China Speed in CGT: From IND to NDA in 20 Months

GCP ClinPlus is proud to have acted as the CRO partner, offering end-to-end support for Platinum Life Biotechnology Co., Ltd.’s stem cell therapy amimestrocel injection (brand name: Rui Bo Sheng). The therapy obtained NMPA approval within only 20 months following its Phase III clinical trial application, highlighting the remarkable efficiency of clinical development in China.

This single-arm, multicenter study enrolled 54 subjects, with an average recruitment rate of approximately 1.04 patients per site per month. Approval from the NMPA was granted within 3 months after the on-site inspection.

How GCP ClinPlus Combines Global Standards with China Speed:
✓ Extensive CGT expertise: involvement in 80+ cell and gene therapy projects
✓ Integrated clinical and regulatory support across the development lifecycle
✓ AI-integrated quality control, shortening data and statistics phases by 30-50%
✓ 210+ product approvals (NMPA/FDA/EMA) supported, with a 100% NMPA audit pass rate

Partner with GCP ClinPlus to advance your CGT innovations with global quality and local efficiency.
global@gcp-clinplus.com