On the evening of January 2, the State Food and Drug Administration conditionally approved the listing of Amymetocel injection applied by Bosheng Excellence Biotechnology (Beijing) Co., Ltd. (hereinafter referred to as "Bosheng Excellence") through the priority review and approval procedure.

This is China's first stem cell therapy drug, used to treat acute graft-versus-host disease with failure of hormone therapy, mainly involving the digestive tract in patients over 14 years old. Graft-versus-host disease is one of the main complications after allogeneic hematopoietic stem cell transplantation, and may cause death in severe cases. Specifically, graft-versus-host disease is a type of multi-organ syndrome that occurs after allogeneic hematopoietic stem cell transplantation when lymphocytes from the donor attack the recipient's tissues, manifested as tissue inflammation and fibrosis mainly involving the skin, gastrointestinal tract, liver, lungs and mucosal surfaces. Amymetocel injection is a human umbilical cord mesenchymal stem cell injection. Its listing provides a new treatment option for patients with graft-versus-host disease.

At present, in the fields of immune damage, diabetes, liver and other diseases, there are stem cell drugs that have entered the clinical trial stage. In recent years, the potential of stem cell therapy has been widely discussed in the medical field, and the public has high expectations for it. With the gradual standardization of national policies on stem cell therapy, a product has finally been approved, and this progress has attracted widespread attention in the medical field.
"This is a historic beginning, marking a historic breakthrough in stem cell therapy." Zhuang Fengfeng, vice president of the Biotechnology Branch of the China Anti-Aging Promotion Association, said that the stem cell industry has been committed to standardizing clinical trials in recent years. The approval of the first product has excited the entire industry, and everyone has seen the way forward.

It is necessary to mention that on December 18, 2024, the US FDA has just approved the listing of Ryoncil developed by Mesoblast for the treatment of steroid-refractory acute graft-versus-host disease in children aged 2 months and above. At that time, it was the first mesenchymal stem cell drug approved for listing in the United States.

Earlier, in August 2024, the world's first mesenchymal stem cell drug for the treatment of chronic motor paralysis was conditionally approved for marketing in Japan, and the manufacturer approved was SanBio.

According to data from the Prospective Research Institute, as of October 2024, a total of 148 stem cell drug clinical research applications (INDs) have been accepted in my country, of which 106 have been approved. From the perspective of cell types that have been approved for IND, as of October 2024, there are 78 mesenchymal stem cell (MSC) drugs, accounting for 73.6%, which is the main cell type for stem cell drug research and development; 10 stem cell drugs derived from iPSC functional cells have been approved.

The cell type used in the Amymetocet injection approved for marketing this time is mesenchymal stem cells. It is worth paying attention to how this drug will be priced.

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