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 - 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） ...

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]

Group 1 - The core point of the article is that JPMorgan has increased its stake in Innovent Biologics (01801) by purchasing 1,635,942 shares at a price of HKD 90.9102 per share, totaling approximately HKD 149 million [1] - After the purchase, JPMorgan's total shareholding in Innovent Biologics is approximately 87,161,800 shares, representing a holding percentage of 5.08% [1]

Core Viewpoint - Recently, Innovent Biologics announced that its high-dose 9mg injection of Ma Shidu Peptide has received acceptance for listing application from the National Medical Products Administration of China, aimed at long-term weight control for adults with moderate to severe obesity [1] Group 1: Clinical Research Results - The Phase III clinical study GLORY-2 demonstrated outstanding results for Ma Shidu Peptide in the Chinese population with moderate to severe obesity, showing an average weight reduction of 18.55% in the 9mg group at week 60, compared to only 3.02% in the placebo group [1] - In the 9mg group, 44.0% of participants achieved a weight reduction of 20% or more, while only 2.6% in the placebo group reached this threshold (P values less than 0.0001) [1] Group 2: Additional Health Benefits - The study also indicated a significant average percentage reduction of 71.9% in liver fat content for the 9mg group, along with notable improvements in key cardiovascular metabolic indicators such as blood pressure, blood lipids, and uric acid levels [1] - The safety profile of the drug was reported to be good, with no new safety signals identified [1]

Core Viewpoint - 信达生物's stock price increased by over 4%, reaching 98 HKD with a trading volume of 405 million HKD [2] Company Summary - 信达生物's stock rose by 4.42% as of the report, indicating positive market sentiment [2] - The current trading price is 98 HKD, reflecting a significant increase in investor interest [2] - The total trading volume reached 4.05 billion HKD, suggesting active trading activity [2]

Core Viewpoint - The announcement from Innovent Biologics regarding the acceptance of the marketing application for its drug, Isemepitide, represents a significant advancement in obesity treatment options in China, potentially providing a new effective and safe choice for patients with moderate to severe obesity [1] Group 1: Company Developments - Innovent Biologics' stock rose over 4%, reaching HKD 98, with a trading volume of HKD 405 million [1] - The marketing application for Isemepitide (9mg) has been accepted by the National Medical Products Administration (NMPA) in China, targeting long-term weight control in adults with moderate to severe obesity [1] - The application is based on the successful results of the Phase III clinical study GLORY-2, which met all primary and key secondary endpoints [1] Group 2: Product Information - Isemepitide is the only GLP-1 class drug that can achieve over 20% weight loss after one year of treatment through a two-step dose titration [1] - The drug aims to provide evidence-based medical support for effective weight management in moderate to severe obesity patients, beyond surgical options [1]

Core Viewpoint - The stock of Innovent Biologics (01801) rose over 4%, reaching HKD 98, with a trading volume of HKD 405 million, following the acceptance of its weight management drug application by the NMPA [1] Group 1: Company Developments - Innovent Biologics announced that its application for the high-dose 9mg injection of the drug Senilemi (a dual receptor agonist for glucagon and GLP-1) for long-term weight control in adults with moderate to severe obesity has been accepted by the NMPA [1] - The application is based on the outstanding results from the Phase III clinical study GLORY-2 (NCT06164873) conducted in China, which achieved all primary and key secondary endpoints [1] - Senilemi 9mg is currently the only GLP-1 class drug that can achieve over 20% weight loss after one year of treatment through a two-step dose titration, providing effective weight management evidence for moderate to severe obesity patients in China [1]