(China Shenzhen, December 2025) — Shenzhen Cell Valley Biomedical Co., Ltd. officially announced that the NK cell-derived exosomes submitted by the company have been formally accepted by the U.S. Food and Drug Administration (FDA) for Drug Master File (DMF) filing, with the number DMF 043001, and the type is Type II DMF. The U.S. FDA has issued an official confirmation letter, marking Shenzhen Cell Valley as the world's first company to obtain the DMF filing for NK cell-derived exosomes, and also the first breakthrough for a China company to complete the U.S. DMF registration in this cutting-edge new drug delivery vector field. Previously, Shenzhen Cell Valley had obtained the DMF approval for exosomes derived from human umbilical cord mesenchymal stem cells (UC-MSCs). The recent milestone approval for exosomes derived from NK cells signifies that the company's exosome manufacturing system, safety and quality control system, and clinical-grade production capabilities now meet the regulatory standards required for FDA registration in the United States. This achievement officially places Shenzhen Cell Valley on the international compliance track, enabling global clinical trials and drug registration applications. Industry Significance: The world's first NK exosome-based DMF (Drug-Mediated Fission) establishes a regulatory foundation for next-generation biopharmaceuticals. Exosomes are recognized as the core carriers of next-gen drug delivery systems (next-gen DDS). NK cell-derived exosomes, with their innate immune activity, anti-tumor potential, ability to cross the blood-brain barrier, and engineering flexibility, are regarded as the most groundbreaking frontier in the global cancer genomics and therapeutics (CGT) industry. As the world's first NK exosome product to obtain FDA DMF approval, this filing will: provide global biopharmaceutical companies with an internationally standardized exosome raw material platform that can be directly cited and used for IND/NDA/BLA, accelerate research and development in areas such as exosome drugs, RNA delivery, immunotherapy, anti-aging, and regenerative medicine, and propel the global CGT (Cell and Gene Therapy) industry from the "cell era" into the "extracellular vesicle (EVs) era". Shenzhen Cell Valley: From China to the world, building a globally leading CGT infrastructure platform. In recent years, Shenzhen Cell Valley has achieved continuous breakthroughs in multiple key areas: the world's first: obtaining FDA approval for NK cell-derived exosome DMF filing (DMF 043001); establishing Shenzhen's first "Cell Product Cross-Border Customs White List"; building China's leading full-process GMP exosome manufacturing platform (R&D—scaling—quality control—lyophilization—transportation); and deploying multiple exosome products in Hong Kong, the Middle East, Europe, and overseas collaborations. Core CGT technologies (exosomes, eVLPs, CAR-NK, MSCs) have achieved global leadership in independent and controllable development. Corporate Statement. Professor Wang Jianxun, Chief Scientist of Shenzhen Cell Valley, stated: "The approval of NK exosome DMF is not only a breakthrough for Shenzhen Cell Valley but also a leap forward for China's CGT industry. We will continue to promote exosomes as the next-generation drug delivery system globally, benefiting more patients." "Professor Shi Yuanyuan, Chairman of Shenzhen Cell Valley, stated: 'From Shenzhen to the world, Shenzhen Cell Valley will continue to export internationally standardized cell and exosome products, accelerate cooperation with global pharmaceutical companies and research institutions, and jointly drive the next-generation biopharmaceutical revolution.' Regarding Shenzhen Cell Valley Biopharmaceutical Co., Ltd., Shenzhen Cell Valley is a leading China-based cell and gene therapy (CGT) underlying technology platform enterprise, with core technologies covering NK cells, CAR-NK, CAR-T, MSC, and exosome/eVLP drug delivery systems. The company has established clinical and production pathways in both Shenzhen and Hong Kong, making it one of the most influential innovative biopharmaceutical enterprises in the Guangdong-Hong Kong-Macao Greater Bay Area."