Summary of the Conference Call for 诺诚健华 Company and Industry Overview - The conference call focuses on 诺诚健华 (Nuo Cheng Jian Hua) and its drug 奥布替尼 (Obutinib) for the treatment of systemic lupus erythematosus (SLE), a chronic autoimmune disease affecting over 8 million patients globally, with more than 1 million in China [2][3]. Key Points and Arguments Clinical Trial Results - The IIb clinical trial results for 奥布替尼 show a significant SL4 response rate at week 48 of 57.1% in the 75 mg QD group compared to 34.4% in the placebo group (p<0.05), indicating substantial efficacy in treating SLE [2][5]. - In a subgroup of patients with more severe disease (baseline steroid dose ≥10 mg/day or baseline urine protein ≥1 g/24 hours), the 75 mg QD group demonstrated even greater efficacy, with differences of 30% and 36% compared to the placebo group [5][8]. - 奥布替尼 exhibited good safety and tolerability, with no new safety signals identified, aligning with the BTK inhibition mechanism and SLE disease biology [2][6]. Steroid Reduction - The treatment group showed a significant reduction in glucocorticoid use, with 71.1% of patients successfully reducing their steroid dose to below 7.5 mg/day compared to 43.6% in the placebo group, highlighting the potential to minimize long-term steroid-related side effects [2][6]. Future Clinical Trials - 诺诚健华 plans to initiate a Phase III clinical trial with 484 patients, focusing on the same efficacy endpoints as the IIb trial, expected to start patient enrollment in Q1 2026 [2][7]. - The trial design aligns with international standards, incorporating mandatory steroid reduction protocols to meet the higher requirements set by the CDE for SLE drug trials [4][9]. Market Potential and Commercialization - 奥布替尼 is the first BTK inhibitor to enter Phase III trials for SLE, presenting a significant market opportunity, especially given the limited availability of new small molecule drugs in the past 20 years [3][8]. - The company plans to establish its own commercialization team post-approval and has synergistic effects with other T2 inhibitors to support market promotion [4][10]. Regulatory Landscape - The CDE has tightened clinical requirements for SLE drugs, necessitating lower steroid doses and more rigorous trial designs. 诺诚健华's Phase III study aims to meet these stringent standards to ensure data consistency with global results [9][10]. International Collaboration - 诺诚健华 has partnered with Xenios to advance overseas market opportunities, focusing on SLE and multiple sclerosis (MS) projects, with expectations for the IIb results to inform future international development strategies [12][13]. Additional Important Information - 奥布替尼's mechanism of action shows high selectivity for BTK, with significant inhibition in preclinical models, supporting its development as an effective SLE treatment [3][8]. - The drug's oral formulation offers advantages in convenience and compliance, avoiding issues associated with large molecule biologics [8]. This summary encapsulates the critical insights from the conference call regarding 诺诚健华's developments in SLE treatment with 奥布替尼, highlighting its clinical efficacy, safety profile, market potential, and strategic plans for future trials and commercialization.

本次研究的主要终点是第48周时的SLE反应指数-4（SRI-4）应答率。第48周时，每天一次75毫克奥布替 尼剂量组的SRI-4应答率显著高于安慰剂组（57.1%vs.34.4%），具有统计学意义（p＜0.05），达到主要 终点。此外，每天一次75毫克奥布替尼剂量组的疗效优于每天一次50毫克剂量组，这表明疗效呈剂量依 赖性的改善趋势。 登录新浪财经APP 搜索【信披】查看更多考评等级 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 诺诚健华医药有限公司（以下简称"公司"）自主研发的BTK抑制剂奥布替尼治疗系统性红斑狼疮（以下 简称"SLE"）的IIb期临床研究达到主要终点，并获国家药品监督管理局（NMPA）药品审评中心 （CDE）批准开展III期注册性临床试验。公司将尽快启动该临床研究，现将主要情况公告如下： 一、奥布替尼临床试验进展情况 近日，公司自主研发的BTK抑制剂奥布替尼治疗SLE的IIb期临床研究达到主要终点，并获CDE批准开展 III期注册性临床试验。该III期研究将评估每日一次（QD）75毫克的给药方案，该方 ...

Group 1 - The core point of the article is the initiation of a clinical trial for GR1803 injection, aimed at evaluating its safety, tolerability, and preliminary efficacy in patients with systemic lupus erythematosus [1] - The clinical trial is an open-label, multi-center Phase Ib/IIa study, with a target enrollment of 44 participants [2] - The drug is a biological product specifically indicated for systemic lupus erythematosus, which is an autoimmune disease affecting multiple systems in the body [1] Group 2 - The trial's primary endpoint includes the assessment of adverse events, while secondary endpoints focus on pharmacokinetic characteristics, immunogenicity, pharmacodynamic indicators, and changes in clinical scores [1] - The drug is administered intravenously with a dosage range of 3 µg/kg to 180 µg/kg over a treatment cycle of 4 weeks [1] - The clinical trial registration number is CTR20254402, with the first public information date set for November 14, 2025 [1]

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]