Milestone Event: Mesoblast’s stem-cell drug receives FDA approval for market launch


2024-12-20

Recently, the U.S. Food and Drug Administration (FDA) announced its approval of Ryoncil (remestemcel), developed by Mesoblast, for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children aged 2 months and older. This marks the first mesenchymal stromal cell (MSC) therapy globally to receive FDA approval.

 

 

This groundbreaking achievement has delivered tremendous encouragement and profound insights to the global stem cell industry, demonstrating that stem cell therapies—after rigorous scientific validation and regulatory approval—can indeed be commercialized to benefit patients. At the same time, it has injected Jiuzhitang Maker, a company dedicated to stem cell research and application, with renewed confidence and momentum.

Mesoblast Throughout the Ryoncil development process, the company faced countless experimental setbacks and rigorous regulatory scrutiny—but remained steadfast in its commitment to scientific rigor, continuously refining both production processes and clinical study designs. By collaborating closely with world-class experts, the team ultimately overcame critical technical challenges and regulatory hurdles, successfully bringing Ryoncil to market.

(Regarding Mesoblast's ups and downs—click to learn more. )

This This isn’t just a victory for Mesoblast—it’s a milestone for the entire stem cell industry. It inspires Jiuzhitang Maker and stem cell research firms around the globe to keep pushing forward, collectively advancing the development of stem cell therapies and contributing even more to the cause of human health.

In the future, Jiuzhitang Maker will draw on Mesoblast’s successful experience to accelerate its product development process and explore allogeneic human therapies. Bone marrow mesenchymal stem cells The application potential is immense—let’s strengthen and deepen our research collaborations, elevate our technological capabilities, and actively participate in the development of international standards. Our goal is to launch even more innovative cell therapy products that will benefit a growing number of patients. At the same time, we look forward to seeing more groundbreaking stem cell-based treatments emerge in the future, offering global patients safer and more effective treatment options—and together, building a brighter future for all.