Shenzhen Cell Valley Breaks Ground on South China Cell Factory: Building a World-Class One-Stop CRO/CDMO Platform for Cell and Gene Therapy

VCBeat has learned that,On July 8, the groundbreaking ceremony for the Shenzhen Cell Valley · South China Cell Factory Project was officially held at the Hepalink Biopharmaceutical Industrial Park in Pingshan District, Shenzhen.

The leaders attending today’s ceremony include the Vice Chairman of the Standing Committee of the Shenzhen Municipal People’s Congress, Guangdong Province; Chairman of the Shenzhen Association for Science and Technology; Vice Chairperson of the Jiusan Society Guangdong Provincial Committee; and Chairperson of the Jiusan Society Shenzhen Municipal Committee.Jiang Yuyang, Director of the Standing Committee of the Pingshan District People's Congress, Shenzhen CityLiao ShuhuaGovernment representatives; Academician of the Chinese Academy of Sciences, Acting Vice President of Southern University of Science and Technology, and Chair Professor of the School of MedicineGu Dongfeng, Chief Scientist of Xingwan Biotech, Foreign Member of the Russian Academy of EngineeringZhang Dan, Dean of the Institute for Biomedical Translation at Southern University of Science and Technology (SUSTech) Pingshan Campus, Foreign Member of the Russian Academy of EngineeringZhang Xumu, Deputy Director of Shenzhen Institute for Drug ControlWang XiaoweiAcademic Representative; Chairman of Pingshan District Industrial Capital Investment Co., Ltd.Lan Lan, Chairman of Shenzhen Xinyang Investment Management Co., Ltd.Wang Jiannan, Vice President of Shenzhen Hepalink Pharmaceutical Group Co., Ltd.Zhang Jie, Vice President of Shenzhen Yuto Packaging Technology Co., Ltd.Cao Xuhui, Founder of Shenzhen Cell Valley Biopharmaceutical CompanyHistorical Originsand representatives from other enterprises.

Deputy Director of the Municipal People's Congress Standing Committee, Jiang Yuyang, stated:

The Shenzhen Municipal Committee of the Communist Party of China and the Shenzhen Municipal People’s Government have attached great importance to the development of the cell and gene therapy industry, launching during the 14th Five-Year Plan periodShenzhen’s “20+8” Strategic Emerging Industries Project: Shenzhen Cell Valley—South China Cell Factory is one of its public service platforms; At present, Shenzhen has missed the optimal window for the development of antibodies and vaccines, making cell and gene therapy a more promising and advanced direction for growth. The third round of legislative review for the "Regulations on Promoting the Cell and Gene Industry in the Shenzhen Special Economic Zone" has been basically approved, and the draft is now open for public comment on the website of the Standing Committee of the Shenzhen Municipal People's Congress. The Regulations propose the introduction of relevant measures to support the development of the cell and gene industry, including improving the industrial and supply chains, providing fiscal funding support, and guiding social capital into the cell and gene sector.

Shenzhen should pursue a differentiated development strategy in the field of cell and gene therapy. Its strengths in formulating laws and regulations, fostering scientific and technological innovation, and attracting talent are key advantages driving the rapid advancement of this sector. The path to growth for the biopharmaceutical industry lies in aggregating incremental gains into significant achievements. A favorable environment for innovative development, underpinned by a comprehensive legal framework, provides robust support and protection for the cell and gene therapy industry.

It is hoped that the Shenzhen Cell Valley South China Cell Factory project will establish industry standards across multiple domains, including R&D, review, manufacturing, transportation, clinical application, and medical practice. By leveraging these standards to guide industrial development and capitalizing on the presence of a branch center of the National Medical Products Administration’s Center for Drug Evaluation in Shenzhen, the project aims to become a flagship CRO/CDMO hub for international standard-setting, thereby truly driving the rapid growth of Shenzhen’s cell and gene therapy industry.

Pingshan is a central hub in eastern Shenzhen and a key node along the Guangzhou-Shenzhen-Hong Kong-Macao Science and Technology Innovation Corridor. It is one of the areas in Shenzhen with the greatest potential for developable space, boasting a solid industrial foundation, a concentration of innovation resources, and strong development momentum.Currently, Pingshan is fully committed to building the Pingshan Park of the Shenzhen National High-Tech Zone, in accordance with the requirements of the Shenzhen Municipal Party Committee and Municipal Government. By focusing on leading industries such as biopharmaceuticals, it aims to cultivate several world-class innovative industrial clusters. Particularly in the biopharmaceutical sector, serving as a core engine for the biopharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area, Pingshan is constructing an integrated industrial ecosystem encompassing R&D innovation, achievement commercialization, and manufacturing, with the goal of establishing a biopharmaceutical science and technology hub of international standards.

In light of the high production standards, significant R&D challenges, and regulatory complexities inherent to the cell and gene therapy sector, Pingshan is actively attracting high-caliber enterprises, research institutions, and clinical centers. It is accelerating the improvement of its industrial innovation service system and specialized supporting facilities. Leveraging the Pingshan National Biotechnology Industry Base, Pingshan is integrating resources to establish a comprehensive, full-chain innovation ecosystem encompassing basic research, R&D and manufacturing, review and evaluation, and clinical application. Furthermore, it is making concerted efforts to remove restrictions on the import, export, and use of cell and gene therapy-related products, thereby stimulating innovation vitality.

Last year, the Pingshan District Government signed a strategic cooperation agreement with Guangdong Junhou Bio to jointly build the largest cell factory in South China. The core R&D team, led by Professor Shi Yuanyuan of an overseas-returnee team, is actively preparing for the establishment of Shenzhen Cell Valley. Professor Shi and his team’s decision to locate Shenzhen Cell Valley in Pingshan demonstrates their full trust and recognition of both Shenzhen City and Pingshan District.Once completed, Shenzhen Cell Valley will be the only company in China providing industrial-grade retroviral vector services, the only entity in China with a core technical team specializing in the industrial R&D and manufacturing of clinical-grade retroviral vectors, and the only one-stop CRO/CDMO service platform for cell and gene therapy in South China, serving pharmaceutical companies, hospitals, and research institutions.

Director Liao Shuhua of the Standing Committee of the Pingshan District People's Congress stated: We hope that Shenzhen Cell Valley will be completed and achieve industrialization at an early date, accelerating the development of the industry and promoting the advancement of public health. Meanwhile, we hope that Shenzhen Cell Valley will not only move fast but also steadily, driving the domestic gene and cell therapy field to new heights and leading the next wave of transformative change in biopharmaceuticals!

The establishment of Shenzhen Cell Valley will significantly reduce the cost of industrial-scale production of cell-based therapies, offering hope for survival to ordinary patients suffering from terminal illnesses.Academician Gu Dongfeng, Acting Vice President of Southern University of Science and Technology (SUSTech), stated that universities and research institutions in Shenzhen, including SUSTech, can provide an academic platform for scientists engaged in the development of cell and gene therapy drugs under government coordination, thereby promoting scientific research and industrial upgrading in China’s cell and gene therapy sector.

Shi Yuanyuan, Chairman of Shenzhen Cell Valley, stated:

The advancement of the *Regulations of Shenzhen Special Economic Zone on Promoting the Cell and Gene Industry*, a key piece of legislation in emerging fields, signifies that Shenzhen is at the forefront of development in cell and gene therapy. The city should fully leverage its first-mover advantage to shape national development trends and, by pursuing disruptive innovation, secure a leading position across China in cell and gene therapy as well as pharmaceutical R&D and manufacturing.

Currently, few CDMOs in China are capable of producing retroviral vectors, and raw materials still rely on imports.Shenzhen Cell Valley Masters China’s Only Clinical-Grade Industrial Production Process for Retroviral Vectors, effectively addressing the "technological bottleneck" issues within China's cell and gene therapy industry. Its robust core technologies and manufacturing processes can resolve key challenges related to the industrialization of cellular immunotherapy products,Optimize processes at the source to significantly reduce costs。

Shenzhen Cell Valley Will Build the Largest Cell Factory and the Largest Retroviral Vector Production Line in South China, to reduce the cost of cell therapy drugs and improve the manufacturing processes of cell products, we are striving to build a world-class, one-stop CRO/CDMO service platform for cell and gene therapy, writing a new chapter in the development of cell and gene therapy in Shenzhen and Pingshan District!