On January 6, 2026, Shenzhen Cell Valley Biomedical Co., Ltd. (hereinafter referred to as "Shenzhen Cell Valley") successfully held its 2025 Annual Middle Management Summary Conference. The meeting was chaired by Chairman and General Manager Shi Yuanyuan, with Deputy General Manager and Chief Scientist Wang Jianxun, Deputy General Manager Xiang Hua, Deputy General Manager and General Manager of Subsidiary Deep Harbour Cell Valley Tang Xiaomeng, and heads of various business and functional departments attending. The conference focused on the three main themes of "systematic review, collaborative improvement, and forward-looking layout" ,comprehensively summarizing the 2025 operational achievements and systematically planning the 2026 development direction.

Multi-Point Coordinated Pattern Takes Shape, Annual Development Highlights Abound

2025 was a year of deepening strategic layout and significantly enhancing core competitiveness for Shenzhen Cell Valley. Adhering to the mission and vision of "Cells Benefit All, Genes Create the Future," the company steadily promoted high-quality development amidst a complex and changing industry environment.

In terms of market expansion, the company's customer base steadily expanded from the South China region to nationwide, gradually covering international markets including Germany, the United States, and Southeast Asia. Currently, the company has established clinical research collaborations with over a hundred tertiary Grade A hospitals, cumulatively submitted more than a hundred Investigator-Initiated Trial (IIT) projects, with over 30 IIT and National Clinical Trial (NCT) approved. Both customer scale and project quality have achieved dual improvement.

Regarding strategic upgrading and organizational construction, in May 2025, Deep Harbour Cell Valley was officially inaugurated as the Group's international business and medical service headquarters. Based in Shenzhen Qianhai and connecting with Hong Kong, it coordinates scientific research, industrial, and policy resources to build a one-stop service platform covering the entire Cell and Gene Therapy (CGT) chain, marking the comprehensive formation of the "Shenzhen-Hong Kong-Zhongshan-Beijing" multi-point coordinated development pattern. During the same period, the Group formally established the International Medical Service Center, accelerating the construction of a specialized and internationalized medical service system.

In terms of qualification and compliance construction,the Group successively passed the ISO 9001:2015 Quality Management System Certification and National High-Tech Enterprise Recognition in 2025; its independently developed and produced human stem cell products obtained the inspection qualification report from the National Institutes for Food and Drug Control (NIFDC); "Umbilical Cord Mesenchymal Stem Cell Vesicles" completed INCI international registration; exosome products derived from MSC cells and NK cells both obtained relevant FDA DMF filings; and the GMP-grade GALV retroviral vector also completed FDA DMF filing, achieving significant breakthroughs for key products and core technologies within the international standards system.

All Departments Synergize Efforts to Build Core Industrial Competitiveness

Focusing on the company's overall strategic objectives, various business and functional departments worked in synergy throughout 2025, continuously solidifying the foundation for industrialization and innovation capabilities.

In terms of production and R&D system construction, the company has completed the establishment of tens of thousands of square meters of standard production workshops and GLP laboratories, forming an integrated full-industry-chain layout of "Vector-Cell-Clinical" . Throughout the year, it completed or advanced nearly a hundred CRO and self-developed projects, with the R&D pipeline continuously enriched. Collaborating with Academician Yan Xiyun's team from the Chinese Academy of Sciences, the company is advancing the global first-in-class CD146-CLL1 dual-target cell therapy new drug development, and has been granted 6 national invention patents for innovative CAR-T cell preparation processes, continuously strengthening its scientific research and innovation capabilities.

The internal management and operational support system has also been continuously optimized. In quality management, the company focused on building a "quality management system" to ensure continuous improvement in product and service quality. In administrative management, through optimizing organizational structure and improving management systems, it further enhanced operational efficiency and management level, providing a solid foundation for the smooth progress of various business activities.

Summarizing 2025: Staying True to the Original Aspiration, Deepening Innovation, Seizing Institutional Opportunities

In his concluding remarks, Chairman Shi Yuanyuan fully affirmed the work achievements of all departments in 2025, particularly the leapfrog progress made in scientific research innovation, strategic deployment, and international compliance breakthroughs. He pointed out that Shenzhen Cell Valley has always adhered to the original aspiration of "treating diseases and saving patients" , positioning itself as a one-stop service platform for the clinical translation of new biomedical technologies, continuously promoting the standardized, large-scale, and international development of cell therapy technologies.

He also emphasized that the Order No. 818 of the State Council, the "Regulation on the Administration of New Biomedical Technology Clinical Research and Translational Clinical Application," has been promulgated and officially implemented since May this year, officially ushering cell therapy into a dual-track development phase of "new biological drugs + medical technologies." Leveraging its forward-looking layout in terms of the number of clinical research pipelines, CAR vector library scale, and industrialization capabilities, Shenzhen Cell Valley has gained significant first-mover advantages and comprehensive competitiveness.

Looking Forward to 2026: Deepening Technology Translation, Connecting the Industrial Ecosystem

Looking ahead to 2026, Shenzhen Cell Valley will continue to deepen technology translation and industrial synergy, increase R&D investment in core cell and gene therapy technologies, further optimize process flows and translation pathways, and enhance the efficiency and safety of bringing cutting-edge technologies into clinical application.

Simultaneously, the company will actively connect with the industrial ecosystem, deepen strategic collaborations with research institutions, medical institutions, and  biomedical enterprises, build a closer and more efficient collaborative innovation network, and promote resource sharing and complementary advantages. By adapting to policy environment changes and seizing the industry development window, Shenzhen Cell Valley will continue to consolidate its industry-leading position, contributing to the high-quality development of the cell therapy industry and the clinical benefit of more patients.