健友股份 20250910 摘要 首先，需要澄清的是，关于乌司奴单抗临床豁免的消息并非 FDA 发布，而是由 一位教授提出的观点。这位教授我们很熟悉，他一直是免临床试验的坚定支持 者。实际上，从 2024 年开始，FDA 在大分子生物类似物领域逐渐转向更为灵 活的小规模临床和临床前风险评估。 对于生物类似物行业而言，目前全球一级 和二级市场基本处于停滞状态，因为研发投入巨大且难以快速见效。当前最大 的挑战在于连续性商业化生产的质量保证以及找到合适的营销合作伙伴。因此， 在未来 5 到 10 年内，能够在财务报表上表现出色的公司将脱颖而出。 尽管专 利到期对原研公司构成巨大冲击，但从整体行业来看，这有利于患者和医保支 付体系。总之，未来 5 到 10 年内，生物类似物行业仍然充满机遇。 健友股份营销团队上半年增长 60%，销售费用增加，团队从区域制转向 全国性和区域性结合，并进行产品线分化，以确保特定方向的产出。 健友股份预计未来三年研发费用控制在 45 亿元以内，小分子药物研发 主要按照欧洲标准，大分子药物研发费用较高，主要投入大分子板块。 生物类似物免临床审批是否降低了中小企业进入市场的门槛？ 生物类似物免 ...

Core Insights - The global top-selling drugs for the first half of 2025 have been released, with Novo Nordisk's semaglutide leading the sales at 166.83 billion USD, followed by Merck's pembrolizumab and Eli Lilly's tirzepatide [1][3][4] Group 1: Top-Selling Drugs - Semaglutide from Novo Nordisk achieved sales of 166.83 billion USD, maintaining its position as the "king of drugs" [1][3] - Pembrolizumab from Merck recorded sales of 151.61 billion USD, ranking second [3] - Tirzepatide from Eli Lilly reached sales of 147.34 billion USD, securing the third position [3] Group 2: Sales Growth and Market Dynamics - Semaglutide's sales growth is driven by its three products: Ozempic (95.46 billion USD), Rybelsus (16.79 billion USD), and Wegovy (54.58 billion USD), with Wegovy showing a remarkable growth of 78% [5][6] - Tirzepatide has rapidly gained market share, with Mounjaro's sales skyrocketing from 4.83 billion USD in 2022 to an expected 115.4 billion USD in 2024 [7] - The competition between semaglutide and tirzepatide is intensifying, with both drugs exceeding 140 billion USD in sales for the first half of 2025 [7] Group 3: Market Challenges - The entry of biosimilars has impacted the sales of established drugs, with Janssen's ustekinumab dropping out of the top 10 due to a significant decline in sales [8] - Ustekinumab's sales fell by 38.6% in the first half of 2025, reaching only 32.78 billion USD [8] - Despite challenges, Johnson & Johnson's daratumumab saw a 21.7% increase in sales, reaching 67.76 billion USD, indicating strong demand in the multiple myeloma market [9][10]

Core Insights - The global top-selling drugs for the first half of 2025 have been released, with Novo Nordisk's semaglutide leading the sales at 166.83 billion USD, followed by Merck's pembrolizumab and Eli Lilly's tirzepatide [1][3][4] Sales Performance - Semaglutide achieved sales of 166.83 billion USD, maintaining its position as the top-selling drug [1][3] - Pembrolizumab (K drug) recorded sales of 151.61 billion USD, while tirzepatide reached 147.34 billion USD [3] - Other notable drugs include apixaban at 111.71 billion USD and dupilumab at 80.15 billion USD [3] Market Dynamics - The competition for the title of "King of Drugs" is intensifying, with new entrants like tirzepatide rapidly gaining market share [1][5] - Semaglutide's sales are bolstered by its three product variants, with the weight loss version, Wegovy, showing a remarkable growth of 78% [5][6] - Tirzepatide has been recognized for its rapid market uptake, with sales skyrocketing from 4.83 billion USD in 2022 to an expected 115.4 billion USD in 2024 [7] Product Innovations - Wegovy has recently gained approval for treating metabolic-associated fatty liver disease, which is expected to further enhance its sales [6] - Tirzepatide is the first and only dual-target GLP-1 receptor agonist approved for type 2 diabetes, positioning it as a strong competitor to semaglutide [7] Market Challenges - The entry of biosimilars has impacted the sales of established drugs, with Johnson & Johnson's ustekinumab dropping out of the top 10 due to a significant sales decline [8] - Ustekinumab's sales fell by 38.6% in the first half of 2025, reflecting the challenges faced by original drugs as patents expire [8] Future Outlook - Daratumumab from Johnson & Johnson has shown a 21.7% increase in sales, indicating strong market potential in the multiple myeloma segment [9][10] - The overall trend suggests a shift in market leadership as newer drugs gain traction and established drugs face competitive pressures [1][5][8]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company's industrial segment is expected to achieve a 14% growth in net profit attributable to the parent company by 2025, with a rapid advancement in the innovative drug pipeline [1] - The company reported a total revenue of 40,624 million yuan in 2023, with a year-on-year growth of 7.71%, and a projected revenue of 44,552 million yuan in 2025, reflecting a growth of 6.32% [1] - The net profit attributable to the parent company is forecasted to reach 3,932 million yuan in 2025, representing an 11.95% increase compared to the previous year [1] Financial Forecasts - Total revenue projections for 2024, 2025, 2026, and 2027 are 41,906 million yuan, 44,552 million yuan, 47,706 million yuan, and 50,406 million yuan respectively [9] - The net profit attributable to the parent company is expected to be 3,512 million yuan in 2024, 3,932 million yuan in 2025, 4,421 million yuan in 2026, and 4,950 million yuan in 2027 [9] - The earnings per share (EPS) is projected to be 2.00 yuan in 2024, 2.24 yuan in 2025, 2.52 yuan in 2026, and 2.82 yuan in 2027 [9] Business Segments - The industrial segment's revenue for the first half of 2025 was 73.17 billion yuan, with a year-on-year growth of 9.24%, and the net profit was 15.80 billion yuan, increasing by 14.09% [8] - The innovative product business generated revenue of 10.84 billion yuan in the first half of 2025, marking a significant increase of 59% [8] - The medical beauty segment reported revenue of 11.12 billion yuan in the first half of 2025, although it experienced a decline of 17.5% year-on-year [8] R&D and Product Development - The company is advancing over 80 innovative drug pipelines, with significant progress in various therapeutic areas including endocrinology and ADC [8] - The medical beauty products are accelerating registration, with several products expected to launch in both domestic and international markets [8]

Core Insights - The autoimmune disease treatment market is the second largest pharmaceutical market globally, with significant growth potential in China [1][2] - The global autoimmune market reached $132.3 billion in 2022 and is expected to grow to $176.7 billion by 2030, with a compound annual growth rate (CAGR) of 3.68% from 2022 to 2030 [1] - China's autoimmune market is only 8% of its oncology market, indicating substantial room for growth compared to the global ratio of 64.5% [1] Group 1: Market Overview - The autoimmune disease market is the second largest after oncology, with a global market size of $132.3 billion in 2022 [1] - The market is projected to grow to $176.7 billion by 2030, reflecting a CAGR of 3.68% [1] - In China, the autoimmune market was valued at $2.9 billion in 2022, significantly lower than the oncology market at $34.7 billion [1] Group 2: Drug Development - The autoimmune sector has seen the emergence of several blockbuster monoclonal antibody drugs [2] - Three monoclonal antibodies are expected to be among the top 10 global drug sales in 2024, each exceeding $10 billion in sales [2] - These include Dupilumab by Sanofi/Regeneron, Risankizumab by AbbVie/BI, and Ustekinumab by Johnson & Johnson [2] Group 3: Disease Complexity - There are approximately 150 known autoimmune diseases, which can be categorized into systemic and organ-specific autoimmune diseases [3] - A study published in 2023 indicated a prevalence rate of about 10% for autoimmune diseases among a cohort of 22 million individuals in the UK, with 63.9% of new cases being female [3] - Autoimmune diseases exhibit seasonal and regional variations in prevalence [3]

Investment Rating - The report indicates a positive outlook for the autoimmune therapy market, suggesting significant growth potential and investment opportunities in the sector [8]. Core Insights - The autoimmune market is the second largest after oncology, with a global market size of $132.3 billion in 2022, projected to reach $176.7 billion by 2030, reflecting a compound annual growth rate (CAGR) of 3.68% from 2022 to 2030 [8]. - The report highlights the potential for multi-target interventions to enhance treatment efficacy in autoimmune diseases, transitioning from monoclonal antibodies to bispecific and multispecific antibodies [19]. - The report emphasizes the significant market space for autoimmune therapies in China, where the autoimmune market size was only $2.9 billion in 2022, representing just 8% of the oncology market size of $34.7 billion, indicating substantial room for growth [8]. Market Overview - The global autoimmune drug market is expected to grow significantly, with the market size projected to increase from $1,323 million in 2022 to $1,767 million by 2030 [8]. - The report provides a detailed analysis of various autoimmune diseases, their prevalence, and the corresponding patient populations globally, including conditions like atopic dermatitis, chronic obstructive pulmonary disease, and rheumatoid arthritis [6][11]. Clinical Research Progress - The report outlines advancements in clinical research for dual-target and multi-target therapies, indicating a shift towards more effective treatment options for complex autoimmune diseases [19][22]. - It discusses the development of several blockbuster monoclonal antibody drugs in the autoimmune sector, with projected sales for top drugs in 2024, including Dupilumab at $14.15 billion and Risankizumab at $11.72 billion [9]. Key Companies to Watch - The report identifies key companies involved in the development of autoimmune therapies, including Sanofi, AbbVie, and Johnson & Johnson, highlighting their leading products and market positions [9][25].

Core Insights - The article highlights the acceleration of globalization among Chinese pharmaceutical and biotechnology companies during the "14th Five-Year Plan" period, emphasizing breakthroughs in innovative drugs and medical devices [1] - The strategy of "going global" is identified as a key approach for these companies to expand their business footprint and enhance core competitiveness and brand influence [1] Group 1: Industry Overview - As of the end of 2024, nearly 500 companies in the A-share pharmaceutical and biotechnology sector are noted, with overseas business revenue reaching 269.04 billion yuan, accounting for 10.90% of total revenue, reflecting an 11.00% year-on-year growth [2] - The transition from "product going global" to "brand going global" is highlighted as a significant shift for Chinese pharmaceutical companies [2] Group 2: Company Strategies - Baiyoutai's journey exemplifies the path of Chinese innovative drugs going global, having established an international standard R&D platform and completed global Phase III clinical trials for its biosimilars [3] - The company entered a critical phase from 2019 to 2021, negotiating licensing agreements with international giants to share risks and accelerate market access [3] - In 2023, Baiyoutai achieved significant milestones with FDA approvals for its biosimilars, marking a recognition of Chinese biopharmaceutical quality in major global markets [3] Group 3: Market Expansion - Pumen Technology has positioned internationalization at the core of its strategy since its listing in 2019, achieving international business revenue of 371 million yuan in 2024, a 14.87% increase [4] - The company focuses on major markets like the EU, Russia, and India, establishing a robust business network across over 120 countries [4][5] - Pumen Technology emphasizes localized operations by forming local teams and subsidiaries to better understand and meet regional market demands [5] Group 4: Innovation and R&D - Continuous innovation and R&D investment are deemed essential for long-term competitiveness in the global medical device market [8] - Baiyoutai maintains a high level of R&D investment, with 778 million yuan allocated in 2024, representing 104.64% of its revenue, focusing on international clinical trials and production optimization [8][9] - Both companies recognize the importance of adhering to the highest regulatory standards to navigate the complexities of different markets [10] Group 5: Future Directions - Baiyoutai plans to optimize its production system and advance more pipelines for global multi-center clinical trials, aiming to enhance brand influence and revenue through international collaborations [11] - Pumen Technology intends to increase R&D resources directed towards overseas markets, ensuring that product development aligns with international needs and trends [10]

Summary of Huadong Medicine Conference Call Company Overview - Huadong Medicine is a leading enterprise in the pharmaceutical industry, with a strong channel advantage, particularly in the metabolic and autoimmune fields. The company was established in 1993 and listed on the Shenzhen Stock Exchange in 2000. Its business encompasses pharmaceutical manufacturing, commercial operations, and medical aesthetics, with pharmaceutical manufacturing being the largest segment. In 2024, the company expects industrial revenue of approximately 14 billion yuan, commercial revenue of about 28 billion yuan, and medical aesthetics revenue of around 2 billion yuan [3][4][7]. Financial Performance - In 2024, Huadong Medicine's total revenue is projected to exceed 40 billion yuan, representing a year-on-year growth of 3%. The net profit attributable to shareholders is expected to grow by over 20%, benefiting from business transformation and the clearance of negative factors [2][4]. Innovation and Product Pipeline - The company is actively developing innovative drugs in the fields of diabetes, weight loss, autoimmune diseases, and oncology. The first domestic generic version of Liraglutide has been approved, with Semaglutide and other products expected to be approved soon. The company is also developing multi-target GLP-1 products such as HDM1,002 and HDM1,005, which are anticipated to quickly capture market share [2][6][14]. Commercial Operations - The commercial segment, primarily located in Zhejiang Province, is expected to generate over 28 billion yuan in revenue in 2024, a 3% increase year-on-year. The company has restored stable profitability through innovative development and has a competitive advantage in market access and network coverage, which synergizes well with its industrial operations [2][7][23]. Medical Aesthetics - The medical aesthetics segment has seen significant success, with the "Girl Needle" product achieving over 1 billion yuan in sales. The company also offers hyaluronic acid and energy source devices, with expectations for double-digit growth in 2025. The acquisition of UK-based Sinclair has facilitated global expansion [8][9][20]. Risks and Challenges - Key risks include potential delays in innovative product development, intensified market competition, and lower-than-expected sales of core products. These factors could impact future performance and require ongoing monitoring and strategic adjustments [10]. ADC and Oncology Developments - Huadong Medicine has made substantial innovations in the ADC (Antibody-Drug Conjugate) field, with significant products like HDM1,022 and HDM1,005 targeting advanced malignancies. The company is also collaborating with other firms to develop CAR-T therapies, which are expected to contribute to revenue growth [15][16][17]. Industrial Microbiology - The industrial microbiology segment has maintained rapid growth of 30%-40% in recent years, contributing significantly to revenue. The company has over 40 years of experience in this field, with leading subsidiaries in the industry. Industrial microbiology revenue is expected to exceed 700 million yuan in 2024, reflecting a 40% year-on-year increase [21][22]. Valuation and Future Outlook - The current market capitalization of Huadong Medicine is over 70 billion yuan, with projected profits for 2025 estimated between 3.9 billion and 4 billion yuan, resulting in a price-to-earnings ratio of less than 20 times. This valuation is considered low given the company's innovative transformation and traditional channel advantages. The company has multiple core innovation pipelines in autoimmune, endocrine, and oncology fields, which are expected to enhance market recognition through potential overseas licensing agreements [24].

2025 年 05 月 09 日 王睿哲 C0062@capital.com.tw 目标价(元) 47.8 公司基本信息 | 产业别 | | | | 医药生物 | | --- | --- | --- | --- | --- | | A 股价(2025/5/8) | | | | 39.03 | | 深证成指(2025/5/8) | | | | 10197.66 | | 股价 12 个月高/低 | | | | 40.8/25.63 | | 总发行股数(百万) | | | | 1754.08 | | A 股数(百万) | | | | 1751.94 | | A 市值(亿元) | | | | 683.78 | | 主要股东 | | | | 中国远大集团有 | | | | | | 限责任公司 | | | | | | (41.67%) | | 每股净值(元) | | | | 13.72 | | 股价/账面净值 | | | | 2.85 | | | 一个月 | | 三个月 一年 | | | 股价涨跌(%) | | 5.8 | 13.5 18.8 | | | 近期评等 | | | | | | 日期 | 收盘价 | | 评级 ...

Company Performance - In Q1 2025, the company reported revenue of 10.74 billion yuan, a year-over-year increase of 3.1%, and a net profit attributable to shareholders of 920 million yuan, up 6.1% year-over-year [1] - The company's non-recurring net profit was 900 million yuan, reflecting a year-over-year growth of 7.0%, while the actual year-over-year growth of non-recurring net profit was 17.2%, indicating double-digit growth [1] - The core subsidiary, China Medical East, achieved revenue of 3.62 billion yuan in Q1 2025, a year-over-year increase of 6.5%, with a consolidated net profit of 843 million yuan, up 12.2% year-over-year [2] Product Performance - The sales of innovative drugs are gaining momentum, with the CAR-T product, Saikeze, seeing a steady increase in effective orders, now covered by over 70 insurance providers [2] - The company’s overseas medical beauty segment faced challenges, with revenue from UK-based Sinclair down 12.3% year-over-year, while domestic medical beauty subsidiary achieved revenue of 250 million yuan, a slight decline of 1.4% [2] - The company’s medical commercial segment performed steadily, with Q1 2025 revenue of 6.93 billion yuan, a year-over-year increase of 3.2%, and a net profit of 120 million yuan, up 7.3% year-over-year [2] Financial Metrics - The overall gross margin for Q1 2025 was 32.9%, an increase of 0.9 percentage points year-over-year, driven by changes in sales structure [3] - The company’s expense ratio was 22.0%, an increase of 0.8 percentage points year-over-year, primarily due to a 2.1 percentage point increase in R&D expense ratio [3] Future Outlook - The company is expected to see continued growth, with diminishing marginal impacts from centralized procurement and the launch of new innovative drugs and medical beauty products [3] - Projected net profits for 2025, 2026, and 2027 are 4.07 billion yuan, 4.78 billion yuan, and 5.57 billion yuan, representing year-over-year growth rates of 15.9%, 17.6%, and 16.5% respectively [3] - The company has received a "buy" investment rating with a target price of 47.8 yuan [1][3]