今日（12月29日），科济药业宣布已向国家药监局提交通用型BCMA CAR-T产品CT0596的两项新药临床试验申请，拟分别启动针对复发/难治性多发性骨 髓瘤及原发性浆细胞白血病的Ib/Ⅱ期注册临床研究。 这是科济药业在通用型CAR-T细胞治疗研发进程中的又一重要进展。 01 "功能性治愈"突围之路 多发性骨髓瘤（MM）是血液系统第二大常见恶性肿瘤，随着人口老龄化，其发病率持续上升。尽管近年来蛋白酶体抑制剂、免疫调节剂以及抗CD38单 抗等靶向药物的陆续问世，显著延长了初治患者的生存期，推动了MM治疗格局的迭代，但该疾病仍被认为无法根治。绝大多数患者会经历多次复发，且 随着治疗线数后移，缓解期逐渐缩短，治疗选择日益匮乏。 当前，多发性骨髓瘤新药研发的核心目标是推动疾病达到更深层次的缓解，实现深度且持久的疾病缓解，对改善患者长期生存具有重要意义。CAR-T疗 法，因其有望实现更深、更持久的缓解，甚至推动疾病走向"功能性治愈"，被视为更具突破潜力的武器。与传统药物相比，CAR-T不仅能够高效清除肿瘤 细胞，还可能重建长期免疫记忆。 然而，现有自体CAR-T疗法仍存在明显瓶颈，例如，个性化制备周期长达数周甚至更久， ...

Core Viewpoint - The event hosted by Kexi Pharmaceutical highlighted the company's advancements in CAR-T cell therapy, its core industry layout, and future development plans, showcasing its competitive strengths and industry prospects [1]. Group 1: CAR-T Technology Development - Kexi Pharmaceutical focuses on addressing key challenges in CAR-T therapy, including immune rejection, low patient accessibility, and balancing efficacy with safety [4]. - The company aims to prioritize clinical needs by targeting difficult-to-treat cancers such as pancreatic cancer and leukemia, while also optimizing technology to reduce treatment costs and improve patient access [4]. - Kexi is developing multi-target universal CAR-T candidates that cover solid tumors, hematological cancers, and autoimmune diseases, involving multiple key targets [4]. Group 2: Production and Operational Strategy - The company plans to establish an integrated intelligent cell manufacturing center capable of producing both autologous and allogeneic CAR-T cells, with an expected annual capacity to serve tens of thousands of patients [4]. - Kexi aims to focus on process automation, management information systems, and supply chain collaboration to continuously lower production costs and enhance product quality [5]. Group 3: Business Development and Strategic Partnerships - Kexi Pharmaceutical has seen a surge in business development (BD) transactions, which have become a significant revenue source for biopharmaceutical companies [5]. - The company emphasizes that the success of BD partnerships relies on product competitiveness and corporate strength rather than external factors, maintaining strong relationships with multinational companies [5]. - Kexi has strategically invested in Ukaize Biomedical (Shanghai) Co., Ltd., enhancing its ecosystem in cell therapy and laying a solid foundation for future technological collaboration and industry expansion [5].