Core Viewpoint - Sagimet Biosciences Inc. is advancing the development of denifanstat (ASC40), a fatty acid synthase (FASN) inhibitor, which has shown positive results in clinical trials for treating moderate to severe acne, indicating its potential as a novel therapeutic option in this area [1][2][3]. Clinical Results - The Phase 3 open-label trial (ASC40-304) enrolled 240 subjects who received denifanstat 50 mg once daily for up to 40 weeks, following a previous 12-week double-blind trial [4]. - Denifanstat demonstrated improvements in all efficacy endpoints beyond the 12-week results, including significant reductions in skin lesion counts and improvements in Investigator's Global Assessment (IGA) scores [5][6]. Safety Profile - Denifanstat was generally well tolerated, with only mild to moderate treatment-emergent adverse events (TEAEs) reported, including dry eye syndrome (5.5%) and dry skin (5.2%) [7]. - No serious adverse events (SAEs) related to denifanstat were reported, and all adverse events were manageable, with no permanent discontinuations due to treatment [7]. Market Context - Acne affects over 50 million people in the U.S., with a significant number requiring chronic management, highlighting the need for effective treatment options [9]. - The inhibition of FASN is considered a promising approach due to its role in sebum production and inflammatory pathways associated with acne [9].

公司于2025年6月4日的公告中宣布地尼法司他(ASC40)在480例患者中开展的治疗中重度寻常性痤疮的 随机、双盲、安慰剂对照的III期临床研究(NCT06192264)达到所有主要、关键次要和次要终点。 歌礼制药-B(01672)发布公告，同类首创(first-in-class)、每日一次口服小分子脂肪酸合成酶(FASN)抑制剂 地尼法司他(ASC40)在中重度寻常性痤疮患者中的III期开放标签研究(NCT06248008)取得积极顶线结 果。 于近期完成的该第二项III期研究是一项在中国开展的开放标签的多中心研究，旨在评估地尼法司他 (ASC40)在240例中重度寻常性痤疮患者中的长期安全性。这240例患者均接受了40周的每日一次地尼法 司他(ASC40)治疗，且此前均接受过12周的地尼法司他(ASC40)或安慰剂治疗。主要终点包括治疗期间 发生的不良事件(treatment-emergent adverse event，TEAE)的发生率;严重不良事件(SAE)的发生率;及因不 良事件(AE)导致停药的发生率。地尼法司他(ASC40)显示出良好的安全性和耐受性特征。大部分治疗期 间发生的不良事件为轻度 ...

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 - The company has announced positive topline results from a Phase III open-label study of its first-in-class oral small molecule FASN inhibitor, ASC40, for moderate to severe acne patients [1] - ASC40 demonstrated good safety and tolerability, with most adverse events being mild to moderate, and no severe adverse events reported [1] - The company has also achieved all primary and key secondary endpoints in a randomized, double-blind, placebo-controlled Phase III clinical study involving 480 patients [2] Group 1 - ASC40 was evaluated in a Phase III open-label study involving 240 moderate to severe acne patients, focusing on long-term safety [1] - The primary endpoints included the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and the rate of discontinuation due to adverse events [1] - The study showed that there were no grade 3 or 4 adverse events related to ASC40, and no deaths were reported [1] Group 2 - The mechanism of action for ASC40 involves inhibiting de novo lipogenesis (DNL) in human sebocytes, directly reducing sebum production and inflammation [2] - Excessive sebum production is a major cause of acne, and ASC40's unique mechanism sets it apart from other acne treatments that do not address the root cause [2] - The company has obtained exclusive rights for ASC40 in Greater China from Sagimet Biosciences Inc. [2]

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。 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」）宣佈，同類首創(first-in-class)、每日一次口服 小分子脂肪酸合成酶(FASN)抑制劑地尼法司他(ASC40)在中重度尋常性痤瘡患者 中的III期開放標籤研究(NCT06248008)取得積極頂線結果。 於近期完成的該第二項III期研究是一項在中國開展的開放標籤的多中心研究， 旨在評估地尼法司他(ASC40)在240例中重度尋常性痤瘡患者中的長期安全性。 這240例患者均接受了40周的每日一次地尼法司他(ASC40)治療，且此前均接受 過12周的地尼法司他(ASC40)或安慰劑治療。主要終點包括：(1)治療期間發生的 不良事件（treatment-emergent adverse event，TEAE）的發生率； ...

Core Insights - CancerVax, Inc. has appointed Dr. George Kemble as Senior Scientific Advisor to enhance its universal cancer treatment platform that utilizes the immune system to combat cancer [1][6]. Company Overview - CancerVax is a pre-clinical biotech company focused on developing a customizable universal cancer treatment platform that aims to detect, mark, and kill only cancer cells [6]. - The company's innovative approach involves disguising cancer cells to resemble well-immunized common diseases, such as measles or chickenpox, to leverage the body's natural immune response [4][6]. Leadership and Expertise - Dr. George Kemble is a seasoned biotech executive with extensive experience in virology, vaccines, and small molecule biologics, previously serving as Chairman of the Board at Sagimet Biosciences Inc. [2]. - His background includes significant roles at MedImmune, where he led research and development efforts, including the launch of FluMist®, the first major innovation in influenza vaccines in over 60 years [3]. Strategic Vision - Dr. Kemble's appointment is expected to bring valuable insights into translating immunology into effective therapies, aligning with CancerVax's mission to reframe cancer as a target the immune system can recognize and defeat [5].

Core Insights - Several biotechnology and pharmaceutical companies experienced significant stock price increases in after-hours trading, driven by corporate updates, clinical milestones, and acquisition speculation [1] Company Updates - China SXT Pharmaceuticals, Inc. (SXTC) saw a 13.6% increase to $1.42, following the announcement of its Strategic Artificial Intelligence Insights Initiative aimed at integrating AI-driven analytics into product planning and market intelligence [2] - Revolution Medicines, Inc. (RVMD) surged 15.1% to $123.65 after reports of Merck's acquisition talks and the FDA granting Breakthrough Therapy Designation to its drug zoldonrasib for treating specific lung cancer patients [3] - KalVista Pharmaceuticals, Inc. (KALV) advanced 14.0% to $18.04 after reporting preliminary unaudited global net product revenue results for Q4 and the full year ended December 31, 2025, along with other operational indicators [4] - Zentalis Pharmaceuticals, Inc. (ZNTL) rose 8.1% to $3.07, likely due to investor reactions to a previous corporate update outlining key milestones for its drug azenosertib [5] - BriaCell Therapeutics Corp. (BCTX) gained 7.3% to $7.81 without new announcements, indicating momentum-driven trading [6] - Sagimet Biosciences Inc. (SGMT) increased 7.7% to $6.00 after announcing plans to present clinical trial results at an upcoming conference, highlighting anti-fibrotic effects observed in patients [7]

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 Viewpoint - The announcement of the New Drug Application (NDA) acceptance for denifanstat (ASC40), a first-in-class oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate to severe acne, marks a significant milestone for the company in providing a potentially groundbreaking therapy for acne treatment [1][2]. Group 1 - The NDA for denifanstat (ASC40) has been accepted by the National Medical Products Administration (NMPA) of China [1]. - The company has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for denifanstat (ASC40) in treating moderate to severe acne [1]. - The Phase III study demonstrated that denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints, significantly improving moderate to severe acne compared to placebo [2]. Group 2 - Denifanstat (ASC40) exhibited good safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2) [2]. - There were no Grade 3 or 4 TEAEs related to denifanstat (ASC40), nor were there any serious adverse events (SAEs) associated with the treatment [2]. - The company has received positive feedback from the NMPA following recent pre-NDA communications regarding the new drug application for denifanstat (ASC40) [2]. Group 3 - The company has obtained exclusive rights for denifanstat (ASC40) in the Greater China region from Sagimet Biosciences Inc. (NASDAQ: SGMT) [2]. - The results of the Phase III study were presented orally at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting held in Paris [2].

Core Insights - The company has completed Pre-NDA communication with the National Medical Products Administration of China regarding denifanstat (ASC40) for the treatment of moderate to severe acne and plans to submit a New Drug Application soon [1][2] - Denifanstat (ASC40) has successfully met all primary, key secondary, and secondary efficacy endpoints in the Phase III study, showing significant improvement compared to placebo [2] - The safety profile of denifanstat (ASC40) is favorable, with all treatment-emergent adverse events being mild or moderate, and no severe adverse events reported [2] Company Developments - The company has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for denifanstat (ASC40) [1] - The results of the Phase III study were presented at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting in Paris on September 17, 2025 [2] - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]