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.
BioLife Solutions
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.
Sartorius
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 A 13th product, Takeda’s Alofisel, was previously approved by the European EMA in 2018, but it was voluntarily withdrawn on December 13, 2024, after clinical data found that its clinical benefit was not justified.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*Note: Previously, Alofisel from Takeda/TiGenix was approved by the EMA, but it was withdrawn in December 2024.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.
To learn more about this expanding field, view the report, “Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) – Advances & Applications, 2025“.
MSC Market Report, 2025
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Filed Under: MSCs, Stem Cells
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About Cade Hildreth, Founder & President
Cade Hildreth is the Founder of BioInformant.com, the world’s largest publisher of stem cell industry news. Cade is a media expert on stem cells, recently interviewed by the Wall Street Journal, Los Angeles Business Journal, and Vogue Magazine.
