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 ...

科济药业-B(02171)发布公告，CT0596(一种靶向BCMA的同种异体CAR-T细胞候选产品)的初步结果已 在第67届美国血液学会(ASH)年会上进行报告。 CT0596IIT初步研究结果已于美国东部时间2025年12月6日下午5:30-下午7:30，在第67届ASH年会上进行 壁报展示，标题为"CT0596(一种靶向BCMA的同种异体CAR-T细胞疗法)在复发╱难治性多发性骨髓瘤 患者中的首次人体研究"(A First-in-Human Study of CT0596,an Allogeneic CAR T-Cell Therapy Targeting BCMA,in Patients with Relapsed/Refractory Multiple Myeloma))。 CT0596是一款靶向BCMA的通用型CAR-T细胞疗法，基于科济药业自主研发的THANK-u Plus平台开 发，目前正在复发╱难治性多发性骨髓瘤(R/R MM)或浆细胞白血病(PCL)中开展研究者发起的临床试 验。CT0596显示出初步良好的安全性及令人鼓舞的疗效信号，在所有预设剂量组均观察到CAR-T细胞 的扩增。除了R/R ...

CT0596 IIT初步研究结果已于美国东部时间2025年12月6日下午5:30-下午 7:30，在第67届ASH年会上进 行壁报展示，标题为"CT0596(一种靶向BCMA 的同种异体CAR-T细胞疗法)在复发 ╱ 难治性多发性骨 髓瘤患者中的首次人体研究"(A First-in-Human Study of CT0596, an Allogeneic CAR T-Cell Therapy Targeting BCMA, in Patients with Relapsed/Refractory Multiple Myeloma))。 CT0596是一款靶向BCMA的通用型CAR-T细胞疗法，基于科济药业自主研发的 THANK-u Plus™平台开 发，目前正在复发╱难治性多发性骨髓瘤(R/R MM)或浆细胞白血病(PCL)中开展研究者发起的临床试 验。CT0596显示出初步良好的安全性及令人鼓舞的疗效信号，在所有预设剂量组均观察到CAR-T细胞 的扩增。除了 R/R MM，本公司还计划在其他浆细胞肿瘤以及自身反应性浆细胞驱动的自身免疫性疾病 中进一步探索。本公司预估2025年下半年提交该品种的IND申请。 ...

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]

Group 1 - The core point of the article is that Kintor Pharmaceutical (科济药业-B) has seen a stock price increase of over 7%, currently trading at 19.98 HKD with a transaction volume of 10.51 million HKD [1] - Kintor Pharmaceutical announced that 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 the basic medical insurance catalog and commercial insurance innovative drug catalog this year [1]

Core Insights - Company Kintor Pharmaceutical (科济药业-B) announced that it will present clinical data for CT0596, a BCMA-targeted allogeneic CAR-T cell candidate, at the 67th American Society of Hematology Annual Meeting [1] - CT0596 is developed 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) [1] - The candidate has shown promising safety and efficacy signals, with CAR-T cell expansion observed across all predefined dose groups [1] - The company plans to explore CT0596 in other plasma cell tumors and autoimmune diseases driven by autoreactive plasma cells [1] - An IND application for CT0596 is expected to be submitted in the second half of 2025 [1]