Recently, the first prescription of Amytosai injection, the first stem cell drug approved for marketing in China, was issued at Peking University People's Hospital for the treatment of haploid transplant patients. The drug costs 19,800 yuan per treatment, and the total cost is about 158,000 yuan if 8 treatments are considered a complete course of treatment.

In comparison with the international market, the U.S. FDA-approved mesenchymal stem cell drug Ryoncil is priced at as high as US$194,000 (about RMB 1.39 million) per dose, which is 70 times the cost of a single dose of Aimitocel injection.

The first approved

The stem cell therapy Amymatosai Injection (trade name: Ruibosheng) developed by Beijing Bosheng Excellence Biotechnology Co., Ltd. was conditionally approved for marketing by the National Medical Products Administration through the priority review and approval procedure on January 2, 2025. It is indicated for the treatment of acute graft-versus-host disease (aGVHD) in patients aged 14 years and above who have failed hormone therapy with the main involvement of the gastrointestinal tract. It became the first mesenchymal stem cell therapy drug approved for marketing in my country.

Currently, mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs) are the two major focuses in the clinical and scientific research fields. Among them, MSCs have become the research core of stem cell therapy at home and abroad due to their wide sources, low immunogenicity, multidirectional differentiation ability and strong immunoregulatory function. These cells can be obtained from almost all organs and tissues, including bone marrow, fat, umbilical cord, placenta, amniotic fluid and fetal tissue, and can differentiate into functional cells of specific lineages.

According to statistics, there are more than 1,300 MSCs-related clinical trials worldwide, covering multiple treatment areas such as orthopedic diseases, cardiovascular diseases, and immune diseases.

In 2011, Cellgram developed by South Korea's Pharmicell was approved for marketing, becoming the world's first stem cell drug for the treatment of myocardial infarction.

On December 18, 2024, the U.S. FDA approved the first MSC therapy, Ryoncil, for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children over 2 months old. The therapy has been recognized by the FDA as an orphan drug, fast track, and priority review.

Ryoncil is derived from mesenchymal stromal cells generated by allogeneic bone marrow. In a multicenter single-arm study, 54 pediatric patients with SR-aGVHD after allogeneic hematopoietic stem cell transplantation (allo-HSCT) participated in the study and received Ryoncil intravenous infusion twice a week for four weeks. Data showed that 28 days after the start of treatment, 16 patients (30%) achieved complete remission and 22 patients (41%) achieved partial remission.

Breaking through the “sky-high price” barrier

As a similar product to Amytosai injection, Ryoncil was approved by the FDA in December 2024 for steroid-refractory acute graft-versus-host disease (SR-aGvHD). Its single treatment cost is $194,000 (about RMB 1.39 million), and a course of treatment requires 8 times, with a total cost of $1.552 million (about RMB 11.14 million). Although this price is lower than Kymriah (US$470,000 per injection), it is still one of the most expensive cell therapies in the world.

High R&D investment, high quality control costs for primary cell culture and huge expenses for cross-continental cold chain transportation are the fundamental reasons for Ryoncil's high price.

As the pioneers of stem cell therapy, South Korea and Japan have launched a number of products, but the prices are still high. South Korea's Cartistem (degenerative arthritis) costs 19,000-21,000 US dollars per dose, and Japan's bone marrow mesenchymal stem cell Temcell for the treatment of aGVHD costs 7,700 US dollars per bag. The standard course of treatment is 4 weeks and 8 bags, with a total cost of 123,000-185,000 US dollars. Both are far higher than similar products in China.

In March 2025, the Hainan Boao Lecheng Stem Cell Conference announced the official pricing of three stem cell treatments for the first time:

Knee osteoarthritis: A single injection of adipose-derived mesenchymal stem cells costs RMB 36,000. The cost is concentrated in cell preparation and quality inspection. The price may drop further after scale-up.

COPD: Airway basal stem cell therapy costs 150,000 yuan per session, which is significantly lower in risk and cost than lung transplantation (over 600,000 yuan);

Heart failure: Umbilical cord-derived mesenchymal stem cells need to be infused once a week for a total of three times, with a total cost of RMB 180,000.

In the second batch of cell and gene therapy technology projects announced on April 26, 2025, the mesenchymal stem cell therapy technology for post-bone marrow transplantation-versus-host disease is priced at 80,000 yuan per time. In sharp contrast, the price of Amytometosyl injection is 19,800 yuan/60 million units, reducing the cost of treatment for the same indication to 25% of the price of Boao technical services.

As a stem cell drug approved by the National Medical Products Administration, Amytosai Injection has demonstrated significant advantages in terms of accessibility in both the international and domestic pricing systems.

AmyTosai uses umbilical cord mesenchymal stem cells, which are not only easy to obtain but also suitable for large-scale production.

Secondly, in the process development and production of Amytometosyl injection, the 3D microcarrier-based stem cell scale culture technology of the School of Biomedical Engineering of Tsinghua University was applied. Through the automated, continuous, and closed three-dimensional cell preparation process pipeline, a single batch can complete the production and preparation of tens or even hundreds of billions of cells. Compared with the traditional cell culture production method, it solves the problems of high labor costs, large production space requirements, and limited batch production of cell products.

Although the price of Ruibosheng is significantly lower than similar international products, the cost of a complete course of treatment of 158,000 yuan is still beyond the financial affordability of many Chinese families. Since most indications for stem cell therapy are rare diseases and the patient base is small, medical insurance negotiations face great resistance. In view of the fact that domestic CAR-T therapy has not yet been included in the medical insurance catalog, innovative models such as "commercial insurance first + installment payment" can be explored to improve patient accessibility.

Accelerating progress

At the policy level, CDE has frequently introduced relevant policies on cell therapy to comprehensively accelerate the clinical transformation of stem cell technology.

In early 2024, CDE issued the "Technical Guidelines for Clinical Trials of Mesenchymal Stem Cells for the Prevention and Treatment of Graft-Versus-Host Disease", which provided specific technical suggestions on clinical trial design and efficacy evaluation of stem cell treatment for graft-versus-host disease (GVHD), aiming to promote the marketing of stem cell drugs.

In February 2024, the newly revised "Guidelines for Industrial Structure Adjustment" included cell therapy drugs and cell culture in the list of encouraged industries.

In May 2024, the Beijing Food and Drug Administration issued the country's first stem cell "Drug Production License".

On June 10, 2025, CDE issued the "Scope, Classification and Interpretation of Advanced Therapeutic Drugs (Draft for Comments)", which clarified for the first time that my country's "advanced therapeutic drugs (ATMPs)" are divided into cell therapy drugs (CTMPs), gene therapy drugs (GTMPs) and other categories, establishing a clear classification framework for the registration and market access of stem cell drugs.

The policy dividend directly drives the activeness of industrial capital. According to public data, there were 53 financing events in the domestic cell therapy industry in 2024, and 50 companies raised a total of more than 3.5 billion yuan.

In addition to the already-launched Amymetocel, more than 20 stem cell drugs in China are in the clinical trial stage, with indications covering GVHD, osteoarthritis, heart failure, etc.

Zhongyuan Xiehe's VUM02 injection (human umbilical cord-derived mesenchymal stem cell injection) has been approved for clinical trials for 8 indications, and the one with the fastest clinical progress has entered Phase III clinical trials.

YFQLXB-UC01 injection is a cryopreserved cell preparation independently developed by Qilu Cell. Its main active ingredient is umbilical cord mesenchymal stem cells. Currently, four clinical trials have been approved, including decompensated liver cirrhosis and moderate to severe acute respiratory distress syndrome.

In April 2025, SBI Biopharma's allogeneic human adipose-derived mesenchymal stem cell injection (AlloJoin) launched a pivotal Phase III clinical trial for knee osteoarthritis.

Conclusion

The treatment price of 158,000 yuan for Amymetocel has become a landmark breakthrough in the commercialization of China's stem cell industry, fully demonstrating the cost control advantages and innovation strength of "China's smart manufacturing". In the future, the sustainable development of the cell industry can be promoted through technological innovation to reduce costs and promote the coverage of medical insurance and commercial insurance policies. With the improvement of the accessibility of stem cell treatment, this industry exploration with 158,000 yuan as the starting point is gradually opening up new possibilities for precision treatment for more patients.

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