The Boao Lecheng International Medical Tourism Pilot Zone in Hainan, as the first legal and compliant medical special zone in China to carry out cell and gene therapy (CGT), has taken advantage of its "pilot first" policy to become the core area for the transformation and application of advanced cell therapies in China.

Entry facilitation: Allow foreign cell technologies that have been approved for market or are in clinical phase II or above to be directly used in Lecheng after review, without having to wait for the conventional domestic approval process. 

Real-world data: The clinical data from Lecheng can be directly used for NMPA registration application, significantly shortening the market entry cycle. 

Dual registration + full traceability: Dual registration by the state and Hainan, with full traceability of cell source, preparation, and usage process. 

Compliance-based charging: Approved projects can be priced publicly for charging, forming a commercial closed loop. 

As of March 22, 2026 (at the 3rd Boao Lecheng Stem Cell Conference): 21 CGT projects with officially registered prices and capable of charging fees have been announced in 5 batches. 

As of May 19, 2026: The latest data shows that Lecheng has cumulatively approved 30 cell therapy projects and has added 9 new CGT projects.

At present, only Amymetosetase injection and hematopoietic stem cell transplantation have been included in the national medical insurance directory. The specific reimbursement ratio needs to refer to the policies of each region. All the promotional claims that "stem cell treatment can cure diabetes and knee arthritis and can be covered by medical insurance" are all false promotions. 

Latest regulatory changes in May 2026 (Order No. 818) 

Core requirement: After May 2026, the national regulations stipulate that stem cell infusion must be carried out in tertiary hospitals. 

Industry landscape transformation: Cell institutions will transform into "cell suppliers" for tertiary hospitals, while hospitals will be responsible for clinical application and safety management.