Ascletis Announces Positive Topline Results from Its Phase III Open-Label Study of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne [Accessibility Statement] Skip Navigation- Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated favorable safety and tolerability in a Phase III open-label study- The exceptional efficacy of denifanstat (ASC40) observed in the Company's previously reported placebo-controlled Phase III trial coupled with a favora ...

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 Viewpoint - The company has selected ASC37, a next-generation monthly subcutaneous injection targeting GLP-1R, GIPR, and GCGR, as a clinical development candidate for obesity treatment, with plans to submit an IND to the FDA in Q2 2026 [1] Group 1: Product Development - ASC37 is developed using the company's AI-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, showing approximately 5 times, 4 times, and 4 times stronger agonistic activity on GLP-1R, GIPR, and GCGR compared to retatrutide [2] - The designed optimization of ASC37 allows for a longer observed half-life, supporting monthly subcutaneous administration with an injection volume not exceeding 1 milliliter, which also provides scalability advantages in manufacturing [2] - In non-human primate studies, ASC37's proprietary depot formulation has an average observed half-life of about 17 days, which is 7 times that of retatrutide in standard liquid formulation [2] Group 2: Clinical Strategy - The company aims to advance ASC37 into clinical trials, with Phase I expected to start in the second half of 2026, as part of a broader strategy to improve treatment options for obesity [3] - ASC37 is being developed as both a monotherapy and in combination therapies for cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH) [3] - The company plans to combine ASC37 with its monthly subcutaneous amylin receptor agonist peptide ASC36 to treat obesity, diabetes, and other metabolic diseases [3]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Ascletis Pharma Inc. 歌禮製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1672） 自願性公告 歌禮選定新一代每月一次皮下注射GLP-1R/GIPR/GCGR 三靶點激動劑多肽ASC37進行臨床開發 本公告乃歌禮製藥有限公司（「本公司」或「歌禮」，連同其附屬公司稱為「本集 團」）自願作出，以使本公司股東及潛在投資者了解本集團的最新業務發展。 本公司董事（「董事」）會（「董事會」）宣布其已選定新一代每月一次皮下給藥的 GLP-1R/GIPR/GCGR[1]三靶點激動劑多肽ASC37注射劑作為臨床開發候選藥物。 歌禮預計將於2026年第二季度向美國食品藥品監督管理局(FDA)遞交ASC37注射 劑治療肥胖症的新藥臨床試驗申請(IND)。 ASC37是一款利用歌禮基於結構的AI輔助藥物發現（Artificial Intelligence-assisted Structure- ...

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]

Market Overview - The Hang Seng Index fell by 1.26%, down 340 points, closing at 26,732 points, while the Hang Seng Tech Index dropped by 2.20% [1] - Early trading volume in the Hong Kong stock market reached HKD 125 billion [1] Hydrogen Energy Sector - The hydrogen energy sector experienced significant gains following the National Energy Administration's encouragement of green hydrogen utilization in coal chemical projects [1] - Reshaping Energy (02570) surged over 55% [1] - Guofu Hydrogen Energy (02582) rose over 11% [1] - Guohong Hydrogen Energy (09663) increased by over 5% [1] - Yihua Tong (02402) saw a rise of 6.8% [1] Pharmaceutical Sector - Basestone Pharmaceuticals-B (02616) increased by over 14% as GIC continued to increase its stake, surpassing 7% ownership [1] - Gilead Sciences (01672) rose over 14%, marking five consecutive days of gains, as it develops ASC36 into a monthly therapy [1] - Laika Pharmaceuticals-B (02105) gained 11.96% after securing a significant BD order worth CNY 2.045 billion for a breast cancer target [1] - Yu Yuan Group (00551) rose over 4% due to an increase in shoe prices and potential market share expansion through overseas capacity growth [1] - JS Global Life (01691) increased by 3.5% as a new product from Joyoung became popular, leading to a two-day stock limit increase for Joyoung Co., Ltd. (002242.SZ) [1] - JD Health (06618) rose by 6.8% post-earnings, with a year-on-year operating profit increase of over 125% and strategic partnerships with several well-known pharmaceutical companies [1] Technology Sector - The Hang Seng Tech Index followed the Nasdaq's decline, dropping over 2% [1] - Alibaba fell by 3.46% [1] - Tencent dropped by 0.91% post-earnings [1] Cryptocurrency Sector - Cryptocurrency-related stocks declined, with Boya Interactive (00434) falling over 5% as Bitcoin dropped below the USD 100,000 mark [2]

Core Viewpoint - The stock of Gilead Pharmaceuticals (01672) has risen over 5%, marking a five-day consecutive increase, with a total weekly gain exceeding 30% [1] Group 1: Stock Performance - As of the report, Gilead Pharmaceuticals' stock is up 5.55%, trading at HKD 12.56, with a trading volume of HKD 18.19 million [1] Group 2: Clinical Development - Gilead Pharmaceuticals announced that its next-generation amylin receptor agonist ASC36 and next-generation GLP-1R/GIPR dual-target agonist ASC35 combination formulation have entered clinical development [1] - The company plans to submit a new drug clinical trial application for ASC36 and ASC35 for obesity treatment to the US FDA in the second quarter of 2026 [1] Group 3: Product Characteristics - ASC36 and ASC35 are proprietary ultra-long-acting combination formulations with superior physicochemical stability, showing no aggregation or precipitation at neutral pH levels [1] - Gilead aims to position ASC36 as a cornerstone for monthly therapy targeting cardiac metabolic diseases, including obesity [1] - ASC36 is expected to achieve better efficacy and tolerability compared to GLP-1 therapies and is an ideal candidate for both monotherapy and combination formulations with other long-acting agents like ASC35 or THRβ agonist ASC47 [1]

Core Viewpoint - The stock of Gilead Sciences (01672) has risen over 5%, marking five consecutive days of gains, with a cumulative increase of over 30% this week, currently trading at 12.56 HKD with a transaction volume of 18.19 million HKD [1] Group 1: Clinical Development - Gilead announced that its next-generation amylin receptor agonist ASC36 and next-generation GLP-1R/GIPR dual-target agonist ASC35 combination formulation have entered clinical development [1] - The company expects to submit a new drug clinical trial application for ASC36 and ASC35 for the treatment of obesity to the US FDA in the second quarter of 2026 [1] Group 2: Drug Characteristics - ASC36 and ASC35 are proprietary ultra-long-acting combination formulations with superior physicochemical stability, showing no aggregation or precipitation due to fibrosis at neutral pH [1] - Gilead aims to position ASC36 as a cornerstone for monthly therapies targeting cardiovascular metabolic diseases, including obesity [1] - ASC36 is anticipated to achieve better efficacy and tolerability compared to GLP-1 therapies, making it an ideal candidate for both monotherapy and combination formulations with other long-acting agents like ASC35 or THRβ agonist ASC47 [1]

Group 1 - Shimai Pharmaceutical has submitted a listing application to the Hong Kong Stock Exchange, with Huatai International as the sole sponsor. The company, founded in 2017, is a pioneer in next-generation T cell engagers (TCE) aimed at utilizing the human immune system to combat cancer. It has developed a next-generation TCE therapy that can be selectively activated in tumors for the treatment of solid tumors, with four self-developed clinical-stage candidates currently in its pipeline [1] - The listing will accelerate research and development, allowing the company to seize market opportunities in the growing TCE sector [1] Group 2 - Gilead Sciences announced that its new generation of once-monthly GLP-1 receptor agonist ASC36 and dual-target agonist ASC35 has entered clinical development. The company expects to submit clinical trial applications to the FDA for ASC36 and ASC35 for obesity treatment by the second quarter of 2026 [2] - ASC36 and ASC35 are proprietary long-acting formulations with superior physicochemical stability, designed to treat metabolic diseases including obesity. ASC36 is positioned as a cornerstone therapy with potential efficacy and tolerability advantages over existing GLP-1 therapies [2] Group 3 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by sustained sales growth of its core product, the BTK inhibitor Orelabrutinib, and upfront payments from licensing agreements [4] - The revenue from Orelabrutinib increased by 45.8% year-on-year, surpassing last year's total revenue. The company's losses narrowed by 74.8% to 70 million yuan, indicating a potential turning point in profitability [4] Group 4 - InnoCare's revenue growth and reduced losses are attributed to the expansion of Orelabrutinib's indications and additional licensing income, which will accelerate the advancement of its innovative pipeline and strengthen its position in the BTK field [4] Group 5 - Ying'en Biopharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors. This drug is an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of this ADC aims to address treatment bottlenecks in resistant solid tumors and enhance the company's pipeline competitiveness, providing new options for solid tumor treatment [3]