Biosyngen's First-in-Class IND for EBV-Positive Lymphoma Therapy Approved in China

GuangzhouApril 11, 2023 /PR Newswire/ --On April 7, 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its official website that Guangzhou Biotheus Pharmaceutical Co., Ltd. (hereinafter referred to as "Biotheus") Global Exclusive首创重定向T Cell Injection New Drug Clinical Trial (IND) Officially Granted Clinical Trial Implied Permission by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This medicine is a product developed through gene modification technology targetingImmunotherapy product expressing receptors for Epstein-Barr virus (EBV) antigens on the surface of autologous T cells, used for treating EBV-positive lymphoma.

CDE Official Website Query Link:https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

Currently marketed cell therapy products, such asCD19 CAR-T, BCMA CAR-T mostly target B cellsLymphoma/ Leukemia or multiple myeloma, unable to treat most EBV-induced lymphomas and lymphoproliferative diseases, while Biotheus’ new pipeline can precisely target EBV virus infection-related lymphomas. Dr. Chen Zhi-Jing, Director and Chief Operating Officer of Biotheus, stated: "Biotheus advances product development with the aim of high-quality growth. This is the second global product from Biotheus to receive IND approval, demonstrating that Biotheus consistently focuses on unmet clinical needs. The pipeline has simultaneously submitted an IND application to the US FDA, and this year, several first-in-class drugs targeting lung cancer, liver cancer, various gastrointestinal tumors, and other cancer types will be filed for Phase I/II clinical trial authorization in China, the US, and Singapore."