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China's First Domestic IL-23p19 Monoclonal Antibody: Innovent's PECONDLE® (Picankibart Injection) Received NMPA Approval
Prnewswire· 2025-11-28 09:06
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].
信达生物(01801.HK):信美悦(匹康奇拜单抗注射液)获国家药监局批准用于治疗中重度斑块状银屑病
Ge Long Hui· 2025-11-28 08:54
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]
信达生物(01801) - 自愿公告 - 信美悦(匹康奇拜单抗注射液)获中国国家药品监督管理局批准用...
2025-11-28 08:44
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) ...
智通港股通持股解析|11月28日
智通财经网· 2025-11-28 00:37
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]
信达生物(01801.HK)获摩根大通增持163.59万股
Ge Long Hui· 2025-11-27 23:32
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]
小摩增持信达生物约163.59万股 每股作价约90.91港元
Zhi Tong Cai Jing· 2025-11-27 11:21
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]
小摩增持信达生物(01801)约163.59万股 每股作价约90.91港元
智通财经网· 2025-11-27 11:17
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]
港股创新药ETF(159567)涨0.23%,成交额11.49亿元
Xin Lang Cai Jing· 2025-11-27 11:13
Core Insights - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 0.23% on November 27, with a trading volume of 1.149 billion yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of November 26, 2024, the fund's shares totaled 9.88 billion, with a total size of 8.495 billion yuan, reflecting a significant increase in both shares and size compared to the previous year [1] Fund Performance - The fund's share count increased by 2398.89% and its size increased by 2148.37% from 3.95 million shares and 378 million yuan on December 31, 2024 [1] - Over the last 20 trading days, the cumulative trading amount reached 31.987 billion yuan, with an average daily trading amount of 1.599 billion yuan [1] - Since the beginning of the year, the cumulative trading amount has been 263.006 billion yuan, with an average daily trading amount of 1.201 billion yuan over 219 trading days [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 68.86% during the management period [2] - The top holdings of the fund include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and China National Pharmaceutical Group, with significant percentages of the portfolio allocated to these stocks [2] - The largest holding is BeiGene, accounting for 10.62% of the portfolio, followed closely by CanSino Biologics at 10.55% and Innovent Biologics at 10.21% [2]
港股科技ETF(159751)涨近1%,多重利好催化港股科技
Sou Hu Cai Jing· 2025-11-27 02:38
Core Viewpoint - The Hong Kong technology sector is experiencing a strong rally, driven by multiple favorable factors including increased expectations for Federal Reserve interest rate cuts and improved market liquidity, alongside significant revenue growth in Alibaba's cloud business and a resurgence in AI focus [1]. Group 1: Market Performance - As of November 27, 2025, the CSI Hong Kong Stock Connect Technology Index (931573) has seen a strong increase, with notable gains in constituent stocks such as Huahong Semiconductor (up 5.36%), Kangfang Biotech (up 4.89%), and Li Auto (up 3.87%) [1]. - The Hong Kong Technology ETF (159751) has risen by 0.73%, marking its fourth consecutive increase, with the latest price reported at 1.1 HKD [1]. Group 2: Influencing Factors - The recent rally in the Hong Kong technology sector is attributed to the anticipated easing of monetary policy by the Federal Reserve, which is expected to enhance liquidity in the market [1]. - The combination of the Federal Reserve's halt on balance sheet reduction and the relaxation of SLR regulations is expected to limit liquidity pressure in the medium term [1]. Group 3: Index Composition - The CSI Hong Kong Stock Connect Technology Index comprises 50 large-cap technology companies with high R&D investment and revenue growth, reflecting the overall performance of leading technology stocks within the Hong Kong Stock Connect [1]. - As of October 31, 2025, the top ten weighted stocks in the index include Alibaba-W, Tencent Holdings, and SMIC, collectively accounting for 66.81% of the index [2].
智通港股通持股解析|11月27日
智通财经网· 2025-11-27 00:36
Core Insights - The top three companies by Hong Kong Stock Connect shareholding ratios are China Telecom (72.63%), Power Assets Holdings (70.19%), and GCL-Poly Energy Holdings (69.17%) [1] - The companies with the largest increase in shareholding amounts over the last five trading days are Universal Gold Group (+12.088 billion), Alibaba Group Holding Limited (+6.346 billion), and Tencent Holdings (+3.004 billion) [1][2] - The companies with the largest decrease in shareholding amounts over the last five trading days are SMIC (-1.278 billion), Ganfeng Lithium (-0.558 billion), and Innovent Biologics (-0.518 billion) [2] Hong Kong Stock Connect Shareholding Ratios - China Telecom (00728): 10.081 billion shares, 72.63% [1] - Power Assets Holdings (01635): 0.375 billion shares, 70.19% [1] - GCL-Poly Energy Holdings (01330): 0.280 billion shares, 69.17% [1] - Other notable companies include: - Hengtian International Investment (01341): 74.74 billion shares, 68.90% [1] - China Shenhua Energy (01088): 2.276 billion shares, 67.38% [1] Recent Increases in Shareholding - Universal Gold Group (03939): +12.088 billion, +37.96584 million shares [2] - Alibaba Group Holding Limited (09988): +6.346 billion, +4.09920 million shares [2] - Tencent Holdings (00700): +3.004 billion, +0.48492 million shares [2] - Other companies with significant increases include: - Yinhua Fund (02800): +2.182 billion, +8.36760 million shares [2] - Kuaishou Technology (01024): +1.750 billion, +2.54847 million shares [2] Recent Decreases in Shareholding - SMIC (00981): -1.278 billion, -1.85636 million shares [2] - Ganfeng Lithium (01772): -0.558 billion, -1.13178 million shares [2] - Innovent Biologics (01801): -0.518 billion, -0.54621 million shares [2] - Other companies with notable decreases include: - WuXi Biologics (02269): -0.513 billion, -1.60715 million shares [2] - New China Life Insurance (01336): -0.435 billion, -0.92361 million shares [2]