此举紧密配合公司多款CAR-T细胞治疗产品的商业化进程，包括已上市的赛恺泽®及处于新药上市申请阶段的实体瘤 CAR-T细胞治疗产品舒瑞基奥仑赛注射液（研发代号"CT041"，拟定商品名"恺力美™"），并为多款通用型CAR-T细 胞治疗产品（如CT0596、CT1190B等）的未来量产奠定基础。在此背景下，提升符合国际标准的CAR-T细胞治疗产能 成为支撑多个产品商业化落地及增强全球竞争力的核心举措。此次交易中，本公司早期无需进行大额资本开支，有效 保留了宝贵现金流用于核心研发与市场拓展。同时，回购机制确保本公司在长期运营后可完整取得资产控制权，既维 持了生产稳定性，又强化了资产布局的灵活性。 （科济药业公众号） 2月13日，科济药业发布公告称，，公司透过其间接全资附属公司上海恺兴诊断技术有限公司，与上海市金山区湾区 高新区的重要平台企业——上海金工企业发展有限公司签署战略合作协议，总投资额不超过人民币3.7亿元，将在上海 市金山区建设先进的CAR-T细胞治疗产品商业化生产基地。 ...

科济药业-B(02171)发布公告，于2026年2月12日(交易时段后)科济药业控股有限公司透过其间接全资附 属公司上海恺兴诊断技术，与上海市金山区湾区高新区的重要平台企业——上海金工企业发展签署战略 合作协议，总投资额不超过人民币3.7亿元，将在上海市金山区建设先进的CAR-T细胞治疗产品商业化 生产基地。此举紧密配合本公司多款CAR-T细胞治疗产品的商业化进程，包括已上市的赛恺泽及处于新 药上市申请阶段的实体瘤CAR-T细胞治疗产品舒瑞基奥仑赛注射液(拟定商品名：恺力美TM)，并为多 款通用型CAR-T细胞治疗产品(如CT0596、CT1190B等)的未来量产奠定基础。在此背景下，提升符合国 际标准的CAR-T细胞治疗产能成为支撑多个产品商业化落地及增强全球竞争力的核心举措。此次交易本 公司早期无需进行大额资本开支，有效保留了宝贵现金流用于核心研发与市场拓展。同时，回购机制确 保本公司在长期运营后可完整取得资产控制权，既维持了生产稳定性，又强化了资产布局的灵活性。总 体来看，此次合作彰显了本公司稳健的财务规划和对CAR-T细胞治疗产业生态系统的深度布局，也表明 该项目高度契合国家及地方的生物医药产业政策， ...

格隆汇2月13日丨科济药业-B(02171.HK)发布公告，2026年2月12日，科济药业控股有限公司透过其间接 全资附属公司上海恺兴诊断技术，与上海市金山区湾区高新区的重要平台企业——上海金工企业发展签 署战略合作协议，总投资额不超过人民币3.7亿元，将在上海市金山区建设先进的CAR-T细胞治疗产品 商业化生产基地。 此举紧密配合公司多款CAR-T细胞治疗产品的商业化进程，包括已上市的赛恺泽®及处于新药上市申请 阶段的实体瘤CAR-T细胞治疗产品舒瑞基奥仑赛注射液(拟定商品名：恺力美TM)，并为多款通用型 CAR-T细胞治疗产品(如CT0596、CT1190B等)的未来量产奠定基础。在此背景下，提升符合国际标准的 CAR-T细胞治疗产能成为支撑多个产品商业化落地及增强全球竞争力的核心举措。此次交易公司早期无 需进行大额资本开支，有效保留了宝贵现金流用于核心研发与市场拓展。同时，回购机制确保本公司在 长期运营后可完整取得资产控制权，既维持了生产稳定性，又强化了资产布局的灵活性。 总体来看，此次合作彰显了公司稳健的财务规划和对CAR-T细胞治疗产业生态系统的深度布局，也表明 该项目高度契合国家及地方的生物医药产 ...

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]

Core Insights - Kintor Pharmaceutical's CT0596 shows promising results in early clinical trials for relapsed/refractory multiple myeloma patients, demonstrating strong anti-tumor activity and good safety profiles [2][3] Clinical Trial Results - The Phase I clinical trial included 8 patients with a median of 4.5 prior treatment lines, indicating a complex and heavily pre-treated population [2] - Overall response rate is high, with 6 out of 8 evaluable patients achieving partial response (PR) or better; 5 of 6 patients receiving full-dose lymphodepletion achieved PR or better, all reaching minimal residual disease (MRD) negativity by week 4 [3] - Three patients achieved stringent complete response (sCR), with one patient maintaining sCR and MRD negativity at 8 months [3] Safety Profile - CT0596 exhibited excellent safety characteristics, with only 4 patients experiencing grade 1 cytokine release syndrome (CRS) and no severe CRS observed [4] - No immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GVHD) was reported, and no dose-limiting toxicities were observed [4] Future Plans - The trial is still in the dose exploration phase, with plans to explore higher cell dosing to determine the recommended dose [4] - The company aims to initiate Phase IB registration clinical studies for CT0596 in 2026 based on encouraging preliminary data [4]

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]