Core Viewpoint - The approval of Xinmei Yue (Pikangqibai Injection) by the National Medical Products Administration marks a significant advancement in the treatment of moderate to severe plaque psoriasis, being the first IL-23p19 monoclonal antibody developed by a domestic company in China [1][2]. Group 1: Drug Approval and Market Impact - Xinmei Yue has been approved for use in adult patients with moderate to severe plaque psoriasis, a chronic and recurrent inflammatory disease affecting over 7 million patients in China, with a significant portion requiring lifelong management [1]. - The drug's approval is based on the results of the Phase III CLEAR-1 study, which demonstrated that over 80% of patients achieved a clearance of more than 90% of skin lesions after four months of treatment [2]. Group 2: Clinical Efficacy and Advantages - The CLEAR-1 study indicates that IL-23p19 targeted antibodies, like Pikangqibai, show significant advantages in maintaining long-term efficacy and convenience of use compared to existing treatments [2]. - Unlike most current biologics that require monthly or bi-monthly injections, Xinmei Yue has been engineered to extend its half-life, allowing for administration once every three months while maintaining strong efficacy, providing a new solution for long-term patient management [2].

Core Insights - The approval of the IL-23p19 monoclonal antibody, Xinmeiyue (Pikangqibai Injection), marks a significant milestone in the treatment of autoimmune diseases in China, specifically for moderate to severe plaque psoriasis in adults, providing a new treatment option for over 7 million patients [1][2] - Hangzhou is emerging as a new hub for pharmaceutical innovation, with all four class 1 innovative drugs approved in the province by the third quarter of 2025 originating from the city, which accounts for 75% of the province's total class 1 innovative drug applications [1] - The Hangzhou Municipal Market Supervision Administration has implemented various measures to accelerate the transformation of innovative results, including a "green channel" for innovative drugs, significantly reducing the time for production licensing and inspections [1][2] Group 1 - The IL-23p19 monoclonal antibody is the first domestically developed drug of its kind approved in China, filling a gap in the drug development landscape [1] - The city of Hangzhou has become a focal point for pharmaceutical innovation, with a notable concentration of new drug approvals [1] - The local government has introduced practical measures to support the pharmaceutical industry, including expedited licensing processes and tailored solutions for individual company challenges [1][2] Group 2 - The market supervision department has actively addressed common industry challenges, resulting in a 37.5% decrease in consultation requests related to production issues [2] - The collaboration between the market supervision department and companies has been highlighted as crucial in navigating key regulatory milestones from research to market approval [2] - In 2025, it is expected that approximately 320 million yuan will be allocated to assist companies in applying for provincial and municipal industrial special funds, further driving pharmaceutical innovation [2]

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]

Core Viewpoint - Innovent Biologics (1801.HK) has received approval from the National Medical Products Administration (NMPA) for its monoclonal antibody injection, Pikanqibai (brand name: Xinmeiyue), for the treatment of moderate to severe plaque psoriasis in adult patients, marking it as the first domestically developed IL-23p19 targeted monoclonal antibody in China [1] Company Summary - The newly approved drug is based on the Phase III CLEAR-1 study conducted in China, demonstrating that over 80% of patients achieved a clearance of more than 90% of skin lesions after four months of treatment [1] - Pikanqibai offers a maintenance treatment regimen with a dosing frequency of once every 12 weeks, which is the longest maintenance dosing interval among similar biologics, requiring only four doses per year [1] - The company plans to continue research on Pikanqibai for other psoriasis subtypes, psoriatic arthritis, and pediatric psoriasis [1] Industry Summary - Psoriasis is a chronic, relapsing, inflammatory, and systemic disease influenced by the interaction between individual and environmental factors, characterized by recurrent episodes and lifelong management [1] - It is estimated that there are over 7 million psoriasis patients in China, with plaque psoriasis being the most common type, and approximately 30% of these patients classified as moderate to severe [1]

Core Viewpoint - The approval of the new drug Xinmei Yue (IBI112) by the NMPA marks a significant advancement in the treatment of moderate to severe plaque psoriasis in China, being the first domestically developed IL-23p19 monoclonal antibody, which offers a longer dosing interval and potential comprehensive benefits for patients [1][2][3] Group 1: Drug Approval and Clinical Results - Xinmei Yue (IBI112) has received approval from the NMPA for the treatment of adult patients with moderate to severe plaque psoriasis [1] - The approval is based on positive results from the pivotal Phase III clinical trial CLEAR-1, where 80.3% of patients achieved PASI 90 and 93.5% achieved sPGA 0/1 at week 16, significantly higher than the placebo group [1][2] - The drug demonstrates a long maintenance dosing interval of every 12 weeks, which is the longest among similar biologics [1][3] Group 2: Patient Impact and Market Potential - There are over 7 million psoriasis patients in China, with plaque psoriasis being the most prevalent, leading to significant impacts on quality of life and mental health [2] - The treatment landscape for moderate to severe plaque psoriasis has evolved from traditional systemic therapies to precision treatments with biologics and small molecule targeted therapies [2] - The focus has shifted towards achieving higher treatment goals, such as PASI 90/100 and significant improvements in quality of life [2] Group 3: Safety Profile - The overall safety profile of Xinmei Yue is favorable, with the most common adverse event being upper respiratory infections, consistent with safety characteristics of similar drugs [2]