"从研发物品进口到药品上市许可，市场监管部门陪伴我们走过了每一个关键节点。"信达生物相关 负责人说。 杭州的创新药产业在市场监管部门的精准服务下持续壮大，2025年预计协助企业申报省市产业专项 资金约3.2亿元，为医药创新注入持续动力。 为推动创新成果加速转化，杭州市市场监督管理局推出了一系列务实举措：为创新药开设"绿色通 道"，实现1类创新药生产许可事项当日受理，许可检查办结时限压缩至7个工作日内；针对企业个性化 难题实行"一事一议"，2025年已解决16个疑难事项；在全省率先开展成品检验贵重仪器设备项目委托检 验，为19家企业缓解了资金压力。 这种精准服务不仅体现在审批提速上，更体现在破解产业共性难题上。面对企业反映的跨省委托生 产、药品共线生产等痛点，市场监管部门推动专题讨论20余次，出台解决方案20余个，推动相关指导原 则出台，使共性难题咨询量同比下降约37.5%。 国内自身免疫疾病治疗领域迎来里程碑进展——11月28日，信达生物制药集团研发的IL-23p19单抗 信美悦（匹康奇拜单抗注射液）正式获得国家药品监督管理局批准（批准文号：国药准字 S20250066），用于治疗适合系统性治疗的中重度斑块状 ...

港股通创新药ETF工银（159217）现任基金经理为刘伟琳、焦文龙。刘伟琳自2025年3月26日管理（或 拟管理）该基金，任职期内收益43.85%；焦文龙自2025年4月10日管理（或拟管理）该基金，任职期内 收益63.95%。 最新定期报告显示，工银瑞信基金（159217）重仓股包括百济神州、康方生物、信达生物、中国生物制 药、中国生物制药、石药集团、三生制药、翰森制药、科伦博泰生物-B、再鼎医药，持仓占比如下： 股票代码股票名称持仓占比持仓股数（股）持仓市值（元）06160百济神州10.84%314.54万5.89亿09926 康方生物10.77%454.20万5.86亿01801信达生物10.43%644.10万5.67亿01177中国生物制药9.82%7184.50万 5.34亿08027中国生物制药9.82%7184.50万5.34亿01093石药集团7.72%4908.40万4.20亿01530三生制药 7.41%1469.60万4.03亿03692翰森制药5.50%908.20万2.99亿06990科伦博泰生物-B3.55%41.14万1.93亿 09688再鼎医药2.79%621.62万1.5 ...

Investment Rating - The report does not explicitly state an investment rating for the industry [2] Core Views - The pharmaceutical and biotechnology sector saw a weekly increase of 2.67%, underperforming the Wind All A index (2.9%) but outperforming the CSI 300 index (1.64%). The raw material drug sector experienced a decline of 4.27%, while chemical preparations and pharmaceutical circulation products increased by 4.18% and 3.71%, respectively [3][8] - Recent policies in Shanghai and Beijing aim to support the high-quality development of the medical device industry, indicating a shift towards innovation and global competitiveness in this sector. The report suggests monitoring the transformation progress of leading companies in the medical device field [3][12] - Flu activity is on the rise, with the percentage of flu-like cases reported by sentinel hospitals in southern provinces reaching 7.8%, up from 6.8% the previous week, and higher than the same period in 2022 and 2024 [3][11] Summary by Sections Market Weekly Review - The pharmaceutical and biotechnology sector increased by 2.67% from November 24 to November 28, 2025, with raw material drugs declining by 4.27% and chemical preparations increasing by 4.18% [8][9] - Individual stock performances included significant gains for Haiwang Biological (38.2%), Yue Wannianqing (36.2%), and Guangji Pharmaceutical (31.7%), while *ST Changyao (-15.3%), Huitai Medical (-9.6%), and Kangwei Century (-8.8%) saw notable declines [11] Industry News and Key Company Announcements Important Industry Events - The report highlights the increase in flu-like illness percentages in both southern (7.8%) and northern (8.6%) provinces, indicating a significant rise in flu activity compared to previous years [11][12] Industry News - Significant approvals were noted, including the NMPA's approval of Xinmeiyue® for treating moderate to severe plaque psoriasis and the FDA's accelerated approval of Sibeprenlimab for IgAN treatment [12][14] Company Announcements - Notable announcements include the FDA approval of a generic injectable drug by Jianyou Co. and the successful completion of a Phase III trial for JS001sc, a subcutaneous PD-1 monoclonal antibody for non-small cell lung cancer [15][16]

Major Events - Excellence Risen (02687) plans to offer 6.6667 million H-shares globally from November 28 to December 3 [1] - Naxin Micro (02676) plans to offer 19.0684 million shares globally from November 28 to December 3 [1] - Stone Four Pharmaceutical Group (02005) received production registration approval for the sustained-release capsule of Tofacitinib (4mg) [1] - Innovent Biologics (01801) received approval from the National Medical Products Administration for its drug, Xinmeiyue® (Pikankizumab injection), for treating moderate to severe plaque psoriasis [1] - Jiangxi Copper (00358) intends to acquire shares of the overseas-listed company SolGold Plc [1] - ZTO Express-W (02057) plans to acquire 100% equity of Zhejiang Xinglian for 178 million yuan to enhance end-to-end domestic and international air logistics capabilities [1] - China Shenhua (01088) completed 168 hours of trial operation for the Beihai Phase II Unit 3 and transferred it to commercial operation [1] - Zhidatech (02650) signed a major contract worth over 100 million yuan for electric vehicle charging stations with Saudi Controls Ltd, expanding into the Middle East market [1] - Hendry (03389) received a voluntary cash offer from Junya at a 12% premium and will resume trading on December 1 [1] - Zijin Mining (02899) donated 20 million HKD to support post-fire reconstruction in Hong Kong's Tai Po District [1] - Guoquan (02517) donated 10 million HKD for fire rescue efforts in Hong Kong's Tai Po [1] - InnoCare Pharma (02577) donated 2 million HKD to assist in fire rescue efforts in Hong Kong's Tai Po [1] Operating Performance - Meituan-W (03690) reported Q3 revenue of approximately 95.5 billion HKD, a year-on-year increase of about 2%, with highlights in flash purchase and global expansion [1] - China Gas (00384) reported a mid-term profit attributable to shareholders of 1.334 billion HKD, with an interim dividend of 0.15 HKD per share [1] - Zhixing Group Holdings (01539) reported a mid-term profit attributable to shareholders of 27.533 million HKD, a year-on-year increase of 35.68%, with gross margin rising to approximately 67.3% [1] - Guofu Quantum (00290) reported mid-term revenue of 1.027 billion HKD, a year-on-year increase of 4564.52% [1] - Yuhua Education (06169) reported an annual adjusted profit attributable to shareholders of 914 million HKD, a year-on-year increase of 95.6% [1] - China Water Affairs (00855) achieved mid-term revenue of approximately 5.183 billion HKD, with a dividend of 0.13 HKD per share [1] - Zhonghui Group (00382) reported annual revenue of approximately 2.489 billion HKD, a year-on-year increase of 7.7% [1]

Investment Rating - The report maintains a positive outlook on the innovative drug sector, indicating a rebound and potential for further growth in the upcoming months [3][6]. Core Insights - The innovative drug sector is expected to see a rebound after previous adjustments, with significant catalysts anticipated in December and January. The results of the national medical insurance negotiations will be released in early December, which may impact the inclusion of domestic innovative drugs in the insurance catalog [3][14]. - The upcoming American Society of Hematology (ASH) conference from December 6-9 is highlighted as a key event, with multiple differentiated hematology products expected to present new data [3][4][42]. - The CXO sector shows a continuous upward trend, supported by the rapid growth of new orders and backlog, ensuring performance release in the next 1-2 years [4][53]. Summary by Sections Innovative Drugs - The report emphasizes the importance of focusing on dual/multi-target drugs for various cancers and chronic diseases, as well as opportunities in ADCs and small nucleic acid therapies [6][15]. - The report notes that the innovative drug financing data is showing marginal improvement, indicating a potential recovery in the sector [6][15]. Biologics - The report mentions positive preliminary results from the Phase II clinical trial of amycretin for Type 2 diabetes, suggesting continued monitoring of its clinical progress [4][46]. Medical Devices - The report highlights the emergence of innovative domestic medical devices, with expectations for profit margins to stabilize and improve as new products are approved [5]. Traditional Chinese Medicine & Pharmacies - The report suggests monitoring companies with strong brand power and good inventory management, such as China Resources Sanjiu and Jichuan Pharmaceutical, due to rising flu incidence [5]. Medical Services and Consumer Healthcare - The report discusses a collaboration between a traditional Chinese medicine group and a local health bureau to enhance the capabilities of grassroots medical services through technology [5]. Key Investment Targets - The report identifies key companies to watch, including Innovent Biologics, Kintor Pharmaceutical, and others in the innovative drug and medical device sectors [7].

Core Insights - The approval of Xinmei Yue (Pikangqibai Injection) by the National Medical Products Administration (NMPA) marks a significant advancement in the treatment of moderate to severe plaque psoriasis in adults, being the first domestically developed IL-23p19 monoclonal antibody in China [1][2] - Psoriasis is a chronic, relapsing inflammatory disease affecting over 7 million patients in China, with a significant portion suffering from moderate to severe forms, highlighting the need for effective and personalized treatment options [1] - The CLEAR-1 study demonstrated that Xinmei Yue achieved a PASI90 response rate of 80.3% at week 16, making it the first IL-23p19 antibody to surpass this threshold in a registered phase III clinical trial [2] Company Developments - Xinmei Yue is the 17th product launched by Innovent Biologics and is a key product in the company's autoimmune portfolio, which is becoming a vital growth driver for the company [2] - The innovative engineering of the antibody structure allows Xinmei Yue to have the longest maintenance dosing interval among similar biologics, requiring only four doses per year, which enhances patient convenience [2] - The company plans to further research Xinmei Yue for additional psoriasis subtypes, psoriatic arthritis, and pediatric psoriasis to expand its therapeutic value and meet clinical needs [2]

Investment Rating - The report does not explicitly state an investment rating for the GLP-1RA drug industry Core Insights - The GLP-1 receptor agonists (GLP-1RA) are a class of drugs that mimic the action of GLP-1, promoting insulin secretion and reducing appetite, leading to blood sugar control and weight loss [2][3] - The global market for GLP-1 drugs is dominated by semaglutide and tirzepatide, with semaglutide achieving sales of $16.6 billion in the first half of 2025, making it the top-selling drug globally [8] - The expiration of patents for major drugs is expected to lead to a surge in generic versions, increasing market competition and reducing treatment costs [11] Summary by Sections GLP-1 Drug Classification and Mechanism - GLP-1RA drugs are categorized into short-acting, long-acting, and ultra-long-acting formulations, each with different pharmacokinetic profiles [2][3] - These drugs are effective in treating conditions such as obesity, type 2 diabetes, and metabolic disorders [4] Market Performance and Patent Expiration - The sales of GLP-1 drugs have shown significant growth, with semaglutide's weight management product Wegovy achieving $5.441 billion in sales, a 78% increase year-over-year [8] - Key patents for drugs like liraglutide have expired, while others like semaglutide will expire in 2026, paving the way for biosimilars [9][11] R&D Progress in China - Chinese companies are advancing in the development of dual-target and multi-target GLP-1 drugs, with significant progress in clinical trials [13][14] - The focus is shifting towards expanding indications for GLP-1 drugs beyond diabetes and obesity to include conditions like Alzheimer's and cardiovascular diseases [15] Future Market Potential - The Chinese GLP-1 market is projected to grow from 9.62 billion yuan in 2020 to 71.7 billion yuan by 2029, with a compound annual growth rate (CAGR) of 22.1% [22] - The inclusion of GLP-1 drugs in national health insurance is expected to enhance market penetration and accessibility [22] Innovation Trends - The industry is witnessing a trend towards multi-target drug development and the introduction of oral formulations to improve patient compliance [28][29] - The competitive landscape is intensifying as both original and generic drug manufacturers seek to establish a foothold in the market [30][31]

银屑病是个体与环境相互影响诱发的免疫介导的慢性、复发性、炎症性、系统性疾病，具有反复发作和 终身管理的特征。据估算，中国银屑病患者超过700万，斑块型占多数，其中约三成属于中重度。 11月28日，信达生物（1801.HK）宣布，匹康奇拜单抗注射液（商品名：信美悦）获得国家药品监督管 理局（NMPA）批准，用于适合系统性治疗的中重度斑块状银屑病成人患者，成为中国首个由本土企业 自主研发的IL-23p19靶点单抗药物。 信达生物称，公司将继续推动匹康奇拜单抗在更多银屑病亚型、银屑病关节炎及青少年银屑病等领域的 研究。（智通财经记者 李潇潇） 此次获批的新药是基于在中国开展的三期研究CLEAR-1。据信达生物介绍，在临床试验中，匹康奇拜 单抗治疗四个月，有超80%的患者皮损能够清除90%以上。进入维持治疗后，匹康奇拜单抗可实现每12 周一次的给药频率，在同类生物药中拥有最长维持给药间隔，维持期每年仅需给药4次。 ...

信达生物(01801)发布公告，本集团自主研发的信美悦 (匹康奇拜单抗注射液，重组抗白介素23p19亚基 (IL-23p19)抗体，研发代号：IBI112)的新药上市申请(NDA)已获中国国家药品监督管理局(NMPA)批准， 用于适合系统性治疗的中重度斑块状银屑病成人患者。信美悦 (匹康奇拜单抗注射液)是首个获批的中国 原研IL-23p19单克隆抗体。在同类生物药中，信美悦 (匹康奇拜单抗注射液)具有最长的维持期给药间隔 (每12周一次)，有望为中国中重度斑块状银屑病患者带来皮损清除、生活质量改善和用药便利性提升等 多方面的综合获益。 本次获批主要基于一项在中国中重度斑块状银屑病受试者中开展的关键III期注册临床研究CLEAR- 1(NCT05645627)的积极结果。该研究结果表明： 信美悦 (匹康奇拜单抗注射液)作为本公司自免领域首创新药物管线的基石药物，是全球首个在注册III期 临床研究中第16周达到主要终点指标，即PASI 90的受试者比例突破80%的IL-23p19抗体药物，并在同类 生物药中具有最长的维持期给药间隔(每12周一次)。信美悦 有望为中国中重度斑块状银屑病患者提供皮 损深度清除、生活质 ...

Accessibility StatementSkip Navigation SAN FRANCISCO and SUZHOU, China, Nov. 25, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved PECONDLE (picankibart injection), a recombinant ...