Stem cells have strong self-repair and regeneration capabilities. Stem cell regeneration intervention has always been considered to be able to cure a variety of difficult and complicated diseases. In recent years, the pace at which global pharmaceutical companies have made breakthroughs in the field of stem cell therapy has continued to accelerate.

Data show that by the end of 2024, there will be more than 8,300 related projects on the US Clinical Trials Registry website. Other data predict that by 2034, the global stem cell market size will grow to approximately US$48.83 billion, an increase of more than 200% from US$15 billion in 2023. It is reported that recently, in the field of stem cells, good news has been repeatedly reported in domestic and foreign markets.

For example, on December 18, 2024, the US FDA announced the approval of Mesoblast's allogeneic bone marrow mesenchymal stromal cell (MSC) therapy Ryoncil (remestemcel) for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children aged 2 months and older. This is the first mesenchymal stromal cell (MSC) therapy approved by the FDA for marketing.

After the FDA approved the mesenchymal stem cell therapy Ryoncil for marketing on December 18, 2024, on January 2, 2025, the National Medical Products Administration conditionally approved the marketing of my country's first stem cell therapy drug, Amymetocet injection, through the priority review and approval procedure, for the treatment of acute graft-versus-host disease (aGVHD) that has failed hormone therapy and mainly affects the digestive tract in patients over 14 years old.
The two drugs were approved only 15 days apart, and both are indicated for hormone-refractory acute graft-versus-host disease. The industry said that with the successive approval of stem cell drugs by the FDA and NMPA, it also indicates that the trend of stem cell innovative drugs has arrived.

It is reported that both approved stem cell drugs focus on mesenchymal stem cells, which are a group of cells with self-renewal and multi-lineage differentiation capabilities, widely distributed in various tissues and organs of the human body, such as bone marrow, umbilical cord, umbilical cord blood or fat. These cells have the potential to differentiate into a variety of mesenchymal series cells (such as osteoblasts, chondrocytes and adipocytes, etc.) or non-mesenchymal series cells, and have the function of cytokine secretion, showing great application potential in the forefront of regenerative medicine and cell therapy.

Data show that mesenchymal stem cell research and application are booming worldwide. So far, 655 mesenchymal stem cell projects have entered the clinical research and development stage. At present, there are about 10 mesenchymal stem cell therapeutic drugs approved for marketing worldwide, of which 4 are used to treat acute graft-versus-host disease (aGVHD).

Data show that graft-versus-host disease is a type of multi-organ syndrome caused by donor-derived lymphocytes attacking recipient tissues after allogeneic hematopoietic stem cell transplantation, which manifests as tissue inflammation and fibrosis mainly involving the skin, gastrointestinal tract, liver, lungs and mucosal surfaces. The approval of the launch of Amymetosai injection and other products, as human umbilical cord mesenchymal stem cell injections, has lit up a new dawn of treatment for patients suffering from illness.

It is reported that from the perspective of cell types that have been approved for clinical research applications (IND), as of October 2024, there are a total of 78 mesenchymal stem cell drugs in my country, accounting for 73.6%, which is the most important cell type for stem cell drug research and development.

Stem cells refer to a type of cell with self-renewal and multidirectional differentiation potential, which has broad application prospects in the field of regenerative medicine. The industry said that in addition to mesenchymal stem cells, the research progress of induced pluripotent stem cells (iPSCs) in the future is also worth looking forward to. Induced pluripotent stem cells (iPSCs) are a type of pluripotent stem cells that introduce a series of induction factors into mature somatic cells and reprogram them into pluripotent stem cells with characteristics similar to embryonic stem cells, which can differentiate into a variety of functional cells in the human body. Recommended attention: Beida Pharmaceuticals, Tailin Bio, and Heyuan Bio, etc.

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