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]

PresentationMark Pruzanski Okay. Why don't we kick things off. Hi, everyone. I'm Mark Pruzanski, I'm the Chairman of the Board of Inventiva and welcome to our investor event. We're going to be telling you today about the next and hopefully best-in-category oral therapy to get to patients with MASH, lanifibranor. We're going to be making forward-looking statements. Here's the agenda. It's going to be pretty packed, and I'm going to get out of your way and introduce you to Andrew in a minute followed by 3 we ...

Presentation of a comparison between digital and glass slide histology from screening biopsies in the Phase 3 NATiV3 studyPresentation of digital pathology data from preclinical studies with lanifibranor Daix (France), New York City (New York, United States), October 7, 2025 -  Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis ...

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].

Core Insights - Novo Nordisk's semaglutide (Wegovy) has received FDA approval for a supplemental new drug application (sNDA) to treat metabolic dysfunction-associated steatotic liver disease (MASH) in patients with moderate to advanced liver fibrosis (F2 or F3) [1][2] - The approval is based on positive results from the Phase III ESSENCE study, which demonstrated significant improvements in liver fibrosis and steatohepatitis without worsening conditions [2][3] - The MASH indication represents a significant opportunity for GLP-1 drugs, with a large unmet clinical need and a projected market capacity exceeding $10 billion by 2025, growing at a compound annual growth rate (CAGR) of 20.19% from 2016 to 2025 [4][5] Group 1: Drug Approval and Study Results - The FDA approval was based on the ESSENCE study, a 240-week randomized, double-blind, placebo-controlled trial involving 1,200 patients [2] - Part 1 of the study showed that 36.8% of patients treated with 2.4 mg semaglutide experienced significant liver fibrosis improvement compared to 22.4% in the placebo group [3] - The study also indicated that 62.9% of the semaglutide group had resolution of steatohepatitis without worsening fibrosis, compared to 34.3% in the placebo group [3] Group 2: Market Context and Competitive Landscape - MASH is a critical area of focus for GLP-1 drugs, with significant unmet clinical needs and strong correlations with metabolic diseases [4][5] - Novo Nordisk's semaglutide is the first and currently the only GLP-1 drug approved for MASH, enhancing its competitive position in the market [3][5] - In the first half of the year, Novo Nordisk reported sales of 112.756 billion Danish Krone for semaglutide, leading the market significantly ahead of competitors [5]

Core Viewpoint - Altimmune, Inc. announced positive preliminary results from the IMPACT 2b clinical trial of its candidate drug pemvidutide for the treatment of Metabolic Associated Steatotic Liver Disease (MASH), but the efficacy disappointed investors, leading to a significant drop in stock price [2]. Group 1: Clinical Trial Results - The trial recruited 212 participants diagnosed with MASH at F2/F3 fibrosis stages, with a low dropout rate of only 9% [6]. - In the intention-to-treat (ITT) analysis, 59.1% of the 1.2 mg group and 52.1% of the 1.8 mg group achieved MASH resolution without worsening fibrosis, significantly higher than the 19.1% in the placebo group (both p<0.0001) [10]. - For fibrosis improvement without worsening MASH, the improvement rates were 31.8% and 34.5% for the treatment groups, compared to 25.9% for the placebo, but the differences were not statistically significant [11]. - AI-assisted analysis showed that 30.6% of the 1.8 mg group had a fibrosis reduction of over 60%, significantly better than the 8.2% in the placebo group (p<0.001) [12]. - The treatment groups showed significant improvements in non-invasive fibrosis assessment indicators compared to the placebo [13]. Group 2: Weight Control and Tolerability - The average weight loss for the 1.2 mg and 1.8 mg groups was 5.0% and 6.2%, respectively, compared to only 1.0% in the placebo group (both p<0.001) [14]. - The overall tolerability of the drug was good, with only 0.0% and 1.2% of participants in the treatment groups discontinuing due to adverse reactions, lower than the 2.4% in the placebo group [16]. - No serious adverse events related to the treatment were reported [17]. Group 3: Expert Commentary - The CEO of Altimmune expressed confidence in pemvidutide's potential to change the treatment landscape for MASH, a condition expected to affect over 27 million people in the U.S. by 2030 [9]. - An expert noted that achieving MASH resolution and weight loss within 24 weeks is uncommon among similar drugs, highlighting pemvidutide's superior tolerability and low discontinuation rate [9]. - The results indicate a promising trend for fibrosis improvement, and the company plans to advance to Phase 3 trials following a successful Phase 2 meeting with the FDA in Q4 2025 [9].