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]

CM512(TSLP/IL-13双抗)目前拓展多个II期临床，授权AZ的CMG901有望2026年于美国递交NDA。早研 布局多技术平台，管线有望逐步推进，后备力量充足。核心产品司普奇拜单抗为首个国产IL-4R单抗， 先发优势明显，2026年医保执行后有望快速放量。IL-4R单抗可靶向特应性皮炎(AD)、慢性鼻窦炎伴鼻 息肉(CRSwNP)等多种II炎症反应性疾病，全球目前仅2款IL-4R单抗获批上市，赛诺菲的度普利尤单抗 自2017年上市后快速放量并持续拓展新适应症，2024年全球销售额超140亿美元。 国金证券发表报告，首次覆盖康诺亚-B，予其"买入"评级，目标价83.29港元。报告指，公司深度布局 差异化布局自免慢病和肿瘤赛道，在研管线众多，核心产品司普奇拜单抗已获批上市， ...

Core Viewpoint - The report from Guojin Securities highlights the promising pipeline of Connoa-B (02162), with its core product, Supacibab, already approved for market. The company is expanding its clinical trials for CM512 (TSLP/IL-13 bispecific antibody) and expects to submit an NDA for CMG901 in the U.S. by 2026. The company has a robust pipeline and is well-positioned for growth, receiving a "Buy" rating with a target price of HKD 83.29 [1]. Group 1: Product Pipeline and Market Potential - Supacibab is the first domestically produced IL-4R monoclonal antibody, providing a significant first-mover advantage. It targets various type II inflammatory diseases, with expectations for rapid market uptake post-2026 when it enters the national medical insurance directory [1]. - The global sales of Dupilumab, a competing IL-4R monoclonal antibody, exceeded USD 14 billion in 2024, indicating a strong market potential for Supacibab, which has already been approved for three indications [1]. - Sales projections for Supacibab are estimated at CNY 0.36 billion in 2024, CNY 1.69 billion in the first half of 2025, and expected to reach CNY 3.31 billion, CNY 9.05 billion, and CNY 16.27 billion from 2025 to 2027 [1]. Group 2: Clinical Development and Competitive Landscape - CM512 is currently in Phase II clinical trials and is positioned as the second globally in development, with significant differentiation advantages in the respiratory market. It targets asthma and COPD, with potential approval by 2029 [2]. - CMG901, a Claudin 18.2 ADC, has been licensed to AstraZeneca and is the fastest progressing globally. It is expected to complete Phase III trials for second-line gastric cancer by 2026 and submit for market approval, with potential milestone payments and royalties for the company [2]. Group 3: Financial Projections and Valuation - The company is projected to achieve revenues of CNY 6.61 billion, CNY 12.55 billion, and CNY 20.64 billion for the years 2025, 2026, and 2027, reflecting year-on-year growth rates of 54%, 90%, and 65% respectively [3]. - The net profit forecast shows a loss of CNY 5.13 billion in 2025, narrowing to a loss of CNY 2.97 billion in 2026, before turning to a profit of CNY 2.01 billion in 2027, with corresponding EPS of -1.72, -0.99, and 0.67 [3]. - A DCF valuation method has been applied, resulting in a target price of HKD 83.29, with an initial "Buy" rating assigned [3].

核心产品司普奇拜单抗为首个国产IL-4R单抗，先发优势明显，26年医保执行后有望快速放量。IL-4R单 抗可靶向特应性皮炎(AD)、慢性鼻窦炎伴鼻息肉(CRSwNP)等多种II型炎症反应性疾病，全球目前仅2款 IL-4R单抗获批上市，赛诺菲的度普利尤单抗自2017年上市后快速放量并持续拓展新适应症，2024年全 球销售额超140亿美金。司普奇拜单抗作为全球第二款、国内首款IL-4R单抗，先发优势明显，非头对头 比较下疗效较度普利尤单抗更优，目前已经获批三项适应症(AD、CRSwNP、过敏性鼻炎SAR，后两者 为独家适应症)。目前司普奇拜单抗已纳入2025年12月国家医保目录，预计26年初执行，进入医保后有 望快速放量。自2024年9月上市以来，2024、2025H1销售额分别为0.36亿元、1.69亿元，预计2025-2027 年销售额分别有望达3.31/9.05/16.27亿元。 该行预测，2025/2026/2027年公司实现营业收入6.61亿/12.55亿/20.64亿元，同比+54%/+90%/+65%，归 母净利润-5.13亿/-2.97亿/2.01亿元，对应EPS为-1.72/-0.99/0.67 ...

麦济生物与康哲药业合作 麦济生物成立于2016年，是一家专注于过敏与自免疾病领域的临床阶段生物制药公司。据招股书披露， 公司已自主研发并建立一条由8款创新候选产品组成的管线，其中进度最快、最核心的资产是抗IL-4Rα 单抗MG-K10。 事实上，IL-4靶点在全球范围内已被验证出巨大的商业价值，赛诺菲的度普利尤单抗在2024年凭借142 亿美元的销售额成为该领域的标杆。 年末，对递表港交所近半年却仍未进入聆讯的IPO(首次公开募股)公司而言，上市失败的概率正在增 大，麦济生物就是其中之一。公司2025年7月14日向港交所提交上市申请书，截至目前尚未进入聆讯。 自2016年成立以来，麦济生物已自主研发并建立一条由8款创新候选产品组成的管线。其中，核心产品 MG-K10为一款长效抗IL-4Rα抗体，2025年10月30日已获得中国国家药监局(NMPA)的上市申请受理。 尽管看起来进度顺利，但麦济生物却在招股书中直言："我们最终可能无法成功开发及上市MG-K10。" 《每日经济新闻》记者注意到，麦济生物的IL-4Rα相关专利与科创板上市公司三生国健(SH688336，股 价60.63元，市值373.96亿元)有过诉 ...

Group 1 - The autoimmune disease market is a blue ocean, with new targets and mechanisms driving rapid industry development. The global autoimmune market reached $132.3 billion in 2022 and is expected to grow to $176.7 billion by 2030, with a CAGR of 3.68% [2][3] - The drug development paradigm is shifting from broad-spectrum anti-inflammatory treatments to precision regulation, with significant room for improvement in efficacy and safety of existing drugs [2][3] Group 2 - Psoriasis affects approximately 125 million patients globally, with a focus on large molecule antibody drugs and a surge in small molecule oral TYK2 inhibitors that may replace existing treatments [3] - Atopic dermatitis impacts over 204 million people worldwide, with Dupilumab achieving sales exceeding $12.9 billion in the first three quarters of 2025, and new oral drugs like STAT6PROTAC showing superior efficacy [3] - The clinical demand for autoimmune diseases remains largely unmet, with domestic companies actively innovating in drug development, focusing on target innovation and expanding indications [4] Group 3 - Companies to watch include: 1. **Xiansheng Pharmaceutical**: Focused on differentiated targets with potential candidates like SIM0278, SIM0709, and SIM0711 [4] 2. **Kangnuo Pharmaceutical**: Rapidly increasing sales of Dupilumab, with peak sales expected to reach 5 billion yuan; CM512 shows promise as a leading TSLPxIL-13 dual antibody [4] 3. **Quansheng Biotechnology**: QX013N targets c-kit for CSU treatment, with additional dual antibody projects expected to submit IND applications between 2025 and 2026 [4] 4. **Yifang Biotechnology**: D-2570 (TYK2 inhibitor) is in Phase II clinical trials for UC, with promising Phase II data for psoriasis [4] 5. **Sanofi Genzyme**: Rapidly advancing IL-5 monoclonal antibody for asthma, with NDA submission expected by 2027 [4]

Core Viewpoint - The article discusses the recent update of China's National Medical Insurance Drug List, which includes 114 new drugs, highlighting the introduction of a commercial health insurance innovative drug directory alongside the basic insurance list, aiming to enhance patient access to innovative treatments and address gaps in drug coverage [6][13]. Group 1: New Drugs in the National Medical Insurance Directory - A total of 114 new drugs have been added to the directory, covering various treatment areas including 36 for tumors, 12 for chronic diseases, and 10 for rare diseases, with the number of class 1 new drugs increasing from 38 to 50, setting a new historical high [6][7]. - Notable "star drugs" include LuKangsa Tazhu (for tumors), Fluorazirase tablets, and Spilumab (for specific dermatitis), which will benefit a wide range of patients, including those with triple-negative breast cancer and chronic sinusitis [7][8]. Group 2: Financial Impact on Patients - The average price reduction for negotiated drugs has historically been around 60%, with 112 out of 127 drugs successfully negotiated this year, resulting in significant cost savings for patients [9]. - The introduction of Spilumab, priced at around 1,000 yuan per injection, is expected to significantly lower the financial burden on patients, making innovative treatments more accessible [9]. Group 3: Implementation Challenges - There are concerns regarding the "last mile" issue in drug availability at hospitals, as many negotiated drugs are still provided through external pharmacies, and hospitals may hesitate to prescribe these due to cost concerns [10][11]. - The new regulations require that hospitals must not limit the availability of negotiated drugs based on overall budget constraints, ensuring that these drugs are accessible to patients [11]. Group 4: Changes in the Drug Directory - This year, 29 drugs were removed from the directory due to being replaced or not produced, with a total of 467 drugs removed over the past eight years for similar reasons [12]. - A six-month transition period has been established for patients using drugs that are not renewed in the directory, ensuring continuity of care [12]. Group 5: Commercial Health Insurance Innovative Drug Directory - The newly established commercial health insurance innovative drug directory includes 19 drugs, focusing on high-value innovative treatments that cannot be covered by the basic insurance directory [13][15]. - The drugs in this directory are characterized by high innovation, significant clinical value, and the need for diverse payment options, with 50% being class 1 new drugs [15]. Group 6: Benefits for Patients - The commercial health insurance directory aims to provide a curated list of high-quality drugs, reducing the selection burden for insurance companies and potentially lowering costs for patients through reduced premiums or increased reimbursement rates [16]. - The integration of the commercial insurance directory with existing medical insurance systems is being explored to enhance patient experience and access to innovative treatments [16]. Group 7: Future Prospects and Challenges - The implementation of the commercial health insurance innovative drug directory is dependent on market mechanisms, with insurance companies determining the usage and timing of these drugs [19]. - Emphasis on actuarial pricing and collaboration between insurance companies and pharmaceutical firms is crucial for the sustainable rollout of these innovative drugs [19].

在2025年国家基本药品目录调整中，谈判成功率达到88%，较上一年的76%有明显提升，创近七年新 高。与此同时，在新晋"国谈药"中，有111种为5年内新上市品种，50种为1类新药，无论是比例还是数 量也均创下历年新高。 而与此同时，仍有近百种（98种）药品在形式审查阶段，就被"国谈"拒之门外。近六成目录外药品在专 家评审阶段未过评，过评率连续两年不足50%。15种药在过评后最终谈判/竞价失败。 "一进一拒"，从正反两个维度体现了国家医保局价值购买的方向——在基本医保的保障边界内，支持真 创新，支持差异化创新。 部分业界观点认为，这一方面是因为在申报和形式审查环节，药企申报意愿持续提升，对规则的认知也 更加清晰，形式审查通过数量和通过率不断提升；另一方面，也与目录内药品涵盖适应证不断丰富，创 新药市场上同靶点、同机制、同适应证药品竞争激烈，医保基金紧平衡等多重原因下，国家医保局对创 新要求不断拔高有关。 182种药未过评背后："四不改"、价格与价值不匹配 国家基本药品目录谈判走进第八个年头，已形成了一套成熟的谈判流程：药企自主申报，专家综合评 审，价格谈判/竞价，最终公布谈判结果。 在今年"国谈"中，国家医保局 ...

Core Insights - The approval rate for drugs outside the national essential drug list has reached a four-year low during the expert review phase, indicating increasing scrutiny and higher standards for innovation [1][4] - The success rate for negotiations in the upcoming 2025 national essential drug list has improved to 88%, up from 76% the previous year, marking a seven-year high [1] - A total of 114 new drugs will be added to the national essential drug list, including 50 innovative first-class drugs, reflecting a significant increase in both quantity and quality [2][8] Group 1: Approval Rates and Trends - The approval rate for drugs in the expert review phase has declined for two consecutive years, with only 41.48% of drugs passing this stage this year [2][3] - In the past three years, the number of drugs passing the formal review has increased, but the expert review approval rate has decreased from 74.2% to 47.0% [3] - Nearly 60% of drugs outside the essential list failed to pass the expert review, highlighting a trend towards stricter evaluation criteria [1][4] Group 2: Reasons for Non-Approval - Several drugs, including first-class innovative drugs, were not approved due to lack of significant clinical value compared to existing treatments [5][6] - The "Four No Changes" principle (no change in active ingredient, indication, administration route, or clinical value) has been identified as a key reason for low approval rates [6] - High prices and mismatched value with existing treatments have also contributed to the rejection of certain drugs, with examples of significant price discrepancies noted [6] Group 3: Support for True Innovation - The national healthcare authority emphasizes support for "true innovation" and "differentiated innovation," aiming to exclude drugs that do not significantly advance clinical outcomes [5][7] - Successful drugs entering the essential list share common characteristics such as filling therapeutic gaps and offering superior alternatives [7] - The overall speed and quantity of innovative drugs entering the national essential drug list have increased, addressing various medical needs including major diseases and rare conditions [8] Group 4: Value-Based Pricing and Evaluation - The negotiation process for the national essential drug list has evolved to include a more systematic and scientific value assessment, enhancing fairness and rigor in price evaluations [10] - The approach to pricing has shifted to support higher payment thresholds for drugs with greater innovation, reflecting a value-based pricing model [10][11] - The importance of robust clinical evidence in supporting claims of additional benefits for new drugs has been highlighted, particularly in competitive therapeutic areas [11][12]

今年的医保目录， 纳入了多款"重磅新药"。 文 ｜ 胡香赟 编辑 ｜ 海若镜 封面来源 ｜ pixabay 今年的医保目录，纳入了多款"重磅新药"。 12月9日上午，国家医保局在北京召开沟通会，对两天前在广州"2025创新药高质量发展大会"公布的新版国家基本医保目录，及首个《商业健康保险创新药 品目录》（"商保目录"）名单，进行了详细解读。 国家医保局方面在沟通会上提到，今年医保目录新增药物114个，覆盖肿瘤、抗感染、慢病等诸多领域。 其中，包括慢病领域集中"更新换代"的新品：GLP-1降糖/减重药替尔泊肽；半年打一针的降脂药英克司兰钠；治疗痛风"富贵病"的多替诺雷片均被纳入。另 外，"过敏救星"司普奇拜单抗、国产流感新药玛舒拉沙韦片、长效生长激素产品怡培生长激素等也纷纷被医保接收。 本次，商保目录共纳入19款产品，包括5款售价百万元、被网友称为"抗癌针"的CAR-T疗法，2款新型阿尔茨海默病药物和多款治疗肿瘤及罕见病的药物。其 中罕见病药物在目录中占比接近1/3。 36氪获悉，19款产品的"降幅"在15%-50%不等（5%为一档，视产品特性而定），略高于行业此前预期的30%以内的降幅区间，但整体低于往年医保 ...