Good News! Source Bio's “Human Umbilical Cord Mesenchymal Stem Cell Injection” IND application was accepted by CDE!
On April 15, 2025, the Center for Drug Evaluation of the State Drug Administration (CDE) formally accepted the application for new drug clinical trial (IND) (acceptance number CXSL2500297) submitted by Yuanpin Cellular Biotechnology Group Co. (“Yuanpin Bio”) for the clinical trial of new drug (IND) (Reception No.: CXSL2500297), which is intended for the treatment of knee osteoarthritis. This drug is intended to be used for the treatment of knee osteoarthritis (KOA), which is another significant progress in the field of stem cell drugs following the approval of IND for “Human Amniotic Membrane Mesenchymal Stem Cell Injection”.
Knee Osteoarthritis (KOA), also known as degenerative arthritis, is a chronic osteoarthritic disease caused by degeneration of cartilage and osteophytes in the knee joint, and is also one of the common chronic pain diseases. The incidence of this disease is extremely high, and it is especially common in the middle-aged and elderly population. According to statistics, the total prevalence of osteoarthritis in China is about 15%, and the number of patients is more than 122 million. Among them, the prevalence rate of people over 60 years old is more than 50%, and that of people over 75 years old is as high as 80%, and the prevalence rate continues to rise with the deepening of population aging.
“Human Umbilical Cord Mesenchymal Stem Cell Injection” adopts an innovative 3D low-oxygen large-scale cell culture process, realizing 3D culture of mesenchymal stem cells through a special carrier, which significantly improves the proliferation efficiency, paracrine function and immunomodulatory ability of stem cells. This breakthrough technology not only successfully enhances the therapeutic potential of human umbilical cord mesenchymal stem cells, but also fully demonstrates Genpine Bio's technological strength in the field of cell process innovation and clinical transformation.
As a high-tech enterprise focusing on the research and development of new stem cell drugs and technological innovation, Yuanpin Bio has made a series of major breakthroughs in the fields of respiratory diseases, sports medicine, reproductive health and tumor immunity. The company has always been adhering to the mission of “all for the sake of human life and health”, with the purpose of benefiting patients, promoting the clinical transformation and application of cell products with high quality, and committing itself to transforming more cell application technologies into safe and effective clinical therapeutic products.
