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

Rhea-AI Summary

RemeGen (NASDAQ:REGMY) has received FDA clearance for Phase II clinical trials of RC148, its independently-developed bispecific antibody targeting PD-1 and VEGF, for treating multiple advanced malignant solid tumors in the United States.

RC148 is currently undergoing clinical trials in China as both monotherapy and combination therapy for advanced solid tumor treatment. This FDA clearance represents a significant milestone in RC148's global development journey.

Positive

• FDA clearance for Phase II clinical trials in the US market
• Expansion of clinical development to international markets
• Dual-targeting capability through bispecific antibody technology (PD-1 and VEGF)
• Ongoing trials in China showing development progress

Negative

• Still in early clinical development phase with no efficacy data reported
• Faces significant competition in the crowded oncology market

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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SOURCE RemeGen Co., Ltd

FAQ

What is RemeGen's RC148 and what did FDA approve?

RC148 is RemeGen's bispecific antibody targeting PD-1 and VEGF for treating advanced solid tumors. The FDA cleared its IND application for Phase II clinical trials in the United States.

What types of cancer will RemeGen's RC148 target?

RC148 is being developed to treat multiple advanced malignant solid tumors. It is currently being tested as both monotherapy and combination therapy.

How does RemeGen's RC148 bispecific antibody work?

RC148 is a bispecific antibody that simultaneously targets two proteins: PD-1 (an immune checkpoint protein) and VEGF (vascular endothelial growth factor), potentially offering dual anti-cancer mechanisms.

What stage of development is RC148 in China?

RC148 is currently undergoing clinical trials in China as both monotherapy and combination therapy for the treatment of advanced solid tumors.

What is the significance of FDA's clearance for RemeGen's RC148?

The FDA clearance represents a significant milestone that allows RemeGen to proceed with Phase II clinical trials in the US market, expediting RC148's global development process.