國內首個通用型幹細胞產品獲得臨床試驗許可 北京新浪網 (2019-01-19 14:56)【國內首個通用型幹細胞產品獲得臨床試驗許可】細胞藥品研發製造企業西比曼生物科技集團日前宣布，公司旗下異體人源脂肪間充質祖細胞注射液AlloJoin於2019年1月16日獲得臨床試驗默示許可，成為首個獲得國家藥品監督管理局臨床試驗許可的通用型幹細胞產品。
Osteoarthritis (KOA) Becomes the First Stem Cell Drug Application Approved in China for Phase II Clinical Trials Jan 17, 2019, SHANGHAI and NEW YORK, Jan. 17, 2019 /PRNewswire/ -- Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today announced that its off-the-shelf allogeneic adipose-derived mesenchymal progenitor cell (haMPC) AlloJoin® therapy for Knee Osteoarthritis (KOA) has been approved as the first stem cell KOA drug application in China for a Phase II clinical trial. China NMPA (formerly CFDA) clarified Cell Therapy Regulations in December 2017 (the "Regulation") whereby all cell therapies are being treated as drug NDA/IND. Following a 60-day period of priority review of CBMG's IND application for AlloJoin® for KOA, CBMG's IND application has become the first stem cell drug application to be approved by CDE for a Phase II KOA clinical trial since the Regulation's release. "We are pleased with this unprecedented milestone," said Tony (Bizuo) Liu, CEO of CBMG. "The Phase I trial for our proprietary AlloJoin® product demonstrated good safety and early efficacy for the prevention of cartilage deterioration, and this new approval from the CDE brings us closer to helping address the unmet medical needs of 57 million KOA patients in China."
About AlloJoin® CBMG's allogeneic adipose-derived mesenchymal progenitor cell (haMPC) AlloJoin® product is an off-the-shelf stem cell therapy developed completely in-house by CBMG over the past 7 years. The entire process to manufacture AlloJoin® involves many of CBMG's therapeutic and drug intellectual properties including certain proprietary trade secrets within a world-class Chemistry, Manufacturing and Controls (CMC) platform, which patents include methods for collecting, transporting, storing and qualitating adipose tissue, separation and purification of adipose stem (progenitor) cells, large-scale clinical grade cell production, formulations and preparations.
About Knee Osteoarthritis According to the Foundation for National Institutes of Health, there are 27 million Americans with Osteoarthritis (OA), and symptomatic Knee Osteoarthritis (KOA) occurs in 13% of persons over 60 years of age. The International Journal of Rheumatic Diseases, 2011 reports approximately 57 million people in China suffering from KOA. Currently no treatment exists that can effectively preserve knee joint cartilage or slow the progression of KOA. Current common drug-based methods of management, including anti-inflammatory medications (NSAIDs), only provide relief of symptoms accompanied by the risk of side effects. The mobility of patients with KOA is compromised, leading to sedentary lifestyle and increases all causes of mortality, doubles the risk of cardiovascular diseases, diabetes, and obesity, and increases the risks of colon cancer, high blood pressure, osteoporosis, lipid disorders, depression and anxiety. According to Epidemiology of Rheumatic Disease (Silman AJ, Hochberg MC. Oxford Univ. Press, 1993:257) 53% of KOA patients will eventually become disabled.
About Cellular Biomedicine Group Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. We conduct immuno-oncology and stem cell clinical trials in China using products from our integrated GMP laboratory. Our GMP facilities in China, consisting of 12 independent cell production lines, are designed and managed according to both China and U.S. GMP standards. Our Shanghai facility includes a "Joint Laboratory of Cell Therapy" with GE Healthcare and a "Joint Cell Therapy Technology Innovation and Application Center" with Thermo Fisher Scientific, whose partnerships focus on improving manufacturing processes for cell therapies. The CBMG pipeline includes preclinical compounds targeting CD20-, CD22- and B-cell maturation antigen (BCMA)-specific CAR-T compounds, and T-cell receptor (TCR) and tumor infiltrating lymphocyte (TIL) technologies. A Phase IIb trial in China for Rejoin® autologous Human Adipose-derived Mesenchymal Progenitor Cell (haMPC) for the treatment of Knee Osteoarthritis (KOA) is ongoing and a Phase II trial in China for AlloJoin™ (CBMG's "Off-the-Shelf" haMPC) has been approved to be conducted. CBMG is included in the broad-market Russell 3000® Index and the small-cap Russell 2000® Index, and the Loncar China BioPharma index. To learn more about CBMG, please visit www.cellbiomedgroup.com.
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