China, Shenzhen, December 2025) — Guangdong JUNJO Pharma Co., Ltd., a wholly-owned subsidiary of Cell Valley Group, officially announced that its GMP-grade GALV retroviral vector (GALV Retroviral Vector) submitted to the U.S. Food and Drug Administration (FDA) has been formally accepted and registered by the FDA Center for Biologics uation (CBER), with the MF number MF 32221. The vector also contains sequences targeting TROP2 and co-expressing mIL-15 (TROP2-IL15). The FDA receipt confirmed this DMF as a Type II Master File. This filing marks the first successful FDA DMF registration for a "retroviral vector" category by a China-based company, and also signifies that Cell Valley Group has become the world's first company to obtain a DMF for a viral vector targeting TROP2 and co-expressing IL-15. 1. China's first breakthrough: Breaking the "zero record" for retroviral vector DMF. To date, only a handful of Chinese companies have completed the formal registration of viral vectors in the United States, and there is no public information indicating that any company has completed the FDA DMF filing for retroviral vectors (Retroviral Vector). The first CAR-T cell drug approved in China, Yikaida by Fosun Kite (now Fosun Kairui), used a retroviral vector imported from Gilead Sciences in the United States. The approval of MF 32221 has made Shenzhen Cell Valley the first Chinese company to complete the FDA DMF filing for a retroviral vector (category: GMP-grade GALV retroviral vector), indicating that Shenzhen Cell Valley has met international standards directly applicable to U.S. originator pharmaceutical companies in terms of viral vector manufacturing, quality systems, GMP pipelines, traceability, biosafety, and consistency. 2. Global First: TROP2-IL15 Vector DMF Paves the Way for Innovative Cell and Gene Therapy Regulation. The FDA's official registration document explicitly states the MF title as "Master File Type II – GMP-grade GALV retroviral vector targeting TROP2 and co-expressing mIL-15". This represents the first time a company has submitted and received acceptance from the FDA for a TROP2-targeting + membrane-bound IL-15 co-expression retroviral vector product DMF worldwide. This technology delivers three groundbreaking global innovations: （1）t pioneers the integration of TROP2 targeting into retroviral vectors, enabling application across multiple solid tumor CAR-T/TCR-T/γδT platforms. （2） The co-expression of mIL-15 significantly enhanced the persistence and killing ability of T cells, which could solve the problem of T cell exhaustion and deficiency in solid tumor microenvironment. （3）The world's first registration pathway for a TROP2-mIL15-like immunotherapy provides a reference FDA regulatory template. This filing not only represents a technological breakthrough for the company, but also marks the first regulatory compliance pathway established for the cell and gene therapy industry in addressing new tumor targets and cytokine strategies. III. Milestone Significance: Completion of the FDA International System Layout for the "Viral Vector-Exosome-Immune Cell Platform" With the filing of MF 32221, Cell Valley Group has established three globally unique DMF portfolios: ✔ The world's first NK exosome DMF (Shenzhen Cell Valley MF 043001) ✔ China's first retroviral vector DMF (Guangdong Junhou MF 32221) ✔ Umbilical cord mesenchymal stem cell (MSC) derived exosome DMF (Shenzhen Cell Valley MF 042035). These three approvals collectively form a full-chain CGT (Cell & Gene Therapy) foundational platform that can be directly referenced by global pharmaceutical companies. This platform includes: GMP-grade retroviral production, immune cell modification, vector exosome delivery systems, international standard quality control systems, and FDA DMF reference systems. This marks the first time a China-based company has achieved the capability of an internationally regulated biopharmaceutical platform integrating "viral vector + exosome + immune cell." IV. Corporate Statement Dr. Shi Yuanyuan, founder of Shenzhen Cell Valley, stated: "The approvals of the retroviral DMF and TROP2-IL15 DMF demonstrate our global competitiveness in the foundational technologies of cell and gene therapy. This vector technology will provide a powerful weapon for treating various advanced solid tumors. We will continue to promote China's CGT technology globally with international standards, ensuring innovative technologies truly enter clinical practice and benefit patients." "Professor Wang Jianxun, Chief Scientist, stated: 'TROP2-IL15 represents a pivotal direction in solid tumor cell therapy. We are honored to be the first global team to complete DMF registration for such a product. This will significantly advance breakthroughs in immune cell therapy for solid tumors.' Regarding Shenzhen Cell Valley / Guangdong Junhou Biotech: Shenzhen Cell Valley and its subsidiaries specialize in building foundational technology platforms for cell and gene therapy (CGT), with business coverage including: GMP manufacturing of retroviral/lymphoviral vectors, CAR-T / CAR-NK / γδT / IL-15 series immune cell platforms, exosomes / eVLP delivery systems, and IND, IIT, DMF registration systems for domestic and international applications. Shenzhen-Hong Kong cross-border cell product supply chain company is dedicated to creating a globally leading CGT infrastructure, providing pharmaceutical companies, research institutions, and hospitals worldwide with high-grade manufacturing capabilities that can directly reference FDA DMF."