On January 2, 2025, China’s National Medical Products Administration (NMPA) granted conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001), marking a significant milestone in the country’s medical and biotechnological advancements. The product is being marketing under the brand name Ruibosheng. This approval designates it as China’s first human umbilical cord-derived mesenchymal stem cell (hUC-MSC) therapy, offering a promising treatment option for steroid-refractory acute graft-versus-host disease (GVHD), a serious and often fatal complication following stem cell transplants.

Amimestrocel is derived from human umbilical cord tissue, a rich source of mesenchymal stem cells (MSCs). These stem cells have regenerative properties and can help repair damaged tissues by promoting healing, reducing inflammation, and modulating the immune response. The therapy has been shown to help patients who do not respond to traditional steroid treatments, providing new hope for those suffering from acute GVHD.

This approval underscores China’s ongoing commitment to advancing cutting-edge medical treatments and expanding the availability of innovative therapies for complex diseases.

Globally Approved MSC-Based Therapies

At present, only 12 MSC products are available to be marketed globally. This includes 11 full approvals and now this 12th conditional approval within China. Only one of these products has been approved for use within the U.S., Mesoblast Limited’s Ryoncil, which received FDA approval on December 18th, 2024. A 13th product, Takeda’s Alofisel, was previously approved by the European EMA in 2018, but it was voluntarily withdrawn on December 13, 2024, after clinical data found that its clinical benefit was not justified.

The other global MSC-based cell therapy approvals include:

  • Republic of Korea:
    • Queencell from Anterogen
    • Cellgram AMI from Pharmicell
    • Cupistem from Anterogen
    • Cartistem from Medipost
    • NeuroNataR from Corestem
  • Japan:
    • Temcell HS from JCR Pharmaceuticals
    • Stemirac from Nipro Corporation
  • Europe:
    • Holoclar from Chiesi Farmaceutici
      *Note: Previously, Alofisel from Takeda/TiGenix was approved by the EMA, but it was withdrawn in December 2024.
  •  India:
    • Stempeucel from Stempeutics
  •  Iran:
    • MesestroCell from Cell Tech Pharmed
  • Canada and the U.S. have both approved:
    • Prochymal, later rebranded as Ryoncil (Remestemcel-L) from Mesoblast
  • China has approved one product:
    • Ruibosheng, a human umbilical cord derived MSC product (amimestrocel injection) from Platinum Life Excellence with Conditional Approval

As MSC research continues to evolve, the success of Ruibosheng (amimestrocel) could pave the way for further breakthroughs in regenerative medicine, and hopefully, additional MSC-based cell therapy approvals.