Stem cell drugs are expected to be marketed in 5-10 years!

In 2019, some progress has been made in clinical transformation of stem cells in China. Clinical research projects have been launched and recruited one after another. At the same time, some projects declared in the form of drugs have also obtained clinical approval, which gives a new dawn to the domestic market of stem cell drugs. Recently, in the 47th Future Science Lecture, Chinese Academy of Sciences experts predicted that in the next five to ten years, there will be regular products of stem cell drugs approved by the state on the market.

Dr. Li Wei, a researcher at the Institute of Zoology of the Chinese Academy of Sciences and deputy director of the State Key Laboratory , said that the research and development of stem cells would be a subversive change for our health and life, and everyone was very concerned about it, but it needed a process. Enough confidence and patience, be positive and optimistic, but not aggressive. It is expected that within a relatively short period of time, regular products of stem cell drugs approved by CFDA will be on the market in five to ten years.

Reform of New Drug Approval System and New Opportunities for Stem Cell Development

In recent years, new policies issued in succession in China have greatly promoted the development and declaration of new stem cell drugs, which is conducive to shortening the marketing time of such therapeutic products. In the past few years, due to certain restrictions of regulatory system, the domestic market of new stem cell drugs is still in a blank state. But now regulatory policies have become clear, and new opportunities for new stem cell drugs to be marketed.

In 2018, China’s new drug clinical approval system formally changed, shortening the waiting period for new drug clinical applications. Since June 2018, eight new stem cell drugs have been registered and accepted. Three new stem cell drugs have received clinical approval under the new implied licensing model. Indications include knee osteoarthritis and diabetic foot.

China is optimizing procedures to speed up the clinical evaluation of urgently needed drugs, and has now put hundreds of varieties into the priority review process. Wen Baoshu, Director of the Business Administration of the Drug Review Center of the State Administration of Food and Drugs, said, “Through the priority review of these drugs, the time for the market of innovative drugs and clinically urgent drugs in China has been shortened from 7 to 8 years before the reform to 2 to 3 years.”

Today, some cell therapies (such as CAR-T) have been given priority reviews. In the future, cell therapy products, including stem cell drugs, are expected to be on the market soon.

State funding supports hundreds of stem cell-related projects

In recent years, the country has been vigorously promoting the development of stem cell clinical transformation. Since 2016, the central government has continuously allocated funds to support the key projects of stem cell and transformation research. It has allocated more than 2.4 billion RMB and supported hundreds of projects. Clinical stem cell research supported by central financial funds involves macular degeneration, spinal cord injury, graft-versus-host disease, heart failure, myocardial infarction, liver disease, severe acute kidney injury and other diseases.

In 2019, the state continued to support clinical research on cell therapy for a major disease or injury in nerve, respiratory, digestive system or skin, using clinical grade stem cell products.

Up to now, 115 research institutes (including military hospitals) have passed the record of clinical stem cell research institutes in China. More than 50 clinical stem cell research projects have been put on record. The diseases involved include acute myocardial infarction, cerebral palsy in children, premature ovarian failure, psoriasis, interstitial lung disease, knee osteoarthritis and Parkin’s disease. Sen disease, retinitis pigmentosa, age-related macular degeneration, ulcerative colitis, bone repair, empty nose syndrome, infertility, lupus nephritis, optic neuromyelitis, thin endometrium, COPD-induced pulmonary hypertension, decompensated hepatitis B cirrhosis, neuropathic pain, meniscus injury.

With the development of clinical transformation of cell therapy, cell production has also attracted much attention. The Guiding Principles for Research and Evaluation of Cell Therapeutic Products (Trial Implementation) in China points out that researchers should constantly optimize the preparation process, reduce the unexpected effects of physical, chemical or biological actions on cell characteristics, and try to achieve automated and completely closed production. Cell automation processing technology will become a new focus of industry development.

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