医药生物 2025 年 11 月 16 日 投资评级：看好（维持） 行业走势图 数据来源：聚源 -19% -10% 0% 10% 19% 29% 2024-11 2025-03 2025-07 医药生物 沪深300 ——行业周报 | 余汝意（分析师） | 刘艺（联系人） | 石启正（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | liuyi1@kysec.cn | shiqizheng@kysec.cn | | 证书编号：S0790523070002 | 证书编号：S0790124070022 | 证书编号：S0790125020004 | 海外 MNC 抢滩 FGF21 靶点，推荐国内投资机会 MASH 是基于较大患者基数、明确临床需求与商业化验证形成的确定性赛道。 根据Frost & Sullivan预测，2030年中国及全球的MASH患病人数将分别达到0.56 亿人和 4.9 亿人。MASH 创新管线众多，FGF21 能够调控脂代谢以及阻止纤维化， 全球药企竞相布局。海外研发格局看，目前依鲁西夫明、Pegozafermin、 Efimosfermin alf ...

Financial Data and Key Metrics Changes - For Q3 2025, net sales totaled $287.3 million, representing a 35% increase quarter over quarter [23][24]. - The company ended Q3 2025 with $1.1 billion in cash and marketable securities, reflecting a strong cash position to support ongoing operations [25][26]. Business Line Data and Key Metrics Changes - Rezdiffra's sales are annualizing at over $1 billion within six quarters of launch, with over 29,500 patients currently on the therapy, up from more than 23,000 at the end of Q2 2025 [4][6][7]. - The number of prescribers for Rezdiffra exceeded 10,000, indicating strong physician penetration [8]. Market Data and Key Metrics Changes - The target population for Rezdiffra is 315,000 diagnosed patients, with a significant portion remaining untreated, providing substantial growth potential [7][10]. - The company is expanding its market presence in Europe, having launched in Germany following European approval [4][15]. Company Strategy and Development Direction - The company aims to maximize the value of Rezdiffra while building its pipeline, focusing on first-line access and payer contracting strategies for 2026 [4][12]. - The strategy includes expanding the pipeline with new assets, such as an oral GLP-1, to enhance treatment options for MASH [17][18]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Rezdiffra's growth potential, citing its best-in-class profile and the expected impact of payer agreements starting January 1, 2026 [11][24]. - The management team highlighted the importance of sustained efficacy and tolerability for long-term chronic use of Rezdiffra [72][75]. Other Important Information - R&D expenses for Q3 2025 were $174 million, primarily due to a one-time expense related to the licensing agreement for MGL-2086 [24][25]. - SG&A expenses increased to $209.1 million, reflecting higher commercial investments to support the Rezdiffra launch [25]. Q&A Session Summary Question: How could AASLD data further de-risk Maestro NASH outcomes? - Management expressed excitement about AASLD and noted positive feedback from gastroenterologists regarding Rezdiffra's efficacy, which gives confidence in the Maestro outcomes trial [30][31][34]. Question: Pros and cons of combining Rezdiffra with MGL-2086 versus other GLP-1s? - Management clarified that MGL-2086 is an orforglipron derivative, emphasizing the rationale for combining it with Rezdiffra to enhance efficacy [37][38]. Question: Thoughts on competitive positioning amid recent M&A in the space? - Management viewed recent M&A as validation of the MASH market and expressed confidence in their long-term strategy and market access [45][46]. Question: Feedback on Rezdiffra's adherence rates and net pricing? - Management confirmed strong adherence rates and indicated that gross-to-net dynamics would likely lead to some future decline in pricing, but they remain optimistic about market access [51][53]. Question: Comments on Aetna's formulary coverage decision? - Management stated that Aetna's decision would not significantly impact access, as Rezdiffra would still be available through prior authorization [59]. Question: Observations on Novo's marketing campaign and path to profitability? - Management noted that while it is early to quantify the impact of Novo's campaign, they are optimistic about the potential for increased diagnoses and emphasized a focus on top-line growth [62][68].

Investment Rating - The report maintains an "Outperform" rating for the industry [8] Core Insights - The report highlights the significant potential of FGF21 as a treatment for MASH (Metabolic Associated Steatotic Liver Disease), with a global patient population potentially reaching nearly 500 million and a market size exceeding $30 billion [5][17] - Recent large-scale business development (BD) deals in the FGF21 space, including Novo Nordisk's $4.7 billion acquisition of Akero Therapeutics and Roche's $3.5 billion acquisition of 89bio, indicate strong interest and investment in this area [5][31] - Key domestic companies to watch include China Biologic Products, Dongyang Sunshine Pharmaceutical, and Huadong Medicine, all of which have promising FGF21-related products in various stages of clinical development [5][31] Summary by Sections 1. Investment Focus on FGF21 - MASH is a common liver disease globally, with a potential patient population of nearly 500 million and a drug market projected to exceed $30 billion [17] - FGF21 shows great promise in addressing core issues of MASH, including significant reductions in liver fat, inflammation improvement, and reversal of fibrosis [23][25] - The global R&D landscape for FGF21 is relatively favorable, with low competition among candidates targeting MASH [25][27] 2. Market Performance Review - The CITIC Pharmaceutical Index rose by 0.3% during the week of September 29 to October 10, 2025, underperforming the CSI 300 Index by 1.2 percentage points [4][42] - Year-to-date, the CITIC Pharmaceutical Index has increased by 23.0%, outperforming the CSI 300 Index by 5.7 percentage points [4][42] - Top-performing stocks during this period included Zhend Medical (+31.8%), Wanbangde (+21.2%), and Changshan Pharmaceutical (+12.9%) [4][59] 3. Clinical Development Highlights - China Biologic Products has a leading position with its single-target FGF21-Fc fusion protein in Phase II clinical trials [31] - Dongyang Sunshine Pharmaceutical's FGF21/GLP-1 fusion protein has shown promising results in reducing liver fat by 47% compared to a 15% reduction in the placebo group [32][34] - Huadong Medicine's multi-target FGF21/GLP-1R/GCGR fusion protein demonstrated a 79% reduction in liver fat in clinical trials, significantly outperforming the placebo [38][40]

Core Insights - The company is introducing lanifibranor as a promising oral therapy for patients with MASH [1][2] - A significant funding round of over $400 million was completed approximately a year ago, enhancing the company's position for the global Phase III NATiV3 trial [2][3] - The company successfully accelerated enrollment for the trial, resulting in over-enrollment, which was announced in April of this year [3]

Core Insights - Inventiva, a clinical-stage biopharmaceutical company, focuses on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and announced four abstract presentations at the upcoming AASLD The Liver Meeting® 2025 [1][6] Presentation Details - The first abstract compares digital images versus glass slides for histopathological evaluation of liver biopsy samples in the NATiV3 study, scheduled for presentation on November 8, 2025 [2][3] - The second abstract discusses continuous digital pathology scoring revealing fibrosis reversal and therapeutic benefits of lanifibranor, with a presentation date of November 9, 2025 [2] - The third abstract highlights high-resolution digital pathology demonstrating antifibrotic and anti-inflammatory effects of lanifibranor in TAA-induced cirrhotic rodent models, also on November 9, 2025 [2] - The fourth abstract combines digital pathology and biomarkers to quantify fibrosis and treatment response to lanifibranor in a TAA-induced cirrhosis model, presented on November 9, 2025 [2] About Lanifibranor - Lanifibranor is Inventiva's lead product candidate, an orally available small molecule that activates all three PPAR isoforms, inducing anti-fibrotic and anti-inflammatory effects [5][6] - It is the only pan-PPAR agonist in clinical development for MASH, with the FDA granting Breakthrough Therapy and Fast Track designations [5] Company Overview - Inventiva is a public company listed on Euronext Paris and NASDAQ, focusing on the research and development of oral small molecule therapies for MASH [6][7]

Summary of Altimmune Conference Call Company Overview - **Company**: Altimmune - **Product**: GLP-1/glucagon dual agonist for MASH (Metabolic Associated Steatotic Liver Disease) and weight loss Key Points Product Development and Efficacy - Altimmune is developing a GLP-1/glucagon dual agonist that targets liver effects and metabolic benefits, showing promising results in a 24-week Phase 2 trial with class-leading MASH resolution and significant weight loss of approximately 6% at 24 weeks [2][3][20] - The drug demonstrated excellent tolerability without dose titration, which is crucial for patient adherence [3][12] - The treatment shows rapid effects on liver health and weight loss, with expectations of continued improvement as treatment progresses [20][23] Regulatory Considerations - The company is preparing for potential FDA approval based on MASH resolution endpoints, with a focus on both traditional biopsy-based and non-invasive tests (NITs) [11][25] - AI-enabled histological assessments for fibrosis are being considered, with positive feedback expected from the FDA in Q4 [8][9][25] - Altimmune plans to incorporate flexibility in trial design to adapt to regulatory changes, potentially moving away from biopsy requirements [25][26] Market Positioning and Competitive Landscape - The recent interest from large pharmaceutical companies in MASH treatments indicates a growing market, with Altimmune positioned to leverage its dual-action therapy [28][30] - The company believes that its single-molecule approach, which combines liver-targeting and metabolic effects, offers a competitive advantage over combination therapies that require multiple drugs [29][34] - Altimmune aims to treat a broad spectrum of patients (F1 to F4) with its drug, addressing both early and late-stage MASH patients [32][33] Financial and Strategic Outlook - Altimmune is focused on improving its balance sheet to fund the Phase 3 trial and is exploring various funding options [39] - The company holds Fast Track status for alcohol use disorder (AUD) and is optimistic about its ongoing trials in this area, with expected readouts in 2026 [36][38] Additional Insights - The company emphasizes the importance of early efficacy in treatment to maintain patient adherence, which is critical given the high discontinuation rates seen with other GLP-1 therapies [16][17] - Altimmune's strategy is to prioritize high-value treatments for complex diseases rather than competing directly in the obesity market, positioning itself as a multifaceted solution provider [38] This summary encapsulates the key insights from the Altimmune conference call, highlighting the company's innovative approach to treating MASH and its strategic positioning in the market.

Core Viewpoint - Inventiva is hosting an analyst and investor event to provide a strategic update ahead of the anticipated Phase 3 topline results for lanifibranor, its lead asset for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) [1] Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for MASH [3] - The company is evaluating lanifibranor, a novel pan-PPAR agonist, in the pivotal Phase 3 NATiV3 clinical trial for adult patients with MASH, a progressive chronic liver disease [3] Event Details - The event will take place on October 8, 2025, from 11:30 am to 2:00 pm ET in New York City, with a live webcast available [1] - The program will include presentations from Inventiva's leadership and insights from key opinion leaders in the MASH field, along with a patient representative [2][5] Key Topics of Discussion - An update on lanifibranor ahead of the anticipated Phase 3 NATiV3 topline results expected in the second half of 2026 [5] - A deep dive into lanifibranor's mechanism of action and clinical evidence, including findings from the Phase 2b trial [6] - Discussion on the design and objectives of the ongoing Phase 3 study, including patient baseline characteristics [6] - Insights from renowned experts in the field, including Dr. Nezam Afdhal, Dr. William Alazawi, Henry E. Chang, and Dr. Arun Sanyal [6]

Core Viewpoint - The GLP-1 drug market is experiencing rapid growth, with sales expected to exceed $50 billion in 2024, driven by the success of drugs like semaglutide, which generated $16.632 billion in sales in the first half of this year, surpassing competitors [1][10] Market Dynamics - The Hong Kong market has seen significant interest in GLP-1 drugs, with companies like Pague Bio experiencing stock price surges, reflecting investor enthusiasm for this sector [1][2] - Pague Bio's stock price reached a new high of HKD 43.28, pushing its market capitalization over HKD 16 billion, positioning it as a potential leader in the innovative weight-loss drug market [2] Company Innovations - Pague Bio has developed a proprietary platform for drug discovery, focusing on chronic diseases, which includes a drug design platform that enhances drug stability and reduces research costs [4] - The company is advancing its lead candidate PB-119 and another promising candidate PB-718, which is a dual receptor agonist targeting GLP-1 and GCGR, showing potential for significant metabolic improvements [5][9] Clinical Developments - Recent clinical trial results for PB-718 demonstrated a 57.14% reduction in liver fat content over 18 weeks, outperforming semaglutide's results in a similar context [7][8] - The MASH (metabolic dysfunction-associated steatotic liver disease) market is projected to reach $100 billion by 2030, with a significant unmet need for effective treatments [6][9] Competitive Landscape - The global GLP-1 market is highly competitive, with Novo Nordisk and Eli Lilly leading the charge, but Eli Lilly's tirzepatide is showing stronger growth, indicating a shift in market dynamics [10][11] - Pague Bio's innovative products, particularly PB-718, are well-positioned to capitalize on the growing demand in the MASH treatment space, potentially reshaping the market landscape [13][14] Future Outlook - The ongoing development of Pague Bio's products, combined with favorable macroeconomic conditions and policy updates in the pharmaceutical sector, suggests a strong potential for growth and market expansion [14]

Core Insights - The global market for GLP-1 drugs is rapidly expanding, with sales expected to exceed $50 billion in 2024, driven by the success of drugs like semaglutide, which generated $16.632 billion in sales in the first half of the year, surpassing competitors [1][10] - The Hong Kong market is witnessing significant interest in GLP-1 drug stocks, exemplified by the 270% surge in shares of Sinovant Biopharma during its IPO and a fourfold increase in shares of Pague Biopharma over three months, indicating strong investor enthusiasm for this sector [1][2] - Pague Biopharma is positioning itself as a challenger to established pharmaceutical giants like Novo Nordisk, with its core product PB-119 recently having its registration application accepted, and promising clinical data emerging for its other candidate PB-718 [1][5] Company Developments - Pague Biopharma has developed a proprietary platform (HECTOR®) for drug discovery, which includes a drug molecule design platform that enhances the stability and efficacy of compounds while reducing research costs [4] - The company is focusing on the development of PB-718, a dual receptor agonist targeting GLP-1 and GCGR, which shows potential for significant metabolic improvements and addresses the complex mechanisms of MASH, a previously challenging area for drug development [5][6] - Recent clinical trial results for PB-718 demonstrated a 57.14% reduction in liver fat content over 18 weeks, outperforming semaglutide's results in a similar context, suggesting PB-718 could offer a valuable treatment option for patients [7][8] Market Context - The MASH patient population is projected to reach 486 million by 2030, with a market potential of $100 billion, highlighting a significant unmet medical need [6] - The competitive landscape for GLP-1 drugs is intensifying, with Eli Lilly's tirzepatide showing strong growth and capturing a larger market share compared to Novo Nordisk's offerings, indicating a shift in market dynamics [10][11] - Pague Biopharma's innovative products, including PB-718 and the GLP-1 receptor agonist PB-119, are expected to enhance the company's market position and valuation, with the potential to become a leading player in the GLP-1 space [9][14] Investment Outlook - The ongoing innovation in the pharmaceutical sector, particularly in the GLP-1 market, is expected to drive significant valuation increases for companies like Pague Biopharma, which is well-positioned to capitalize on the growing demand for effective treatments [14] - The recent trends in the Hong Kong stock market, coupled with favorable macroeconomic conditions, suggest a strong potential for continued investment in the biotech sector, particularly for companies with robust product pipelines [14]

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [5]. Core Insights - The approval of semaglutide for the treatment of metabolic dysfunction-associated steatotic liver disease (MASH) is expected to enhance drug usage and diagnostic demand [2][11]. - MASH has a prevalence rate of 1.5-6.5%, with over 250 million patients globally, and the number of cases is projected to double by 2030 [2][15]. - Non-invasive diagnostic methods are anticipated to experience significant growth with the introduction of new MASH drugs, as they offer better patient compliance and cost-effectiveness compared to invasive procedures [3][30]. Summary by Sections Market Performance - The pharmaceutical sector underperformed the overall market, with the biopharmaceutical sector rising by 3.08% [1]. - The current price-to-earnings ratio (TTM) for the pharmaceutical sector is 39.94x, which is at the 82.34th percentile of the past five years [1]. Drug Development and Approval - Semaglutide received FDA approval on August 15, 2025, for treating MASH patients with mid to late-stage liver fibrosis [11]. - Several drugs targeting MASH are in various stages of development, with notable progress from domestic companies like Zhengda Tianqing and Gilead [2][18]. Non-Invasive Diagnostic Methods - Non-invasive methods, such as imaging and blood tests, are expected to become the gold standard for MASH diagnosis as awareness and treatment options improve [3][30]. - FibroScan, developed by Echosens, is highlighted as a leading non-invasive diagnostic tool for liver fibrosis, gaining recognition from multiple health organizations [37][38]. Company Earnings Forecasts - Key companies in the sector, such as Mindray Medical and WuXi AppTec, are projected to maintain strong earnings growth, with PE ratios decreasing over the forecast period [4].