Cell & Gene Therapy Programs

 

On January 29, 2026, SYS6055 Injection, independently developed by CSPC Pharmaceutical Group, obtained the clinical trial implied approval from the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2500947). As China's first clinically approved in-vivo CAR-T therapy for relapsed/refractory aggressive B-cell lymphoma, it breaks the technical barriers of conventional ex vivo CAR-T, delivering more accessible and innovative treatment options for patients.

 

I. Core Challenge: RCL Testing Dilemma for Non-Canonical VSVG-Enveloped Lentiviruses

The primary safety risk of in-vivo CAR-T lies in replication-competent lentivirus (RCL) contamination, which may cause uncontrolled viral replication in vivo and insertional mutagenesis, posing severe safety concerns. It serves as a core review focus for regulatory submissions by NMPA, FDA and other authorities.

SYS6055 adopts engineered envelope T cell-targeted lentivirus, distinct from traditional VSVG-enveloped lentiviral vectors such as VSV-G and Cocal-G. Conventional RCL assays are only compatible with VSVG-enveloped viruses, with limitations including insufficient specificity, low sensitivity and non-compliance with regulatory requirements. These shortcomings fail to meet the project's customized testing needs and become a critical bottleneck for IND submission.

 

II. HyQure Solution: Customized RCL Testing + Full-Cycle Biosafety Services

Leveraging in-depth technological expertise in the cell and gene therapy (CGT) sector, HyQure Biotech developed world-leading customized biosafety testing solutions tailored to the specific requirements of CSPC's SYS6055 project, ensuring compliant and efficient project advancement.

Customized RCL Testing to Break Technical Bottlenecks of Engineered VSVG Envelopes

Aligned with CDE's Guidelines on Common Issues and Technical Requirements for Replication-Competent Lentivirus Detection and FDA guidance documents, a dedicated testing system for non-VSVG-enveloped lentiviruses has been established. This bridges the domestic gap in RCL detection for non-VSVG-enveloped lentiviruses and ensures vector safety in line with global filing standards.

Full-Cycle Biosafety Testing to Consolidate Quality Assurance for Innovative Drugs

We provide one-stop services covering cell bank characterization, RCL detection and multi-dimensional sequencing profiling.

In strict accordance with ICH Q5A and Chinese Pharmacopoeia standards, comprehensive testing items including identity verification, purity analysis and adventitious agent screening are completed for Master Cell Banks (MCB) and Working Cell Banks (WCB). Combined with NGS technology, whole-genome characterization of lentiviral vectors is performed to guarantee intact vector structure and absence of abnormal insertion, achieving full-process biosafety control from raw materials to final products.

Global Compliance & Efficient Delivery to Accelerate Global Launch of Innovative Drugs

A dedicated green channel was launched for the SYS6055 project, with optimized testing workflows and senior technical teams deployed. While ensuring accurate and reliable data, the testing timeline was significantly shortened. Regulatory-compliant test reports for global submissions were delivered efficiently, facilitating rapid NMPA implied approval and laying a solid foundation for subsequent overseas registration.

 

III. Value Demonstration: Pioneering In-vivo CAR-T Testing to Drive Industrial Innovation

The successful support for the clinical approval of CSPC SYS6055 marks a milestone case for HyQure Biotech in the field of in-vivo CAR-T biosafety testing. As one of the first domestic enterprises to develop customized RCL testing for in-vivo CAR-T, HyQure Biotech has built a comprehensive technical system covering special enveloped lentivirus testing, full vector characterization and cell bank qualification. It has supported multiple CGT candidates entering clinical development, maintaining leading technical strength and service capabilities in the industry.

 

Moving forward, HyQure Biotech will continue to focus on CGT biosafety testing. With cutting-edge global technologies, customized solutions and professional high-efficiency services, we will empower more innovative pharmaceutical enterprises to overcome technical barriers and accelerate R&D progress. We strive to support the safe launch and globalization of Chinese innovative medicine, and boost the high-quality development of China's cell and gene therapy industry.