The Boao Lecheng International Medical Tourism Pilot Zone in Hainan is the first legal and compliant medical special zone in China that conducts cell and gene therapy (CGT) operations.

On May 15th, the National Medical Products Administration issued a notice, announcing the implementation of the "Implementation Measures for the Protection of Drug Trial Data" (hereinafter referred to as the "Implementation Measures").

Recently, the China Biotechnology Development Center released the "Guidelines for the Clinical Research of New Technologies for Induced Pluripotent Stem Cells (Version 1)", which will come into effect on May 1, 2026.

Recently, the financing activity in the cell and gene therapy (CGT) sector has been steadily increasing. Seven related companies have completed financing in succession.

According to the official website of CDE and industry statistics, in that month, CDE received a total of 14 new drug clinical trial applications (IND) in the CGT field. Among them, 3 applications were granted conditional approval for clinical trials.

Recently, a series of key events in the global regenerative medicine field have occurred simultaneously, and China has made several landmark achievements in this field.

Recently, the China Biotechnology Development Center released the "Guidelines for Clinical Research of New Technologies in Tissue Stem Cell Therapy (Version 1)", which will come into effect on May 1, 2026.

In May 2026, the Drug Evaluation Center of the National Medical Products Administration (CDE) officially released the "2025 Annual Drug Evaluation Report".