Beijing, China — November 7, 2025 — Chongqing Precision Biotech Co., Ltd. today announced that Puzolcabtagene Autoleucel Injection (pCAR-19B) has received marketing approval from the National Medical Products Administration (NMPA).

This product becomes the first CAR-T authorized in China specifically for the treatment of pediatric and adolescent patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). Puzolcabtagene Autoleucel includes a humanized anti-CD19 binding domain. By incorporating humanization technologies optimized for MHC responsiveness in Chinese populations, pCAR-19B is designed to reduce immunogenicity and minimize the likelihood of anti-drug antibody (ADA) formation—thereby mitigating risks associated with HAMA responses.    

The clinical development of pCAR-19B followed a single-arm, open-label study design. Phase 1 was led by Prof. Zhou Jianfeng at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, serving as Principal Investigator (PI). Phase 2 pivotal study was co-led by Prof. Wang Tianyou of Beijing Children’s Hospital, Capital Medical University, and Prof. Zhang Yicheng of Tongji Hospital, in collaboration with more than ten top tertiary hospitals in China.

Clinical Outcomes

As of April 18th, 2024, a total of 64 patients with highly refractory disease characteristics were enrolled with a median follow-up of 211 days:

· Median age: 11 years (range: 3–21)

· 75% carried at least one high-risk prognostic gene

· 56.25% had high bone marrow tumor burden (≥50% blasts)

Key efficacy outcomes included:

· Best CR/CRi rate within 3 months: 90.63% (58/64), with 78.13% of patients (50/64) achieving CR and 12.5% of patients (8/64) achieving CRi

· Among CR/CRi responders, MRD-negative rate reached 98.27%

· At 3 months, CR/CRi was maintained in 76.56% (49/64) of patients; median overall survival (OS) reached 23.92 months (95% CI: 9.86–NR) 

“For children who have exhausted available lines of therapy, Puzolcabtagene Autoleucel opens a new window of possibility,”said Prof. Wang Tianyou, Beijing Children’s Hospital, Capital Medical University, leading Principal Investigator of this pivotal program.“We hope it will soon benefit a broader patient population.”

“The development of Puzolcabtagene Autoleucel involved a total R&D investment of approximately 300 million RMB and the efforts of over 300 researchers. From target discovery to technical breakthroughs and final industrialization, our team conducted more than a thousand process optimizations and addressed dozens of technical challenges,”said Prof. Qian Cheng, Chairman and Chief Scientist of Chongqing Precision Biotech. “The approval of Puzolcabtagene Autoleucel marks a milestone in our development program. We plans to accelerate the translation of additional innovative pipelines for hematologic and solid tumors, aiming to provide expanded treatment options for patients with malignancies.”

About Chongqing Precision Biotech

Founded in January 2016 by Prof. Qian Cheng and a core technical team in partnership with Zhifei Biological Group (Zhiyuan Investment), Chongqing Precision Biotech Co., Ltd. is a high-tech company focused on the research, development, and application of gene and cell therapies. The company currently has a research team of over 300 members, equipped with more than 3,000 advanced instruments, and has established an 18,000 m² integrated R&D and manufacturing platform. A regional cell manufacturing center covering 100,000 m² is under construction, forming a complete biopharmaceutical industrial system integrating R&D and production.

Chongqing Precision Biotech has developed a comprehensive cell therapy technology portfolio covering both personalized and universal products. In addition to pipelines for hematologic malignancies and solid tumors, the company is advancing next-generation point-of-care CAR-T manufacturing and in vivo production technologies, and is exploring oncolytic viruses and gene therapy approaches. The company has established six core technology platforms:

· PSIONCAR Platform – humanized structure and high-efficacy 

· PRIMCAR Platform – for enhanced safety and durability

· UCAR-T and CAR-NK platforms– for convenience and high uniformity

· HyeCAR platform – for multi-antigen recognition and relapse prevention

· PhiCAR platform– to overcome tumor physical microenvironment barriers

The company’s more than ten ongoing pipelines cover three major areas: solid tumors, hematologic malignancies, and autoimmune diseases. The company has obtained regulatory approval in China for four Class I biologics covering ten indications, making it one of the leading innovative biopharma companies in the country.

The company boasts end-to-end independent capabilities for the development, production, and testing of plasmids, vectors, and cells—enabling simultaneous R&D and manufacturing of 5-6 projects annually. It continues to refine both its standard (14-day) and fast (2-day) manufacturing processes, driving down production costs to make CAR-T therapies more affordable and accessible to patients.

Chongqing Precision Biotech has established collaborations with international institutions, including the Perez Scremini Foundation and the University of Navarra, Spain. The company plans to establish branches in developed regions such as Europe, America, and Japan to support its global CAR-T product registration, broaden technical services, and pursue worldwide license-out deals，aiming to expand access to CAR-T therapies for patients worldwide.

References：

[1] A Phase 2 Clinical Trial of Anti-CD19 CAR-T (pCAR-19B) in Chinese Pediatric and Young Adult with Relapsed/Refractory (R/R) CD19+ B-ALL: The First Pivotal Study in an Asian Population. https://doi.org/10.1182/blood-2024-206408

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