Core Insights - The article reports that Innovent Biologics has received approval for its first domestically developed IL-23 p19 targeted drug, Pikanqi Baiduan (匹康奇拜单抗), for the treatment of moderate to severe plaque psoriasis, marking a significant milestone in the Chinese pharmaceutical industry [1][3]. Drug Approval and Development - Pikanqi Baiduan is a recombinant anti-IL-23p19 antibody that specifically binds to the IL-23p19 subunit, blocking the IL-23 receptor-mediated signaling pathway to exert anti-inflammatory effects [1][3]. - The approval is based on the positive results from the Phase III CLEAR-1 clinical trial, which met all primary and key secondary endpoints [3]. Company Portfolio - As of now, Innovent Biologics has a total of 16 new drugs approved for market, including 12 innovative drugs and 2 improved biological products, with a focus on oncology, metabolism, and autoimmune diseases [6].

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 - 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 - 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]