Recently, Shenzhen Cell Valley Biopharmaceutical Group Co., Ltd. has received a Master File Acknowledgement Letter issued by the Center for Biologics uation and Research of the U.S. Food and Drug Administration (FDA CBER). The letter confirms that FDA CBER has accepted the Type II Master File submitted by the company and assigned the file number MF 32802, titled Master File Type II – Human Peripheral Blood-Derived NK Cell Preparation.

This achievement marks substantial progress made by Shenzhen Cell Valley in NK cell preparation techniques, quality control, batch management and the development of an international CMC documentation system, laying solid compliance foundations for future domestic and overseas clinical research, IND submissions, cross-border collaboration and international multi-center trials.

NK cell therapy advances toward an international CMC system 

As pivotal effector cells of the innate immune system, NK cells can recognize and eliminate tumor cells, virus-infected cells and abnormal immune cells, emerging as a key development frontier in global cell therapy. Distinct from highly personalized treatments such as CAR-T therapy, NK cells boast unique strengths in allogeneic application, large-scale production, standardization and safety, boasting broad application prospects in treating tumors, viral infections, immune disorders and aging-related diseases.

The newly approved Type II Master File centers on the company’s self-developed human peripheral blood-derived NK cell preparation system, encompassing core technical documents concerning cell sourcing, manufacturing procedures, quality assessment, release testing and stability analysis, which will serve as critical CMC supporting materials for subsequent clinical research and global regulatory filings. Per FDA’s official notice, the assigned MF number uniquely identifies the master file, and relevant data will be reviewed by the authority when this file is cited in future IND, BLA and other related applications.

 Building an international public service platform for cell therapy 

 Focused steadily on cell and gene therapy, Shenzhen Cell Valley has built a one-stop CRO/CDMO and clinical translation service platform covering immune cells, stem cells, viral vectors, non-viral delivery systems, exosomes and engineered virus-like particles. The company facilitates the systematic development of cell therapy products spanning research discovery, process optimization, GMP-compliant manufacturing, quality management and clinical application submissions.

The FDA CBER validation of its Type II Master File represents another vital international milestone following the establishment of multiple fundamental cell and gene therapy platforms. The filed documentation strengthens the international compliance credentials of the company’s NK cell products, and offers referable, compatible and reviewable CMC data support for partnering hospitals, research institutions, biotech enterprises and global collaborators.

Shenzhen Cell Valley states that it will further accelerate quality system development and clinical translation cooperation aligned with international standards focusing on NK cells, CAR-NK, CAR-T, TCR-T, exosomes and engineered delivery systems, facilitating the global expansion of China’s cell and gene therapy technologies.

About FDA Master File 

An FDA Master File refers to technical documentation submitted to the authority to support applications for pharmaceuticals, biologics and related products. It does not equate to marketing approval, but can be cited by authorized parties in IND, BLA and other regulatory submissions to back the review of CMC information involving manufacturing processes, quality control, raw materials and preparation systems. The official acknowledgement and issuance of MF 32802 verifies the inclusion of Shenzhen Cell Valley’s NK cell preparation system into the FDA regulatory documentation framework.

Cross-border Delivery of Shenzhen Cell Valley’s NK Cells

Good news: Shenzhen Cell Valley accomplished China’s first cross-border delivery of clinical-grade cell products. The enterprise was enlisted on Shenzhen’s whitelist and approved special item catalogue for cross-border biomedical special substances by the end of 2025, making it the first domestic firm authorized to deliver NK cells and other cell products internationally.