Puzolcabtagene Autoleucel: First Approval

Funding The preparation of this review was not supported by any external funding. DeclarationsAuthorship and Conflict of interest Yahiya Y. Syed is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicableAdditional information about this Adis Drug Review can be found here AbstractPuzolcabtagene autoleucel [普利得凯®] is an autologous, humanized anti-CD19 chimeric antigen receptor (CAR) T-cell therapy developed by Chongqing Precision Biotech for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), B-cell leukemia and lymphoma, and non-Hodgkin lymphoma. CAR T-cell therapy is a personalized immunotherapy in which a patient’s own T cells are genetically engineered to recognize and eliminate malignant cells through direct cytotoxicity, induction of apoptosis, and TNF ligand-mediated signaling pathways. To reduce immunogenicity, puzolcabtagene autoleucel incorporates a humanized CD19-specific single-chain variable fragment. On 4 November 2025, puzolcabtagene autoleucel received its first approval in China for the treatment of CD19+ relapsed or refractory (R/R) B-ALL in patients aged 3–21 years. This article summarizes the key developmental milestones leading to this first approval. © Springer Nature Switzerland AG 2026