RemeGen's Independently-Developed Bispecific Antibody RC148 Approved to Proceed Phase II Clinical Trial in US by FDA

Written by PR Newswire

YANTAI, China, Aug. 8, 2025 /PRNewswire/ -- On August 8^th, RemeGen Co., Ltd. (688331.SH/09995.HK) announces clearance of IND application by Food and Drug Administration (FDA) for phase II clinical trials for its independently-developed bispecific antibody, RC148, for the treatment of multiple advanced malignant solid tumors in the US.

RC148 is a PD-1 and VEGF-targeting bispecific antibody, an innovative molecule developed by RemeGen using its bispecific antibody technology platform. Currently, the clinical trials of RC148 as monotherapy and combination therapy for the treatment of advanced solid tumor are proceeding in China.

The clearance of IND application by the FDA is a significant milestone for RC148 which should expedite its global development process.

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