Denifanstat

Phase 1 clinical trial to evaluate the PK of a combination of denifanstat and resmetirom ongoing with data readout expected 1H 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Ascletis announced completion of its pre-NDA consultation with China’s NMPA and plans to submit an NDA for denifanstat in China for treatment of moderate-to-severe acne vulgaris SAN MATEO, Calif. , Nov. 13, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the quarter ended September 30, 2025 , and provided recent corporate updates. “This is a dynamic period for Sagimet as we explore the therapeutic potential of FASN inhibition across different indications,” said David Happel , Chief Executive Officer of Sagimet. “As part of our MASH development program targeting cirrhosis of the liver, we have initiated a Phase 1 PK trial evaluating the compatibility of a once-daily combination of denifanstat and resmetirom. We plan to use this data, if positive, to advance the combination to proof-of-concept studies in MASH patients with F4 fibrosis. Additionally, we initiated a Phase 1 clinical trial of our second FASN inhibitor, TVB-3567, for development of an acne indication. We continue to explore how FASN inhibition could benefit patients living with conditions that are currently underserved by approved therapies,” he concluded. Recent Corporate Highlights In September 2025 , Sagimet dosed the first participants in a Phase 1 pharmacokinetic (PK) trial of a combination of its oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and a thyroid hormone receptor beta (THR-β) agonist, resmetirom. The Phase 1 PK trial of denifanstat and resmetirom is an open-label, 2-cohort study and has enrolled approximately 40 healthy adult participants. The objectives are to evaluate multiple-dose and single-dose pharmacokinetics, identify any potential drug-drug interactions (DDI), and assess the safety and tolerability of the combination. Topline data from this trial are anticipated in the first half of 2026 and, if positive, may be used to advance the development of the combination for patients living with metabolic dysfunction associated steatohepatitis (MASH) into a Phase 2 clinical trial, subject to consultation with regulatory authorities. In October 2025 , Ascletis Pharma Inc., the parent company of Sagimet’s license partner for China , Ascletis Bioscience Co. Ltd. ( Ascletis ), announced that it completed its pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) for denifanstat for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon to the NMPA. Effective November 1 , Marie O’Farrell, Ph.D., was promoted to Chief Scientific Officer and Liz Rozek , J.D., was promoted to Chief Legal & Administrative Officer. The Phase 1 PK trial of denifanstat and resmetirom is an open-label, 2-cohort study and has enrolled approximately 40 healthy adult participants. The objectives are to evaluate multiple-dose and single-dose pharmacokinetics, identify any potential drug-drug interactions (DDI), and assess the safety and tolerability of the combination. Topline data from this trial are anticipated in the first half of 2026 and, if positive, may be used to advance the development of the combination for patients living with metabolic dysfunction associated steatohepatitis (MASH) into a Phase 2 clinical trial, subject to consultation with regulatory authorities. Publications and Presentations In November 2025 , Sagimet presented two posters at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2025: In a secondary analysis of the denifanstat phase 2b FASCINATE-2 clinical trial, denifanstat elicited a significant ≥2-stage improvement in fibrosis in F3 MASH patients, and improved liver fibrosis and several noninvasive biomarkers in a subpopulation of qFibrosis stage 4 MASH patients identified by AI-based digital pathology (here). An analysis utilizing spatial computational histology relying on baseline fibrosis features was used to predict response to denifanstat (here). In October 2025 , Sagimet presented the data from Ascletis’ Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris in China at the 2025 Fall Clinical Dermatology Conference (here). As reported by Ascletis , in the clinical trial of 480 patients, once daily 50 mg denifanstat met all efficacy endpoints and was generally well-tolerated. In September 2025 , Ascletis presented Phase 3 clinical trial data in acne at the European Academy of Dermatology and Venerology (EADV) 2025 Congress (here). In a secondary analysis of the denifanstat phase 2b FASCINATE-2 clinical trial, denifanstat elicited a significant ≥2-stage improvement in fibrosis in F3 MASH patients, and improved liver fibrosis and several noninvasive biomarkers in a subpopulation of qFibrosis stage 4 MASH patients identified by AI-based digital pathology (here). An analysis utilizing spatial computational histology relying on baseline fibrosis features was used to predict response to denifanstat (here). Anticipated Upcoming Milestones Sagimet anticipates the data read out of its Phase 1 clinical trial to evaluate the PK and tolerability of a combination of denifanstat and resmetirom in the first half of 2026. Subject to consultation with regulatory authorities, Sagimet anticipates starting a Phase 2 clinical trial in moderate to severe acne patients in 2026 following its ongoing Phase 1 clinical trial of TVB-3567 for development of an acne indication. Financial Results for the Three and Nine Months Ended September 30, 2025 Cash, cash equivalents and marketable securities as of September 30, 2025 were $125.5 million . Research and development expense for the three and nine months ended September 30, 2025 , was $9.7 million and $32.3 million, respectively, compared to $12.7 million and $24.2 million for the three and nine months ended September 30, 2024 , respectively. General and administrative expense for the three and nine months ended September 30, 2025 was $4.6 million and $13.8 million, respectively, compared to $4.2 million and $12.0 million for the three and nine months ended September 30, 2024 , respectively. Net loss for the three and nine months ended September 30, 2025 was $12.9 million and $41.5 million, respectively, compared to $14.6 million and $29.4 million for the three and nine months ended September 30, 2024 , respectively. About Sagimet Biosciences Sagimet is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic pathways in conditions resulting from the overproduction of the fatty acid, palmitate. Denifanstat, an oral, once-daily pill, met all primary endpoints in its Phase 2b FASCINATE-2 clinical trial in MASH as well as all primary and secondary endpoints in Sagimet’s license partner for China’s Phase 3 clinical trial in moderate-to-severe acne. A combination of denifanstat and resmetirom is currently being tested in a Phase 1 PK clinical trial and is planned to be developed for cirrhotic patients living with F4-stage MASH. TVB-3567, a second oral FASN inhibitor which is planned to be developed for acne, is currently being tested in a Phase 1 first-in-human clinical trial. For additional information about Sagimet, please visit www.sagimet.com. About MASH MASH is a progressive and severe liver disease which is estimated to impact more than 265 million people worldwide. MASH is characterized by the build-up of fat in the liver and various degrees of inflammation and fibrosis along with systemic metabolic changes including dyslipidemia (increased fat levels in blood) and insulin resistance. Patients with moderate to severe disease who have advanced fibrosis (F3) or cirrhosis (F4) have the highest risk of liver-related outcomes such as decompensation, hepatocellular carcinoma, and liver transplantation. There are few approved treatments for non-cirrhotic MASH (stages F1, F2 and F3 fibrosis) and no approved treatments for MASH cirrhosis (F4). About Acne There are 5.1 million acne patients treated by dermatologists annually in the U.S., and a total U.S. acne market of over 50 million people.1,2 There is no cure for acne; and due to its pathology, most patients require chronic management and multiple courses of treatment for flare control annually. Additionally, adherence to topical therapies is lower than with oral agents, with an estimated 30% to 40% of patients not adhering to their topical treatments.3 Forward-Looking Statements This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding: the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis , and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements; and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Joyce Allaire LifeSci Advisors JAllaire@LifeSciAdvisors.com Media Contact: Michael Fitzhugh LifeSci Advisors mfitzhugh@lifescicomms.com Source: Sagimet Biosciences Inc.

这些年看着中国创新药一步步走出国门，越来越觉得这事儿像开了家面向全球的“出海超市”——不是冷冰冰的商品罗列，而是实打实的“各取所需、互相成就”。从门口最扎眼的重磅好药，到货架深处的潜力新品，再到专门解决小众需求的定制款，每一层都藏着中外药企的默契，也藏着中国医药创新这些年的硬功夫。 一层货架：黄金核心区——闭眼入的全球标杆硬货 一走进这个“超市”，最吸睛的肯定是入口处的黄金核心区。这里摆的没有花架子，全是经过全球临床验证的“硬通货”，是中国创新药的“门面担当”——价值密度最高、交易金额最大，帮跨国药企稳稳拿下主流市场，也让咱们中国创新药凭着真本事敲开全球大门，抢占话语权。 货架上的硬货：爆款单品+豪华套餐 核心区的C位，全是“全球首创”或“同类最优”的重磅药，就像超市里被抢疯的限量典藏款，懂行的一眼就知道价值。 荣昌生物的维迪西妥单抗就是典型，作为咱们国内首个获批的ADC药（也就是大家说的“生物导弹”），针对HER2阳性乳腺癌、胃癌的效果比同类药好不少，当时被美国Seagen以1.75亿美元预付款+26亿美元里程碑拿下，后来借着辉瑞收购的渠道铺向全球——咱们靠硬实力赚了真金白银，美方也拿到了管线核心资产，买卖双方都划算。 翰森制药的两款“全球授权爆款”更是核心区新晋王牌：一款是CDH17靶向ADC药物HS-20110，2025年10月将大中华区以外全球权益授权给罗氏，8000万美元预付款+14.5亿美元里程碑，总额超15.3亿美元，是中国ADC领域出海重磅案例；另一款是GLP-1/GIP双受体激动剂HS-20094，同年6月授予Regeneron海外独占许可，同样收获8000万美元预付款+19.3亿美元里程碑，Ⅲ期临床数据亮眼，成了代谢赛道“全球抢手货”。 还有启光德健与美国Biohaven的合作，以130亿美元潜在总金额创下新高，堪称“超市顶奢套装”，让中国创新药在全球高端授权市场站稳脚跟。 除了单打独斗的爆款，还有“一站式采购套餐”。信达生物的IBI363/IBI343/IBI3001肿瘤组合，三款药覆盖实体瘤、血液肿瘤核心靶点，像极了超市联名限量套装，2023年被武田制药以12亿美元首付款+102亿美元里程碑拿下，总价114亿美元（比信达过去六年半营收总和还多），成了武田布局全球肿瘤管线的关键。 恒瑞医药的合作更是多点开花：2025年3月将Lp（a）口服小分子项目授权给默沙东，2亿美元预付款+17.7亿美元里程碑；此前还与GSK打包12款自免、炎症、肿瘤候选药，潜在总交易额超13亿美元，实打实体现了中国药企的平台研发实力。 能上核心区的规矩：硬实力说话 想进核心区得闯三道关：临床数据成熟到III期以上（或I期就有碾压性优势）、适应症市场超百亿美元、全球具备不可替代优势。这里定价不玩虚的，临床效果越突出、市场越大，价格越高；合作模式要么是全球独家授权，要么是整组管线打包，跨国药企买的是“确定能赚钱的市场”，咱们卖的是“经过验证的真本事”，每一笔大额交易，都是咱们从“本土玩家”升级为“全球核心伙伴”的证明。 二层货架：成长潜力区——低成本押注未来的潜力股 逛完核心区，旁边的成长潜力区也很有看头。这里的药虽没到全球顶尖水平，但胜在踩中风口或解决了未被满足的细分需求，像超市里的网红潜力款——现在价值不算顶尖，但增长曲线清晰、合作风险可控，是跨国药企“低成本布局未来”的好选择，咱们也能借着这些赛道打磨本事、积累经验。 潜力股的两类玩法：风口赛道+应急刚需 一类是追着风口走的赛道型药物。恒瑞的GLP-1类管线套餐（HRS-7535/HRS9531/HRS-4729）就很典型，三款药覆盖不同人群肥胖、糖尿病需求，其中HRS-7535减重效果优于同类竞品，2023年恒瑞与阿斯利康合作，对方拿下除中国外全球权益，总交易额达60亿美元，成了海外药企布局代谢赛道的“潜力押注”。 迈威生物的双靶点siRNA药物2MW7141是潜力区“黑马”，2025年9月以最高10亿美元总额授权给Kalexo Bio，用于血脂调控与心血管事件预防，采用非LNP递送系统，临床前就有First-in-class潜力，是中国小核酸药物出海的代表案例。 歌礼制药的ASC40瞄准NASH（非酒精性脂肪性肝炎）这个小众但需求迫切的赛道，作为全球为数不多进入临床后期的NASH药，凭着“人无我有”的稀缺性，以1500万美元预付款+1.9亿美元里程碑敲开美国Sagimet Biosciences大门，这就是“小赛道也能做出大文章”。 另一类是应对突发需求的刚需药。君实生物的VV116在新冠期间表现亮眼，安全性好还能口服，被美国Coherus BioSciences以1亿美元预付款+11亿美元里程碑拿下，覆盖欧美主流市场，像超市里的应急储备品，在需求峰值期实现“快速兑现、双方受益”。 科兴的新冠灭活疫苗更不用多说，累计出口超10亿剂、总规模超百亿美元，成了很多国家的防疫必备，咱们输出技术和产能，他们解决燃眉之急，妥妥的双赢。 这里的合作逻辑：风险共担，红利共享 能进潜力区的药，只需满足两个条件：临床数据初步验证、市场需求增速可见。定价跟着风口走，赛道增长越快、差异化越明显，溢价越高；合作模式多是“区域授权+里程碑分成”，跨国药企不用一次性砸太多钱，咱们也能跟着赛道成长分红利——今天一起布局，明天一起赚钱。 三层货架：小众溢价区——专攻难治领域的高价值精品 往超市深处走，还有一片“小众溢价区”。这里的药不跟主流赛道挤，专门盯着阿尔茨海默病、神经退行性疾病、多重耐药菌感染这些“硬骨头”——研发难度高、成功率低，但市场需求迫切，像超市里的高端定制精品，虽受众窄，但“人无我有”的稀缺性让它价值不菲，既能帮跨国药企填补细分空白，也让咱们靠技术壁垒赚得高溢价。 精品的两种打开方式：首创突破+技术改良 一类是瞄准“无药可治”领域的首创药。诺诚健华和Zenas BioSciences的合作很有代表性，双方成立合资公司聚焦神经与自身免疫领域创新药，潜在总价20亿美元。这类药研发周期动辄15年以上、临床成功率不足10%，但一旦成功就能填补全球空白，像定制奢侈品，高风险背后是高回报——咱们共享全球资源和收益，美方也能布局高潜力难治领域。 恒瑞医药的HRS-1893也一样，针对神经相关适应症，凭着国内领先的研发突破，以10.13亿美元里程碑总价成了Braveheart Bio布局神经领域的“稀缺补位品”，证明了“难啃的骨头更有价值”。 另一类是优化现有疗法的改良药。绿叶制药的利斯的明透皮贴剂，专门解决阿尔茨海默病患者口服药“依从性差”的痛点，通过区域授权进入日本等亚太市场，年销售额稳步增长，证明“把现有药做精也能走得远”。 恒瑞的新型抗菌药针对多重耐药菌感染，填补了全球抗菌药空白，以800万美元预付款+1.2亿美元里程碑被欧洲药企采购，精准解决小众刚需，双方都受益。 小众药的赚钱逻辑：稀缺性就是话语权 能进这个区域的药，关键就两点：临床需求未被满足、技术壁垒够高。定价不看市场大小，看稀缺性——研发越难、空白越大，溢价越高；合作模式多是联合开发或里程碑+销售分成，风险共担、收益共享。咱们不跟巨头正面竞争，在小众领域站稳脚跟，反而能掌握定价话语权，这是聪明的突围。 特殊区域：定制服务台——按需匹配的价值共创伙伴 逛完标准化货架，超市角落还有个“定制服务台”。这里不摆固定产品，凭着中国创新药的研发实力，给跨国药企“量身定制”合作方案——不管是管线缺口、渠道短板，还是成本控制需求，都能对症下药。这已经不是“卖产品”，而是实打实的“做伙伴”，让合作没有上限。 定制服务的两种玩法：区域精准匹配+规模化适配 君实生物的特瑞普利单抗是区域定制典范。专门瞄准美国晚期鼻咽癌这个“小众但急需”的适应症，获批后美国定价8892.03美元/瓶（国内仅1912.96元，价差超30倍）。与Coherus的合作不是简单授权，而是联合运营：对方负责美国推广和渠道，咱们负责生产和临床支持，FDA获批后还能拿2500万美元里程碑+销售分成，预计美国年销售峰值达2亿美元——这就是“精准定位+优势互补”的威力。 复宏汉霖的汉曲优，作为曲妥珠单抗的生物类似药，是肿瘤领域“通用必备品”，通过授权给Accord Healthcare等企业覆盖欧洲、拉美、亚太多个市场，2025年上半年全球销售额14.07亿元。合作方式灵活，根据不同区域定价、渠道特点调整条款，咱们靠稳定产能和一致质量占领市场，跨国药企低成本补全管线，皆大欢喜。 定制服务的核心：互相成就，长期绑定 这个服务台的竞争力就是“灵活”——定价无固定标准，看合作深度和资源投入；合作模式可大可小，既能做单一区域授权，也能搞全球联合商业化；风险共担、利益共享，跨国药企降低研发风险，咱们避开海外商业化壁垒。说到底，这是中国创新药的思维升级：不再是等着被采购的“商品”，而是主动匹配资源、共创价值的“合作伙伴”。 简单说，授权不是“一卖终身”，而是“约定租期内的权益共享”，既保障跨国药企排他性，也给中国药企留有余地，符合全球创新药合作惯例。 这家“超市”的底气：2025年再升级，全面性拉满 现在的“中国创新药出海超市”，早已不是早期的“单品货架”，而是覆盖超50家药企、百余种药物、全赛道的综合平台： - 企业类型：既有恒瑞、翰森、信达等头部巨头，也有迈威、歌礼、诺诚健华等新锐药企，还有科兴、复宏汉霖等细分领域龙头； - 赛道覆盖：ADC、双抗、siRNA、GLP-1类、肿瘤、代谢、神经、抗感染等热门及小众领域全覆盖，2025年上半年授权总额660亿美元，已超2024年全年； - 合作规模：单笔交易从千万美元到130亿美元不等，“小而美”的小众授权和“百亿美元级”重磅合作兼具，满足不同跨国药企需求。 未来，只会有更多首创药上架，更多像NewCo这样的灵活合作模式出现。这家“中国创新药出海超市”，终将让“中国创新”成为全球医药市场的信任标签，让中外药企都能找到合心意的合作，真正实现“分层选‘药’，全球共赢”。