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]

Core Viewpoint - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for PECONDLE (picankibart injection), a novel treatment for moderate-to-severe plaque psoriasis, marking a significant advancement in the management of this chronic condition in China [1][5]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focusing on developing high-quality medicines for various diseases, including oncologic, autoimmune, cardiovascular, and metabolic conditions [11]. - The company has launched 17 products and has multiple assets in clinical trials, indicating a robust pipeline and commitment to innovation [11]. Product Details - PECONDLE (picankibart injection) is the first IL-23p19 monoclonal antibody independently developed by a Chinese enterprise, targeting the IL-23p19 subunit to treat moderate-to-severe plaque psoriasis [9][10]. - The product has shown superior efficacy in clinical trials, with over 80% of subjects achieving a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at Week 16 [5][6]. - The dosing interval for PECONDLE is once every 12 weeks during the maintenance period, which is the longest among comparable biologics, enhancing patient convenience [5][6]. Clinical Trial Insights - The approval was based on the CLEAR-1 Phase 3 clinical trial, which demonstrated significant efficacy and safety in Chinese participants with moderate-to-severe plaque psoriasis [4][6]. - At Week 16, the picankibart group showed a PASI 90 achievement rate of 80.3% and a sPGA 0/1 rate of 93.5%, significantly higher than the placebo group [6]. - The overall safety profile of picankibart was favorable, with upper respiratory tract infections being the most common adverse event, consistent with other IL-23p19 agents [6]. Market Context - The prevalence of psoriasis in China exceeds 7 million, with plaque psoriasis being the most common form, affecting quality of life and mental health [2][8]. - The treatment landscape for moderate-to-severe plaque psoriasis has shifted towards precision therapies, with a focus on long-term maintenance and improved quality of life [3][4].

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 adults, being the first domestically developed IL-23p19 monoclonal antibody in China [1][2] Group 1: Drug Approval and Characteristics - Xinmei Yue® is approved for systemic treatment of moderate to severe plaque psoriasis in adults, offering a dosing interval of every 12 weeks, which enhances patient convenience and quality of life [1] - The approval is based on positive results from the pivotal Phase III clinical trial CLEAR-1, which demonstrated significant efficacy compared to the placebo group [1] Group 2: Clinical Trial Results - At week 16, the proportion of patients achieving PASI 90 and sPGA 0/1 in the Xinmei Yue® group was 80.3% and 93.5% respectively, significantly higher than the placebo group (2.0% and 13.1%) with p-values < 0.0001 [1] - The Xinmei Yue® group also showed superior results in key secondary endpoints such as PASI 75, PASI 100, sPGA 0, and DLQI 0/1, all with p-values < 0.0001 [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, and no new safety signals were identified [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 信美悅® （匹康奇拜單抗注射液）獲中國國家藥品監督管理局 批准用於治療中重度斑塊狀銀屑病 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣佈，本集團自主研發的信美悅® （匹康奇拜單抗注 射液，重組抗白介素23p19亞基（「IL-23p19」）抗體，研發代號：IBI112）的新藥上 市申請（「NDA」）已獲中國國家藥品監督管理局（「NMPA」）批准，用於適合系統 性治療的中重度斑塊狀銀屑病成人患者。信美悅® （匹康奇拜單抗注射液）是首個 獲批的中國原研IL-23p19單克隆抗體。在同類生物藥中，信美悅® （匹康奇拜單抗 注射液）具有最長的維持期給藥間隔（每12週一次） ...

Core Insights - The top three companies by Hong Kong Stock Connect holding ratios are China Telecom (72.69%), Gree Power Environmental (69.23%), and Haotian International Construction Investment (68.93%) [1][2] - The companies with the largest increase in holding amounts over the last five trading days are WanGuo Gold Group (+12.079 billion), Alibaba-W (+11.504 billion), and Tencent Holdings (+2.873 billion) [1][2] - The companies with the largest decrease in holding amounts over the last five trading days are SMIC (-1.455 billion), Innovent Biologics (-0.665 billion), and New China Life Insurance (-0.523 billion) [2] Group 1: Hong Kong Stock Connect Holding Ratios - China Telecom (00728) has a holding of 10.09 billion shares, representing 72.69% [1] - Gree Power Environmental (01330) has a holding of 0.28 billion shares, representing 69.23% [1] - Haotian International Construction Investment (01341) has a holding of 7.48 billion shares, representing 68.93% [1] - Other notable companies include China Shenhua (67.29%) and Tianjin Chuangye Environmental Protection (66.32%) [1] Group 2: Recent Increases in Holdings - WanGuo Gold Group (03939) saw an increase of +12.079 billion, with a change of +37.936 million shares [1] - Alibaba-W (09988) increased by +11.504 billion, with a change of +7.638 million shares [1] - Tencent Holdings (00700) increased by +2.873 billion, with a change of +0.469 million shares [1] Group 3: Recent Decreases in Holdings - SMIC (00981) experienced a decrease of -1.455 billion, with a change of -2.128 million shares [2] - Innovent Biologics (01801) decreased by -0.665 billion, with a change of -0.691 million shares [2] - New China Life Insurance (01336) saw a decrease of -0.523 billion, with a change of -1.111 million shares [2]

Group 1 - JPMorgan Chase & Co. increased its stake in Innovent Biologics (01801.HK) by acquiring 1,635,942 shares at an average price of HKD 90.9102 per share, totaling approximately HKD 149 million [1] - Following this transaction, JPMorgan's total holdings in Innovent Biologics rose to 87,161,791 shares, increasing its ownership percentage from 4.99% to 5.08% [1]

Group 1 - On November 24, JPMorgan increased its stake in Innovent Biologics (01801) by acquiring 1,635,942 shares at a price of HKD 90.9102 per share, totaling approximately HKD 149 million [1] - Following the acquisition, JPMorgan's total shareholding in Innovent Biologics reached approximately 87,161,800 shares, representing a stake of 5.08% [1]