Vcanbio Cell&Gene Engineering Corp.,Ltd. (600645.SH) announced that its wholly-owned subsidiary, Wuhan Optics Valley Vcanbio Pharmaceutical Co., Ltd., received a Clinical Trial Application Acceptance Notice for VUM02 Injection from the Center for Drug Evaluation (CDE) of the National Medical Products Administration on August 1, 2025. The acceptance number is CXSL2500651.
VUM02 Injection (Human Umbilical Cord-Derived Mesenchymal Stromal Cell Injection) is a cryopreserved cell preparation independently developed by the company. It is a new drug composed of human umbilical cord-derived mesenchymal stromal cells (UC-MSC) prepared through screening of healthy newborn umbilical cord tissue, followed by in vitro isolation, expansion, harvesting, and cryopreservation. The clinical indication is intended for the treatment of pulmonary fibrosis after pneumonia.
As of the announcement date, no similar cell drugs for treating post-pneumonia pulmonary fibrosis have been marketed globally, with the most advanced competing drugs still in early-stage development. This indication application is supported by previously obtained clinical research data on COVID-19 and Phase I clinical trial data for idiopathic pulmonary fibrosis.
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