Strictly Guarding the Lifeline of Quality, Empowering a New Future for the Industry | Leaders from the Shenzhen Office for Drug and Medical Device Supervision Visit Shenzhen-Hong Kong Cell Valley for

On May 22, 2025, a delegation led by Mr. Yuan Shuai, Team Leader of the Shenzhen Municipal Office for Drug and Medical Device Supervision and Administration (hereinafter referred to as the "City Drug and Device Office"), visited Shenzhen-Hong Kong Cell Valley (Shenzhen) Medical Technology Co., Ltd. (hereinafter referred to as "Shenzhen-Hong Kong Cell Valley"). The visit focused on critical initiatives including cell therapy product R&D, GMP production compliance, and end-to-end quality management.The delegation highly commended Shenzhen-Hong Kong Cell Valley's role as a benchmark for technological innovation and quality management. They emphasized the need for synergistic government-enterprise collaboration to propel Shenzhen's biopharmaceutical industry toward globalization, accelerating the delivery of cutting-edge medical breakthroughs to patients.

Accompanied by Professor Shi Yuanyuan, the delegation toured the international business and medical services headquarters of the Cell Valley Group, gaining comprehensive insights into the company's development model, strategic roadmap, and industrial layout.

During the symposium, Professor Shi Yuanyuan, Founder of Shenzhen-Hong Kong Cell Valley, provided a detailed overview of the company's latest advancements in the cell therapy sector. He highlighted significant achievements in core product registration, compliance management of clinical studies, and industrialization outcomes. Professor Shi underscored the company's commitment to establishing a "Zero-Defect" quality management system aligned with the highest international standards. Leveraging the Cell Valley Group's robust capabilities in production, R&D, and industrial scaling, Shenzhen-Hong Kong Cell Valley is dedicated to setting a compliance benchmark for the industry. Currently, over ten cell therapy products have entered clinical trial stages. The company plans to work closely with the City Drug and Device Office, steadfastly adhering to the principle of "Quality First, Patients Foremost," to ensure steady progress in the cell therapy field and contribute to Shenzhen's vision of becoming a global innovation hub for biopharmaceuticals.

In his remarks, Mr. Yuan Shuai stated that cell therapy represents a strategic high ground in the medical revolution. He noted that enterprises must not only have the courage to explore the "no-man's-land" of technology but also strictly guard the "lifeline of safety." He specifically highlighted the "South China Cell Factory" project led by Shenzhen Cell Valley, describing it as a major public technical service platform for Shenzhen and the only domestic platform currently capable of GMP-compliant industrial production of clinical-grade retroviral vectors. Combined with the successful establishment of Shenzhen-Hong Kong Cell Valley, the Cell Valley Group has built a closed-loop ecosystem encompassing R&D, production, and clinical application. Mr. Yuan praised the company's development model of "Independent R&D + Clinical Translation + Industrial Implementation," noting that it effectively balances scientific foresight with practical industrial viability. He expressed hope that, driven by policy support and industry collaboration, cell therapy technologies will achieve broader, more inclusive application.