White Paper on Regulations for China’s Cell and Gene Therapy (CGT) Industry: Entering a New Compliance Era of "Dual-Track Parallel Development"

2026 marks a watershed for the development of China’s Cell and Gene Therapy (CGT) industry. The Regulation on the Administration of Clinical Research and Clinical Transformation and Application of Biomedical New Technologies (State Council Decree No. 818) officially came into force on May 1. Subsequently, the National Medical Products Administration (NMPA) qualified CGT medicinal products for the 30-day review pathway for clinical trials. China’s CGT sector has bid farewell to unregulated expansion and ushered in a new compliance era featuring "dual-track parallel development" with clarified regulations, defined development pathways and improved review efficiency.

01 Establishment of the "Dual-Track" Regulatory Framework

At present, the core regulatory framework governing China’s CGT sector is the "dual-track system" established by two state council-level regulations, which clearly differentiates two translation pathways: medical technologies and medicinal products.

02 Decree No. 818: Core Red Lines and Requirements

High Threshold for Access
Institutions conducting clinical research must be Grade A tertiary hospitals equipped with qualified academic committees and ethics committees. Principal investigators shall be licensed physicians with senior professional titles.

Mandatory Zero-Charge Rule
Sponsors and research institutions are prohibited from charging subjects any fees during clinical research. This provision fundamentally closes loopholes for the grey practice of commercialization under the guise of research.

30-Year Data Retention Requirement
Clinical research records and source documents must be retained for 30 years upon completion of research; records involving offspring shall be preserved permanently. This imposes stringent requirements on hospitals’ data management capabilities.

Defined Legal Liabilities
Severe penalties are stipulated for unauthorized research involving prohibited technologies or studies with major ethical concerns, including fines of up to 20 times the illegal gains and lifetime industry bans for responsible persons.

03 Medicinal Product Review and Approval: The Era of Accelerated 30-Day Review

On July 3, 2026, the NMPA issued new policies to include eligible CGT medicinal products in the 30-day review pathway for clinical trial applications, shortened from the previous 60 working days. This efficiency is comparable to international standards, aiming to:

• Encourage simultaneous global R&D: Support international multi-center clinical trials conducted in China and eliminate the "China time lag".
• Prioritize key areas: Grant priority review to innovative products targeting malignant tumors, rare diseases, hereditary diseases, immune disorders and neurodegenerative diseases.

04 Lanke Biotech: Driving CGT Innovation Rooted in Compliance

Faced with the renewed regulatory landscape, Lanke Biotech regards compliance and quality as the lifeline of corporate growth, and has built a capability system fully aligned with the new regulatory policies.

Clear Strategic Path Focused on the Medicinal Product Track

The Company concentrates on developing scalable and standardized Ex vivo CAR and In vivo CAR cell therapy products. We firmly pursue the medicinal product registration pathway, highly consistent with the regulatory orientation of the NMPA.

Quality System Aligned with New Regulations

We operate complete GMP cell manufacturing facilities and standardized quality control systems, ensuring full traceability and auditability of data across R&D and production, fully meeting strict quality requirements for medicinal product review.

Compliant Layout of Clinical Resources

We collaborate with multiple Grade A tertiary hospitals across China to conduct clinical trials and build an integrated "R&D + Process Development + Clinical" platform. All clinical activities strictly comply with high standards set by Decree No. 818 concerning institutional qualifications and ethical review.

As China’s CGT industry shifts from follower to leader on the global stage, Lanke Biotech will continue to safeguard innovation through compliance and validate therapeutic efficacy with superior quality. We aim to collaborate with clinical and industry partners to advance the high-quality development of precision medicine in China.