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China Greenlights First Stem Cell Therapy On Mixed Clinical Findings

Supportive Regulatory Environment

 
• By Dexter Jie Yan

China has granted its first approval for a stem cell therapy, to domestic firm Platinum Life Biotech’s umbilical cord-derived mesenchymal stem cell product for corticosteroid-failed acute graft-versus-host disease with gut involvement.

Mesenchymal cell
The hUC-MSC PLEB001 is a human umbilical cord-derived mesenchymal stem cell (MSC) therapy. • Source: Shutterstock

China has granted its first regulatory approval for a stem cell therapy despite mixed results from the supporting Phase II clinical trial on which the marketing green light was based.

On 2 January, the National Medical Products Administration (NMPA) conditionally approved hUC-MSC PLEB001, a human umbilical cord-derived mesenchymal stem cell (MSC) therapy for the treatment of corticosteroid-failed acute graft-versus-host disease...

Key Takeaways
  • China has conditionally approved its first stem cell therapy, Platinum Life Biotech's hUC-MSC PLEB001 for corticosteroid-failed acute graft-versus-host disease with gut involvement.

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