Chinese biopharmaceutical company RemeGen Co., Ltd. (SHA:688331, HKG:09995) announced on Friday that it has received clearance from the United States Food and Drug Administration to initiate Phase II clinical trials for its bispecific antibody RC148.
RC148 is a novel bispecific antibody designed for the treatment of multiple advanced malignant solid tumours targeting both PD-1 and VEGF. It was developed using RemeGen's proprietary bispecific antibody technology platform.
Clinical trials for RC148, both as a monotherapy and in combination treatments, are currently ongoing in China.
FDA approval to proceed with US trials represents a major milestone in RC148's global clinical development strategy.
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RemeGen receives FDA approval to advance RC148 into Phase II trials for solid tumours