics for metabolic diseases, utilizing proprietary technologies for drug discovery [8].

Core Insights - Ascletis Pharma Inc. has completed enrollment in a U.S. Phase IIa study for its once-monthly subcutaneous (SQ) depot formulation of the small molecule GLP-1 receptor agonist ASC30, targeting obesity treatment [3][4] - The Phase IIa study is a 12-week, randomized, double-blind, placebo-controlled trial involving 65 participants with obesity or overweight, all having at least one weight-related comorbidity [4][3] - Topline data from the study is expected in the first quarter of 2026, marking a significant milestone in the development of ASC30 [2][7] Study Details - The Phase IIa study evaluates the efficacy, safety, and tolerability of ASC30 in participants with a body mass index (BMI) of 30 kg/m or higher, or 27 kg/m but less than 30 kg/m [4] - The study consists of three cohorts with different doses, totaling 65 participants [4] - The ultra-long-acting SQ depot formulation of ASC30 demonstrated a 46-day observed half-life in a Phase Ib study, supporting its once-monthly administration [2][5] Technology and Development - ASC30 is developed using Ascletis' Ultra-Long-Acting Platform (ULAP), which allows for a longer half-life compared to traditional albumin-dependent technologies [6][7] - The proprietary formulation shows a favorable peak-to-trough ratio of approximately 1.5 to 1, indicating its potential as a once-monthly treatment option for obesity [7][6] - ASC30 is a first and only investigational small molecule GLP-1R biased agonist designed for both oral and subcutaneous administration [9][10] Company Overview - Ascletis Pharma Inc. is a biotechnology company focused on developing therapeutics for metabolic diseases, utilizing advanced technologies such as Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) [10] - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [10]

Core Insights - Ascletis Pharma Inc. has successfully completed the Phase III clinical trial for denifanstat (ASC40), demonstrating significant efficacy in treating moderate-to-severe acne vulgaris compared to placebo [1][4] - The company plans to submit a New Drug Application (NDA) to the China National Medical Products Administration (NMPA) following a pre-NDA consultation [2][3] Group 1: Clinical Trial Results - Denifanstat (ASC40) met all primary, key secondary, and secondary efficacy endpoints in the Phase III trial, showing significant improvement in acne vulgaris [1][4] - The safety profile of denifanstat (ASC40) was favorable, with all treatment-emergent adverse events being mild or moderate, and no serious adverse events reported [4] Group 2: Regulatory and Development Plans - Ascletis has completed the pre-NDA consultation with NMPA, which began in June 2025 and concluded in October 2025, and plans to submit the NDA soon [2][3] - The results of the Phase III study were presented at the European Academy of Dermatology and Venereology Congress in September 2025 [5] Group 3: Company Overview - Ascletis Pharma Inc. is a biotechnology company focused on developing therapeutics for metabolic diseases, utilizing advanced drug discovery technologies [6] - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [6]

Core Insights - Ascletis Pharma Inc. has selected ASC35, a once-monthly GLP-1R/GIPR dual peptide agonist, as a clinical development candidate for obesity treatment, with an IND submission expected in Q2 2026 [2][3][4] Group 1: Drug Efficacy and Characteristics - ASC35 has an average observed half-life of approximately 14 days in non-human primate studies, which is 6-fold longer than tirzepatide, supporting its once-monthly subcutaneous dosing in humans [1][4] - In head-to-head studies, ASC35 demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide in diet-induced obese mice, with ASC35 reducing body weight by 33.6% versus 19.6% for tirzepatide [1][5][7] - ASC35 is approximately 4-fold more potent than tirzepatide for both GLP-1R and GIPR in vitro, indicating its potential as a best-in-class treatment for obesity [1][4][7] Group 2: Development and Technology - ASC35 was developed using Ascletis' proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, which allow for optimized drug design and manufacturing scalability [4][10] - The pharmacokinetic relationship established in non-human primates suggests that ASC35 may have a predicted half-life of 30 days or longer in humans, enhancing its therapeutic profile [4][7] - Ascletis plans to explore combination studies of ASC35 with other therapeutic candidates, including ASC36 and ASC47, to address multiple metabolic diseases [9] Group 3: Strategic Vision - The selection of ASC35 reflects Ascletis' commitment to innovation in the treatment of obesity and metabolic diseases, complementing its existing portfolio of small molecule candidates [8] - The company aims to provide a more versatile and patient-friendly titration schedule with ASC35's once-monthly dosing [8]

Core Insights - Ascletis Pharma Inc. is conducting a randomized, double-blind, placebo-controlled study (ASC47-103) to evaluate the safety, tolerability, and preliminary efficacy of ASC47 in combination with semaglutide for obesity treatment [2][5] - The study has successfully enrolled 28 participants in less than two months, indicating strong interest in new obesity treatment options [3][8] - Topline data from the study is expected to be released in the fourth quarter of 2025 [4][8] Company Overview - Ascletis Pharma Inc. is a biotechnology company focused on developing and commercializing therapeutics for metabolic diseases, utilizing proprietary platforms for drug discovery [6] - The company is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [6] Study Details - The ASC47-103 study includes three cohorts receiving single doses of ASC47 (10 mg, 30 mg, and 60 mg) or placebo, along with four doses of semaglutide (0.5 mg, once weekly) [5] - ASC47 is characterized as an ultra-long-acting subcutaneously administered thyroid hormone receptor beta selective small molecule agonist, with a half-life of up to 40 days [3][5] - In preclinical studies, ASC47 demonstrated superior fat mass reduction compared to semaglutide and tirzepatide in diet-induced obese mouse models [3]

Core Insights - Ascletis Pharma Inc. has initiated a Phase I clinical trial for ASC50, an oral small molecule inhibitor targeting interleukin-17 (IL-17), aimed at treating psoriasis [2][3] - The trial is randomized, double-blind, and placebo-controlled, involving both healthy participants and patients with mild-to-moderate plaque psoriasis [3] - Preclinical data suggests that ASC50 has higher oral exposure, a longer half-life, and strong efficacy, positioning it as a potential best-in-class treatment for psoriasis [1] Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing innovative therapeutics for metabolic diseases [4] - The company utilizes its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP) to develop drug candidates in-house [4] - Ascletis is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [4]