Asia Cell & Gene Therapeutics Group (Cayman Islands; aCGT) wholly owns two operating entities in Hong Kong and Shanghai: (1) Asia Cell & Gene Therapeutics (H.K.) Co., Ltd. (established in 2014) and (2) Shanghai aCell Therapeutics Co., Ltd. (established in 2016).
aCGT focuses on the development of cell and gene therapeutic drugs and their global filing & clinical trials.
Currently, aCGT’s ‘off-the-shelf’ cell therapeutic product, Allogenic Umbilical-Cord Mesenchymal Stem Cell Intravenous Injection (classified as National Class 1 New Drugs), is in phase I clinical trials for the treatment of two indications - burns & COPD, under the approval of China’s National Medical Products Administration (NMPA). Phase II clinical trials are ongoing for another three indications - ankylosing spondylitis (AS), liver cirrhosis & acute respiratory distress disorder (ARDS). Additionally, we are applying for a direct Phase II clinical trial for the treatment of AS, under the approval of the United States FDA, and have received positive pre-IND responses from FDA.
Meanwhile, we plan to apply for IND to China NMPA and/or the United States FDA from 2025 Q1 and the following, for aCGT's three cell therapeutic products derived from induced pluripotent stem cells (iPSC): iPSC-derived iOPC (oligodendrocyte precursor cells) for the treatment of spinal cord injury, iPSC-derived iNPC (neural precursor cells) for the treatment of stroke, and iPSC-derived CAR-iNK for the treatment of systemic lupus erythematosus (SLE). Preliminary preclinical data demonstrate that some of our products outperform their US counterparts.
Note: Since China NMPA issued regulations to officially establish stem cells as drugs (instead of medical technique) in 2017, the research and development of umbilical cord mesenchymal stem cells as drugs in China has been prospering. aCGT is currently the entity with the largest number of IND registrations approved for clinical trials by the NMPA in China. Recently, in the bi-annual meeting of Beijing Food and Drug Administration in 2024 Q3, the authority issued China's first ‘Drug Production License’ to stem cell product (particularly, umbilical cord-derived mesenchymal stem cell product). Considering the positive clinical trial data that aCGT has obtained so far, the first ‘Drug Production License’ to umbilical cord-derived stem cells has greatly increased the certainty of aCGT’s multiple umbilical cord stem cell drugs to be approved for NDA and drug production license in the future.