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【Good News】 Shenzhen Cell Valley Successfully Completes China's First Cross-Border Delivery of Clinical-Grade Cell Products

Date:01-16  Hits:  Belong to:Corporate News

Recently, Shenzhen Cell Valley Biomedical Co., Ltd.. (hereinafter referred to as "Shenzhen Cell Valley") announced exciting news. After successfully being approved for the Shenzhen  2025 Pilot Program "White List" for Special Articles in Entry-Exit Biomedicine and receiving certification for the Positive Item List, the company achieved a key milestone on January 13, 2026 — NK cell products successfully exited the country via the customs "White List" dedicated channel to Hong Kong, China. This makes Shenzhen Cell Valley the first enterprise in China to realize the cross-border delivery of clinical-grade cell products through this channel, injecting strong momentum into the international development of the cell therapy industry in the Guangdong-Hong Kong-Macao Greater Bay Area.


As the first landmark achievement in the implementation of "whitelist" enterprise qualifications, this cross-border delivery of cell products, while complying with safety regulatory requirements and human waste management standards, was completed within just 3 hours from the Shenzhen Cell Valley production base to full customs clearance procedures. This accomplishment demonstrates the simultaneous enhancement of cross-border customs efficiency and biosafety management capabilities, enabling China's cell therapy industry to seize global competitive advantages and establish benchmarks. Concurrently, this cross-border delivery fully reflects Shenzhen Cell Valley's comprehensive strengths in technical systems, quality control, and compliance capabilities.


Professor Shi Yuanyuan, Chairman of Shenzhen Cell Valleystated: "As the first domestic pilot enterprise licensed to export clinical research-grade cell products, we have not only achieved technological breakthroughs but also established a compliant closed-loop system of 'Shenzhen R&D-Hong Kong Transformation-Global Services'. The successful export of NK cell product exemplifies this closed-loop practice. We will further facilitate the import and export of products listed in the positive list, fully unleashing our technological capacity to serve global clients."

 

In the future, Shenzhen Cell Valley will leverage the qualifications of 'whitelist' enterprises and cross-border full-chain capabilities to continuously advance the internationalization of its products, using Hong Kong as a hub to serve patients globally. Simultaneously, it will deepen collaborative efforts with Hong Kong and international partners to drive innovative development in the cell therapy industry across the Guangdong-Hong Kong-Macao Greater Bay Area and worldwide.

 

 


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Shenzhen Cell Valley Biopharmaceutical Co., Ltd.​​ is a comprehensive one-stop outsourcing service provider in China focused on the cell and gene therapy industry. It is also one of the first CRO/CDMO companies in the country to possess GMP industrial production capabilities for clinical-grade retroviral vectors . The company is a major public technical service platform construction project for CRO/CDMO in Shenzhen and is included among the city's latest announced "20+8" strategic emerging industry projects.Shenzhen Cell Valley has the capability for standardized and industrialized production of GMP-grade cell products such as CAR-T cells. Its primary production lines include those for various cell products like CAR-T, CAR-NK, CAR-M, γδT, TIL, and TCR-T. Additionally, the company operates production lines for various viral vectors, including RVV, LVV, non-viral vectors, and AAV, as well as for cellular raw materials used in producing therapeutics such as exosomes, genetically engineered antibodies, cytokines, oncolytic viruses, and vaccines.
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