证券研究报告 | 公司动态点评 2025 年 07 月 11 日 福瑞股份（300049.SZ） MASH 新药上市进程加快，看好诊断设备持续放量 | 财务指标 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业收入（百万元） | 1,154 | 1,349 | 1,727 | 2,457 | 3,629 | | 增长率 yoy（%） | 14.4 | 16.9 | 28.0 | 42.3 | 47.7 | | 归母净利润（百万元） | 102 | 113 | 188 | 290 | 462 | | 增长率 yoy（%） | 3.8 | 11.5 | 65.8 | 54.4 | 59.4 | | ROE（%） | 9.6 | 9.2 | 12.7 | 16.9 | 21.1 | | EPS 最新摊薄（元） | 0.38 | 0.43 | 0.71 | 1.09 | 1.74 | | P/E（倍） | 98.7 | 88.5 | 53.4 | 34.6 | 21.7 | | P/B（倍） | 6 ...

撰文丨王聪 编辑丨王多鱼 排版丨水成文 随着肥胖症、糖尿病及其他代谢综合征的日益普遍， 代谢功能障碍相关脂肪性肝炎 （MASH） 的发病率也在上升。目前，全球约有 1 亿人患有 MASH，预计到 2030 年，这一数字将达到 3.57 亿。 MASH 是肝硬化、肝细胞癌进展的关键因素，也是导致肝移植的主要原因。尽管饮食和运动等生活方式的改变是治疗 MASH 的主要手段，但对大多数患者而言， 通过减重实现逆转颇具挑战性。迄今为止，美国 FDA 仅批准了一款药物 Resmetirom 用于 MASH 的治疗，因此，迫切需要确定新的药物靶点并开发出有效的治 疗手段来应对患者群体庞大且日益增长的 MASH。 2025 年 6 月 30 日，江苏大学 严永敏 团队在 Cell 子刊 Cell Biomaterials 上发表了题为 ： Oral administration of DSPE-PEG-cholic acid-modified ACDVs loaded with siLIMA1 for anti-MASH therapy 的研究论文。 该研究提出了一种大规模获取 人工细胞来源囊泡 （ACDV） 的新策略， ...

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need [3] - The company's medication, Rezdiffra (resmetirom), is the first and only FDA-approved treatment for MASH with moderate to advanced fibrosis [3] Equity Awards Announcement - On June 15, 2025, Madrigal granted equity awards to 36 new non-executive employees as part of its 2023 Inducement Plan [1] - The total equity awards included options to purchase 2,184 shares of common stock and 21,125 time-based restricted stock units [2] - The exercise price for the options is set at $295.57 per share, equal to the closing price on the grant date, with a vesting schedule that includes 25% vesting on the first anniversary and 6.25% vesting quarterly thereafter [2]

Denifanstat/Resmetirom Combination Development Program May 29, 2025 Forward-Looking Statements and Disclaimer This presentation 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 document, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding possible or assum ...

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2] - The company's primary medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist targeting the underlying causes of MASH [2] - Rezdiffra is the first and only medication approved by the FDA for treating MASH with moderate to advanced fibrosis, specifically stages F2 to F3 [2] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis, corresponding to stage F4c [2] Upcoming Events - Madrigal Pharmaceuticals will participate in the 46th Annual Global Goldman Sachs Health Care Conference on June 11, 2025, at 10:40 A.M. EDT [1] - The presentation will be available via live webcast, with a replay accessible after the event [1]

SAN MATEO, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced it will host a virtual key opinion leader (KOL) event on Thursday, May 29, 2025 at 1:00 PM ET. To register, click here. The event will feature Rohit Loomba, MD, MHSc (Professor of Medicine, Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Ce ...

整理 | GLP1减重宝典内容团队 CG-0416 的肝脏特异性激活使肝内活性代谢物浓度比外周组织高 20 倍，从而最大限度地降低全身 THR-β 激活，并提高长期安全性。 2. 肌肉保存突破 在26周饮食诱导肥胖 (DIO) 小鼠模型中，CG-0416 与低剂量 司美格鲁肽联合使用表现出： 脂肪量减少 66%（与司美格鲁肽 单药治疗相比） 肌肉脂肪减少比为 0.18 kg/kg（现有疗法为 0.35-0.63 kg/kg） 临床转化优势 在欧洲肝病研究协会 (EASL) 年会上，柯君医药 公布了其在研的肝脏靶向甲状腺激素β受体 (THR-β) 前药 CG-0416 的最新临床前研究结果。 该研究数据在"最新海报"环节中展示，突显了 CG-0416 在代谢功能障碍相关脂肪性肝炎 (MASH) 和体重管理方面的三重治疗潜力：与标准疗 法相比，肝脏脂质蓄积减少 58%；减重效果提高 66%；肌肉流失率降低 50%。这些研究结果使 CG-0416 成为同时治疗 MASH 和肥胖症的新 型双机制候选药物。 突破当前治疗局限性 GLP-1 受体激动剂（例如司美格鲁肽、替泽帕肽）在持续控制体重和保持肌肉质量方面面临挑战， ...

Core Insights - Madrigal Pharmaceuticals has successfully launched Rezdiffra (resmetirom) for nonalcoholic steatohepatitis (NASH) in April 2024, achieving net sales of $137.3 million in Q1, surpassing the $100 million per quarter threshold [1] Company Performance - The drug Rezdiffra has shown strong market performance shortly after its launch, indicating a robust demand in the NASH treatment space [1] Market Context - The success of Rezdiffra reflects the growing interest and investment in biotech stocks, particularly those focused on FDA-regulated industries and significant health conditions like NASH [1]

Core Insights - Madrigal Pharmaceuticals announced positive two-year results from the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra, showing significant improvements in liver health metrics among patients with compensated MASH cirrhosis [1][2][3] Group 1: Study Results - The study involved 122 patients, with 113 completing two years of treatment, demonstrating a mean reduction of 6.7 kPa in liver stiffness, which is statistically significant [5][8] - 65% of patients with clinically significant portal hypertension (CSPH) at baseline moved to lower risk categories by year two, indicating a positive shift in patient outcomes [4][8] - Among patients with probable CSPH at baseline, 57% transitioned to the no/low CSPH category, further supporting the efficacy of Rezdiffra [4] Group 2: Safety and Tolerability - Rezdiffra was well-tolerated, with a low discontinuation rate due to adverse events; the most common side effects included diarrhea, COVID-19, and nausea [6][8] - Safety data were consistent with previous studies, reinforcing the drug's favorable safety profile [6] Group 3: Mechanism and Future Trials - Rezdiffra acts as a THR-β agonist, which is mechanistically supported to improve outcomes in patients with compensated MASH cirrhosis [7] - A larger placebo-controlled study is anticipated to confirm the benefits of Rezdiffra in this high-risk population, with ongoing trials expected to provide further insights [2][14] Group 4: Market Context - MASH is projected to become the leading cause of liver transplantation in the U.S., highlighting the urgent need for effective treatments [10][11] - An estimated 1.5 million patients have been diagnosed with MASH in the U.S., with Madrigal targeting approximately 315,000 patients with moderate to advanced fibrosis [12]

Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on denifanstat for treating metabolic dysfunction associated steatohepatitis (MASH), with promising results from recent clinical trials and plans for further studies [2][5]. Clinical Development - The Phase 2b FASCINATE-2 trial of denifanstat in MASH patients showed successful results, especially in F3 stage patients [2]. - Denifanstat demonstrated similar pharmacokinetic characteristics and tolerability in a Phase 1 trial for patients with and without hepatic impairment [2]. - A Phase 1 clinical trial to evaluate the combination of denifanstat and resmetirom is anticipated to start in the second half of 2025, with results expected in the first half of 2026 [3][12]. Preclinical Data - Preclinical data presented at EASL 2024 indicated that the combination of a FASN inhibitor (TVB-3664) and resmetirom significantly improved liver disease markers, achieving an 80% improvement in NAS compared to 33% and 25% improvements from monotherapies [3][6]. Financial Results - For the quarter ended March 31, 2025, Sagimet reported a net loss of $18.2 million, compared to a net loss of $6.6 million for the same period in 2024 [8][16]. - Research and development expenses increased to $15.3 million from $5.3 million year-over-year, while general and administrative expenses rose to $4.5 million from $3.5 million [12][16]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $144.6 million [12][17]. Corporate Updates - The company successfully completed end-of-Phase 2 interactions with the FDA in October 2024, paving the way for Phase 3 trials in MASH [5]. - Leadership changes include George Kemble transitioning to non-executive Chair of the Board and the appointment of Beth Seidenberg as Lead Independent Director [5]. Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [10]. - The renaming of NAFLD to MASLD and NASH to MASH aims to reduce stigma and improve diagnosis [10].