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From 'Last Mile' to 'Global Pioneer': Cell Valley's Core Strength by 2025 Leading the leapfrog development of cell and gene therapy industry

Date:01-28  Hits:  Belong to:Corporate News


At the Group’s recent annual summary meeting, Professor Shi Yuanyuan, Chairman and General Manager of Cell Valley Group, systematically presented the Group’s strategic layout, technological breakthroughs and large-scale achievements in the field of Cell and Gene Therapy (CGT).At this critical juncture when the national 《Regulations for the Administration of Clinical Research and Translational Application of New Biomedical Technologies (Order No. 818) is about to take effect, Cell Valley has taken the lead in completing the full-chain positioning covering underlying technologies, compliance systems, clinical translation and international delivery. It has become one of the very few domestic enterprises and a highly scarce enterprise globally that serves as a “one-stop platform enterprise for new biomedical technologies”.

 

With the core concept of 'using magic to defeat magic', we aim to build the foundational capabilities of the CGT industry.

 

Cell Valley has not remained at the level of single-cell products or single vector technologies, but has proactively established the world's only operational "Four Core Platforms": an ultra-large-scale target library, a dual-track delivery system for viruses and non-viruses (retroviral vectors, eVLPs, and exosomes), a high-purity and high-efficiency cell preparation and quality control system, and a clinical application and commercial incubation platform. The synergy of these four platforms truly achieves a closed-loop integration of the entire process from "basic research—industrial production—clinical application—commercial transformation," directly addressing the long-standing "last mile" challenge in the CGT industry.

 

Product and delivery capabilities are growing rapidly

 

By 2025, Cell Valley has achieved leapfrog growth in multiple core metrics: the delivery volumes of NK cells, CAR-T, CAR-NK, and exosome products have more than doubled year-on-year, with both the cell and cell-derived product pipelines and the vector pipelines ranking among the top in the global single-enterprise sector. Against the backdrop of simultaneous policy support and clinical demand explosion, its advantages in industrialization, standardization, and replicability have been fully validated.


The business performance has achieved a leapfrog growth, and the scale effect has begun to be released


In 2025, Cell Valley achieved a 110% year-on-year revenue growth based on the high base of full‑scale production in 2024, with its core businesses maintaining strong momentum. Over the same period, the number of customers increased by approximately 60% year on year, covering more than 160 cooperative institutions at home and abroad, including partnerships with 125 Class III Grade A hospitals, and more than 30 IIT and NCT clinical research projects approved.Along with the simultaneous expansion of delivery capacity and order volume, both the parent group and the newly established subsidiary Deep Harbour Cell Valley have officially joined the ranks of enterprises above designated size, marking that its operational scale, financial standardization and sustainable growth capability have been doubly recognized by the government and the market.


Compliance and Internationalization Achieve Milestone Breakthrough

 

Cell Valley has successively obtained the titles of National High-tech Enterprise, Specialized, Refined, Unique and Innovative Small and Medium-sized Enterprise, and ISO Quality System Certification, and became the first pilot enterprise in China to achieve cross-border delivery of clinical-grade cell products. At the international regulatory level, exosomes, NK exosomes, and retroviral vectors have successively obtained FDA DMF filings in the United States, with several being "the first in the world," marking the first systematic entry of China's local CGT enterprises into the global clinical and drug registration reference system.

 

Shenzhen-Hong Kong linkage and global layout, release long-term growth momentum


Relying on the Qianhai Free Trade Zone and the Shenzhen-Hong Kong collaboration mechanism, Cell Valley has continuously deepened cooperation with Class III Grade A hospitals, academician teams, top international medical institutions and listed companies, promoting the implementation of IIT clinical research, academician-led new drug translation and regional preparation centers. Meanwhile, the establishment of the International Medical Service Center has enabled Cell Valley to form new growth drivers in the fields of product export, patient referral and medical tourism.


Looking to the future, Cell Valley is ready to become the 'first enterprise'.


Looking ahead to 2026, Cell Valley has clearly outlined its goals of completing the implementation of public service platforms in multiple s, launching Series A financing, and entering the pre-IPO phase. More importantly, its core capabilities centered on the "CGT chip factory" are providing sustainable and scalable infrastructure-level solutions for the cell and gene therapy industry in China and even globally.


From "Fast Growth" to "High Quality", Entering a New Stage


Revenue doubling, full compliance with qualifications, platform maturation, and international breakthroughs—multiple indicators collectively point to one conclusion: Cell Valley has completed a pivotal transition from a "technology-driven innovative enterprise" to a "platform company with scalable and standardized output capabilities." With the continuous implementation of public service platforms, accelerated international market expansion, and increasingly clear capital pathways, Cell Valley is steadily advancing toward its central position in the CGT industry.


Cells Benefit All Living Beings; Genes Create the Future.


As CGT enters its era of true scaling and clinical value realization, Cell Valley is emerging as the 'benchmark solution' for the next phase of the industry, defined by 'three years of strategic planning and pioneering full-chain implementation.'


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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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