业绩减亏因公司拓展市场，阿达木单抗、托珠单抗销售额提升，乌司奴单抗在美国上市，授权许可及销 售收入增长。 近日，百奥泰发布公告称，预计 2025 年度实现归属于母公司所有者的净利润与上年同期相比，将减少 亏损，实现归属于母公司所有者的净利润为-28,000.00 万元到-39,000.00 万元，减少亏损 12,030.38 万元 到 23,030.38 万元。 （百奥泰公告） ...

百奥泰公告称，2025年1 - 12月，公司预计实现营收9 - 9.7亿元，较上年增加1.57 - 2.27亿元。归属于母 公司所有者的净利润为-2.8 - -3.9亿元，将减少亏损1.20 - 2.30亿元；扣非净利润为-3.8 - -4.9亿元，将减 少亏损0.66 - 1.76亿元。业绩减亏因公司拓展市场，阿达木单抗、托珠单抗销售额提升，乌司奴单抗在 美国上市，授权许可及销售收入增长。 ...

Company Overview - 博锐生物 has submitted a listing application to the Hong Kong Stock Exchange, with Huatai International and JPMorgan serving as joint sponsors [1] - The company is a leading integrated biopharmaceutical firm in China, focusing on comprehensive immunotherapy solutions for autoimmune and inflammatory diseases, as well as tumor immunology [1] - 博锐生物 ranks first among Chinese pharmaceutical companies in revenue from biologics for autoimmune diseases for two consecutive years starting in 2023, according to Frost & Sullivan [1] - The company has eight commercialized products and is transitioning from a proven molecule development enterprise to an innovation-driven biopharmaceutical company, including the development of ADC candidates [1] Industry Insights - The autoimmune disease market is one of the fastest-growing pharmaceutical sectors globally, with blockbuster drugs like Dupilumab, Risankizumab, and Ustekinumab each generating over $10 billion in revenue in 2024 [1] - In China, the market size for autoimmune diseases is projected to grow from RMB 17.4 billion in 2020 to RMB 32.8 billion in 2024, and is expected to reach RMB 289.9 billion by 2035, with a compound annual growth rate (CAGR) of 21.9% [1] - The market share of biologics is rapidly expanding, increasing from RMB 4.2 billion in 2020 to RMB 17.1 billion in 2024, and is anticipated to reach RMB 212.6 billion by 2035 [1] Tumor Immunology Market - Tumor immunology is a cornerstone of modern cancer treatment, utilizing the immune system to identify and eliminate cancer cells, encompassing cell immunotherapy, cytokines, cancer vaccines, and antibody therapies [2] - The success of immune checkpoint inhibitors has transformed the landscape of tumor treatment [2] - The proportion of tumor immunotherapy drugs in the overall oncology drug market in China is expected to grow from 11.3% in 2024 to 47.5% by 2035 [2] - The market size for tumor immunotherapy drugs in China is projected to increase from RMB 14.8 billion in 2020 to RMB 29.3 billion in 2024, and further expand to RMB 495.4 billion by 2035 [2]

Investment Rating - The report does not explicitly state an investment rating for the interleukin industry Core Insights - The interleukin family consists of various cytokines that play significant roles in immune regulation, inflammation, and cancer, with many related drugs and clinical pipelines in development [4][5] - The IL-12 and IL-23 cytokines are crucial in immune modulation and have become important therapeutic targets for autoimmune diseases such as psoriasis and Crohn's disease [9][10] - The market for IL-4Rα drugs in allergic diseases is expanding, with two main drugs approved in China for treating allergic asthma and other conditions [16] - IL-1β inhibitors are gaining traction in gout treatment, with a notable increase in patient numbers projected for high uric acid levels and gout by 2030 [23][25] - Artificial intelligence is enhancing drug development processes across various stages, significantly reducing the time required for drug discovery and optimization [31][32] Summary by Sections Interleukin Family Overview - The interleukin family includes multiple members categorized into several groups, each with distinct roles in immune response and disease [3][4] - Key interleukins such as IL-1, IL-2, IL-6, IL-10, and IL-17 are involved in autoimmune and inflammatory diseases, with existing drugs and clinical pipelines targeting these cytokines [5] Market Status of IL-12/IL-23 - Several drugs targeting IL-12 and IL-23 have been approved for treating autoimmune diseases, with notable examples including Ustekinumab and Guselkumab [8][10] - The first fully human monoclonal antibody targeting IL-12/IL-23, Iroquois, is set to launch in 2025 for moderate to severe plaque psoriasis [10] IL-4 in Allergic Diseases - Two IL-4Rα drugs have been approved in China for allergic diseases, with Dupilumab included in the national medical insurance list [16] - The report outlines ongoing clinical trials for additional IL-4Rα therapies targeting various allergic conditions [17] IL-1β Inhibitors in Gout Treatment - The report highlights the increasing prevalence of high uric acid and gout, with projections indicating significant growth in patient numbers by 2030 [21][23] - The first IL-1β monoclonal antibody, Canakinumab, has been approved for gout treatment, with a projected global sales figure of $1.5 billion by 2024 [25] Role of Artificial Intelligence in Drug Development - AI is transforming drug discovery by streamlining processes and improving efficiency, reducing the time for lead compound optimization from approximately 65 months to 30 months [32] - The integration of AI in drug development enhances the accuracy of personalized medicine and accelerates the identification of effective drug candidates [31][32]

Core Insights - IBD represents a significant unmet clinical need with a complex pathogenesis and no current cure, affecting over 10 million people globally, with projections of 1.5 million patients in China by 2025 and a market size of $100 billion by 2032 [1][2] Group 1: IBD Overview - Inflammatory Bowel Disease (IBD) includes Ulcerative Colitis (UC) and Crohn's Disease (CD), characterized by a complex autoimmune nature and unclear mechanisms [1] - The clinical remission rates for most IBD drugs remain low, typically between 10%-20%, with high-dose approved drugs achieving over 15% [3] Group 2: Treatment Landscape - The treatment landscape for IBD is evolving with the introduction of new therapies, including IL-23 p19 monoclonal antibodies and JAK inhibitors, following the initial success of TNF-α targeting drugs [2] - New generation therapies, such as TL1A monoclonal antibodies, show promising clinical data, with duvakitug achieving a 47.8% clinical remission rate in UC and 48% endoscopic remission in CD [3] Group 3: Market Dynamics - Major multinational corporations (MNCs) are rapidly expanding their presence in the IBD market, with expectations of high transaction values for quality clinical-stage assets exceeding $2 billion [4] - Chinese innovative pharmaceutical companies are emerging with differentiated products, such as the oral S1P modulator and various promising candidates in clinical trials [4]

Core Insights - The recent inclusion of AbbVie's innovative drug, Risankizumab (brand name: Skyrizi), in the 2025 National Medical Insurance Directory represents a significant breakthrough for Crohn's disease treatment, as it will be reimbursed starting January 1, 2026, reducing the financial burden on patients [1][2][3] Group 1: Disease Overview - Crohn's disease is a chronic inflammatory bowel disease that primarily affects young adults aged 18-35, with symptoms including abdominal pain, diarrhea, and weight loss [1] - The number of Crohn's disease patients in China is increasing at an annual rate of 5%-10%, leading to significant healthcare costs for families [2] Group 2: Treatment Landscape - Risankizumab is the first IL-23 inhibitor specifically targeting moderate to severe active Crohn's disease, with over 40 countries having real-world usage experience for more than three years [2] - The drug has shown impressive efficacy, with mucosal healing effects approximately double that of similar drugs and 85% of patients maintaining clinical remission for two years [2] Group 3: Financial Implications - Prior to its inclusion in the insurance scheme, the high cost of Risankizumab made it a challenging option for many patients, often leading to difficult choices between treatment efficacy and affordability [3] - With the drug now covered by insurance, the out-of-pocket expenses for patients will significantly decrease, making it more accessible and alleviating financial pressure on families [3]

Core Viewpoint - He Mei Pharmaceutical is urgently seeking an IPO after 23 years of product development, with its first drug Mufemilast recently approved, amidst a highly competitive market for psoriasis treatments [1][4]. Company Overview - Founded in 2002, He Mei Pharmaceutical has raised over 1.2 billion yuan and incurred losses exceeding 1.1 billion yuan, achieving a valuation of 3.9 billion yuan without any products on the market [1][3]. - The company has been in a continuous state of high cash burn, with significant R&D expenditures primarily focused on Mufemilast, which has taken over 16 years to develop [2][3]. Product Development - Mufemilast's development timeline began in 2009, with clinical trials starting in 2012, and it received approval for treating moderate to severe plaque psoriasis in September 2025 [2]. - The R&D costs for Mufemilast accounted for 60% of the total R&D expenses from 2023 to mid-2025, reflecting the heavy investment required for its development [2]. Market Competition - The psoriasis drug market in China is highly competitive, with 18 approved targeted therapies, including 5 small molecules and 13 biologics, leading to a fierce price war [4][5]. - Major competitors include established products from international pharmaceutical giants, which have already captured significant market shares [4][5]. Pricing Strategy - He Mei Pharmaceutical plans to set Mufemilast's initial annual treatment cost between 52,700 and 119,900 yuan, positioning it above some small molecule competitors but below the price of leading biologics [7]. - The relatively high pricing strategy may hinder Mufemilast's competitiveness, especially among price-sensitive patients requiring long-term treatment [7][8]. Commercialization Challenges - The commercialization of Mufemilast is expected to be slow due to the nature of psoriasis as a chronic disease, which requires extensive academic promotion and trust-building among healthcare professionals [8]. - Even if Mufemilast successfully launches, it may not generate significant revenue quickly enough to offset the company's ongoing losses [8].

Core Viewpoint - He Mei Pharmaceutical is urgently seeking an IPO after 23 years of product development, with its first drug Mufemilast recently approved, amidst a highly competitive market for psoriasis treatments [1][6]. Company Overview - Founded in 2002, He Mei Pharmaceutical has raised over 1.2 billion RMB and incurred losses exceeding 1.1 billion RMB, achieving a valuation of 3.9 billion RMB despite having no products on the market [1][5]. - The company has been heavily reliant on external financing, completing six rounds of funding from 2021 to the end of 2024, with a post-investment valuation reaching 3.9 billion RMB after the E round [5]. Product Development - The development of Mufemilast has taken 16 years, starting from preclinical research in 2009 to receiving approval for treating moderate to severe plaque psoriasis in September 2025 [3]. - Research and development expenses for Mufemilast accounted for 60% of the total R&D costs, with losses reported at 156.4 million RMB for 2023 and projected losses of 123.4 million RMB for 2024 [3][4]. Market Competition - The psoriasis drug market in China is projected to grow from 18.2 billion RMB in 2024 to 48.3 billion RMB by 2028, with 18 approved targeted therapies already available, including 13 biologics [6][7]. - He Mei Pharmaceutical faces intense competition from established players like Novartis and Eli Lilly, which have already captured significant market shares with their products [6][7]. Pricing Strategy - He Mei Pharmaceutical plans to price Mufemilast between 52,700 RMB and 119,900 RMB annually, positioning it above some small molecule competitors but below the price of established biologics [8]. - The higher pricing strategy may hinder Mufemilast's competitiveness in a market where patients are sensitive to treatment costs, especially for chronic conditions requiring long-term medication [8][9]. Commercialization Challenges - The commercialization of Mufemilast is expected to be slow due to the need for long-term academic promotion and building trust among healthcare professionals [9]. - Even with successful market entry, Mufemilast is unlikely to generate significant revenue quickly, making it difficult for He Mei Pharmaceutical to reverse its overall loss situation [9].

Core Viewpoint - 百奥泰 reported a revenue of 684 million yuan for the first three quarters of 2025, representing a year-on-year growth of 17.57%, while the net loss narrowed to 224 million yuan, indicating improved financial performance [1] Group 1: Financial Performance - The company achieved a revenue of 684 million yuan in the first three quarters, marking a 17.57% increase year-on-year [1] - The net loss for the same period was 224 million yuan, showing a reduction in losses compared to the previous year [1] Group 2: Product Development and Approvals - Several products have been approved for sale, including Adalimumab and Tocilizumab in China and other regions, and Bevacizumab in multiple countries [1] - BAT1806 (Tocilizumab) and BAT2206 (Ustekinumab) have been approved in Europe, with sales managed by partners [2][3] - The company is advancing its innovative drug pipeline, with BAT5906 and BAT4406F expected to submit applications for market approval soon [2][3] Group 3: Market Expansion and Strategy - The company is preparing for participation in centralized procurement, optimizing production capacity and supply chain to enhance competitiveness [2] - New guidelines in the EU and the US for biosimilars are expected to lower R&D costs, providing a competitive advantage for the company [2] Group 4: Clinical Trials and Research - BAT6026 is currently in Phase II clinical trials for atopic dermatitis, while BAT8008 is set to begin Phase III trials for cervical cancer and HER2-negative breast cancer in mid-2026 [3] - Ongoing clinical research for BAT8008 in combination with BAT1308 has shown positive efficacy signals, leading to an expansion of the sample size [3] - BAT7111 is in Phase I dose escalation studies, progressing smoothly with three doses explored [3]

Core Viewpoint - Johnson & Johnson's (JNJ) first-in-class drug Icotrokinra has been submitted for market approval in China, targeting moderate to severe plaque psoriasis in adults and children aged 12 and older, marking a significant step in its commercialization process in the country [1][4]. Group 1: Drug Development and Approval - Icotrokinra, an oral peptide drug developed by Johnson & Johnson with an investment of nearly $1 billion from Protagonist, is the first IL-23R antagonist to seek market approval globally [2]. - The drug has already been submitted for approval in the United States and Europe earlier this year, with expectations of peak annual sales exceeding $5 billion [2]. - The Chinese submission has been prioritized for review by the CDE, based on its demonstrated efficacy and safety in multiple international clinical trials [4]. Group 2: Clinical Trial Results - The ICONIC-ADVANCE1 and 2 trials, which are randomized controlled Phase III studies, evaluated the efficacy and safety of Icotrokinra compared to placebo and the first approved TYK-2 inhibitor, deucravacitinib, in moderate to severe plaque psoriasis patients [3]. - Icotrokinra achieved significant primary endpoints at week 16, showing superior skin clearance rates compared to both placebo and deucravacitinib, with a similar incidence of adverse events [3]. - Long-term data from the ICONIC-LEAD study indicated sustained skin clearance and good safety profiles for Icotrokinra at week 52 [4]. Group 3: Future Research and Comparisons - Johnson & Johnson has initiated the Phase III ICONIC-ASCEND study, which aims to demonstrate the superiority of Icotrokinra over the injectable biologic drug ustekinumab in a head-to-head comparison [4].