科济药业-B(02171)发布公告，将于第67届美国血液学会年会上展示CT0596(一种靶向BCMA的同种异体 CAR-T细胞候选产品)的临床数据。摘要和进一步信息将于美国东部时间2025年11月3日后公布。 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，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。公司预估2025年下半年提交该品种的IND申请。 ...

Core Viewpoint - The article discusses the promising results of a phase 1 clinical trial combining CD19-targeting and BCMA-targeting CAR-T cell therapies for treatment-refractory systemic lupus erythematosus (rSLE), highlighting its safety and potential clinical efficacy [2][3][8]. Group 1: Clinical Trial Overview - A phase 1 clinical trial was conducted to evaluate the co-infusion of CD19-targeting and BCMA-targeting CAR-T cells in rSLE patients, showing good safety and promising clinical efficacy [3][8]. - The trial involved 15 patients (14 females and 1 male) who had previously undergone lymphocyte-depleting therapy [6]. Group 2: Safety and Efficacy Results - During a median follow-up of 712 days, no dose-limiting toxicities were observed, with 86.7% of patients experiencing grade 1 cytokine release syndrome, and no neurotoxicity or treatment-related deaths reported [7]. - By week 12, 80% of patients achieved low disease activity status (LLDAS) and DORIS remission criteria, indicating significant improvement in immune homeostasis [9]. Group 3: Mechanistic Insights - The study identified that CD19⁺ B cells and CD19⁻ BCMA⁺ long-lived plasma cells were the main sources of autoantibodies in rSLE patients, supporting the rationale for dual-targeting therapy [6]. - Multi-omics analysis confirmed the elimination of autoreactive CD19⁺ BCMA⁺ clones and the restoration of initial IgM/IgD B cells, suggesting a durable downregulation of interferon-stimulated and BAFF-dependent features [9].

赛恺泽® I期临床试验更新结果已于多伦多时间2025年9月17日早上，在第22 届IMS年会上进行壁报展 示，标题为"复发╱难治性多发性骨髓瘤患者接受 zevor-cel治疗的长期随访"("Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma")。 赛恺泽®是一种用于治疗多发性骨髓瘤(MM)的全人抗自体BCMA CAR-T细胞产品。国家药品监督管理 局于2024年2月23日批准赛恺泽®新药上市申请，用于治疗复发或难治性多发性骨髓瘤成人患者，既往 经过至少3线治疗后进展(至少使用过一种蛋白酶体抑制剂及免疫调节剂)。泽沃基奥仑赛注射液于2019 年获得美国 FDA的再生医学先进疗法(RMAT)及孤儿药称号。 科济药业-B(02171)发布公告，赛恺泽®(泽沃基奥仑赛注射液，产品编号： CT053，一种靶向BCMA的 自体CAR-T细胞产品)的长期随访更新结果已在第 22届国际骨髓瘤学会年会上进行壁报展示。 ...

科济药业-B(02171)发布公告，赛恺泽(泽沃基奥仑赛注射液，产品编号：CT053，一种靶向BCMA的自 体CAR-T细胞产品)的长期随访更新结果已在第22届国际骨髓瘤学会年会上进行壁报展示。 赛恺泽I期临床试验更新结果已于多伦多时间2025年9月17日早上，在第22届IMS年会上进行壁报展示， 标题为"复发╱难治性多发性骨髓瘤患者接受zevor-cel治疗的长期随访"("Long term Follow-up of Zevor- cel in Patients with Relapsed/Refractory Multiple Myeloma")。 赛恺泽是一种用于治疗多发性骨髓瘤(MM)的全人抗自体BCMA CAR-T细胞产品。国家药品监督管理局 于2024年2月23日批准赛恺泽新药上市申请，用于治疗复发或难治性多发性骨髓瘤成人患者，既往经过 至少3线治疗后进展(至少使用过一种蛋白酶体抑制剂及免疫调节剂)。泽沃基奥仑赛注射液于2019年获 得美国FDA的再生医学先进疗法(RMAT)及孤儿药称号。 ...

Core Viewpoint - The long-term follow-up results of the CAR-T cell product Zevor-cel (赛恺泽®) for treating relapsed/refractory multiple myeloma were presented at the 22nd International Myeloma Society Annual Meeting [1] Group 1: Product Information - Zevor-cel is an autologous CAR-T cell product targeting BCMA, specifically designed for the treatment of multiple myeloma (MM) [1] - The product received approval from the National Medical Products Administration on February 23, 2024, for use in adult patients with relapsed or refractory multiple myeloma who have progressed after at least three lines of treatment [1] - Zevor-cel was granted Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designation by the FDA in 2019 [1] Group 2: Clinical Trial Updates - The updated results of the Phase I clinical trial were presented on September 17, 2025, at the IMS annual meeting, focusing on long-term follow-up for patients treated with Zevor-cel [1] - The presentation was titled "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" [1]

Core Viewpoint - The article discusses the potential of engineered long-lived CAR-T cells as a delivery platform for biologics, particularly for chronic diseases requiring long-term treatment, highlighting the advantages of a single-dose, long-lasting therapeutic approach [2][3][15]. Group 1: Challenges of Current Biologics - Recombinant proteins, while effective in treating various diseases, have a short half-life in the body, necessitating repeated injections for chronic conditions [2]. - GLP-1 drugs, such as semaglutide and tirzepatide, require weekly injections to maintain their effects, leading to potential weight regain upon discontinuation [2]. - Repeated infusions of peptide/protein biologics can lead to the formation of immune responses, reducing efficacy and potentially causing immunopathological issues [2]. Group 2: Innovations in Delivery Platforms - The research team from Tsinghua University developed long-lived CAR-T cells as a novel delivery platform for biologics, achieving stable delivery of GLP-1 in animal models with a single infusion [3][14]. - Previous methods using AAV vectors for delivering therapeutic proteins have limitations due to their short duration of effect, typically less than two years [5]. - CAR-T cells have shown promise in treating rare diseases, functioning as "living" drugs that can replicate and survive in the body, potentially achieving long-term efficacy [5]. Group 3: Recent Research Developments - The team created immortal-like functional T cells (T IF cells) through gene editing, which can exist safely in the body for extended periods and provide long-term tumor relief [6]. - Further modifications to T IF cells allowed for the targeting and elimination of eosinophils, providing a potential long-term treatment for allergic asthma with a single injection [9]. - The GD2T IF cells were engineered to deliver GLP-1, effectively controlling weight and blood sugar levels in obese mice with a single infusion, achieving "cure" indicators [14][15]. Group 4: Practical Considerations for CAR-T Cell Therapy - For CAR-T cells to be a practical delivery platform for chronic disease biologics, three conditions must be met: elimination of chemotherapy preconditioning, long-term maintenance of sufficient CAR-T cell numbers, and careful selection of targets to avoid damage to normal cells [11][12][13]. - The GD2 target was chosen due to its overexpression in certain tumors and minimal expression in normal tissues, showing good efficacy in clinical trials without significant off-target effects [13]. Group 5: Future Implications - The research indicates that the engineered GD2T IF cells could serve as a reliable platform for stable production of biologics, offering a one-time treatment solution for chronic diseases [15]. - Although current CAR-T cell therapies are costly, the expectation is that as prices decrease, this method will become more cost-effective compared to repeated injections of biologics [15].

Group 1 - Stansai Biotech has successfully completed the key dose escalation trial of its GCC19CART for patients with refractory metastatic colorectal cancer in the United States [1][2] - The trial involved 12 participants, with 6 (54.5%) achieving objective response, and at the higher dose level of 2×10^6 CAR-T cells/kg, 4 out of 5 (80%) patients achieved objective response with a median duration of response of 6.9 months [1][2] - The company aims to discuss the next steps for clinical development of GCC19CART with the FDA, targeting colorectal cancer and other solid tumors expressing GCC [2][3] Group 2 - GCC19CART is developed based on Stansai's proprietary CoupledCAR platform technology, specifically targeting colorectal cancer and showing unprecedented anti-tumor activity in difficult-to-treat cases [2] - The company has achieved a 100% success rate in its Maryland manufacturing facility, ensuring seamless scalability for future clinical and commercial production needs [2] - Stansai is also expanding its product pipeline to include other solid tumors, such as prostate cancer, with promising clinical activity demonstrated in its PAP CAR-T product [3]

Group 1 - The stock price of Boteng Co., Ltd. closed at 23.68 yuan on August 5, 2025, down by 0.10 yuan, a decrease of 0.42% from the previous trading day [1] - The trading volume on that day reached 5.53 billion yuan, with a turnover rate of 4.65% [1] - A rapid rebound occurred at 1 PM, with a price increase of over 2% within 5 minutes, peaking at 24.18 yuan [1] Group 2 - Boteng Co., Ltd. operates in the chemical pharmaceutical industry, focusing on custom research and development production services for pharmaceuticals [1] - The company is registered in Chongqing and is involved in areas such as weight loss drugs and CAR-T cell therapy [1] - On August 5, the net outflow of main funds was 18.52 million yuan, with a cumulative net outflow of 318 million yuan over the past five days [1]

Core Viewpoint - The article highlights the recent financial activities and market performance of Shanghai Yinos Biotech Co., Ltd., including its financing activities and stock performance trends [1]. Financing Activities - Yinos received a net financing inflow of 18.91 million yuan last week, ranking 412th in the market [1]. - The total financing amount for the week was 123 million yuan, while the repayment amount was 104 million yuan [1]. Market Performance - Over the past 5 days, the main capital outflow from Yinos was 3.33 million yuan, with a price decline of 0.43% [1]. - In the last 10 days, the main capital inflow was 27.64 million yuan, resulting in a price increase of 1.88% [1]. Company Overview - Shanghai Yinos Biotech Co., Ltd. was established in 2010 and is located in Shanghai, primarily engaged in technology promotion and application services [1]. - The company has a registered capital of 1.41 billion yuan and a paid-in capital of 1.06 billion yuan [1]. - The legal representative of the company is Chang Yan [1]. Investment and Intellectual Property - Yinos has invested in 3 external companies and participated in 68 bidding projects [1]. - The company holds 15 trademark registrations and 79 patents, along with 223 administrative licenses [1].

Core Viewpoint - Japan's regenerative medicine and related products are lagging behind the US and Europe in practical applications, with significant investments planned to enhance production capabilities by 2027 [1][2]. Group 1: Investment Plans - Nikon and four other Japanese companies plan to invest over 100 billion yen by 2027 to significantly increase production of iPS cell products and other advanced pharmaceuticals [1][2]. - Nikon will invest approximately 10 billion yen to expand its production base in Koto, Tokyo, increasing the cleanroom area by 50% and tripling its workforce by 2030 [2]. - AGC plans to invest 50 billion yen in its Yokohama facility to set up production equipment for regenerative medicine cells, with potential for mRNA vaccine production if necessary [2]. Group 2: Market Position and Challenges - The US has approved 25 drugs in the gene and CAR-T fields, Europe 22, while Japan has only 10, indicating a significant gap in production capabilities [1][2]. - Japan's domestic companies have a weak production foundation, which could hinder access to advanced medical treatments and reduce the competitiveness of the Japanese pharmaceutical industry [1][2]. Group 3: Government Support - The Japanese government will provide 38.3 billion yen in subsidies over four years to support equipment investment and talent development for CDMO in regenerative medicine [3]. - Emerging companies, such as SanBio and Cuorips, are seeking conditional production and sales licenses for their regenerative medicine products, indicating a growing interest in this sector [3]. Group 4: Market Growth Potential - The market for regenerative medicine products in Japan is projected to reach 53.8 billion yen by 2030, doubling from approximately 2024 levels [3].