Recently, Shenzhen Cell Valley Biopharmaceutical Co., Ltd. has achieved a significant breakthrough in the core underlying technologies of cell and gene therapy. The company's independently developed invention patent "Method for Electroporation-Free, Batch Preparation of Immune Cell Therapy Products and Its Products" has been officially authorized by the National Intellectual Property Administration (Authorization Announcement No.: CN120866421B, Authorization Date: March 3, 2026). This patent proposes an innovative solution to the key technical challenges in the engineered preparation of immune cells, providing critical technical support for the large-scale production of next-generation cell therapy products.

Breaking Through the Bottleneck of Traditional Electroporation with Non-Viral Vectors, Building a New Generation of Immune Cell Engineering Technology

In the current R&D and production processes of cell therapy products such as CAR-T and CAR-NK, gene editing and gene delivery are critical steps in constructing engineered immune cells. Traditional non-viral vector methods typically rely on electroporation for gene editing or exogenous gene delivery, but this technology has notable limitations:

· Electroporation can easily cause cell damage, reducing cell viability

· Complex processes with insufficient production stability

· Higher costs in large-scale industrial production

To address these industry-wide challenges, Shenzhen Cell Valley's R&D team proposed an electroporation-free immune cell engineering technology pathway. This technology utilizes stable cell lines to produce engineered virus-like particles (eVLP), enabling efficient gene editing and functional modification of immune cells while maintaining high cell activity and precision engineering.

Compared to traditional methods, this technology offers significant advantages:

· No electroporation required，, significantly reducing cell damage

· Higher gene editing efficiency, improving engineering success rates

· More complete preservation of cell function

· Better suited for industrial-scale batch production

This technological breakthrough provides a crucial pathway for the large-scale and standardized production of cell therapy products.

Addressing Key Challenges in T-Cell Therapy

In practical applications, using this patented technology, Cell Valley has developed the world's first CD7 KO + CD7 CAR T-cell therapy product. By leveraging CD7 eVLP vectors to achieve CD7 gene knockout and combining it with CD7 CAR retroviral delivery, the technology effectively resolves the common fratricide issue in T-cell therapy, offering a new solution for immunotherapy in T-cell leukemia and related diseases.

It is widely recognized in the industry that CAR-T therapy targeting T-cell malignancies has long faced the technical bottleneck of fratricide. The introduction of this patented technology provides a new technical pathway for the engineered implementation of related therapeutic strategies.

Strengthening the Foundational Technology Platform for Cell Therapy

As a key innovation platform in China's cell and gene therapy industry, Shenzhen Cell Valley has been advancing its core foundational technology layout in areas such as viral vectors, immune cell therapy, exosome technology, and gene delivery systems, and has established a comprehensive technical system covering R&D, production, and clinical translation.

The acquisition of this patent further strengthens the company's proprietary intellectual property system in eVLP gene delivery platforms and immune cell engineering technologies. These technologies can not only be applied to CAR-T cell therapy products but can also be extended to the development and production of various engineered immune cell therapies, such as CAR-NK and TCR-T.

Advancing the Industrialization of Cell Therapy

With the formal implementation of China's "Regulations on the Clinical Research and Clinical Translation of New Biomedical Technologies" (Order No. 818), the cell and gene therapy industry is ushering in significant development opportunities. Industry experts point out that the key to future competition will lie not only in single product pipelines but also in foundational technology platforms and large-scale production capabilities.

The recently authorized "Electroporation-Free Immune Cell Engineering Technology" by Shenzhen Cell Valley offers a new technical pathway for cell therapy products that enables high efficiency, low damage, and scalable production. This will also provide critical support for the R&D and industrialization of more innovative cell therapy products in the future.

Moving forward, Shenzhen Cell Valley will continue to drive core technological innovation and clinical translation. Leveraging its GMP production system and one-stop CDMO/CRO service capabilities, the company aims to accelerate the application of cell and gene therapy technologies in oncology and other major disease areas, contributing more innovative achievements to China's biopharmaceutical industry.