Osteoarthritis stem cell therapy was accepted by CDE

With the rapid approval of new drugs, China's cell therapy technology is also good news. Following the treatment of biopharmaceous human pulp-filled stem cell injection, inter-filling stem cells (cord) for injection was accepted by the Drug Review Center (CDE) of the State Administration of Food and Drug Administration, on November 7, on the official website of CDE, Sibiman Biological Group (NASDAQ: CBMG) applied for CCM-ALAM.1 isomer-sourced inter-fat recharge progenitor cell injection was accepted, receiving the number CXSL1800109. The declared drug type is a new class 1 drug for therapeutic biologics.
it is understood that the application for stem cell technology AlloJoin® therapy stems from Sibiman's mature cell technology platform and reJoin ® between the sources of self-fat to treat the clinical study data of knee osteoarthritis. In addition to the safety and effective progenitor cells in the treatment of knee osteoarthritis that have been proven in previous ReJoin® clinical trials, the safety of allogeneic fat-filled progenitor cells has also been determined in the AlloJoin® clinical trial. Moreover, animal experiments completed by Sibiman biology also provide preliminary evidence of the effects of heterogenetic fat-filled progenitocytes in treating knee osteoarthritis.
data show that osteoarthritis is a kind of joint cartilage wear, destruction, loss, and associated with bone growth around the section of a dedefed disease, mainly manifested in joint pain and dysfunction, the incidence rate of noncommunicable diseases ranked in the top 10. Data show that 8.1% of people over the age of 50 in China have symptomatic knee osteoarthritis, a total of more than 30 million people.
currently, routine treatment for osteoarthritis patients in China includes oral anti-inflammatory painkillers and amino glucose drugs, injection of sodium glazate in the joint cavity, physiotherapy and surgery. There is no effective intervention to prevent the progress of arthritis, and a new treatment is urgently needed. Sibiman's breakthrough in new drugs has also been interpreted by the industry as a breakthrough in new treatments.
November 9, Sibiman related person in charge of the introduction to the author, this is the first common type of isometric fat source stem cell products were accepted, but also Sibiman biology in China successfully obtained the third new drug acceptance. Previously, in April this year, the State Drug Administration accepted a clinical trial application for Sibiman C-CAR011, an anti-CD19 inlay antigen-inset antigen-receiving T-cell immunotherapy for adult B-cell non-Hodgkin's lymphoma and acute lymphoblastic leukemia.
" In recent years, Sibiman has continuously strengthened its investment in cell therapy research and development and GMP layout, and currently holds nearly 80 patents (including authorized and filed) for stem cell and immunocytocyte technology, including 13 international patents and 10 PCT patents. In addition, Sibiman in Beijing, Shanghai and Wuxi set up to meet the U.S. FDA standards and China's national standards of research and development and GMP production facilities cell production facilities, a total of 12 independent production lines. In different cities, Sibiman organisms have multiple cell libraries that can be used to store cells from individual sources, as well as advanced cold chain temperature control systems (IT cloud systems) that monitor cell culture, storage and transport. The above-mentioned person in charge pointed out. (Bio Valley)