药物临床试验登记与信息公示平台数据显示，智翔（上海）医药科技有限公司/重庆智翔金泰生物制药 股份有限公司的一项评价GR1803注射液在系统性红斑狼疮受试者中安全性、耐受性和初步有效性的开 放、多中心Ib/IIa期临床试验已启动。临床试验登记号为CTR20254402，首次公示信息日期为2025年11 月14日。 该药物剂型为注射液，规格为20mg/2ml/瓶，用法用量为3 ug/kg - 180 ug/kg，静脉滴注，用药时程为4周 一个周期，给药一周期。本次试验目的是评价GR1803注射液在自身免疫性疾病受试者中的安全性、耐 受性、药代动力学、免疫原性和初步有效性。 GR1803注射液为生物制品，适应症为系统性红斑狼疮。它是一种自身免疫性疾病，可累及全身多系 统，症状有面部红斑、关节痛、蛋白尿等。诊断依靠临床表现、抗体检测等。 本次试验主要终点指标包括不良事件；次要终点指标包括药代动力学特征、免疫原性特征、药效学指标 及临床评分变化。 目前，该实验状态为进行中（尚未招募），目标入组人数44人。 风险提示：市场有风险，投资需谨慎。本文为AI大模型基于第三方数据库自动发布，任何在本文出现 的信息（包括但不限于个 ...

Core Viewpoint - The article discusses the promising results of a phase 1 clinical trial combining CD19-targeting and BCMA-targeting CAR-T cell therapies for treatment-refractory systemic lupus erythematosus (rSLE), highlighting its safety and potential clinical efficacy [2][3][8]. Group 1: Clinical Trial Overview - A phase 1 clinical trial was conducted to evaluate the co-infusion of CD19-targeting and BCMA-targeting CAR-T cells in rSLE patients, showing good safety and promising clinical efficacy [3][8]. - The trial involved 15 patients (14 females and 1 male) who had previously undergone lymphocyte-depleting therapy [6]. Group 2: Safety and Efficacy Results - During a median follow-up of 712 days, no dose-limiting toxicities were observed, with 86.7% of patients experiencing grade 1 cytokine release syndrome, and no neurotoxicity or treatment-related deaths reported [7]. - By week 12, 80% of patients achieved low disease activity status (LLDAS) and DORIS remission criteria, indicating significant improvement in immune homeostasis [9]. Group 3: Mechanistic Insights - The study identified that CD19⁺ B cells and CD19⁻ BCMA⁺ long-lived plasma cells were the main sources of autoantibodies in rSLE patients, supporting the rationale for dual-targeting therapy [6]. - Multi-omics analysis confirmed the elimination of autoreactive CD19⁺ BCMA⁺ clones and the restoration of initial IgM/IgD B cells, suggesting a durable downregulation of interferon-stimulated and BAFF-dependent features [9].

Core Viewpoint - China Antibody-B (03681) has seen a significant stock price increase of over 15%, currently trading at 2.7 HKD, with a transaction volume of 6108.39 HKD, following the release of its interim performance announcement for the period ending June 30, 2025 [1] Financial Performance - The total other income and revenue for the reporting period is approximately 9.802 million RMB, representing a year-on-year increase of 126.95% [1] - Research and development costs amounted to 32.74 million RMB, with a reduction in losses by 40.8 million RMB, primarily due to decreased expenses related to the preparation for the BLA of Shuxili monoclonal antibody and reduced hiring costs [1] Clinical Development - The company has made significant progress in its clinical trial projects and pipeline development, particularly with its two core products, Shuxili monoclonal antibody and SM17 [1] - Shuxili monoclonal antibody has achieved breakthrough results in preclinical studies for the treatment of systemic lupus erythematosus (SLE), demonstrating unique advantages in regulating the autoimmune network and protecting against organ damage [1] - The product has shown a significant reduction in anti-double-stranded DNA (anti-dsDNA) antibody levels and has outperformed existing drugs in improving proteinuria and renal pathological damage associated with lupus nephritis (LN) [1]

Core Insights - The article discusses a groundbreaking study led by Professor Xu Huji from the Second Affiliated Hospital of Naval Medical University, which successfully utilized CRISPR gene-edited universal CAR-T cell therapy to treat three patients with refractory autoimmune diseases [2][3] - Professor Xu was recognized in Nature's 2024 list of top ten individuals for his contributions to the field, highlighting the collaboration with Huaxia Yingtai, founded by Professor Lin Xin from Tsinghua University, to conduct human trials for systemic lupus erythematosus [2] Research Findings - The study published in Nature Medicine details a phase 1 trial of allogeneic CD19-targeting T cells (STAR-T cells, YTS109) for treatment-refractory systemic lupus erythematosus (SLE) with lupus nephritis (LN) [3] - The trial involved five patients who underwent lymphocyte depletion therapy followed by administration of STAR+ T cells at a dosage of 3×10⁶ cells per kilogram [8] - The primary endpoint was safety and the systemic lupus erythematosus response index 4 (SRI-4) at three months, with secondary endpoints including clinical remission and quality of life at six months [8] Results and Implications - Results indicated good tolerance for YTS109, with only mild cytokine release syndrome observed and no cases of graft-versus-host disease [10] - All five patients achieved SRI-4 response by the third month, with four patients showing a significant and sustained decrease in disease activity score from an average of 31.30 to 5.35 by the sixth month [10] - Quality of life assessments showed improvement for all patients, and kidney biopsies confirmed inflammation reduction and tissue repair, suggesting YTS109 as a promising treatment for severe, refractory SLE with LN [10]

Core Insights - The National Medical Products Administration (NMPA) has accepted the market application for AstraZeneca's Avolimumab injection for the treatment of systemic lupus erythematosus (SLE) [1] Company Summary - Avolimumab is a first-in-class fully human monoclonal antibody that targets the type I interferon receptor 1 (IFNAR1), thereby blocking the activity of type I interferons [1] - The IFNAR1 receptor forms a heterodimer with IFNAR2, which is a key cytokine involved in regulating the inflammatory pathways of SLE [1] - Increased signaling through the type I interferon receptor is associated with higher disease activity and severity in SLE [1]