The U.S. FDA has issued an official confirmation letter, marking that Shenzhen Cell Valley has become the first company globally to obtain DMF filing for NK cell-derived exosomes. It also represents a groundbreaking achievement as the first time a Chinese enterprise has completed U.S. DMF registration in this cutting-edge novel drug delivery vector field.

Previously, Cell Valley had already obtained DMF filing for exosomes derived from human umbilical cord mesenchymal stem cells (UC-MSCs) (see details: Good News | Shenzhen Cell Valley Exosomes Obtain FDA DMF Filing). This milestone achievement of obtaining filing for NK cell-derived exosomes signifies that Shenzhen Cell Valley's exosome manufacturing system, quality assurance system, and clinical-grade production capabilities have met the U.S. FDA registration requirements, officially entering the international compliance sequence available for reference in global clinical trials and drug registration applications.

Exosomes are recognized as the core carriers of next-generation drug delivery systems (next-gen DDS), and NK cell-derived exosomes are regarded as the most groundbreaking cutting-edge direction in the global cell and gene therapy (CGT) industry due to their inherent immune activity, anti-tumor potential, ability to cross the blood-brain barrier and room for engineering modification.

As the world’s first NK cell-derived exosome product to secure FDA DMF filing, this registration will:

Shenzhen Cell Valley has consistently achieved breakthroughs in multiple key areas in recent years:

Professor Wang Jianxun, Chief Scientist of Shenzhen Cell Valley, stated:

"The approval of the NK exosome DMF is not only a breakthrough for Shenzhen Cell Valley but also a significant leap for China's CGT industry. We will continue to promote the global implementation of exosomes as a next-generation drug delivery system, benefiting more patients."

Professor Shi Yuanyuan, Chairman of Shenzhen Cell Valley, stated:

"From Shenzhen to the world, Shenzhen Cell Valley will continue to deliver internationally standardized cell and exosome products, accelerate collaborations with global pharmaceutical companies and research institutions, and jointly promote the next-generation biomedicine revolution."

Shenzhen Cell Valley is a leading Chinese enterprise of underlying platform technology for Cell and Gene Therapy (CGT). Its core technologies cover NK cells, CAR-NK, CAR-T, MSC, and exosome/eVLP drug delivery systems. With clinical and production pathways established in both Shenzhen and Hong Kong, the company is one of the most influential innovative biomedical enterprises in the Guangdong-Hong Kong-Macao Greater Bay Area.