此次获批是基于早前发表在《新英格兰医学杂志》上的MANDARA 全球III期临床研究结果，该研究是 首个针对复发/难治性EGPA的生物制剂非劣效性头对头研究,，比较了本瑞利珠单抗与此前唯一获批治 疗EGPA的生物制剂美泊利珠单抗在复发/难治性EGPA患者中的疗效与安全性1,2,。研究结果显示，本瑞 利珠单抗治疗组中近60%的患者实现缓解，与美泊利珠单抗组一致。而且，本瑞利珠单抗治疗组中41% 的患者可完全停用口服糖皮质激素（OCS），高于美泊利珠单抗治疗组的26%（95%置信区间：1,31） 1。此外， MANDARA研究的开放标签扩展期研究（OLE）结果显示，从美泊利珠单抗转换至本瑞利珠 单抗治疗的患者，其OCS停药率最高可达43.5%。同时，本瑞利珠单抗的耐受性良好，其安全性与美泊 利珠单抗相比没有临床意义的差异。 EGPA是一种罕见的累及多个系统的自身免疫性疾病，主要表现为外周血及组织中嗜酸性粒细胞 （EOS）增多、浸润及中小血管坏死性肉芽肿性炎症。呼吸道和肺部是最常受累的器官，表现为难治性 的喘息，呼吸困难，经常需要口服或注射糖皮质激素（简称全身激素）。但随着疾病进展，EGPA会引 发多器官的不可逆损 ...

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 Insights - The new National Medical Insurance Directory has added 114 new drugs, surpassing last year's addition of 91, with 50 being first-class innovative drugs, achieving an overall success rate of 88%, an improvement from 76% in 2024 [1][2] Group 1: New Drug Additions - The total number of drugs in the directory has increased to 3,253, significantly enhancing coverage for key areas such as oncology and chronic diseases [2] - The directory includes 38 global innovative drugs and 50 first-class innovative drugs, marking a historical high for new additions [2] - Notable inclusions are the first globally approved red blood cell maturation agent, Rotecip, for treating lower-risk myelodysplastic syndromes, and the first domestically developed IL-4Rα antibody drug, Kangyueda, for multiple indications [3][4] Group 2: Oncology Innovations - Several innovative oncology drugs have been added, including Tagolizumab, the first PD-L1 monoclonal antibody approved for nasopharyngeal carcinoma, and non-covalent BTK inhibitor, Jebatib, for relapsed mantle cell lymphoma [4][5][6] - ADCs (antibody-drug conjugates) have gained attention, with new entries like Lukanasatuzumab and Ruikangquzuzumab, targeting advanced breast cancer and non-small cell lung cancer [7][8] Group 3: Chronic Disease Treatments - The directory has included innovative drugs for chronic diseases, such as Novartis' PCSK9 mRNA interference drug for cholesterol management, addressing patients who cannot reach LDL-C targets [14] - AstraZeneca's biologic drug Benralizumab for severe eosinophilic asthma has also been added, providing targeted treatment options for patients [15][16] Group 4: Influenza Treatments - The new directory has incorporated two domestic antiviral drugs for influenza, Masurashave and Angladiv, which have shown promising clinical results in reducing symptoms and viral load [17]

Group 1 - Netflix announced an agreement to acquire Warner Bros. Discovery for an enterprise value of approximately $82.7 billion, focusing on its film studios and HBO Max streaming assets, including top IPs like Harry Potter and Game of Thrones, aiming to build a "super content" empire, with the deal expected to face strict antitrust scrutiny [3] - OpenAI plans to respond to Google's Gemini 3 with the upcoming GPT-5.2, which is now expected to launch on December 9, ahead of its original schedule [3] - SpaceX is reportedly seeking an $800 billion valuation through a share sale, although Elon Musk denied the accuracy of this report, stating that revenue from NASA is expected to account for no more than 5% of the company's income by 2026 [4] Group 2 - X, the social platform owned by Musk, was fined €120 million under the EU's Digital Services Act for allegedly violating content moderation regulations [4] - Microsoft is in talks with Broadcom to design future custom chips, potentially shifting from its current supplier Marvell [4] Group 3 - Xingqi Eye Care has multiple products included in the National Medical Insurance Directory, with a notable product priced at 1.78 yuan per piece, expected to positively impact long-term operations [6] - Kexin Pharmaceutical's CAR-T drug has entered the commercial insurance innovative drug directory, drawing market attention [6] - Wuliangye will adjust the price of its eighth-generation product starting next year, offering a discount of 119 yuan per bottle from a base price of 1019 yuan [7] Group 4 - Huawei's CEO emphasized the importance of AI research while focusing on the application of large models and big data in agriculture and technology over the next 3-5 years [6] - BYD's chairman noted a decline in domestic sales due to technological lag and user demand issues, indicating the need for significant technological breakthroughs [7] - Baidu Kunlun Chip plans to file for an IPO in Hong Kong as early as Q1 next year, with a recent valuation of 21 billion yuan [7] Group 5 - Samsung Electronics achieved a key breakthrough in 4nm process technology, improving yield rates to 60-70%, which is expected to enhance its competitiveness in advanced manufacturing [12] - SK Hynix announced plans to localize EUV photoresist to reduce dependence on Japanese suppliers [12]

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]

Group 1 - The core viewpoint is that the large patient base for COPD and the limitations of traditional treatment options create a significant opportunity for innovative therapies, which are expected to reshape the treatment landscape and generate substantial market growth [1][2]. - COPD is a prevalent chronic disease in China, affecting approximately 100 million people, and is the third leading cause of death in 2021, highlighting the urgent need for better treatment options [1]. - The current awareness and standardized treatment rates for COPD in China are low, with only 0.9% awareness and 4.5% lung function testing rates, indicating a significant opportunity for improvement in diagnosis and treatment [1]. Group 2 - Recent approvals of innovative therapies, such as ensifentrine and dupilumab, have broken the long-standing absence of new mechanism drugs in the COPD field, leading to an accelerated iteration of treatment options [2]. - The FDA approved ensifentrine in June 2024 as the first new mechanism inhalation product for COPD maintenance treatment in over 20 years, representing a significant advancement in therapy [2]. - Merck's acquisition of Verona for approximately $10 billion underscores the value of innovative COPD treatments and the potential for further market expansion [2]. Group 3 - Chinese innovative pharmaceutical companies are actively developing key targets for COPD treatment, with notable progress in the PDE3/4 inhibitor space, exemplified by companies like Hengrui Medicine and China Biologic Products [3]. - Hengrui Medicine's innovative drug HRS-9821 has entered a collaboration agreement with GSK, which includes a $500 million upfront payment and a potential total deal value of around $12 billion, highlighting the global recognition of Chinese innovation [3]. - The ongoing development of various innovative pipelines in the COPD sector indicates a promising future for Chinese companies in securing external licensing opportunities [3].

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]

Pharmaceutical Sector - The pharmaceutical sector in China is showing strong performance, with significant transactions such as the $1.25 billion deal enhancing market confidence in the quality and market value of Chinese innovative drugs [1] - Chinese pharmaceutical companies are increasingly making their mark in global licensing transactions and showcasing their clinical pipeline potential at major conferences like ASCO [2] - The outlook for the pharmaceutical sector is optimistic, with expectations of a reversal in market trends by 2025, driven by innovative drugs and the recovery of left-side sectors [1][2] Biopharmaceuticals - GSK announced FDA approval for mepolizumab as an additional maintenance treatment for poorly controlled chronic obstructive pulmonary disease (COPD) patients, with projected global sales of €1.784 billion in 2024 [3] - There is a growing interest in IL-5 targeted drugs, with several domestic companies already engaged in this area [3] Medical Services & Consumer Healthcare - Alcon reported Q1 2025 surgical business net sales of $1.338 billion, a 1% year-on-year decline, but a 2% increase at constant exchange rates [4] - Vision care business net sales reached $1.106 billion in Q1 2025, reflecting a 1% year-on-year growth, driven by innovations in contact lenses [4] Medical Devices - Johnson & Johnson Medical launched the SOUNDSTAR CRYSTAL ultrasound catheter in the U.S. for cardiac ablation procedures, indicating a rich pipeline of innovative products [5] - There is a strong long-term demand trend for innovative medical devices, with a focus on leading companies that are expected to rapidly scale new products [5] Pharmacies - A recent initiative by multiple government departments aims to enhance the health promotion functions of retail pharmacies, indicating a supportive policy environment for non-drug product expansion [6] - Continuous optimization of industry regulations and the implementation of drug traceability measures are expected to create a more favorable environment for pharmacies [6]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The A-share pharmaceutical index has increased by 1.8% this week and 4.3% year-to-date, outperforming the CSI 300 by 1.9% and 5.6% respectively [3][8] - The H-share biotechnology index has seen a rise of 6.7% this week and 36.4% year-to-date, outperforming the Hang Seng Technology Index by -7.4% and 19% [3][8] - The report highlights a significant increase in the number of domestic innovative drugs presented at the ASCO conference, with 25 oral presentations and 24 rapid oral presentations, marking a new high [14] Summary by Sections Industry Performance - A-share raw materials (+4.0%), chemical drugs (+3.6%), biological products (+1.7%), medical services (+1.4%), and pharmaceutical commerce (+1.2%) have shown notable price increases, while medical devices (+0.5%) and traditional Chinese medicine (+0.2%) have seen smaller gains [3][8] - Top performers in A-shares include Shengguojian (+100%), Haichen Pharmaceutical (+52%), and Shutaishen (+49%), while New Ganjing (-12%), Gongdong Medical (-10%), and Jinhao Medical (-9%) faced declines [3][8] R&D Progress and Corporate Developments - GSK's IL-5 monoclonal antibody has been approved for the treatment of COPD, marking a significant milestone as the first IL-5 drug approved for this indication [3] - The report notes strategic partnerships, such as Jingyin Pharmaceutical's collaboration with CRISPR Therapeutics to develop next-generation long-acting FXI-targeting siRNA therapies [3] Investment Strategy - Recommended sub-industry rankings are: Innovative drugs > CXO > Traditional Chinese medicine > Medical devices > Pharmacies > Pharmaceutical commerce [9] - Stock selection strategies include focusing on growth in innovative drugs, undervalued stocks in traditional Chinese medicine, high dividend stocks in traditional Chinese medicine, and left-side opportunities in raw materials and certain CXO and medical devices [9]