坐落在高新区的合源生物科技股份有限公司，是国内免疫细胞治疗创新药研发和产业化领域的领军企 业，公司首款产品"源瑞达"填补了成人急性淋巴细胞白血病治疗的空白，去年11月，其治疗淋巴瘤的新 适应症获批，成为国内目前唯一覆盖白血病与淋巴瘤两大血液肿瘤适应症的CAR-T（嵌合抗原受体T细 胞）产品。 "公司的快速发展，离不开高新区这片创新沃土所提供的全方位、系统性支持。比如，围绕企业全生命 周期，高新区提供了从事前咨询、事中协调到事后服务的全方位创新服务，让我们成功取得了京津冀地 区首张细胞领域《药品生产许可证》。此外，高新区产业引导基金参与公司多轮融资，人才引进、评价 激励等方面的创新举措，帮助我们吸引了海内外顶尖科研人才。"合源生物政府事务总监朱瑞贺表示， 接下来，企业将在拓展适应症、扩增产能、推进全球布局等领域持续深耕。 眼下，高新区聚集了100余家细胞及基因治疗产业链上下游企业，形成了包含细胞提取制备、细胞存 储、冷链物流、创新研发、小试中试、审评审批、临床应用等环节的全产业链。此外，在创新药物、医 疗器械、医药服务等领域多点开花，产业实力稳步提升。 （来源：天津日报） 转自：天津日报 本报讯（记者 马晓冬） ...

Core Viewpoint - The National Healthcare Security Administration (NHSA) has completed the expert review for the 2025 National Basic Medical Insurance (BMI) catalog and the commercial insurance innovative drug catalog, marking the eighth adjustment since its establishment and the first inclusion of a commercial insurance innovative drug catalog [1][2]. Group 1: CAR-T Products Approval - Five CAR-T products have successfully passed the expert review and will be included in both the basic medical insurance and commercial insurance innovative drug catalogs, laying the groundwork for future negotiations and access [1][2]. - The approval of these CAR-T products is seen as a positive signal, indicating the regulatory body's commitment to improving access to cutting-edge therapies [1][3]. - The review process emphasized the innovation level, efficacy, and the ability to fill treatment gaps, with CAR-T therapies receiving unanimous approval [2][5]. Group 2: Impact on Patients and Companies - The introduction of the commercial insurance innovative drug catalog is expected to significantly reduce out-of-pocket expenses for patients, making high-cost CAR-T treatments more accessible [3][4]. - Companies view the catalog as a "second channel" for innovative drugs, alleviating pricing pressure during negotiations with basic medical insurance and potentially expanding market share [4][5]. - The collaboration between pharmaceutical companies and insurance providers is anticipated to evolve towards deeper cooperation, exploring mechanisms like outcome-based payments and risk-sharing [4][5]. Group 3: Future Outlook - Companies express cautious optimism regarding the inclusion of CAR-T products in the commercial insurance innovative drug catalog, supported by policy direction, clinical value, and practical experience [5][6]. - The ongoing expansion and optimization of the commercial insurance catalog are expected to further benefit patients in need of CAR-T therapies [6].

Core Insights - The article highlights the revolutionary impact of CAR-T therapy in treating adult relapsed acute B lymphoblastic leukemia (B-ALL), showcasing a successful case where a patient achieved complete remission after treatment [1][4][7] Group 1: CAR-T Therapy Development - The first CAR-T therapy for adult relapsed B-ALL in China, "Nakiolun", was approved in 2023, filling a significant gap in immunotherapy options for this patient population [2][4] - CAR-T therapy has shown high efficacy, with a reported objective response rate (ORR) of 82.1% and a minimal residual disease (MRD) negative rate of 100% within three months of treatment [4][6] Group 2: Patient Outcomes and Survival Rates - Adult patients with relapsed B-ALL have a median overall survival of only 2-6 months, with a 5-year survival rate below 10% [3][6] - CAR-T therapy offers a promising alternative, as evidenced by a patient who, after traditional treatments failed, achieved long-term remission through CAR-T, highlighting its potential to improve survival outcomes significantly [3][7] Group 3: Challenges and Future Directions - Despite its effectiveness, CAR-T therapy faces challenges such as being used only as a last resort after exhausting other treatment options and its high cost, approximately 1.2 million yuan (around 120,000 USD) [6][7] - There is a clinical ambition to reposition CAR-T therapy from a last-line treatment to an earlier intervention for patients with first relapse or MRD positivity, which could potentially replace traditional stem cell transplants [7]