机构：天风证券 研究员：杨松/曹文清 临床数据显示，该药在多种实体瘤尤其在胃癌后线治疗领域表现优异，II期临床达到主要终点。在 ASCO 2025 公布的研究中，相较于接受TPC 治疗的患者，CT041 在入组的所有至少二线治疗失败的 CLDN18.2 阳性G/GEJC患者中显著改善PFS（mPFS 3.25 vs 1.77 个月，HR = 0.366），同时展现了OS 获 益趋势（7.92 vs 5.49 个月,HR 0.693，单侧p=0.0416）。在实际接受输注的患者中，CT041 和TPC 的 mPFS 分别为4.37 个月 vs 1.84 个月，HR 为0.304，mOS 为8.61 个月 vs 5.49 个月，HR 为0.601。 通用型CAR-T 平台THANK-u Plus加速推进，CT0596 疗效信号积极在自体CAR-T 商业化取得里程碑式 成果后，公司同步布局通用型CAR-T 技术平台 THANK-u Plus，致力于实现细胞治疗的标准化和批量化 生产。该平台通过优化NKG2A 调控机制，使CAR-T 在不同免疫环境下仍具持续扩增能力，显著改善了 异体细胞治疗中的免疫排斥问题。基于此平 ...

Core Insights - Kogei Pharmaceuticals has submitted two new drug clinical trial applications for its universal BCMA CAR-T product CT0596 to the National Medical Products Administration, targeting relapsed/refractory multiple myeloma and primary plasma cell leukemia [1][17][22] - The development of universal CAR-T therapies is seen as a significant advancement in the treatment of multiple myeloma, which remains incurable despite recent therapeutic advancements [2][19] - CT0596 is developed on the THANK-u Plus platform, which enhances the product's durability and safety by gene editing to reduce the risk of graft-versus-host disease and immune rejection [4][21] Group 1: Clinical Development - CT0596 has shown promising preliminary efficacy and safety in early human studies, with 6 out of 8 patients achieving partial response or better, and no severe adverse events reported [4][21] - The submission of clinical trial applications marks the entry of CT0596 into the registration clinical development phase, potentially providing new treatment options for patients with R/R MM and pPCL [5][22] - Kogei plans to explore CT0596's application in other plasma cell tumors and plasma cell-driven autoimmune diseases [5][22] Group 2: Technological Advancements - The THANK-u Plus platform allows for immediate use and mass production of CAR-T cells, significantly reducing treatment costs compared to autologous CAR-T therapies [3][20] - Kogei has developed a robust pipeline of universal CAR-T products targeting various malignancies, including blood cancers and solid tumors, leveraging the advantages of the THANK-u Plus platform [6][23] Group 3: Market Position and Future Directions - Kogei's self-developed CAR-T product, Sazekai (Zewokaiolun), has been approved for use in relapsed or refractory multiple myeloma, with significant market penetration across over 20 provinces in China [29] - The company is actively pursuing partnerships to enhance the development and commercialization of its universal CAR-T products in mainland China [28][29] - The competitive landscape for CAR-T therapies is intensifying, with multiple companies exploring dual-target strategies and innovative delivery methods to improve patient outcomes [14][30]

本报讯 （记者金婉霞）近日，科济药业控股有限公司（以下简称"科济药业"）在第67届美国血液学会 （"ASH"）年会进行壁报展示了CT0596在复发/难治性多发性骨髓瘤患者中的首次人体研究数据。根据 最新的临床试验（NCT06718270）数据显示，由科济药业研发的三基因编辑通用型靶向BCMA的CAR-T 产品CT0596在早期临床试验中表现优异，不仅展现出强劲的抗肿瘤活性，更呈现出良好的安全可控 性，为深陷治疗困境的骨髓瘤患者带来了新的曙光。 截至2025年8月31日的评估数据显示，CT0596的疗效令人振奋：总体缓解率高：在8例可评估患者中， 有6例达到了部分缓解（PR）及以上疗效；深度缓解潜力显著：在接受全剂量清淋预处理的6例患者 中，有5例达到PR及以上，且这6例患者全部在治疗第4周达到了微小残留病（MRD）阴性。MRD阴性 是目前多发性骨髓瘤治疗中极为重要的预后指标，通常意味着更深的缓解程度和更长的生存获益；完全 缓解案例：共有3例患者达到严格意义的完全缓解（sCR），其中01号患者疗效持续稳定，截至第8个月 仍维持sCR且MRD阴性。所有8例患者均出现CAR-T细胞扩增，且疗效不受基线NK细胞NKG ...

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 - 科济药业 is actively repurchasing its shares to enhance shareholder value while continuing to develop innovative CAR-T therapies for unmet clinical needs [1][2] Group 1: Share Repurchase Activity - On November 6, 科济药业 announced the repurchase of 1.734 million shares at a price range of HKD 14.350 to HKD 15.8, totaling HKD 26.3078 million [1] - In the past month, the company has conducted three repurchase activities, acquiring a total of 2.189 million shares for a cumulative amount of HKD 33.9758 million [1] - The company has a repurchase plan allowing it to buy back up to 1% of its total issued shares in the open market [1] Group 2: Company Overview and Product Pipeline - 科济药业 is a biopharmaceutical company focused on developing innovative CAR-T cell therapies to address unmet clinical needs, including hematologic malignancies, solid tumors, and autoimmune diseases [1] - The company has 10 CAR-T pipeline products, including 4 autologous CAR-T and 6 universal CAR-T, all of which are self-developed with global rights [1] - The all-human BCMA autologous CAR-T product,赛恺泽, has been approved for marketing in China, while the Claudin18.2 autologous humanized CAR-T product,舒瑞基奥仑赛, is the first CAR-T product for solid tumors to submit a new drug application globally [1] Group 3: Recent R&D Achievements - On November 3, 科济药业 announced new clinical data for its universal CAR-T products, CT0596 and CT1190B, showing promising safety and efficacy signals for treating relapsed/refractory multiple myeloma and non-Hodgkin lymphoma, respectively [2] - As of June 30, 2026, the company reported cash and cash equivalents exceeding HKD 1.26 billion, indicating a strong financial position to support ongoing operations and share repurchase plans [2] - The management expressed commitment to maintaining the share repurchase program, adjusting it based on market conditions to further protect shareholder interests [2]

Core Viewpoint - Kexing Pharmaceutical Holdings Limited has announced promising clinical data for its universal CAR-T products CT0596 and CT1190B, indicating good safety and efficacy signals for treating relapsed/refractory multiple myeloma and non-Hodgkin lymphoma [1][2] Group 1: Clinical Data and Product Development - The clinical data for CT0596 and CT1190B shows encouraging results in treating relapsed/refractory multiple myeloma and non-Hodgkin lymphoma, respectively [1][2] - Kexing's universal CAR-T products can significantly reduce production costs by over 80% compared to autologous CAR-T therapies, addressing issues of high costs and patient accessibility [2] - The company has developed proprietary technology platforms, THANK-uCAR® and the upgraded THANK-u Plus®, to enhance the accessibility of CAR-T therapies and minimize immune rejection [3] Group 2: Market Context and Competitive Landscape - The current autologous CAR-T therapies are highly customized, leading to prices exceeding 1 million yuan, with only 20% of eligible patients in the U.S. able to access treatment, and an even lower percentage in China [2] - Kexing Pharmaceutical is positioned as a leading player in the domestic CAR-T therapy market, with significant achievements in the autologous CAR-T field [4] - The company aims to launch its first universal CAR-T product within the next 4-5 years, expanding treatment options for patients [3]

Core Insights - Kintor Pharmaceutical (02171.HK) announced clinical data for its universal BCMA CAR-T product CT0596 and universal CD19/CD20 CAR-T product CT1190B, both showing promising safety and efficacy signals for treating relapsed/refractory multiple myeloma (R/R MM) and non-Hodgkin lymphoma (R/R NHL) respectively [1][2] Group 1: Product Development - CT0596 is a universal CAR-T cell therapy targeting BCMA, currently undergoing investigator-initiated clinical trials for R/R MM and plasma cell leukemia (PCL), with plans to submit an IND application in the second half of 2025 [1] - CT1190B targets CD19/CD20 and is involved in clinical trials for treating relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc) [2] Group 2: Company Overview - Kintor Pharmaceutical is a biopharmaceutical company focused on developing innovative CAR-T cell therapies to address unmet clinical needs, including hematologic malignancies, solid tumors, and autoimmune diseases [2] - The company has established end-to-end capabilities in CAR-T cell research and development, from target discovery to commercial-scale production, positioning itself as a leading global player in CAR-T therapy [2] - Kintor currently has 10 CAR-T pipeline products, including 4 autologous CAR-T and 6 universal CAR-T, all of which are self-developed with global rights [2]

Core Viewpoint - Kintor Pharmaceutical Co., Ltd. (科济药业-B) has seen a significant increase in stock price, attributed to the upcoming presentation of clinical data for CT0596 at the 67th American Society of Hematology (ASH) annual meeting and the recent approval of its CAR-T drug for inclusion in insurance directories [1]. Group 1: Stock Performance - Kintor Pharmaceutical's stock price rose over 7% during trading, with a current increase of 5.70%, reaching HKD 19.85 [1]. - The trading volume amounted to HKD 13.3487 million [1]. Group 2: Clinical Data Presentation - The company announced that it will present clinical data for its drug CT0596 at the ASH annual meeting [1]. Group 3: Regulatory Developments - On September 20, the National Healthcare Security Administration announced the completion of expert review work for the first version of the commercial insurance innovative drug directory [1]. - Kintor's CAR-T drug, Sai Ke Ze, along with four other CAR-T drugs, successfully passed the expert review, indicating a potential inclusion in this year's basic medical insurance directory and commercial insurance innovative drug directory [1].

Group 1 - Kintor Pharmaceutical (科济药业-B) shares rose over 7%, currently up 6.39% at HKD 19.98, with a trading volume of HKD 10.51 million [1] - The company announced it will present clinical data for CT0596 at the 67th American Society of Hematology (ASH) annual meeting [1] - On September 20, the National Healthcare Security Administration announced the completion of expert review for the first version of the commercial insurance innovative drug catalog, with Kintor's CAR-T drug, Sai Ke Ze, among five CAR-T drugs that passed the review, potentially entering this year's basic medical insurance and commercial insurance innovative drug catalog [1]