China's First CAR-T Therapy for Pediatric Leukemia, PujiLunsa Injection (pCAR-19B), Receives NDA Acceptance from NMPA
Precision Biotech
Gene and Cell Therapy Developer
July 23, 2024
eMedClub News
On July 22, Chongqing Precision Biotech Co., Ltd. (hereinafter referred to as "Precision Biotech"") announced that its self-developedChina's Class I biological new drug pCAR-19B Cell Autologous Infusion Preparation (Pucilencer Injection) NDA Accepted by National Medical Products Administration (NMPA)This product is the first CAR-T product in China specifically targeting childhood leukemia, used to treat patients aged 3-21 with CD19-positive relapsed/refractory acute lymphoblastic leukemia (ALL).
Leukemia is one of the most common malignant tumors globally, with both the total number of cases and the annual increase showing an upward trend. Among them, acute lymphoblastic leukemia (ALL) is the most common malignant tumor in children, with an incidence rate of about (3-5)/100,000. It is also one of the main diseases causing death in children and adolescents, of which B-ALL accounts for approximately 80% of ALL.The successful acceptance of the pCAR-19B NDA makes it有望成为中国在该治疗适应症首个上市的创新生物药.
In addition, Precision Biotech has developed a treatment product for adult leukemia targeting hematological tumors, which has now entered Phase II clinical research. MC-1-50, developed on the short-term and highly efficient preparation platform PRIMCAR® and targeting CD19, is currently undergoing Phase I clinical trials for two indications at Peking University Cancer Hospital and Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine. C-13-60 is China's first CAR-T product targeting CEA to enter registrational clinical trials, and C-4-29 is the first domestically produced product with dual applications for both hematological and solid tumors.Accelerating Innovation in Malignant Tumor Treatment.
pCAR-19B, optimized for the Chinese population, enhances the structure of the Chimeric Antigen Receptor (CAR) and employs a safer gene transduction vector system, resulting in improved efficacy and safety. Data from the Phase I clinical trial showed that all 9 enrolled patients achieved complete remission (CR), with an overall response rate of 100%. Additionally, minimal residual disease (MRD) was negative in all patients who first achieved CR. No dose-limiting toxicity (DLT) or treatment-related deaths occurred, demonstrating favorable overall safety and tolerability.
pCAR-19B Research Milestones
eMedClub
In February 2019, pCAR-19B was approved by the National Medical Products Administration (NMPA) to commence clinical trials, marking China's first CAR-T registrational clinical trial for children and adolescents with B-cell acute lymphoblastic leukemia.
In November 2019, the Phase I clinical trial of pCAR-19B was launched at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
In January 2022, the Phase II clinical trial of pCAR-19B 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. The clinical trial was subsequently conducted in the hematology departments of more than 10 tertiary hospitals across China, aiming to better evaluate the efficacy and safety of pCAR-19B.
In November 2023, pCAR-19B, the first CAR-T product in China for treating childhood leukemiaApproved for inclusion in the "Breakthrough Therapy Designation" list.
In June 2024, pCAR-19B Autologous Cell Infusion Preparation (Pujilun Injection)Proposed inclusion in the "Priority Review Category", for the treatment of CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia patients aged 3 to 21.
The "last mile" of product launch is the endpoint, as well as the starting point!pCAR-19B is the first NDA-accepted indication product of Chongqing Precision Biotech Co., Ltd., marking a historically significant milestone for the company.In the next 3-5 years, with more new drugs being approved for marketing, Chongqing Precision Biotech Co., Ltd. will provide more innovative drugs that are accessible, affordable, and effective for patients in China and even globally!
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