Another Domestic CAR-T Therapy Approved in China for Pediatric Leukemia: Pucabtagene Autoleucel (Pulidekai®)
Precision Biotech
Gene and Cell Therapy Developer
According to the Insight database, Pujilun Race by Precision Biotech isThe First in ChinaCAR-T Product Approved for Marketing to Treat Childhood Leukemia。
As of April 18, 2024, a total of 89 patients were enrolled and underwent leukapheresis, among which 64 received pCAR-19B infusion. There were no manufacturing failures. Among the infused patients, 6.25% were refractory, and 93.75% had relapsed, requiring multi-line treatments or allogeneic stem cell transplantation. The median age of the patients was 11 years.(Age range: 3-21 years), 56.25% were male. Additionally, 75% of the patients carried at least one high-risk gene. The median baseline bone marrow blast load was 58.3%, and 56.25% of the patients had a higher bone marrow blast load.（≥50%）。
Median follow-up of 211 days,The best ORR was 90.63%, with 78.13% of patients achieving CR and 12.5% achieving CRi, surpassing the efficacy reported by currently commercialized anti-CD19 CAR-T therapy products in R/R B-ALL.
In addition,98.27% of ORR patients achieved negative minimal residual disease.（MRD）Negative Remission。The ORR at 3 months was 76.56%. Median duration of response（DOR）10.61 months, median overall survival（OS）For 23.92 months.
In terms of safety, cytokine release syndrome (CRS) Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS) Occurred in 98.44% and 50% of patients, respectively. ≥3 grade CRS and ICANS occurred in 29.69% and 39.06% of patients, respectively. The median durations of ≥3 grade CRS and ICANS were 4 days and 3 days, respectively. No deaths caused by CRS or ICANS were reported.
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, 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 leading causes of death in children and adolescents, where B-ALL accounts for approximately 80% of ALL cases.
According to the Insight database, four CAR-T products targeting CD19 have been approved for marketing in China, including the product introduced by Fosun Kite.Axicabtagene Ciloleucel, JW Biologics'Relmacabtagene Autoleucel, Heyuan Biotech'sNaciorlen, and Hengrunda Sheng'sRanimilust。Chongqing Precision Biotech Co., Ltd.PukilunsaiIs the 5th approved product in ChinaCD19 CAR-T Product.
Insight Database Compiled the 2025 Global New Drug Approval and Market Launch List(Updated once at the beginning of each month, currently updated to October)，Scan the QR code below and reply with the keywordNew Drug ApprovalCan be obtained for free.
