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]

Core Insights - Ascletis Pharma Inc. is set to present preliminary studies on its oral GLP-1 receptor agonist ASC30 and weight loss drug candidate ASC47 at the 85th Scientific Sessions of the American Diabetes Association in Chicago [1][5] Group 1: ASC30 - ASC30 is an investigational GLP-1 receptor biased small molecule agonist that can be administered both orally and via subcutaneous injection [3] - It is a new chemical entity with patent protection in the U.S. and globally until 2044 [3] - The first-in-human single ascending dose study will be presented under poster number 750-P on June 22, 2025 [2] Group 2: ASC47 - ASC47 is an adipose-targeted, ultra-long-acting small molecule agonist that selectively targets thyroid hormone receptor beta [4] - It is designed to achieve high drug concentrations in adipose tissue, demonstrating unique properties for obesity treatment [4] - The ongoing Phase I clinical trial in combination with semaglutide for obesity treatment began dosing participants in May 2025 [4][2] Group 3: American Diabetes Association (ADA) - The ADA is a leading nonprofit organization focused on diabetes prevention, cure, and improving the lives of those affected by diabetes [5] - The 85th Scientific Sessions will take place from June 20 to 23, 2025, in Chicago, setting the agenda for clinical practice and research innovation [5] Group 4: Ascletis Pharma Inc. - Ascletis is an innovative R&D-driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic diseases [6] - The company covers the entire value chain from drug discovery and development to GMP manufacturing [6] - Ascletis has multiple clinical-stage drug candidates in its metabolic disease pipeline, addressing unmet medical needs globally [7]

Core Insights - Ascletis Pharma Inc. announced that denifanstat (ASC40), a first-in-class oral fatty acid synthase (FASN) inhibitor, successfully met all primary and secondary endpoints in a Phase III clinical trial for moderate to severe acne vulgaris [1][6][10] Clinical Trial Overview - The Phase III trial was a randomized, double-blind, placebo-controlled study conducted in China with 480 patients, comparing 50 mg denifanstat to a placebo over 12 weeks [2] - Baseline characteristics were well balanced between the treatment and placebo groups, with total lesion counts of 102.2 for denifanstat and 102.1 for placebo [11] Efficacy Results - Primary endpoints showed a treatment success rate of 33.2% for denifanstat versus 14.6% for placebo (p<0.0001) [3] - Denifanstat achieved a 57.4% reduction in total lesion count compared to 35.4% for placebo (p<0.0001) and a 63.5% reduction in inflammatory lesions compared to 43.2% for placebo (p<0.0001) [3] - Key secondary endpoint results included a 51.9% reduction in non-inflammatory lesions for denifanstat versus 28.9% for placebo (p<0.0001) [3] Safety Profile - Denifanstat demonstrated a favorable safety and tolerability profile, with treatment-emergent adverse events (TEAEs) comparable to placebo [4] - No TEAEs related to denifanstat exceeded 10%, and all reported adverse events were mild or moderate [4] Mechanism of Action - Denifanstat works by directly inhibiting facial sebum production and inflammation, addressing the underlying causes of acne [5] - This mechanism differentiates denifanstat from other acne treatments that do not target the root cause of the condition [5] Comparative Efficacy - In non-head-to-head comparisons, denifanstat was found to be 98% and 178% more effective than sarecycline and doxycycline, respectively, in terms of placebo-adjusted treatment success [7][8] - Denifanstat was also 60% more effective than clascoterone cream regarding treatment success [7][8] Market Potential - Denifanstat is positioned as a first-in-class oral acne therapeutic with exceptional efficacy and a favorable safety profile, potentially improving patient compliance compared to topical treatments [9] - The company plans to submit denifanstat for approval to the China National Medical Products Administration (NMPA) [6]

Core Insights - Ascletis Pharma Inc. has received FDA clearance for the investigational new drug (IND) application for ASC50, an oral small molecule IL-17 inhibitor aimed at treating mild-to-moderate plaque psoriasis [3][6] - ASC50 shows promising preclinical data, including higher oral exposure, longer half-life, and strong efficacy, positioning it as a potential best-in-class treatment for psoriasis [2][4] Company Overview - Ascletis is an innovative R&D driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic and other diseases while addressing unmet medical needs globally [7] - The company utilizes an Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) platform for drug development, with ASC50 being the first oral small molecule candidate in immunology from this platform [6] Clinical Development - The Phase I clinical trial for ASC50 will be a randomized, double-blind, placebo-controlled study conducted at multiple sites in the U.S., with patient dosing expected to start in the third quarter of 2025 [5][6] - Preclinical studies indicate that ASC50 has a lower clearance rate compared to existing oral IL-17 inhibitors currently in clinical development, suggesting a potentially advantageous pharmacokinetic profile [4]

Core Insights - Ascletis Pharma Inc. is conducting a randomized, double-blind, placebo-controlled study (ASC47-103) to evaluate the safety and preliminary efficacy of ASC47 in combination with semaglutide for obesity treatment [3][6] - ASC47 is an adipose-targeted, ultra-long-acting small molecule agonist with a half-life of up to 40 days, showing promising results in preclinical studies [4][6] - The combination of low-dose ASC47 and semaglutide resulted in a 56.7% greater reduction in body weight with muscle preservation compared to semaglutide alone in a mouse model [2][4] Study Design - The ASC47-103 study includes three cohorts receiving single ascending doses of ASC47 (10 mg, 30 mg, and 60 mg) or placebo, along with four doses of semaglutide (0.5 mg, once weekly) [3][6] - Topline data from the ASC47-103 study are anticipated in the fourth quarter of 2025 [5] Company Overview - Ascletis Pharma Inc. is a biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic diseases and addressing unmet medical needs globally [7]

Core Insights - Ascletis Pharma Inc. is presenting preliminary studies of ASC47, a weight loss drug candidate, at the 32nd European Congress On Obesity (ECO 2025) in Malaga, Spain [1] Group 1: Presentation Details - The oral presentation titled "ASC47, An Adipose-Targeted, Muscle-Preserving Weight Loss Drug Candidate For Obesity, Demonstrated Significant Weight Loss And Preserved Muscle In DIO Mice" will take place on May 13, 2025 [2] - A guided poster presentation titled "ASC47, a Muscle-Preserving Weight Loss Drug Candidate in Healthy Participants: A First-in-human Single Ascending Dose Study" is also scheduled for May 13, 2025 [3] Group 2: About ASC47 - ASC47 is an adipose-targeted, ultra-long-acting subcutaneously injected thyroid hormone receptor beta selective small molecule agonist developed in-house at Ascletis [3] - The drug shows dose-dependent high drug concentrations in adipose tissue and has completed Phase Ib single subcutaneous injection studies in Australia [3] - The U.S. FDA has cleared the Investigational New Drug (IND) application for ASC47 in combination with semaglutide for obesity treatment [3] Group 3: About Ascletis Pharma Inc. - Ascletis is an innovative R&D driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic diseases [5] - The company covers the entire value chain from discovery and development to GMP manufacturing and has multiple clinical stage drug candidates in its metabolic disease pipeline [5] Group 4: About European Congress on Obesity - The European Congress on Obesity (ECO) is an annual scientific congress established by the European Association for the Study of Obesity (EASO), which includes professionals from various areas of obesity research, prevention, and management [4]

Core Insights - Ascletis Pharma Inc. announced positive interim results from a Phase Ib study of ASC30, a small molecule GLP-1 receptor agonist, demonstrating a 36-day half-life for its ultra-long-acting subcutaneous injection formulation in patients with obesity [2][4][8] - The oral tablet formulation of ASC30 showed a potential best-in-class weight loss of 6.3% after four weeks of treatment [5] Group 1: Study Results - The Phase Ib study involved three ultra-long-acting subcutaneous injection formulations of ASC30, with one formulation achieving a 36-day half-life, supporting less frequent administration [3][4] - The study included eight patients receiving the ASC30 formulation and two on placebo, indicating a well-structured clinical trial design [3] Group 2: Safety Profile - ASC30 SQ injection was well tolerated, with no serious adverse events reported and the majority of gastrointestinal-related adverse events being mild [6] - No significant elevations in liver enzymes or abnormal findings in laboratory tests were observed, indicating a favorable safety profile [6] Group 3: Product Development - ASC30 is designed for both once-daily oral and once-monthly subcutaneous administration, providing flexibility in treatment options for obesity [7][9] - The formulation is stable around neutral pH, allowing for potential co-formulation with other drugs, which could enhance its therapeutic applications [4] Group 4: Market Implications - The once-monthly injection could significantly reduce the number of devices and cartridges needed compared to weekly injectables, potentially improving patient compliance and convenience [8] - The unique properties of ASC30 as a small molecule GLP-1R biased agonist position it favorably in the obesity treatment market [9][10]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on January 24, 2024. Registration No. 333-276664 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Sagimet Biosciences Inc. (Exact name of registrant as specified in its charter) 2834 Delaware (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) David Happel President ...

Table of Contents As filed with the Securities and Exchange Commission on January 23, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Sagimet Biosciences Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 2834 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Sagimet Biosciences Inc. 155 ...