FGF21

Search documents
医药生物:FGF21:海外MNC抢滩的MASH明星靶点
Huafu Securities· 2025-10-12 08:49
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]