Recently, Cell Valley Group has achieved a significant milestone in the internationalization of core cell and gene therapy technologies. The group's wholly-owned subsidiary, Guangdong Junhou Biopharmaceutical Co., Ltd., has successfully completed the "eVLP-CD7-KO virus-like particle (CD7 gene knockout engineered virus-like particle)" filing with the U.S. Food and Drug Administration ( Drug Master File ( DMF ) under the reference number MF 32547, which has been officially accepted by the FDA's Center for Biologics uation and Research (CBER).

This achievement marks a critical breakthrough for Shenzhen Cell Valley in the field of next-generation gene delivery systems (Gene Delivery Platform) and signifies the formal entry of China's original cell engineering technology into the international regulatory framework. It lays a solid foundation for future global clinical development and industrial collaboration in cell and gene therapy products.

01/Next-Generation Gene Delivery System: The eVLP Technology Platform

eVLP (engineered Virus-Like Particle) is a rapidly emerging novel gene delivery technology platform. By engineering virus-like particles, this technology enables the delivery of gene-editing tools or functional proteins while eliminating the risk of viral replication, positioning it as one of the key directions for next-generation gene delivery systems.

Building on this foundation, the Cell Valley R&D team developed the eVLP-CD7-KO virus-like particle, which enables precise editing of key immune cell genes and offers the following technical advantages:

· No electroporation ( Non-electroporation ) required, significantly reducing cell damage

· High-efficiency gene editing capability, enhancing immune cell engineering efficiency

· Higher cell viability and stability

· Suitable for industrial-scale production

Compared to traditional electroporation or viral vector delivery methods, this technology provides a more efficient and safer gene-editing solution for immune cell engineering.

02/Solving the 'Fratricide' Challenge in T-Cell Therapy

One of the key applications of this technology platform is the development of CD7 KO + CD7 CAR T-cell therapy products。

In CAR-T therapy for diseases like T-cell leukemia, the therapeutic target CD7 is also present on the surface of T-cells, often leading to mutual attacks among CAR-T cells—a phenomenon known as "Fratricide".

The eVLP-CD7-KO technology developed by Cell Valley enables precise knockout of the CD7 gene in immune cells, combined with CD7 CAR gene insertion, effectively avoiding fratricide and providing a critical technical pathway for T-cell tumor immunotherapy.

Industry experts believe that engineered immune cell therapy for T-cell malignancies has long faced key technical challenges, and CD7 gene knockout engineering technology is regarded as a major breakthrough direction in this field.

03/FDA DMF Filing: A Critical Step into the International Regulatory System

The DMF (Drug Master File) is an essential regulatory document used by the U.S. FDA to document critical drug materials, manufacturing processes, and quality control systems.

Completing the DMF filing signifies:

· Technical documentation has been incorporated into the FDA regulatory system for filing

· It can be referenced by global pharmaceutical companies or IND applicants for clinical submissions

· It establishes a compliance foundation for future international clinical research and commercial collaborations

The eVLP-CD7-KO virus-like particle DMF filing completed by Shenzhen Cell Valley marks a significant step in the internationalization of this technology platform and provides key technical support for the future development of global cell therapy products.

04/Building China's Original CGT Core Technology Platform

In recent years, Shenzhen Cell Valley has continued to advance the development of core technology platforms for cell and gene therapy, with a focus on:

· Viral vector platform

· Immune cell engineering technology platform

· eVLP gene delivery system

· Extracellular vesicle (EV) delivery system

Through these technological systems, the company is building a comprehensive industrial chain platform covering gene delivery, cell engineering, GMP manufacturing, and clinical translation.

As the cell and gene therapy industry enters a phase of rapid development, platform companies with core technological innovation capabilities and large-scale production capacity will become key drivers of industry progress.

The recent FDA DMF filing for the eVLP-CD7-KO technology not only demonstrates Shenzhen Cell Valley's continuous innovation in immune cell engineering but also signifies that China's original cell engineering technologies are gradually gaining international recognition.

Moving forward, Shenzhen Cell Valley will continue to drive core technological innovation and clinical translation, accelerating the application of cell and gene therapies in oncology and other major diseases, thereby contributing China's innovative strength to the global biopharmaceutical industry.