The state of new drug evaluation of Zhongyuan Xiehe blockbuster stem cells has gone back strangely

According to the website of the State Food and Drug Administration (CFDA), the review status of Zhongyuan Xiehe heavy-duty stem cell drug umbilical cord mesenchymal stem cell anti liver fibrosis injection has regressed from "in approval" to "in review", and whether it can be approved for clinical use in a short period of time remains in doubt The share price of the drug rose continuously after the declaration status changed to "in approval" last week, and the market expects that this is the first approved clinical stem cell drug after the new deal of stem cell is released The CFDA website shows that the clinical application of the drug was changed to "under approval" on March 5, but it was returned to "under review" yesterday According to the public information, in approval means that the drug has been submitted to CFDA for signature, and it is expected to be approved within 1-2 months according to other drug declaration processes; while in review means that the drug is still undergoing technical review in CFDA technical approval department, and the time for product approval is unpredictable As of the press release, Zhongyuan Xiehe has not yet responded to the review retrogression Umbilical cord mesenchymal stem cells anti fibrosis injection was used in the treatment of liver fibrosis Yinhe securities research report pointed out that China has 20 million chronic viral hepatitis patients and 120 million hepatitis B carriers, which is the highest prevalence of liver disease in China In addition, the incidence rate of alcoholic liver, fatty liver and drug-induced hepatitis also increased significantly There are about 70 million patients with liver fibrosis At present, there is no specific drug for treatment The market potential is huge It is worth mentioning that up to now, China's policies and regulations are still blank in the field of stem cells, which seriously restricts the application of related drugs Recently, the Ministry of science and technology of the people's Republic of China issued the implementation plan for key projects of stem cell and translational medicine in the national key research and development plan (Draft for comments), launched the pilot work of key projects of "stem cell and translational medicine" in the national key research and development plan, and strengthened the input and layout of stem cell foundation and transformation.