21世纪经济报道记者 韩利明 日前，国家药监局发布公告，明确要求孟鲁司特制剂（包含片剂、咀嚼片、颗粒和口溶膜四种剂型）在说明书中新增神经精神不良反 应的警示语，注明"其中包括个别严重反应如抑郁和自杀倾向等；若不停药，这些症状可能持续存在"。同时，在不良反应中增加"口 吃（结巴）"。 图片来源：国家药监局官网 公告要求，国内所有孟鲁司特药品的上市许可持有人，均应按上述要求修订说明书，并在2026年3月12日前报国家药监局药审中心或 省级药监部门备案。备案后9个月内，已出厂的药品说明书及标签要全部更换。 公开资料显示，孟鲁司特钠（编者注：孟鲁司特与孟鲁司特钠是同一种药物，规范的药物名称为孟鲁司特钠）由默沙东原研（商品 名：Singulair，顺尔宁），是一种强效选择性白三烯受体拮抗剂，适应症为2岁至14岁儿童哮喘的预防和长期治疗，包括预防白天和夜 间的哮喘症状，治疗对阿司匹林敏感的哮喘患者以及预防运动诱发的支气管收缩；减轻过敏性鼻炎引起的症状（2岁至14岁儿童的季 节性过敏性鼻炎和常年性过敏性鼻炎）。 随着默沙东专利到期，国内企业开展仿制。21世纪经济报道记者以"孟鲁司特"为关键词，在国家药监局官网共查询到62条 ...

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ （来源：医学界） 转自：医学界 在重度哮喘治疗迈入生物制剂时代的背景下，疾病的异质性仍是制约治疗应答与预后的关键挑战。近期，一项基于丹麦全国真实世界数据的研 究，通过长达26年的回顾性随访与轨迹聚类分析，首次系统识别出重度哮喘患者在接受生物制剂治疗前存在的三种典型疾病演进轨迹[1]。本 文特对此研究进行解读，以期为重度哮喘个体化、精准化的干预策略提供新视角与实践路径。 轨迹分野：三类演进路径定义异质性病程 该研究纳入丹麦重度哮喘登记系统中755例接受生物制剂治疗的患者，结合1995年至2022年的处方数据库与临床随访数据，通过吸入性糖皮质 激素（ICS）治疗强度序列分析与无监督轨迹聚类，识别出三类特征鲜明的疾病演进路径，深刻诠释了重度哮喘的异质性本质[1]。 第一类为"慢性重度型"（26%），患者呈现持续高炎症负荷特征：中位病程长达35年，是三类中病程最长的群体；肺功能损害最为严重，第1 秒用力呼气容积占预计值百分比（FEV1%pred）中位数仅64%；骨质疏松症、骨折、肥胖症等与糖皮质激素暴露相关的合并症发生率显著高于 其他群体，且就 ...

Core Viewpoint - The 2025 National Medical Insurance Negotiation has commenced, with significant price reductions expected, exceeding initial estimates by 40%-50% for many companies [1][6]. Group 1: Negotiation Overview - The negotiation began on October 30, 2023, and is expected to last 4-5 days, starting with basic medical insurance directory negotiations followed by commercial insurance innovative drug price discussions [2][3]. - This marks the 8th adjustment of the medical insurance directory since the establishment of the National Medical Insurance Bureau, involving a five-step process: preparation, application, expert review, negotiation, and result announcement [5]. Group 2: Participants and Dynamics - Numerous representatives from major pharmaceutical companies, including domestic and international firms like Shiyao Group, Green Leaf Pharmaceutical, and Pfizer, participated in the negotiations [9]. - The pace of negotiations appeared faster than in previous years, with representatives exiting the venue more frequently without prolonged discussions [9]. Group 3: Key Changes in Negotiation Structure - A significant change this year is the introduction of a commercial insurance innovative drug directory, aimed at integrating basic medical insurance and commercial insurance, enhancing the multi-tiered medication security system [13][14]. - There are 79 drugs that applied for both the basic medical insurance directory and the commercial insurance innovative drug directory, with a sequential negotiation process established [16]. Group 4: Future Implications - The commercial insurance innovative drug directory may serve as a transitional model for innovative drug payments, allowing drugs to first enter the commercial directory before potentially being included in the basic medical insurance directory after gathering real-world data [17].

Core Points - The 2025 National Medical Insurance Negotiation (referred to as "Guo Tan") commenced on October 30, 2023, in Beijing, with negotiations expected to last 4-5 days [2][3] - This marks the 8th adjustment of the medical insurance catalog since the establishment of the National Medical Insurance Bureau, involving five stages: preparation, application, expert review, negotiation, and announcement of results [3] - A total of 644 drugs passed the formal review for the 2025 catalog, with 534 approved for the basic medical insurance catalog and 121 for the commercial insurance innovative drug catalog [3] Group 1 - The first day of negotiations focused primarily on common drugs, including those for infections, anesthesia, and diabetes, while innovative drugs are scheduled for discussion on the second and third days [3] - Some representatives expressed that the price reductions proposed by the National Medical Insurance Bureau were significantly lower than expected, with estimates being 40%-50% below the most pessimistic forecasts [3][5] - The pace of negotiations appeared to be faster than in previous years, with representatives exiting the venue every few minutes, contrasting with the lengthy discussions seen in past negotiations [5] Group 2 - The introduction of the commercial insurance innovative drug catalog is a significant change this year, aimed at integrating basic medical insurance and commercial insurance to better meet diverse medication needs [8][9] - Negotiations for the commercial insurance innovative drug catalog are expected to take place on November 1 and 2, 2023 [9] - A total of 79 drugs applied for both the basic medical insurance and commercial insurance innovative drug catalogs, with a priority given to those that successfully pass the basic medical insurance negotiations first [9][10] Group 3 - The commercial insurance innovative drug catalog will allow for greater participation from commercial insurance companies in the decision-making process regarding drug inclusion and pricing negotiations [9] - Five high-cost CAR-T products are confirmed to be included in the final negotiation list for the commercial insurance innovative drug catalog [10] - Future payment models for innovative drugs may involve initially placing them in the commercial insurance catalog before transitioning to the basic medical insurance catalog after gathering real-world data [10]

Core Viewpoint - Chronic Obstructive Pulmonary Disease (COPD) has a high prevalence and mortality rate, indicating a significant unmet medical need for new treatment options [1] Group 1: Unmet Medical Needs in COPD - COPD is a leading cause of disability and death globally, with approximately 300 million cases worldwide and 100 million in China [1] - Current standard treatments (LAMA/LABA/ICS) have been in use for 40 years and carry risks of pneumonia, cardiovascular issues, and urinary tract infections, highlighting the urgent need for new therapies [1] Group 2: PDE3/4 Inhibitors and Market Activity - Merck acquired Verona for $10 billion to obtain Ensifentrine, while GSK spent approximately $12.5 billion to acquire HRS-9821 from Hansoh Pharma, reflecting the importance of the respiratory market and PDE3/4 targeted drugs [2] - PDE3 and PDE4 inhibitors have synergistic effects, potentially improving airway smooth muscle contraction and controlling inflammation, thus showing significant application potential [2] - Ensifentrine received FDA approval in June 2024, with sales reaching $217 million by Q2 2025, representing a 44% quarter-over-quarter growth, indicating substantial market potential [2] Group 3: Targeted Therapies for Eosinophilic Phenotype - Dupilumab (IL-4R) and mepolizumab (IL-5) have been successfully approved for COPD, focusing on high eosinophil count populations [3] - Dupilumab, the first targeted therapy for COPD, was approved by the FDA in 2024, with sales exceeding $14 billion in 2024 [3] - Mepolizumab showed positive results in trials with eosinophilic phenotype patients, demonstrating a correlation between eosinophil count and reduced acute exacerbation rates [3] Group 4: Emerging Targets and Domestic Innovations - TSLP and ST2/IL33 targets currently lack approved drugs, but domestic companies are innovating [4] - Amgen/AZ's tezepelumab is the only TSLP monoclonal antibody on the market, while domestic firms like Zhengda Tianqing and Kangnuo are developing differentiated therapies with promising efficacy [4] - The ST2/IL33 target, which is upstream of IL-4/IL-13, is being explored by domestic companies, with no approved drugs globally yet [4]

Investment Rating - The industry investment rating is "stronger than the market" (预计6个月内，行业指数表现强于市场表现5%以上) [35] Core Viewpoints - The report emphasizes the importance of multi-party collaboration in supporting the development of innovative drugs and medical devices, highlighting the integration of data, policy, and funding as essential elements for growth [4] - The report notes that recent measures from the Financial Supervisory Administration and the Medical Insurance Bureau aim to promote the development of commercial health insurance, which will provide additional support for the innovation and development of drugs and medical devices [4] Summary by Sections Industry Insights - The Medical Insurance Bureau's recent meetings have established a comprehensive support system for innovative drugs and medical devices, involving various stakeholders such as research institutions, enterprises, medical institutions, financial companies, and government departments [4] - The Financial Supervisory Administration has released measures to enhance the quality of commercial health insurance, which will further support the biopharmaceutical industry's innovation [4] Investment Strategy - The report suggests focusing on innovative pharmaceutical companies with rich pipelines, such as 恒瑞医药 (Hengrui Medicine), 百济神州 (BeiGene), and 中国生物制药 (China Biologic Products) [6] - It also highlights companies with significant single-product potential and those leading in advanced technology platforms, recommending关注 (focus on) companies like 凯莱英 (Kailaiying) and 药明康德 (WuXi AppTec) [6] Market Performance - The pharmaceutical sector experienced a decline of 0.84% last week, ranking last among 28 industries, while the Shanghai and Shenzhen 300 Index rose by 1.23% [9][21] - The report indicates that the pharmaceutical sector's valuation is currently at 30.91 times (TTM), with a premium of 37.32% compared to the overall A-shares excluding financials [27]

Core Viewpoint - The treatment of asthma has evolved from mere symptom control to achieving clinical cure, supported by advancements in modern medicine and the introduction of biological agents [2][3] Group 1: Asthma Treatment Insights - Asthma has the highest prevalence among chronic respiratory diseases globally, while chronic obstructive pulmonary disease (COPD) ranks first in China, with asthma in second place [2] - The clinical cure goals for asthma include four "zeros": no obvious symptoms, no asthma attacks, normal lung function, and no need for oral steroids [2] - Various biological agents such as omalizumab, mepolizumab, benralizumab, and dupilumab have shown promising clinical cure rates, providing more options for patients [2] Group 2: Challenges and Future Directions - The usage rate of biological agents in China is currently low, presenting challenges for broader adoption [2] - Long-term use of biological agents can effectively reduce acute attacks, emergency visits, and hospitalizations, making them cost-effective in overall healthcare expenditure [2] - Ongoing research is focused on developing targeted drugs for different cytokines and pathways, with new biological agents expected to enter clinical use [3] - Achieving the goal of clinical cure for asthma requires collaborative efforts from healthcare providers, patients, government, and society [3]