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]

Market Overview - The Hang Seng Index and the Hang Seng China Enterprises Index rose by 2.5% and 2.4% respectively last week, influenced by improved investor sentiment due to expectations of a U.S. interest rate cut[1] - On Friday, the main board trading volume shrank nearly 30% to HKD 146.2 billion, marking the lowest for the month[1] - The Hang Seng Index and the Hang Seng China Enterprises Index fell by 0.3% and 0.4% respectively on Friday[1] Company Performance - Baidu Group reported a 7% year-on-year decline in revenue for Q3, resulting in a net loss of RMB 11.23 billion, although its stock rose by 1.0% on Friday[1] - Meituan's Q3 revenue increased by 2.0% year-on-year, but due to a more than 50% rise in distribution costs, it recorded a net loss of RMB 18.63 billion, leading to a 1.4% drop in its stock price on Friday[1] - Luk Fook Holdings reported a 25.6% year-on-year increase in revenue to HKD 6.84 billion and a 42.5% rise in net profit to HKD 620 million, aligning with its profit forecast[1] Sector Insights - The automotive sector saw GAC Group's stock surge by 16.6% on Friday, reaching a one-year high, following the delivery of its electric vehicle Aion UT super and the launch of a solid-state battery production line[4] - The renewable energy and utility sectors experienced a general rise, with notable increases in stocks like Dongfang Electric (up 9.3%) and Harbin Electric (up 6.3%) due to a 15.6% year-on-year increase in national electricity market trading volume in October[4] - The healthcare sector's Hang Seng Medical Care Index rose by 3.9% last week, although it fell by 0.9% on Friday[5] Economic Indicators - The China Manufacturing Purchasing Managers' Index (PMI) for November 2025 was reported at 49.2%, indicating a slight improvement but remaining below the growth threshold for eight consecutive months[3] - Large enterprises' PMI decreased by 0.6 percentage points to 49.3%, while small and medium enterprises saw increases of 0.2 and 2.0 percentage points, reaching 48.9% and 49.1% respectively[3]

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]

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） ...