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[Good News] Shenzhen Cell Valley Approved for the "Whitelist" of Pilot Enterprises for Entry-Exit Special Items

Date:01-06  Hits:  Belong to:News & Events

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Recently, the Joint Regulatory Mechanism Office for Entry-Exit Biopharmaceutical Special Items of Shenzhen publicly released the "Whitelist" of proposed pilot enterprises (institutions) and the Positive List of Special Items for 2024 on the Shenzhen Municipal Development and Reform Commission website.After a rigorous process including material verification, expert review, on-site inspection, solicitation of departmental opinions, and deliberation by the joint meeting, the first batch of 13 enterprises and institutions in the city were approved for the "Whitelist." Shenzhen Cell Valley was successfully selected, with core raw materials for cell therapy, such as viral vectors, approved for the Positive List of Special Items for entry and exit.

This selection marks a significant achievement in the implementation of the Pilot Work Plan for the Joint Regulatory Mechanism for Entry-Exit Biopharmaceutical Special Items in Shenzhen. The plan aims to optimize the entry and exit processes for special biopharmaceutical items and improve customs clearance efficiency through the establishment of a joint regulatory mechanism, while ensuring biosafety and regulatory effectiveness. This initiative will not only help enhance the international competitiveness of Shenzhen's biopharmaceutical industry but also provide more and better biopharmaceutical products and services for patients at home and abroad.

Looking ahead, Shenzhen Cell Valley will leverage this opportunity of being included in the "Whitelist" to continue increasing investment in scientific research and tackling core underlying technologies. At the dawn of 2025, the company aims to expand more international business and drive continuous innovation and breakthroughs in new cell therapy technologies.

 


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Shenzhen Cell Valley Biopharmaceutical Co., Ltd. is a leading one-stop comprehensive outsourcing service provider for China’s cell and gene therapy industry. It is also among the first domestic CRO/CDMO enterprises to hold GMP-compliant industrial production capabilities for clinical-grade retroviral vectors. As a key project for the construction of Shenzhen’s public technical service platform for CRO/CDMO, the company has been listed in the city’s newly announced "20+8" strategic emerging industries initiative.
Shenzhen Cell Valley is equipped with the capacity to conduct standardized and industrialized production of GMP-grade cellular products including CAR-T cells. Its core production lines cover a full spectrum of cellular products such as CAR-T, CAR-NK, CAR-M, γδT, TIL and TCR-T. In addition, the company runs production lines for a diverse range of viral vectors (including RVV, LVV and AAV) and non-viral vectors, as well as for cellular raw materials for therapeutic development—such as exosomes, genetically engineered antibodies, cytokines, oncolytic viruses and vaccines.
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