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Recently, the Ministry of Commerce, the National Health Commission, and the National Medical Products Administration jointly issued a notice on expanding the pilot work of opening up in the medical field, which stated that foreign-invested enterprises are allowed to engage in the development and application of human stem cell, gene diagnosis and treatment technologies in Beijing, Shanghai, Guangdong Free Trade Zone, and Hainan Free Trade Port for product registration, listing, and production.

 

 

 

In recent years, China has successively issued a series of policies, from clinical research to industrial development, clearly supporting and encouraging the development of innovative stem cell technologies and the transformation and landing of products. As stated in the 14th Five Year Plan, the focus will be on developing stem cell therapy, specific immunoglobulin, gene therapy products, immune cell therapy, etc. The Technical Guidelines for Clinical Trials of Human Stem Cells and Their Derived Cell Therapy Products (Trial) provide technical guidance for the research and development, registration and application, and clinical trials of stem cell products.

 

 

 

Supported by a series of favorable policies, the field of stem cell innovative drugs has broad prospects, and pharmaceutical companies are actively expanding into this area. Some institutions have pointed out that since the standardized development of stem cell innovative drugs in China in 2020, the number of domestic stem cell IND has almost doubled every year. Currently, the number of domestic stem cell IND has reached nearly 100, and many of these stem cell innovative drugs have entered the research and development stage after clinical phase II.

 

 

 

It is reported that in June 2024, Platinum's excellent "Amimatosa Injection" became the first stem cell innovative drug in China to be accepted for market application by the National Medical Products Administration. The clinical indication for this stem cell drug application is acute graft-versus-host disease (aGVHD) with hormone failure.

 

 

 

Data shows that Amimatosa injection has demonstrated significant efficacy and safety in the treatment of acute graft-versus-host disease (aGVHD) that has failed hormone therapy by utilizing human umbilical cord mesenchymal stem cells to repair damaged tissues and regulate immune function.

 

 

 

The institution stated that stem cells are known as "universal cells" in the medical field, and can differentiate into various functional cells or tissue organs under specific conditions or signals. It may be applied to the repair of almost all important tissues and organs in the human body and to the study of many medical challenges faced by humans, with great potential in cell replacement, tissue repair, disease treatment, and other areas.

 

 

 

Although there are currently no approved stem cell innovative drugs on the market in China, institutions have pointed out that stem cell innovative drugs have entered relevant guidelines for indications such as chronic ischemic diseases in the lower limbs, systemic lupus erythematosus, decompensated liver cirrhosis, heart failure, etc., and are also recommended in the fields of anti-aging, plastic surgery, and cosmetic surgery. Looking ahead to the future, with the continuous catalysis of stem cell innovative drug policies and the application and approval of domestic stem cell new drugs, the domestic stem cell innovative drug industry has entered a good investment stage. It is recommended to pay attention to companies with clinical stage stem cell innovative drug pipelines.

 

 

 

In recent years, Zhongyuan Union Medical College has extended its business to the field of stem cell drugs. Its equity partner, Beijing Sanyi Heze Biotechnology, and Capital Medical University jointly applied for the "Human Dental Pulp Mesenchymal Stem Cell Injection" for the treatment of chronic periodontitis, which began Phase II clinical trials in May 2023. The VUM02 injection (human umbilical cord derived mesenchymal stem cell injection) independently developed by its wholly-owned subsidiary Wuhan Optics Valley Zhongyuan has six indications for clinical application.

 

 

 

For example, on January 18th of this year, Tianshi Li announced that its innovative stem cell drug, human umbilical cord mesenchymal stem cell injection (B2278 injection), has been approved by the National Medical Products Administration to enter clinical trials for the treatment of chronic heart failure.

 

 

 

And Huabang Health also stated on the interactive platform that the company's equity partner, Hebei Life Origin, is the construction and operation party of the Hebei Province Stem Cell Bank. Its core business is the storage of cells such as neonatal stem cells and adult immune cells, as well as the clinical research and application transformation of stem cell products.

 

 

 

In addition, Boya Stem Cells, a subsidiary of Boya Life Sciences, was approved as a provincial-level engineering research center in Jiangsu Province as early as 2018, providing effective support and guarantee for the innovation and development of the local stem cell industry, as well as for the key technology research and development that hinders the transformation and upgrading of the industry and the development of key industries. In recent years, Boya has made extensive layouts in regions such as Beijing Tianjin Hebei, Yangtze River Delta, and Guangdong Hong Kong Macao Greater Bay Area, promoting the development of the cell industry in these areas. It is reported that in 2022, Boya Stem Cell, a subsidiary of Boya Life, was appointed as the first vice chairman unit of the China Stem Cell Industry Alliance, further promoting the development of China's stem cell industry.

 

 

 

Industry insiders have stated that since the 12th Five Year Plan for Science and Technology explicitly listed "stem cell research" as one of the six major scientific studies, relevant support policies have been introduced one after another, and China's stem cell industry has developed rapidly with broad application prospects. In addition to the domestic market, innovative stem cell drugs in overseas markets are also experiencing catalysis. It is reported that the first stem cell innovative drug in the United States is expected to be approved by the end of 2024. Mesoblast resubmitted its marketing application for remestemcel-L to the FDA in July 2024, with a PDUFA date of January 7, 2025, and is expected to be the first approved stem cell innovation drug in the United States.