作为革命性的癌症免疫治疗方法，CAR-T细胞疗法被认为是目前最有前景的肿瘤治疗方式之一，但其高 达百万元的治疗费用却让众多普通患者望而却步。 不过，此种状况有望迎来积极的变化。 一方面，包括科济药业的泽沃基奥仑赛注射液在内的5款CAR-T药物均被纳入首版商保创新药目录；另 一方面，通用型CAR-T产品有望大幅降低成本。 近日，针对市场关注的相关问题，中国基金报记者专访了CAR-T细胞疗法领军企业——科济药业董事会 主席李宗海。 【导读】科济药业董事会主席李宗海：通用型CAR-T产品有望将成本降至1万元/针左右 但美国的商贸环境和支付能力比中国更强，中国的支付能力相对较弱。目前，中国正在改进，随着政策 的不断优化，我们将有机会迎头赶上。 从技术角度来看，中美两国各有优势。在血液瘤的CAR-T产品开发上，中国已经与国际最领先水平基本 同步，甚至在某些方面更有优势。 在实体瘤的CAR-T产品开发上，中国已经领先海外较多时间，我们科济药业已经申报了实体瘤药证，但 海外还没有任何产品进入关键临床阶段。 在通用型CAR-T技术方面，目前中国在全球处于领先地位；在自体CAR-T方面，中国处于全球第一方 阵。 从更长远来看， ...

【导读】科济药业董事会主席李宗海：通用型 CAR-T 产品有望将成本降至 1 万元 / 针左右 中国基金报记者 尹振茂 作为革命性的癌症免疫治疗方法， CAR-T 细胞疗法被认为是目前最有前景的肿瘤治疗方式 之一，但其高达百万元的治疗费用却让众多普通患者望而却步。 不过，此种状况有望迎来积极的变化。 一方面，包括科济药业的泽沃基奥仑赛注射液在内的 5 款 CAR-T 药物均被纳入首版商保创 新药目录；另一方面，通用型 CAR-T 产品有望大幅降低成本。 近日，针对市场关注的相关问题，中国基金报记者专访了 CAR-T 细胞疗法领军企业 —— 科 济药业董事会主席李宗海。 李宗海表示，通用型 CAR-T 产品是公司未来发展的核心引擎，该领域的市场空间将更加广 阔，生产成本和管理成本也更低；未来或可将成本降低到 1 万元 / 针左右，甚至更低，有望 最大程度提高药物的可及性。 以下是此次专访的主要内容。 科济药业董事会主席 李宗海 全球首款 NDA 实体瘤 CAR-T 产品 预计明年上半年将获批上市 中国基金报：目前全球 CAR-T 产品的发展状况和竞争格局是怎样的？ 李宗海： 从全球来看，目前发展比较强的主要是美 ...

编辑丨王多鱼 排版丨水成文 2025 年 12 月 9 日， 在第 67 届 美国血液学会 （ASH） 年会上， 启函生物 进行了一场口头报告及多场 海报展示，公布了其 同种异体 CAR-T 项目 积极的临床结果，以及支持其 in vivo CAR-T 项目 开发的基 础性临床前数据。 启函生物 的口头报告重点介绍了三项评估 QT-019B 治疗多种 自身免疫疾病 的 IIT 临床数据，共纳入 20 例受试者。治疗耐受性良好，未发生超过 1 级的细胞因子释放综合征 （CRS） 事件，且未报告免疫效应 细胞相关神经毒性综合征 （ICANS） 或严重感染。 QT-019B 是由启函生物开发的一种"现货型"同种异体 CAR-T 细胞产品，其以健康供者外周血的白细胞单 采产物为起始原材料，经基因编辑，稳定表达两种不同的嵌合抗原受体 （CAR） ，分别靶向 CD19 和 BCMA，从而使 QT-019B 具备同时识别并清除表达 CD19 和 BCMA 细胞的能力。此外，为降低移植物 抗宿主病 （GvHD） 风险，该细胞产品通过基因敲除方式消除了 T 细胞受体 （TCR） 的表达；同时，为 减少同种异体免疫排斥，通过多重 ...

药明巨诺-B(02126)发布公告，宣布在第67届美国血液学会年会上公布JWCAR201的IIT研究数据。 JWCAR201是药明巨诺自主研发的靶向CD19/CD20的自体CAR-T产品。 截至2025年10月30日，本研究已入组的7例受试者完成了JWCAR201回输，初步完成了三个剂量组的安 全性，疗效以及药代和药效动力学(PK/PD)的探索。 本次研究中回输的7例患者，中位年龄56岁(范围：42至72岁)，42.9%为男性。该队列患者表现出显著的 高风险特征：DLBCL-NOS占比85.7%，non-GCB亚型占比57.1%，国际预后指数(IPI)评分≥3占比 57.1%，双表达淋巴瘤(MYC/BCL2)占比71.4%，巨大病灶(≥7 cm)28.6%，P53异常占比42.9%。另外， 42.9%的患者既往接受过≥3线治疗，71.4%的患者为塬发性难治，85.7%的患者对最近一次治疗方案耐 药。所有患者在参加本研究前均接受过多种治疗方案，仍疾病进展，急需新的有效治疗手段。 截至2025年10月30日，本研究初步结果显示，7例患者中最佳总缓解率(ORR)达到100%(7/7)，完全缓解 率(CRR)达到85 ...

截至2025年10月30日，本研究已入组的7例受试者完成了JWCAR201回输，初步完成了三个剂量组的安 全性，疗效以及药代和药效动力学(PK/PD)的探索。 本次研究中回输的7例患者，中位年龄56岁(范围：42至72岁)，42.9%为男性。该队列患者表现出显著的 高风险特征：DLBCL-NOS占比85.7%，non-GCB亚型占比57.1%，国际预后指数(IPI)评分≥3占比 57.1%，双表达淋巴瘤(MYC/BCL2)占比71.4%，巨大病灶(≥7 cm)28.6%，P53异常占比42.9%。另外， 42.9%的患者既往接受过≥3线治疗，71.4%的患者为塬发性难治，85.7%的患者对最近一次治疗方案耐 药。所有患者在参加本研究前均接受过多种治疗方案，仍疾病进展，急需新的有效治疗手段。 截至2025年10月30日，本研究初步结果显示，7例患者中最佳总缓解率(ORR)达到100%(7/7)，完全缓解 率(CRR)达到85.7%(6/7)。除1例患者D90部分缓解(PR)煺出研究外，余6例患者的缓解均持续至D180或 在更长随访中，中位缓解持续时间(DOR)、无进展生存期(PFS)和总生存期(OS)均尚未达到 ...

Core Viewpoint - The preliminary results of CT0596, an allogeneic CAR-T cell therapy targeting BCMA, were reported at the 67th American Society of Hematology (ASH) Annual Meeting, indicating promising safety and efficacy signals in patients with relapsed/refractory multiple myeloma [1][2]. Group 1 - CT0596 is developed based on the company's proprietary THANK-u Plus platform and is currently undergoing investigator-initiated clinical trials for relapsed/refractory multiple myeloma (R/R MM) and plasma cell leukemia (PCL) [2]. - Initial results show good safety and encouraging efficacy signals, with CAR-T cell expansion observed across all predefined dose groups [2]. - The company plans to explore CT0596 in other plasma cell tumors and autoimmune diseases driven by autoreactive plasma cells [2]. Group 2 - The company anticipates submitting an Investigational New Drug (IND) application for CT0596 in the second half of 2025 [2].

Core Viewpoint - The preliminary results of CT0596, an allogeneic CAR-T cell therapy targeting BCMA, were reported at the 67th American Society of Hematology (ASH) Annual Meeting, indicating promising safety and efficacy signals in patients with relapsed/refractory multiple myeloma [1][2]. Group 1 - CT0596 is developed based on the company's proprietary THANK-u Plus™ platform and is currently undergoing investigator-initiated clinical trials for relapsed/refractory multiple myeloma (R/R MM) and plasma cell leukemia (PCL) [2]. - Initial results show good safety and encouraging efficacy signals, with CAR-T cell expansion observed across all predefined dose groups [2]. - The company plans to explore CT0596 in other plasma cell tumors and autoimmune diseases driven by autoreactive plasma cells [2]. Group 2 - The IND application for CT0596 is expected to be submitted in the second half of 2025 [2].

Core Viewpoint - WuXi AppTec's CAR-T cell therapy, Rukiyou Lunsai injection, is making progress in negotiations to be included in the commercial health insurance innovative drug directory, which is expected to reduce patient medication costs and benefit more patients [1] Group 1 - WuXi AppTec's stock price increased by over 10%, reaching HKD 3.82 with a trading volume of HKD 4.63 million [1] - The CAR-T therapy is the first domestically approved Class 1 CAR-T product in China, with a post-launch pricing of RMB 1.29 million per injection [1] - On October 30, WuXi AppTec announced a strategic cooperation supplementary agreement with Regeneron Pharmaceuticals, marking a significant upgrade in their long-term partnership [1] Group 2 - The supplementary agreement allows WuXi AppTec to receive up to USD 50 million in payments, which includes milestone payments for the development of the MAGE-A4 product, regulatory oversight of drug manufacturing processes, option exercise fees, and milestone payments for lentiviral vector manufacturing processes [1]

Market Overview - The A-share market experienced a significant decline, with major sectors such as telecommunications, electronics, and defense leading the drop, while steel and non-ferrous metals provided some support [1][2] - The Shanghai Composite Index closed down 0.73% at 3986.9 points, and the ChiNext Index fell 1.84% to 3263.02 points, indicating a broad market downturn [2] - Trading volume increased to 2.46 trillion yuan, up from 2.29 trillion yuan the previous day, indicating heightened market activity despite the decline [2] Sector Performance - High-profile sectors like AI, semiconductor, and communication equipment saw significant pullbacks, while rare earths, steel, and coal sectors showed resilience [4][8] - Specific stocks such as "Yizhongtian" in the CPO concept faced substantial declines, with New Yisheng down 7.9% and Tianfu Communication down 11.56% [4][6] Investment Sentiment - Analysts suggest that the downward space for indices is limited, with expectations of fluctuations around the 4000-point mark, indicating a potential for a "high-low switch" market [1][10] - Investors are advised to hold onto their positions and focus on companies with lower previous gains but higher future earnings certainty [1][10] Future Outlook - The market is expected to experience structural upward trends, driven by a combination of domestic economic recovery and positive signals from U.S.-China trade discussions [11][14] - Key sectors to watch include AI, semiconductor, and renewable energy, with a focus on companies that have shown consistent performance and growth potential [12][14]

Core Insights - The 2025 European Society for Medical Oncology (ESMO) annual meeting held in Berlin showcased significant clinical research results from various domestic pharmaceutical companies, indicating that ESMO could act as a catalyst for business development (BD) in innovative drugs from China [1][2]. Group 1: Clinical Research Highlights - Bai Li Tianheng's drug, Iza-bren, an EGFR×HER3 dual antibody ADC, received considerable attention at ESMO, with a reported 100% objective response rate (ORR) at the World Lung Cancer Conference [3]. - The overseas multi-center study of Iza-bren included 107 patients across various cancer types, showing a cORR of 55% and a median progression-free survival (mPFS) of 5.4 months, highlighting its broad-spectrum treatment potential [3][4]. - The study included a higher proportion of heavily pre-treated patients (57.9%) compared to earlier domestic studies, confirming the drug's efficacy across different populations [4]. Group 2: Market Reactions and Stock Performance - Following the ESMO conference, stocks of companies like Decipher Biosciences, Kintor Pharmaceutical, and Kelun Pharmaceutical saw significant increases after presenting their clinical data [2]. - Kintor Pharmaceutical's CAR-T therapy for pancreatic cancer showed promising results, with a 83.3% disease-free survival rate at 9 months, leading to a 7.01% increase in stock price [5][6]. Group 3: Business Development Opportunities - The ESMO meeting highlighted over 50 targets across various development paths, with a focus on "ADC+IO" and "dual/multi-antibody" therapies [7]. - Companies are increasingly focusing on differentiated mechanisms of action and complementary therapeutic areas for new BD opportunities, as traditional PD-1 targets become saturated [10]. - Recent BD agreements, such as the one between Hansoh Pharmaceutical and Roche for HS-20110, indicate a continued interest in innovative drug development, with potential milestone payments reaching up to $14.5 billion [10].