Asia Cell & Gene Therapeutics Group (Cayman Islands; aCGT) wholly owns three operating entities in the United States of America, Hong Kong and Shanghai of PRC: (1) aCGT USA (established in 2024), (2) CHINA STEM CELL THERAPY (H.K.) CO., LIMITED. (established in 2014) and (3) Asia Cell & Gene Therapeutics (Shanghai) Co., Ltd. (established in 2016).

aCGT focuses on pre-clinical and clinical development of stem cell-based cell and gene therapeutic products.

Currently, aCGT’s ‘off-the-shelf’ cell therapeutic product, Allogenic Umbilical-Cord Mesenchymal Stem Cell Intravenous Injection (UCMSC), 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 are developing multiple cell therapeutic products derived from induced pluripotent stem cells (iPSC): iPSC-derived OPC (oligodendrocyte precursor cells, iOPC) for the treatment of spinal cord injury, iPSC-derived iNPC (neural precursor cells, iNPC) for the treatment of stroke, iPSC-derived CAR-iNK for the treatment of systemic lupus erythematosus (SLE) and iPSC-derived islet cells for the treatment of diabetes. Pre-IND responses have been received from CDE for two products and IND applications are ongoing.

Additionally, as a by-product of UCMSC, the cell culture supernatant and its derivatives (i.e. exosome) provide valuable raw materials for cosmetic products. Therefore, as one of the already-available profitable products, aCGT is supplying and distributing these materials to global cosmetic companies.

aCGT is the first company worldwide that is developing mesenchymal stem cell and iPSC-based cellular products simultaneously. aCGT is even trying to investigate the synergistic effect of the cellular products from these two categories.

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). Following that, mesenchymal stem cell-based cellular products have been approved for marketing by FDA and NMPA, respectively, for the treatment of aGVHD. Considering the positive clinical trial data that aCGT has obtained so far, such progress 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.