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On November 10, the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration announced that the pCAR-19B autologous cell infusion preparation (hereinafter referred to as pCAR-19B), submitted by Chongqing Precision Biotech Co., Ltd., has been approved for inclusion in the "Breakthrough Therapy Designation." It is indicated for the treatment of patients aged 3 to 21 years with CD19-positive relapsed/refractory acute lymphoblastic leukemia (B-ALL). The product is expected to be launched in 2024.
Currently, there are no CAR-T products approved in China for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia in children and adolescents. As the first domestically produced CAR-T product for this indication to enter pivotal clinical trials, pCAR-19B has been included in the breakthrough therapy evaluation process based on its remarkable clinical efficacy and patient benefits demonstrated in its registrational clinical study, significantly improving the objective response rate compared to existing treatments.Currently, the pivotal clinical study of pCAR-19B has reached its primary endpoint. We look forward to the disclosure of more meaningful results related to pCAR-19B and its accelerated availability under China's breakthrough therapy designation, providing an effective new option for pediatric and adolescent patients with relapsed/refractory B-cell acute lymphoblastic leukemia.pCAR-19B, independently developed by Chongqing Precision Biotech Co., Ltd., is protected by an invention patent. It is a cellular immunotherapy product designed for the treatment of malignant hematological diseases originating from CD19-positive B cells and represents the first humanized CAR-T product in China targeting this indication. It also employs a safer gene transduction vector system, enhancing both its efficacy and safety.In February 2019, pCAR-19B received the implied permission for clinical trials as a Class I biological new drug from the National Medical Products Administration.In November 2019, the Phase I clinical study was officially launched at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, with Professor Zhou Jianfeng serving as the PI (Principal Investigator). This registration trial is also the first CAR-T registration clinical trial in China targeting B-cell acute lymphoblastic leukemia in children and adolescents. Data from the Phase I clinical trial showed that all 9 enrolled patients achieved complete remission (CR), with an overall response rate of 100%. Moreover, minimal residual disease (MRD) was negative in all patients who achieved CR for the first time. No dose-limiting toxicity (DLT) or treatment-related deaths occurred, indicating good overall safety and tolerability.In February 2022, the Phase II pivotal clinical trial was officially launched at Beijing Children's Hospital affiliated with Capital Medical University and Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology. Professor Wang Tianyou and Professor Huang Liang served as the leading principal investigators (leading PI) of the clinical trial. The trial has since been carried out in the hematology departments of more than 10 tertiary hospitals across China, aiming to better evaluate the efficacy and safety of pCAR-19B.Currently, Precision Biotech has obtained tacit approval for four CAR-T cell class I biological new drugs and seven indications. The registration clinical trials are proceeding smoothly and have achieved excellent clinical data. pCAR-19B is not only aimed at patients aged 3-21 with CD19-positive relapsed/refractory B-ALL, but also approved in China to conduct clinical research on other indications, including: patients aged 22-70 with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia; patients aged 75 and below with relapsed/refractory CD19-positive diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma.The company has independently developed core technologies in the field of cell therapy and mastered key technologies such as immune cell therapy (multi-target CAR-T, universal CAR-T, solid tumor CAR-T, efficient production of CAR-T), stem cell therapy, and gene therapy. It has laid out more than ten product research and development pipelines for leukemia, lymphoma, myeloma, renal cancer, colorectal cancer, lung cancer, breast cancer, etc., and has obtained four Class I biological new drug approvals for CAR-T cells and seven indications (including solid tumors) for registered clinical trials.
Source of the article:Precision Biotech
