11月24日，百奥泰(688177)举行2025年第三季度业绩说明会。公司此前发布的三季报显示，前三季度实 现营业收入6.84亿元，同比增长17.57%；净利润为-2.24亿元，同比有所减亏。 百奥泰是一家从事创新药和生物类似药研发的全球性生物制药企业，目前已推动多款药物获批上市，其 中贝塔宁 （枸橼酸倍维巴肽）已在中国获批上市；阿达木单抗已在中国及英国获批上市、托珠单抗已 在中美欧瑞士英国获批上市；贝伐珠单抗已在中美欧巴西获批上市；乌司奴单抗已在欧美获批。 对于公司报告期内营收增长和亏损收窄的情况，百奥泰董事长、总经理李胜峰在业绩说明会上表示，公 司本季度营收同比增长主要原因来源于国内阿达木单抗注射液和托珠单抗注射液销售收入持续增长。亏 损收窄主要原因为成本费用类增长比例小于营收增长比例。公司将一如既往拓展营收规模，同时继续降 低成本及优化运营效率，争取早日实现盈利。 对于生物类似药在海外的拓展方向，李胜峰称，在海外拓展方面，公司产品如BAT1806（托珠单抗）和 BAT2206（乌司奴单抗）已在美欧获批并已由合作伙伴Organon和Hikma分别在美国市场进行推广，同 时公司还有多个产品已在欧美及其他市场 ...

2025.11.24 本文字数：2412，阅读时长大约4分钟 作者 |第一财经 吴斯旻 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中生 物药占比增加，"谈判药品同通用名仿制药上市自动属于目录范围"的医保政策则为生物类似药挂网入院 及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升，却 也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中 国仿制药发展报告（2025）》（下称"报告"）显示，中国仿制药市场规模多年维持在9000亿元水平，企 业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年前增 加了超过2/3，但当年增长主要由少数企业和既往过评品种的持续获批推动；而在生物类似药领域，截 至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23个药品通用 名。 此外，有业界观点认为，在中国仿制药行业市场集 ...

2025.11. 24 本文字数：2412，阅读时长大约4分钟 作者 | 第一财经 吴斯旻 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中 生物药占比增加，"谈判药品同通用名仿制药上市自动属于目录范围"的医保政策则为生物类似药挂网 入院及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升， 却也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的 《中国仿制药发展报告（2025）》（下称"报告"）显示，中国仿制药市场规模多年维持在9000亿元 水平，企业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年 前增加了超过2/3，但当年增长主要由少数企业和既往过评品种的持续获批推动；而在生物类似药领 域，截至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23 个药品通用名。 此外，有业界观点认为，在中国仿制药行业市 ...

品种同质化加剧，成为仿制药市场竞争的底色。 近年来，"带量采购"政策让优质优价的仿制药加速临床准入与经济性替代。与此同时，随着"国谈"中生物药占比增加，"谈判药品同通用名仿制药上市自动 属于目录范围"的医保政策则为生物类似药挂网入院及院内推广提供便利。 双重趋势下，中国仿制药行业的市场竞争加剧——仿制药的研发水平和一致性评价通过率明显提升，却也面临"品种同质化"和"生产拼成本"等发展困境。 近日，中国医学科学院药物研究所、中国医药工业信息中心和中国食品药品检定研究院联合发布的《中国仿制药发展报告（2025）》（下称"报告"）显示， 中国仿制药市场规模多年维持在9000亿元水平，企业与品种数量的增加正进一步加剧市场存量竞争。 第一财经梳理报告发现，在化学仿制药领域，2024年，通过一致性评价或视同过评的品种数较三年前增加了超过2/3，但当年增长主要由少数企业和既往过 评品种的持续获批推动；而在生物类似药领域，截至2024年，我国已有41家制药企业的87款生物类似药（包含胰岛素）获批上市，但仅涉及23个药品通用 名。 此外，有业界观点认为，在中国仿制药行业市场集中度较低的背景下，不仅要审慎看待仿制研发"扎堆"现象 ...

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of 56.44 CNY, indicating a potential upside from the current price of 47.48 CNY [3][6]. Core Insights - The company has shown significant revenue growth, with a 301.0% increase in revenue for the first three quarters of 2025, amounting to 5.66 billion CNY. The net profit attributable to the parent company was -5.98 billion CNY, reflecting a 13.9% year-on-year improvement [10]. - The report highlights successful clinical advancements and commercialization efforts, with multiple new clinical trials set to commence and ongoing collaborations expected to enhance revenue streams [10]. - The financial forecasts have been adjusted, with a downward revision for 2025 revenue and R&D expenses, while 2026 revenue and management expenses have been increased. The projected net profits for 2025-2027 are -7.35 billion CNY, -6.55 billion CNY, and -2.91 billion CNY respectively [3][10]. Financial Summary - Revenue projections for 2025 are set at 747 million CNY, with a year-on-year growth of 274.1%. By 2026, revenue is expected to reach 1.066 billion CNY, growing at 42.6% [5]. - The company is expected to incur a net loss of 735 million CNY in 2025, improving to a loss of 655 million CNY in 2026, and further narrowing to 291 million CNY by 2027 [5]. - The gross margin is projected to be 93.5% in 2025, with a net margin of -98.4% [5]. - The company’s market capitalization is estimated at 225.55 billion CNY based on discounted cash flow valuation [11].

Core Insights - The TNF-α inhibitor market is experiencing rapid growth due to the increasing prevalence of autoimmune diseases and the urgent treatment needs of a large patient population [1][5][12] - In China, the market penetration rate of TNF-α inhibitors was only 0.31% in 2018, compared to 13.36% in the U.S., indicating significant growth potential for the industry [1][5] - The market size for TNF-α inhibitors in China is projected to reach 16.3 billion yuan in 2024, representing a year-on-year increase of 25.4% [1][5] TNF-α Inhibitor Industry Overview - TNF-α inhibitors are targeted biological agents that reduce inflammation and immune activation, primarily used for various autoimmune diseases [4][5] - The development of TNF-α inhibitors began in the 1990s, with the first drug, Infliximab, approved in 1998, marking the start of a new era in treating autoimmune diseases [4][5] Current Market Status - The TNF-α inhibitor market is expanding rapidly, attracting numerous domestic pharmaceutical companies, which has led to increased market penetration and growth [1][5] - The leading TNF-α inhibitors in the market include Adalimumab, Etanercept, and Infliximab, with Adalimumab holding a market share of 48.83% [6][7] Competitive Landscape - The TNF-α inhibitor industry is characterized by a dominance of foreign pharmaceutical companies, with local companies like Innovent Biologics and Junshi Biosciences rapidly gaining market share [7][9] - The competition is intensifying as more companies enter the market, leading to price reductions and increased pressure on profit margins [12] Future Trends - Future developments in the TNF-α inhibitor market will focus on improving therapeutic efficacy and reducing side effects through structural modifications and personalized treatment approaches [10][11] - The industry is expected to see increased competition, with many companies entering the market, leading to potential market consolidation as some may exit due to pricing pressures [12] - There is a growing opportunity for domestic companies to expand into international markets, particularly in North America and Europe, where demand for TNF-α inhibitors is rising [13]

Core Viewpoint - Ankylosing Spondylitis (AS) predominantly affects young males, and early diagnosis and standardized treatment are crucial to prevent disability [1][2][3] Group 1: Disease Characteristics - AS is a chronic inflammatory disease that leads to inflammation at the tendon insertion points of the spine, resulting in fibrosis and calcification, which can cause spinal stiffness [1] - The incidence of AS is relatively low in China, but the total number of patients is significant, with a male-to-female ratio of 2:1 to 3:1, and the peak age of onset is between 20 and 30 years [2] - Common symptoms include pain in the neck, chest, lower back, buttocks, hips, and large joints, with severe cases leading to spinal deformities and stiffness [2][3] Group 2: Diagnosis and Treatment - The average delay in diagnosis from the onset of symptoms to confirmation can take several years, often due to patients' lack of awareness about AS [3] - Early diagnosis is critical as there are currently no medications that can reverse joint deformities already present in AS patients [3] - Treatment options include non-drug therapies such as exercise, non-steroidal anti-inflammatory drugs (NSAIDs), traditional disease-modifying antirheumatic drugs (DMARDs), and biological agents like Adalimumab [5][6] Group 3: Patient Management and Education - Patients are encouraged to engage in daily physical activities, starting with low-intensity exercises to improve joint function and prevent stiffness [4][6] - Smoking is identified as a risk factor that can worsen AS symptoms, and quitting smoking is recommended for better outcomes [6] - Maintaining a positive mindset is emphasized as it can enhance the effectiveness of standardized treatment [6]

Core Viewpoint - The 2025 edition of the "Pharmacopoeia of the People's Republic of China" officially implemented on October 1, 2025, serves as a critical standard for drug safety and a guide for the development of the pharmaceutical industry in China [3][4]. Summary by Sections New Additions and Revisions - The new edition includes 159 newly added varieties and 1,101 revised varieties, totaling 6,385 varieties [3][4]. - It introduces 69 new general technical requirements and revises 133, along with 33 new guiding principles and 17 revisions [3]. Focus on Domestic Innovations - The pharmacopoeia emphasizes the inclusion of domestically developed drugs with independent intellectual property rights, such as trastuzumab and rituximab, marking their first inclusion in an international pharmacopoeia [4][5]. - It highlights the addition of five anti-tumor drugs and medications for pediatric use, such as growth hormone for treating children's growth disorders [4]. Safety Standards and International Alignment - The new edition raises safety standards for drug residues, increasing the number of controlled pesticide residues in traditional Chinese medicine from 33 to 47 [7]. - It aligns with international standards, facilitating the registration process for Chinese drugs abroad and enhancing the global competitiveness of Chinese pharmaceuticals [7][8]. Comprehensive Drug Standards - The pharmacopoeia covers a wide range of categories, including traditional Chinese medicine, chemical drugs, biological products, excipients, and packaging materials, establishing a comprehensive national drug standard system [8].

Core Insights - Inflammatory Bowel Disease (IBD) includes Ulcerative Colitis (UC) and Crohn's Disease (CD), affecting over 3 million patients in the US and Europe, with no current cure available [1] - The global IBD drug market is expected to reach $37 billion by 2030, with a shift in sales from TNF inhibitors to IL-23 inhibitors and JAK inhibitors [2] - The emergence of new therapeutic targets and mechanisms is crucial due to the high percentage of patients who do not respond to initial treatments [2] Group 1: IBD Overview - IBD encompasses UC and CD, with symptoms that can lead to severe complications like bowel perforation [1] - Current first-line treatments for mild to moderate CD include corticosteroids and traditional immunosuppressants, while anti-TNF agents are preferred for moderate to severe cases [1] - There is a significant need for new therapies as up to 30% of patients do not respond to initial treatments, and up to 40% may lose response over time [1] Group 2: Market Dynamics - The sales proportion of TNF inhibitors is declining, while IL-23 inhibitors and JAK inhibitors are gaining market share [2] - Ustekinumab contributes approximately $7.8 billion to the IBD market, while Vedolizumab is projected to reach $6.107 billion in global sales by 2024 [2] - Major pharmaceutical companies like AbbVie, Johnson & Johnson, and Merck are actively involved in the IBD market [2] Group 3: Investment Opportunities - New therapeutic targets such as TL1A are being explored, with several phase 3 studies currently underway [2] - Companies to watch include Abivax, Chenxin Pharmaceutical, and others focusing on new mechanisms and dual antibodies [2] - The industry is expected to see significant growth driven by differentiated second-line therapies and innovative product development [2][3]

Group 1 - AbbVie demonstrated strong market performance with a stock price increase of 4.05% on September 11, marking a cumulative rise of 4.97% over three days, reaching an all-time high during intraday trading, reflecting market confidence in the pharmaceutical giant [1] - A significant event attracting market attention is AbbVie's patent settlement agreement with a generic drug manufacturer, ensuring that its core drug, Upadacitinib (RINVOQ), will not face generic competition until April 2037, providing a stable market advantage and a solid foundation for R&D and business expansion [1] - RINVOQ has broad applications in treating various autoimmune diseases and is set to receive EU and FDA approval for a new indication for giant cell arteritis by April 2025, further enhancing AbbVie's leadership position in the immunology field [1] Group 2 - AbbVie's strategy extends beyond a single domain, having entered the medical aesthetics and ophthalmology markets through the acquisition of Allergan, and the blood cancer sector through the purchase of Pharmacyclics, while collaborating with several biotech companies to accelerate the development and market entry of high-potential drugs [2] - The company's development path illustrates essential conditions for a successful enterprise, emphasizing the importance of not solely relying on short-term trends or blockbuster products, but rather maintaining the ability to continuously invest stable cash flow into innovation and broaden the business moat [2]