Siltuximab

2025年11月12日，百济神州（688235.SH）发布2025年第三季度报告，公告称公司前三季度实现营收275.95亿元，同比增长44.2%;归属于上市公司股东的净利润11.39亿元，同比扭亏为盈;扣非净利润9.69亿元，同比扭亏为盈;基本每股收益0.81元。 据公司说明，本次业绩增长主要系由于产品收入增长和费用管理推动了经营效率的提升。 百济神州有限公司的主营业务是研究、开发、生产以及商业化创新型药物。公司的主要产品是百悦泽、百泽安、百汇泽、安加维、倍利妥、凯洛斯、萨温珂、凯泽百、普贝希（安维汀生物类似药）、百拓维（注射用戈舍瑞林微球）、泰菲乐（达拉非尼）、迈吉宁（曲美替尼）、维全特（帕唑帕尼）、飞尼妥（依维莫司）、赞可达（塞瑞替尼）。 2025 年一季报显示，公司营业总收入 80.48 亿元，同比增长 50.17%；实现归母净利润 - 9450.3 万元，同比减亏 95.05%；扣非归母净利润 - 1.96 亿元，同比减亏 90.42% 2025 年中报显示，公司主营收入 175.18 亿元，同比增长 46.03%；归母净利润 4.50 亿元，同比扭亏为盈；扣非净利润 2.61 亿元，同比扭亏为盈；资产负债率 40.15%；毛利率 86.77%；财务费用 1046.70 万元；投资收益 1.09 亿元，研发费用72.78亿元。 商业模式 以研发与商业化一体化为核心，呈现出高效且稳健的运营特征。全链条自主运营：业务覆盖新药研发、临床试验、药品生产及全球市场推广全流程，通过自建临床团队开展试验，在成本控制与运营效率上形成差异化优势；核心产品驱动营收：泽布替尼在海外市场表现亮眼，替雷利珠单抗国内销量领先，两款核心产品构成营收主要支柱，同时有多款新药处于持续研发推进阶段；合作赋能与盈利改善：与安进等国际企业开展合作，一方面获取资金支持，另一方面借助合作方渠道拓展产品市场；2025 年上半年实现盈利，财务状况呈现稳健发展态势。 独特价值 明星药物的引领作用与充足的新药储备。明星药物竞争力显著：泽布替尼用于血液瘤治疗，在疗效和副作用控制上表现优于部分同类进口药物，打破了相关领域的国外垄断格局。替雷利珠单抗聚焦实体瘤治疗，是国产 PD-1 药物中较早进入欧美主流市场的品种之一；新药储备布局广泛：除核心药物外，多款处于后期研发阶段的新药可与核心药物联合应用，还在解决癌症耐药问题上有所探索，覆盖多种常见癌症类型。 护城河 研发效率优势：拥有约 3700 人的全球临床团队，试验推进效率较高，例如某款药物从确定剂量到启动关键试验仅耗时 4 周，快于行业平均水平；专利与管线壁垒：核心药物具备全球专利保护，在研管线包含 48款药物，覆盖多数癌症领域，后续产品可实现接力，降低单一产品迭代风险；全球供应链韧性：国内外生产工厂均符合全球高标准，美国工厂的布局可规避部分关税影响，保障全球供应稳定性；同时海外市场的布局也降低了单一地区政策变动带来的风险。 主力持仓 百济神州 2025 三季报主力持仓数据显示，共有 185 家机构参与持仓，累计持有 3095.91 万股，市值 95.01 亿，持仓比例 26.91%，但较上期减持 3057.41 万股。这体现出机构对其仍有较高关注度和持仓规模，不过也存在阶段性减持动作，需结合公司管线进展、行业动态等进一步观察。若后续机构因对行业政策、公司新药研发进度不及预期等因素持续减持，可能对股价形成压制。 截至11月12日收盘，百济神州股价为293.62元/股，涨5.62%，市值4523.7亿元。 今日行情 12日，A股三大股指低开，盘中一度集体翻红。截至下午收盘，沪指跌0.07%，报4000.14点，深证成指跌0.36%，创业板指跌0.39%。两市成交额1.96万亿，全市超3500只个股下跌。 板块题材上，保险、医药、油气开采及服务、燃气、脑机接口、金属铝板块涨幅居前；培育钻石、光伏、影视院线、能源金属、人形机器人概念股跌幅居前。 医药据说是根据12月底到1月的流感高发预期，预期需求端上升。 而光伏板块是关于收储预期，市场上有一则“利空消息”使股市预期“落空”。此等扰乱市场的行为使得有关公司，协会官方出来辟谣。光伏乘着反内卷的风，有国家站台。目前不看资金，看趋势。 免责声明：文章表述的意见不构成任何投资建议，投资者据此操作，风险自担。

Poster presentations at ASH highlight advances in the understanding and research of Castleman disease, cold agglutinin disease, B-cell lymphoma, and other hematologic conditions BRIDGEWATER, N.J., Nov. 3, 2025 /PRNewswire/ -- Recordati Rare Diseases Inc. today announced the presentation of new data related to its growing portfolio of treatments for rare hematologic disorders at the 67th American Society of Hematology (ASH) Annual Meeting, which takes place December 6-9, 2025, in Orlando, Fla. In a series of nine poster presentations, Recordati researchers and independent investigators will present research detailing advances in Castleman disease (CD), cold agglutinin disease (CAD)/cold agglutinin syndrome (CAS), and immune-related complications of CAR T-cell therapy. Highlights include a report on the development of an artificial intelligence (AI) model that evaluates CD tissue samples; an analysis of the morbidity burden and healthcare costs among patients with idiopathic multicentric Castleman disease (iMCD); the first real-world evaluation of sutimlimab in the treatment of patients with CAD or CAS; and a prospective evaluation of siltuximab in the prevention or treatment of cytokine release syndrome (CRS) after CAR T-cell therapy. "We are particularly excited about the long-term safety data for sutimlimab in cold agglutinin disease and the growing body of research investigating the use of siltuximab in Castleman disease," said Milan Zdravkovic, Executive Vice President, Research & Development and Chief Medical Officer at Recordati. "Also notable is the poster describing an innovative, AI-based approach to lymph node analysis, which could represent a meaningful step toward earlier and more consistent diagnosis of Castleman disease, one of the most difficult hematologic conditions to diagnose accurately. Altogether, the datasets presented at ASH 2025 reflect Recordati's ongoing commitment to advancing care for people living with rare hematologic disorders." "The ASH Annual Meeting is an important opportunity to showcase research advances in hematologic diseases, and we are pleased that the meeting organizers have accepted nine abstracts related to our therapies," said Mohamed Ladha, President and General Manager at Recordati Rare Diseases North America. "Together with our independent research partners, Recordati is at the forefront of advancing potential therapeutic solutions for people living with devastating conditions such as Castleman disease. We look forward to these data sparking further dialogue and collaboration as we continue in our efforts to improve patients' lives." The ASH 2025 Annual Meeting will feature the following poster presentations: Castleman Disease Poster number: 2606 Title: Retrospective real-world data analysis of morbidity burden and healthcare costs in idiopathic multicentric Castleman disease compared with matched controls (BURDEN-iMCD) Presenting author: Sudipto Mukherjee, MD, PhD, MPH, Cleveland Clinic Poster number: 3001 Title: Comprehensive analysis of subtype-specific outcomes and management in Castleman disease: a 20-year cohort study Presenting author: Yoshito Nishimura, MD, PhD, MPH, Mayo Clinic Poster number: 3002 Title: Automated grading of Castleman disease histopathology using an attention-based multiple-instance learning model Presenting author: Muir Morrison, PhD, University of Utah Poster number: 3009 Title: Pediatric idiopathic multicentric Castleman disease is often severe and responds to siltuximab Presenting author: Bridget Austin, MS, Perelman School of Medicine, University of Pennsylvania, Center for Cytokine Storm Treatment & Laboratory Poster number: 3006 Title: Epidemiology and clinical characteristics of idiopathic multicentric Castleman disease in Spain (ARCANA study): Prevalence cohort Presenting author: José-Tomás Navarro, MD, PhD, Catalan Institute of Oncology, Josep Carreras Leukaemia Research Institute Poster number: 4788 Title: Siltuximab-mediated suppression of CRP is associated with clinical response in idiopathic multicentric Castleman disease Presenting author: Jean-Francois Rossi, MD, PhD, Université de Montpellier Cold Agglutinin Disease (CAD) Poster number: 6242 Title: Real-world safety of sutimlimab in patients with CAD/CAS: a multinational, multicenter, observational, prospective cohort study Presenting author: Alexander Röth, MD, West German Cancer Center, University Hospital Essen, University of Duisburg-Essen CAR T-Cell Therapy Toxicity (including in B-Cell Lymphoma)* Poster number: 2385 Title: Safety and immunomodulatory effects of siltuximab prophylaxis prior to standard of care CD19 directed chimeric antigen receptor T-cell (CD19.CART) therapy for B-cell lymphomas: final Phase I trial results Presenting author: Nathan Denlinger, DO, MS, The Ohio State University Wexner Medical Center, James Comprehensive Cancer Center Poster number: 5919 Title: Siltuximab versus tocilizumab for the management of CAR T-cell associated cytokine release syndrome Presenting author: Mayur Narkhede, MD, University of Alabama at Birmingham *These studies were conducted as investigator-sponsored studies without research involvement by Recordati. About Idiopathic Multicentric Castleman Disease (iMCD) Idiopathic multicentric Castleman disease is a rare cytokine-driven disorder that may be life-threatening and can affect people of any age. Its symptoms often resemble those of malignant lymphoma, autoimmune, or infectious diseases, making it difficult to diagnose. iMCD is a subtype of Castleman disease (CD), which is a group of rare conditions that affect the immune system, characterized by swollen lymph nodes and a broad range of inflammatory signs and symptoms. The cause of iMCD is unknown, and there are no known risk factors. Some people with iMCD have elevated levels of interleukin 6 (IL-6), a cytokine that is produced in the body during inflammation and which plays a central pathological role in iMCD; IL-6 elevation may explain some of the symptoms patients experience, such as swollen lymph nodes, fever, unexplained weight loss, and night sweats. About Cold Agglutinin Disease (CAD) Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia (AIHA), characterized as a low-grade lymphoproliferative disorder of the bone marrow. In CAD, autoantibodies bind to erythrocytes at temperatures ≤37°C, leading to complement-mediated hemolysis. CAD symptoms include severe, debilitating fatigue and other clinical manifestations (e.g., dyspnea, tachycardia) that can impact patients' quality of life. While the median age of onset is approximately 60 years, CAD has been diagnosed in patients as young as 30. About Recordati Rare Diseases Recordati Rare Diseases is Recordati's dedicated business unit focused on Rare Diseases. Recordati is an international pharmaceutical Group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas, and APAC, with over 4,500 employees. Recordati Rare Diseases' mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies. We work side-by-side with rare disease communities to increase awareness, improve diagnosis, and expand availability of treatments for people with rare diseases. Recordati Rare Diseases Inc. is the company's U.S. corporate headquarters located in Bridgewater, NJ, with the global headquarter offices located in Milan, Italy. For full prescribing information, including approved indications and important safety information about marketed products, please visit: . SOURCE Recordati 21% more press release views with Request a Demo