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 ...

Group 1: Macro Economic Insights - The current internal and external environment is increasingly complex and severe, necessitating counter-cyclical and cross-cyclical adjustments. The report aligns with the Fourth Plenary Session's assessment of the economic situation, highlighting the impact of trade issues on global economic growth and the need for a consumption-driven economic model in China [4][5]. - The report indicates improvements in price operations, with both CPI and PPI showing year-on-year increases in October. It emphasizes the need for coordinated macro policies to promote reasonable price recovery, including advancing the construction of a unified national market and boosting consumption [4]. Group 2: Monetary Policy Adjustments - The report outlines changes in the monetary policy framework, emphasizing the construction of a scientific and robust monetary policy system and a comprehensive macro-prudential management system. This indicates a future focus on systematic development in monetary policy [5][6]. - The importance of stabilizing growth has been elevated, with monetary policy expected to remain "moderately loose," including potential rate cuts and reserve requirement ratio reductions as necessary. The report suggests that the broad fiscal or social financing will be a major support in 2026, with a need for lower financing costs for residents and enterprises [6][7]. Group 3: Banking Sector Insights - Banks are accelerating the disposal of non-performing assets, particularly real estate, due to multiple considerations including capital consumption and market risks. This strategy aims to alleviate capital pressure and supplement profits amid rising retail risks [11][12]. - The report highlights significant disparities in the scale and impairment provisions of non-performing assets among listed banks, with state-owned banks accelerating asset disposals to release capital and enhance profitability [12][13]. Group 4: Agricultural Sector Insights - The pig farming sector is entering a destocking cycle driven by policy and market factors, with a recommendation to actively invest in leading companies like Wens Foodstuffs and Muyuan Foods due to the sector's defensive attributes amid low prices [17][18]. - The beef cattle sector is experiencing a favorable demand cycle, with expectations of continued profitability improvements through 2027. The report suggests investing in companies within the beef cattle industry chain [18]. Group 5: Pharmaceutical Sector Insights - The report discusses the promising results of DR10624 for treating severe hypertriglyceridemia, showing significant reductions in triglyceride levels and liver fat. The company maintains a "buy" rating based on projected net profits for 2025-2027 [30][31]. - The competitive landscape in the pharmaceutical sector is intensifying, with multiple multinational corporations targeting the FGF21 pathway, indicating a potential for differentiated market positioning for the company [31].

Investment Rating - The investment rating for Huadong Medicine is maintained as "Buy" [1] Core Insights - The Phase II results of DR10624 for treating severe hypertriglyceridemia (SHTG) showed significant efficacy, with triglyceride levels reduced by up to 74.5% and liver fat eliminated by up to 67% during a 12-week treatment period [4] - The company is expected to achieve net profits of 4.06 billion, 4.72 billion, and 5.54 billion yuan for the years 2025 to 2027, with corresponding EPS of 2.32, 2.69, and 3.16 yuan [4] - The current stock price corresponds to a PE ratio of 18.3, 15.8, and 13.5 for the years 2025, 2026, and 2027 respectively [4] Financial Summary - Revenue projections for Huadong Medicine are 40.62 billion, 41.91 billion, 44.68 billion, 47.95 billion, and 51.83 billion yuan from 2023 to 2027, with year-over-year growth rates of 7.7%, 3.2%, 6.6%, 7.3%, and 8.1% respectively [8] - The gross margin is expected to improve from 32.4% in 2023 to 35.4% in 2027, while the net margin is projected to increase from 7.0% to 10.7% over the same period [8] - The return on equity (ROE) is forecasted to rise from 13.2% in 2023 to 15.7% in 2027 [8] Clinical Development and Market Position - The company is advancing its clinical pipeline, with DR30206 in Phase I/II and HDM2005 expected to present Phase I data at the ASH annual meeting in December 2025 [6] - Huadong Medicine is also exploring the MASH indication for DR10624, with data expected in the first half of 2026, positioning itself in a competitive market with multiple multinational corporations targeting FGF21 [5]

Core Insights - Huadong Medicine's subsidiary, Zhejiang Daer Biotechnology, announced significant results from the Phase II clinical study of the first-in-class long-acting triple agonist DR10624 for treating severe hypertriglyceridemia (SHTG) at the AHA 2025 conference [1][3] Group 1: Product and Clinical Research - DR10624 is a first-in-class long-acting triple-target agonist that uniquely targets FGFR1c/Klothoβ (FGF21R), GLP-1R, and GCGR, designed using the MultipleBody technology platform [2] - The drug intervenes in metabolic regulation by enhancing lipid oxidation, suppressing fat generation, improving insulin sensitivity, promoting fat breakdown, and effectively reducing appetite [2] - The Phase II clinical study results for DR10624 were presented as a groundbreaking report at AHA 2025, marking a significant achievement for Chinese cardiovascular research [3] Group 2: Market Potential and Competitive Landscape - SHTG poses a growing public health burden, with limited effective clinical treatment options currently available, highlighting a significant unmet medical need [3] - Huadong Medicine is preparing for the Phase III clinical study of DR10624, having submitted a clinical trial application to the FDA in September 2025, which was approved in October 2025 [4] - The focus on the FGF21 target presents a high barrier to entry and scarcity in the global market, with few similar drugs in clinical stages, indicating substantial future growth potential [4][5] Group 3: Strategic Positioning - Huadong Medicine's strategic evolution in endocrine therapy has progressed from traditional glucose-lowering drugs to weight management and now to cutting-edge indications like SHTG, enhancing its technological moat [5]

Core Insights - The article highlights the significant achievements of Huadong Medicine's subsidiary, Zhejiang Daor Bio, in the development of DR10624, a first-in-class long-acting triple agonist for treating severe hypertriglyceridemia (SHTG), which was showcased at the AHA 2025 conference [1][3] Group 1: Clinical Trial Results - DR10624 demonstrated a rapid and significant reduction in triglyceride levels, atherosclerotic lipids, and liver fat content in patients with SHTG during its Phase II clinical trial [1][3] - The trial results indicated that 89.5% of patients treated with DR10624 achieved triglyceride levels below 500 mg/dL, and 19.1% reached levels below 150 mg/dL, with a median percentage reduction in triglycerides of up to 75% [6][9] - After 12 weeks of treatment, DR10624 significantly reduced liver fat content, with a median percentage reduction of up to 67% compared to the placebo group [8] Group 2: Mechanism of Action - DR10624 is designed as a long-acting triple-target agonist, uniquely targeting FGFR1c/Klothoβ, GLP-1R, and GCGR, which allows it to intervene in metabolic regulation from multiple dimensions [2][10] - The drug enhances lipid oxidation, suppresses fat generation, improves insulin sensitivity, promotes fat breakdown, and effectively suppresses appetite, showcasing its unique advantages in treating metabolic diseases [2][10] Group 3: Strategic Positioning and Market Potential - The recognition of DR10624 at the AHA conference marks a historic breakthrough for Chinese scholars in cardiovascular research and drug development [3][10] - Huadong Medicine's focus on the FGF21 target, which has high barriers to entry and limited competition, positions the company favorably in the metabolic disease treatment landscape [10][11] - The global interest in FGF21 has led to significant investments from major pharmaceutical companies, indicating a strong consensus on its potential as a core target for metabolic disease therapies [10][11] Group 4: Future Developments - Huadong Medicine is preparing for Phase III clinical trials for DR10624, having submitted clinical trial applications to the FDA and received approvals for various indications [9][12] - The company is expanding its product pipeline, including multiple GLP-1 related products, which are progressing through clinical development for diabetes and weight management [12][13]

Core Insights - The acquisition of Akero Therapeutics by Novo Nordisk for $5.2 billion marks a significant move into the FGF21 space, indicating the growing importance of metabolic disease treatments, particularly for metabolic dysfunction-associated steatotic liver disease (MASH) [2][12] - FGF21 is rapidly becoming a key target in the treatment of metabolic diseases, with major pharmaceutical companies like GSK and Roche also making substantial investments in similar assets, reflecting a competitive landscape reminiscent of the GLP-1 market boom [3][19] - The market for MASH is projected to reach $32.2 billion by 2030, driven by the increasing prevalence of obesity and type 2 diabetes, highlighting the commercial potential of FGF21 therapies [13][19] Company Strategies - Novo Nordisk's acquisition of Akero Therapeutics is part of a broader strategy to enhance its portfolio in the metabolic disease sector, especially after facing competitive pressures [16][18] - GSK's acquisition of Boston Pharmaceuticals' FGF21 asset aims to fill gaps in its MASH treatment offerings and is expected to complement its existing therapies [15][18] - Roche's acquisition of 89bio's FGF21 drug pegozafermin is intended to strengthen its position in cardiovascular and metabolic disease markets, showcasing a trend of major companies consolidating their portfolios through strategic acquisitions [16][18] Market Dynamics - The FGF21 target is emerging as a lucrative opportunity, with the potential to replicate the success seen with GLP-1 drugs, which have transformed into leading treatments for metabolic disorders [19][23] - The unique ability of FGF21 therapies to address late-stage liver disease (F4) provides a competitive edge over existing treatments, which are limited to earlier disease stages [13][19] - The ongoing trend of mergers and acquisitions in the FGF21 space is expected to intensify, driven by the substantial market size and the need for innovative therapies in metabolic diseases [22][23] Clinical Developments - Akero's Efruxifermin has shown promising clinical results, with nearly 50% improvement in liver fibrosis for F2-F3 MASH patients after 96 weeks of treatment, indicating its potential as a leading therapy in this area [11][19] - The advancements in protein engineering have allowed FGF21 drugs to overcome previous limitations, such as short half-lives, enabling less frequent dosing and enhancing their commercial viability [9][19] - Chinese pharmaceutical companies are also making strides in the FGF21 space, focusing on multi-target agents that could provide synergistic effects in treating metabolic disorders [20][21]

Core Viewpoint - The report from Kaiyuan Securities highlights the rapid growth of innovative drug revenue for East China Pharmaceutical, with multiple products entering a harvest phase, maintaining a "buy" rating [1] Financial Performance - The pharmaceutical industrial revenue for the first half of 2025 reached 7.317 billion yuan, a year-on-year increase of 9.24% [1] - The net profit attributable to the parent company was 1.580 billion yuan, up 14.09% [1] - Innovative drug revenue amounted to 1.084 billion yuan, reflecting a significant growth of 59% [1] - The pharmaceutical commercial segment generated 13.947 billion yuan, with a 2.91% increase, and a net profit of 226 million yuan, up 3.67% [1] - The medical beauty segment reported 1.112 billion yuan, showing a quarter-on-quarter growth from Q1 to Q2 [1] - The industrial microbiology segment achieved 368 million yuan, marking a 29% increase [1] Product Development - The company is experiencing rapid growth in innovative drugs, with a product matrix being established [1] - The impact of centralized procurement on existing business is limited, while the innovative pipeline continues to deliver results [1] - The drug DR30206 (PD-L1 | TGFB | VEGF) is currently in clinical phases I/II, with data expected by the end of 2025 [1] - In the ADC category, ROR1ADC, MUC17ADC, and FGFR2bADC have entered clinical stages, while CDH17ADC has submitted an IND [1] - The oral small molecule GLP-1 drug HDM1002 for glycemic control and weight loss has commenced phase III clinical trials [1] - The FGF21R/GCGR/GLP-1R agonist DR10624 has completed phase II clinical trials for severe hypertriglyceridemia in China and is currently conducting phase II trials for MAFLD/MASH [1]

Core Viewpoint - The recent Phase II clinical trial results of HDM1002, an oral GLP-1 receptor agonist developed by the company, demonstrate significant weight loss and metabolic improvement, with good safety and tolerability, providing a strong basis for further clinical research [2][5]. Group 1: Clinical Trial Results - The Phase II clinical trial involved 185 participants and lasted 16 weeks, assessing the safety and efficacy of HDM1002 in overweight or obese individuals without diabetes [2]. - After 12 weeks of treatment, the percentage change in body weight from baseline for the HDM1002 100 mg BID, 200 mg BID, 400 mg QD, and placebo groups were -4.63%, -6.08%, -6.83%, and -2.88% respectively, with the 200 mg BID and 400 mg QD groups showing statistically significant differences compared to the placebo [3]. - The proportion of participants in the 200 mg BID and 400 mg QD groups who experienced a weight loss of ≥5% was 63.0% and 56.5%, respectively, both significantly higher than the placebo group [3]. Group 2: Safety and Tolerability - Most treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) were mild, with no severe adverse events reported [5]. - The most common TEAEs in the HDM1002 groups were gastrointestinal events, including nausea, vomiting, and diarrhea, all of which were mild to moderate in severity [5]. Group 3: Future Development and Product Pipeline - The successful results of the Phase II trial mark an important milestone in the development of HDM1002, which is now progressing to Phase III clinical research [5]. - The company has established a comprehensive and differentiated product pipeline around the GLP-1 target, including both oral tablets and injectables, with ongoing clinical trials for various innovative drugs [5].

Core Insights - The MASH market is experiencing significant growth, with Madrigal's drug Rezdiffra achieving sales of $317 million in its first year, including $137 million in Q1 of this year [1][3][5] - The competitive landscape is intensifying, with multiple companies developing drugs targeting various mechanisms, including THRβ, GLP-1, and FGF21 [1][2][11] - Madrigal has entered a collaboration with CSPC to acquire global rights to the oral GLP-1 agonist SYH2086, aiming to combine it with Rezdiffra for enhanced treatment [1][8] Group 1: Market Performance - Rezdiffra has shown strong sales performance, exceeding market expectations, with quarterly sales increasing significantly since its launch [3][5] - The drug has demonstrated clear clinical benefits in a Phase 3 study, with 25.9% and 29.9% of patients achieving MASH resolution without worsening fibrosis [6] - The patient penetration rate for Rezdiffra remains low at 5%, indicating substantial growth potential in the target population [6][7] Group 2: Competitive Landscape - The MASH treatment landscape is evolving from single-target competition to multi-target strategies, with a focus on combination therapies [2][11] - GSK's acquisition of FGF21 agonist Efimosfermin alfa for $2 billion highlights the increasing interest in this therapeutic area [1][11] - Companies like Akero are also making strides with their FGF21-based therapies, showing promising results in reversing liver fibrosis [11][12] Group 3: Strategic Collaborations - Madrigal's partnership with CSPC to develop a dual oral therapy combining Rezdiffra and SYH2086 reflects a strategic move to enhance treatment efficacy and patient compliance [1][8][9] - The collaboration aims to leverage the strengths of both drugs, addressing the complex mechanisms involved in MASH treatment [9][10] - The focus on combination therapies is seen as a necessary approach to navigate the competitive landscape and improve patient outcomes [10][12]

Core Viewpoint - Tirzepatide, a drug by Eli Lilly, has shown impressive sales growth and market penetration, significantly impacting the company's stock performance since its approval in May 2022, with a stock price increase of 180% [1][16]. Group 1: Sales Performance and Market Position - Tirzepatide achieved a combined revenue of $5 billion in Q1 2025, accounting for 39% of Eli Lilly's total revenue, with a year-on-year growth rate exceeding 100% [1][12]. - As of Q1 2025, Eli Lilly's total prescription volume in the U.S. for GLP-1 receptor agonists reached 53.3%, surpassing its main competitor, Novo Nordisk [3][5]. - The rapid growth in prescription volume for tirzepatide is attributed to higher patient acceptance and superior efficacy compared to semaglutide [5][10]. Group 2: Clinical Efficacy and Competitive Advantage - In head-to-head clinical trials, tirzepatide demonstrated superior weight loss results compared to semaglutide, with an average weight loss of 20.2% versus 13.7% [8][9]. - The trial results support tirzepatide's position as a more effective treatment option, which is expected to sustain its sales growth [6][10]. Group 3: Market Dynamics and Future Challenges - The demand for GLP-1 drugs has surged, leading to supply shortages for semaglutide, which has allowed tirzepatide to capture excess demand [11][12]. - The competitive landscape is intensifying, with 179 GLP-1 drug candidates in clinical stages from 45 companies, indicating potential future sales pressure for both semaglutide and tirzepatide [12][14]. - Patent expirations for semaglutide in key markets like China and India in 2026 may lead to significant price reductions for generic versions, impacting tirzepatide's market position [14][15]. Group 4: Investment Opportunities - Tirzepatide's success has stimulated investment interest across the GLP-1 supply chain, with various companies advancing their own GLP-1 drug candidates [16][17]. - Notable companies in the GLP-1 space include Hengrui Medicine, which has multiple candidates in clinical trials, and other firms like East China Pharmaceutical and Innovent Biologics that are also progressing rapidly [17].