Core Viewpoint - Ascletis Pharma Inc. announced positive topline results from a Phase III open-label study of denifanstat (ASC40), a first-in-class oral fatty acid synthase (FASN) inhibitor for treating moderate-to-severe acne vulgaris, indicating a potential breakthrough in acne treatment [1] Group 1: Study Results - Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile in a Phase III open-label study involving 240 patients, with most treatment-emergent adverse events (TEAEs) being mild (grade 1) or moderate (grade 2) [1] - No grade 3 or 4 adverse events or serious adverse events (SAEs) related to denifanstat (ASC40) were reported, and no deaths occurred during the study [1] Group 2: Mechanism of Action - The mechanism of action for denifanstat (ASC40) includes direct inhibition of sebum production by inhibiting de novo lipogenesis (DNL) in human sebocytes and reducing inflammation by decreasing cytokine secretion and Th17 differentiation [1] - This unique mechanism sets denifanstat (ASC40) apart from most other acne treatments, which do not address the underlying cause of acne [1] Group 3: Regulatory Progress - The New Drug Application for denifanstat (ASC40) for acne has been accepted by the China National Medical Products Administration, indicating progress towards commercialization [1] Group 4: Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing potential best-in-class and first-in-class therapeutics for metabolic diseases [1] - The company utilizes proprietary technologies such as Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) to develop multiple drug candidates, including small molecules and peptides [1]

Core Insights - Ascletis Pharma Inc. is advancing its investigational drug ASC30, a GLP-1 receptor agonist, into a Phase II study for type 2 diabetes, with topline data expected in Q3 2026 [2][5] Group 1: ASC30 Development - ASC30 has shown a placebo-adjusted weight loss of up to 7.7% in a completed 13-week Phase II study for obesity, demonstrating better gastrointestinal tolerability compared to other treatments [1][3] - The Phase II study for diabetes will evaluate ASC30's efficacy, safety, and tolerability, focusing on changes in HbA1c and body weight among approximately 100 participants [5][6] - ASC30 is designed for once-daily oral administration and has been developed in-house by Ascletis as a first and only investigational small molecule GLP-1R fully biased agonist [4][6] Group 2: Clinical Study Details - The obesity Phase II study involved 125 participants and reported a treatment discontinuation rate due to adverse events of 4.8% [3] - The study for diabetes is randomized, double-blind, and placebo-controlled, with participants assigned to different dosages of ASC30 [5] - The primary endpoint of the diabetes study is the mean change in HbA1c from baseline, with secondary endpoints including fasting blood glucose and body weight changes [5]

Core Insights - Ascletis Pharma Inc. has selected ASC37 injection, a next-generation GLP-1R/GIPR/GCGR triple peptide agonist, for clinical development, with an Investigational New Drug Application (IND) submission to the FDA expected in Q2 2026 [2][5]. Group 1: Product Development - ASC37 has an average observed half-life of approximately 17 days in non-human primate studies, which is 7-fold longer than retatrutide, supporting once-monthly subcutaneous dosing [1][4]. - The in vitro activity of ASC37 is approximately 5-fold, 4-fold, and 4-fold more potent than retatrutide for GLP-1R, GIPR, and GCGR, respectively [1][3]. - ASC37 is engineered for a longer half-life compared to retatrutide, allowing for a subcutaneous injection volume of one milliliter or less, which also provides manufacturing scalability advantages [3][4]. Group 2: Clinical Strategy - The company plans to initiate a Phase I study for ASC37 in the second half of 2026, as part of its strategy to enhance treatment options for obesity [5]. - ASC37 is being developed both as a monotherapy and in combination with ASC36, another peptide agonist, to address cardio-metabolic diseases including obesity and diabetes [5]. Group 3: Technological Innovation - Ascletis utilizes its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies to design and optimize multiple once-monthly subcutaneous ultra-long-acting peptides [6][8]. - The ULAP technology allows for precise control over the release of peptides, improving clinical outcomes by reducing peak-to-trough ratios [6].

Core Insights - Ascletis Pharma Inc. has received acceptance for its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class oral fatty acid synthase inhibitor aimed at treating moderate-to-severe acne vulgaris, by the China National Medical Products Administration (NMPA) [2][3] - The Phase III clinical trial results demonstrated that denifanstat (ASC40) met all primary and secondary efficacy endpoints, showing significant improvement in acne vulgaris compared to placebo, with a favorable safety profile [4][5] Group 1 - The acceptance of the NDA is a significant milestone for Ascletis in its efforts to commercialize denifanstat (ASC40) [3] - Denifanstat (ASC40) has completed both Phase II and Phase III studies for the treatment of moderate-to-severe acne vulgaris [3][5] - The Phase III study results were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025, indicating the company's active engagement in scientific discourse [5] Group 2 - The Phase III study reported that all treatment-emergent adverse events (TEAEs) related to denifanstat (ASC40) were mild or moderate, with no severe adverse events observed [4] - Ascletis has licensed denifanstat (ASC40) from Sagimet Biosciences Inc. for exclusive rights in Greater China, highlighting strategic partnerships in drug development [5] - Ascletis Pharma Inc. is focused on developing and commercializing innovative therapeutics for metabolic diseases, utilizing advanced technologies in drug discovery [6]

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]