The Center for Drug Evaluation (CDE) website in China has indicated that Tcelltech’s TX103, a chimeric antigen receptor (CAR) T cell therapy targeting B7-H3, has received tacit approval to proceed with clinical trials for the treatment of malignant glioblastoma. Suzhou Porton Biologics Ltd, Tcelltech’s Contract Development and Manufacturing Organization (CDMO) partner, will provide pharmaceutical production services and handle regulatory filings in China and the United States for the project.
TX103 has demonstrated excellent safety and efficacy signals in early clinical trials for the treatment of recurrent malignant gliomas. Malignant gliomas are highly malignant, with glioblastoma (GBM) being the most prevalent type. These tumors are prone to recurrence after surgery and currently lack effective treatment methods post-recurrence, leading to low survival rates and a poor prognosis. The clinical need for effective treatments remains unmet.- Flcube.com
