长春高新公告，控股子公司金赛药业注射用GenSci136的境内生产药品注册临床试验申请获得国家药品 监督管理局受理。注射用GenSci136是金赛药业自主研发的治疗用生物制品1类药物，拟用于治疗免疫球 蛋白A肾病（IgAN）。该药物作为B细胞成熟抗原（BCMA）三聚体融合蛋白，可结合B淋巴细胞刺激 因子（BlyS）和增殖诱导配体（APRIL），阻断BlyS及APRIL与B细胞膜受体之间的相互作用，具有治 疗体液免疫紊乱、致病抗体为核心机制造成组织损伤的多种自身免疫性疾病的潜力。 ...

| 受理品种目录浏览 | 在审品种目录浏览 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 年 | 2025 v | 药品类型: | रुहेर | ▼ 申请类型: | それ | V | | | 受理号: | 请输入受理号 | 药品名称: | 请输入药品名称 | 企业名称: | 请输入企业名称 | | 查询 | | 序号 | 受理号 | 药品名称 | 药品类型 | 申请类型 | 注册分类 | 企业名称 | 承办日期 | | | JXSS2500153 | 戈鲁利单抗注射液 | 治疗用生 物制品 | 进口 | 1 | Alexion Europe SAS;Patheon Italia S.P.A .; AstraZeneca Global R&D (China) Co., Ltd .; | 2025-12-24 | | 2 | JXSS2500152 | 戈鲁利单抗注射液 | 治疗用生 物制品 | 讲口 | 1 | Alexion Europe SAS;Patheon Italia S.P.A .; AstraZeneca Gl ...

该I期研究为在健康成年人和系统性红斑狼疮(SLE)患者中进行的随机、双盲、安慰剂对照、单剂量递增 试验，旨在评估LBL-047的安全性、耐受性、药代动力学╱药效动力学及初步临床有效性。该研究的健 康志愿者部分由上海市公共卫生临床中心孟现民教授作为主要研究者，而SLE部分由上海交通大学医学 院附属仁济医院叶霜教授和陈盛教授作为主要研究者。 维立志博-B(09887)发布公告，评价LBL-047安全性、耐受性、药代动力学╱药效动力学及初步临床有效 性的I期临床研究首例受试者已成功用药。 LBL-047是一种双特异性融合蛋白，由人源化抗血树突状细胞抗原2(BDCA2)抗体及经改造的跨膜激活 剂及钙调亲环素配体相互作用分子(TACI)胞外域组成，其通过选择性清除pDC以降低1型干扰素生成， 并抑制B细胞激活因子(BAFF)及增殖诱导配体(APRIL)信号通路来阻断B细胞活化、分化及生成抗体。 该差异化方法通过靶向自身免疫性疾病致病机制的两大驱动因素，具备治疗多种自身免疫性适应症的潜 力。此外，LBL-047亦已通过Fc区改造延长半衰期得到优化。 ...

该I期研究为在健康成年人和系统性红斑狼疮(SLE)患者中进行的随机、双盲、安慰剂对照、单剂量递增 试验，旨在评估LBL-047的安全性、耐受性、药代动力学╱药效动力学及初步临床有效性。该研究的健 康志愿者部分由上海市公共卫生临床中心孟现民教授作为主要研究者，而SLE部分由上海交通大学医学 院附属仁济医院叶霜教授和陈盛教授作为主要研究者。 LBL-047是一种双特异性融合蛋白，由人源化抗血树突状细胞抗原2(BDCA2)抗体及经改造的跨膜激活 剂及钙调亲环素配体相互作用分子(TACI)胞外域组成，其通过选择性清除pDC以降低1型干扰素生成， 并抑制B细胞激活因子(BAFF)及增殖诱导配体(APRIL)信号通路来阻断B细胞活化、分化及生成抗体。 该差异化方法通过靶向自身免疫性疾病致病机制的两大驱动因素，具备治疗多种自身免疫性适应症的潜 力。此外，LBL-047亦已通过Fc区改造延长半衰期得到优化。 （原标题：维立志博-B(09887)：LBL-047于I期试验的首例受试者用药） 智通财经APP讯，维立志博-B(09887)发布公告，评价LBL-047安全性、耐受性、药代动力学╱药效动力 学及初步临床有效性的I期临床 ...

诺诚健华联合创始人、董事长兼首席执行官崔霁松博士说："ICP-488已经在治疗银屑病的II期临床中展 示了良好的有效性和安全性，目前III期入组接近尾声，CLE则是我们ICP-488开发的第二个适应症。与 需要注射的生物制剂相比，诺诚健华的高选择性TYK2抑制剂是口服小分子药物，为皮肤疾病患者提供 了更便捷的用药选择。我们将加速推进ICP-488的临床开发，解决未被满足的治疗需求。" 关于诺诚健华 2025年12月23日，中国北京，生物医药高科技公司诺诚健华(上交所代码：688428；香港联交所代码： 09969)今日宣布，公司自主研发的新型TYK2抑制剂ICP-488治疗皮肤型红斑狼疮(CLE)获国家药品监督 管理局(NMPA)药品审评中心(CDE)批准开展II期临床试验。 ICP-488是一款口服的高选择性TYK2变构抑制剂，通过特异性结合TYK2JH2结构域，阻断IL-23、IL-12 和I型干扰素等炎性细胞因子的信号转导，从而抑制自身免疫性疾病和炎症性疾病的病理过程。 CLE是红斑狼疮常见的类型，属于自身免疫性疾病，以皮肤病变为主。CLE特征为多样性皮损，少数患 者可能发展为系统性红斑狼疮并累及内脏器 ...

Core Viewpoint - Nocera Biopharma's new TYK2 inhibitor soficitinib has received approval for II/III clinical trials for treating chronic spontaneous urticaria (CSU), which is expected to enhance the company's market position in the dermatology sector [1][2] Company Summary - Nocera Biopharma's stock rose over 4%, currently trading at 13.69 HKD with a transaction volume of 37.91 million HKD [1] - Soficitinib is a highly selective oral TYK2 inhibitor developed for various T-cell related autoimmune diseases, with a focus on dermatological conditions such as atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1] - The approval from the National Medical Products Administration (NMPA) marks a significant milestone for the company in advancing its clinical pipeline [1] Industry Summary - There are approximately 50 million patients suffering from chronic spontaneous urticaria globally, with the CSU market projected to reach 3 billion USD by 2029 [2]

Group 1 - The core point of the article is that Nocera Biopharma (09969) has seen its stock price increase by over 4% following the announcement of the approval for its new TYK2 inhibitor, soficitinib, to conduct Phase II/III clinical trials for chronic spontaneous urticaria (CSU) [1] - Soficitinib is a highly selective oral TYK2 inhibitor developed by the company, aimed at treating various T-cell related autoimmune diseases, with a focus on dermatological conditions such as atopic dermatitis, vitiligo, nodular prurigo, and urticaria [1] - TYK2 is a key kinase in the JAK-STAT signaling pathway, playing an important role in the inflammatory disease mechanism, and soficitinib works by blocking cytokine signaling pathways that drive mast cell activation and inflammation, thereby alleviating symptoms of CSU [1] Group 2 - There are approximately 50 million patients suffering from chronic spontaneous urticaria globally, and the CSU market is projected to reach $3 billion by 2029 [2]

Company Overview - Hemay Pharmaceutical Co., Ltd. (referred to as "Hemay") submitted its second prospectus to the Hong Kong Stock Exchange on December 1, 2025, aiming for a main board listing, with Guotai Junan Securities as the sole sponsor [1] - Established in 2002, Hemay focuses on the discovery and development of proprietary small molecule drugs for autoimmune diseases and tumors, maintaining a leading position in the development of treatments for psoriasis, Behçet's disease, and inflammatory bowel disease [1] Financial Performance - For the fiscal year ending December 31, 2024, Hemay reported other income of approximately RMB 0.05 billion and a net loss of RMB 1.23 billion, with a 20% year-on-year increase in net loss for the first half of 2025 [1][6] - In the first half of 2025, other income was RMB 0.04 billion, with a net loss of RMB 0.73 billion, reflecting a 26.93% year-on-year increase in net loss [7] - The company’s cash flow from operating activities was -RMB 0.52 billion as of June 30, 2025, with cash reserves of approximately RMB 0.73 billion at year-end [7] Product Pipeline - Hemay has developed seven small molecule drug candidates, including its core product Mufemilast, which has received NDA approval in China for the treatment of moderate to severe plaque psoriasis [2] - Hemay022, another candidate, is undergoing a Phase III clinical trial for advanced ER+/HER2+ breast cancer [3] - Mufemilast is also being evaluated for Behçet's disease in a pivotal Phase III trial and has received orphan drug designation from the FDA [2] Market Potential - The psoriasis drug market in China is projected to reach RMB 18.2 billion by 2024, with a compound annual growth rate (CAGR) of 30.5% from 2019 to 2024, and is expected to grow to RMB 48.3 billion by 2028 [8] - The market for Behçet's disease drugs in China is anticipated to grow from RMB 490 million in 2019 to RMB 666.6 million by 2024, with a CAGR of 6.4% [12] Competitive Landscape - As of the latest data, there are 17 approved targeted therapies for psoriasis in China, including five small molecule drugs and twelve biologics, with some showing superior efficacy in head-to-head clinical trials [11] - Hemay's Mufemilast is positioned against established treatments like Apremilast, which has been recommended in clinical guidelines for Behçet's disease [15] Comparable Companies - Hemay's peer in the industry, Qianxin Biopharmaceutical-B (2509.HK), had an IPO on March 20, 2024, with a market capitalization of approximately HKD 4.397 billion [16]

Company Overview - Hangzhou Gaoguang Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with CICC and CMB International as joint sponsors [1] - The company focuses on developing safe and effective therapies for patients with autoimmune and inflammatory diseases, particularly in the challenging field of neuroinflammation, with a unique advantage in world-class candidates for treating Alzheimer's and Parkinson's diseases [1] Product Pipeline - The core products TLL-018, TLL-041, and TLL-009 are the only highly selective TYK2/JAK1 inhibitors globally [4] - TLL-018 is expected to be a first-in-class and best-in-class therapy for chronic spontaneous urticaria (CSU) and rheumatoid arthritis (RA), with two Phase III trials currently underway in China [4] - TLL-041 is the first and only brain-penetrant selective TYK2/JAK1 inhibitor, targeting neurodegenerative diseases, and the collaboration with Biohaven is the largest publicly disclosed transaction in China's neurodegenerative disease sector [4] Financial Performance - The company's revenue decreased from approximately RMB 225.6 million in 2023 to RMB 0 in 2024, primarily due to upfront payments received from licensing agreements [6] - The company recorded a profit of RMB 73.79 million in 2023 but is projected to incur losses of approximately RMB 226.37 million in 2024 and RMB 190.35 million in 2025 [7] Industry Overview - The global pharmaceutical market is expected to grow from USD 1.32 trillion in 2019 to USD 1.54 trillion in 2024, with a CAGR of 3.1%, and further expand to USD 2.41 trillion by 2033 [8] - The Chinese pharmaceutical market is projected to grow at a CAGR of 3.5%, reaching RMB 1.87 trillion by 2028 and RMB 2.68 trillion by 2033 [8] - The global autoimmune disease drug market is expected to grow from USD 116.9 billion in 2019 to USD 143.1 billion in 2024, with a CAGR of 5.8% from 2024 to 2028 [10]

Company Overview - Hangzhou Gaoguang Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with CICC and China Merchants International as joint sponsors [1] - The company focuses on developing safe and effective therapies for patients with autoimmune and inflammatory diseases, particularly in the challenging field of neuroinflammation, with a unique advantage in world-class candidate drugs for Alzheimer's and Parkinson's diseases [1] Product Pipeline - The core products TLL-018, TLL-041, and TLL-009 are the only highly selective TYK2/JAK1 inhibitors globally, with TLL-018 expected to be a first-in-class and best-in-class therapy for chronic spontaneous urticaria (CSU) and rheumatoid arthritis (RA) [4] - The company is conducting two Phase III registration trials for CSU and RA in China and plans to submit a New Drug Application (NDA) to the National Medical Products Administration by the end of 2026 [4] - TLL-041 is the first and only brain-penetrant selective TYK2/JAK1 inhibitor for neurodegenerative disease treatment, with a significant collaboration with Biohaven, marking the largest publicly disclosed transaction in China's neurodegenerative disease sector [4] Financial Performance - The company's revenue is projected to decrease from approximately RMB 225.6 million in 2023 to zero in 2024, primarily due to upfront payments received from licensing agreements with Biohaven and Jianyi Tengchuan [6] - The company recorded a profit of RMB 73.79 million in 2023 but is expected to incur losses of approximately RMB 226.37 million in 2024 and RMB 190.35 million in 2025, driven by operational expenses and changes in the fair value of financial instruments [7] Industry Overview - The global pharmaceutical market is expected to grow from USD 1.32 trillion in 2019 to USD 1.54 trillion in 2024, with a compound annual growth rate (CAGR) of 3.1%, and further expand to USD 2.41 trillion by 2033, with a CAGR of 5.3% from 2028 to 2033 [8] - The Chinese pharmaceutical market is projected to grow at a CAGR of 3.5%, reaching RMB 1.87 trillion by 2028 and RMB 2.68 trillion by 2033, driven by demographic changes and healthcare reforms [8] - The global autoimmune disease drug market is expected to grow from USD 116.9 billion in 2019 to USD 143.1 billion in 2024, with further growth anticipated to USD 217 billion by 2033 [9]