RemeGen Co., Ltd. (688331.SH/09995.HK) announced on August 8th that the Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for RC148, enabling Phase II clinical trials of the bispecific antibody for treating multiple advanced malignant solid tumors in the United States.
Novel Dual-Targeting Mechanism
RC148 represents an innovative therapeutic approach as a PD-1 and VEGF-targeting bispecific antibody. The molecule was developed using RemeGen's proprietary bispecific antibody technology platform, combining two distinct mechanisms of action in a single therapeutic agent. This dual-targeting strategy aims to simultaneously address immune checkpoint inhibition through PD-1 blockade and anti-angiogenic effects through VEGF targeting.
Expanding Global Clinical Development
The FDA clearance represents a significant regulatory milestone that should expedite RC148's global development process. Currently, clinical trials of RC148 are already proceeding in China, where the compound is being evaluated both as monotherapy and in combination therapy approaches for the treatment of advanced solid tumors.
The approval to conduct Phase II trials in the United States marks RemeGen's expansion into international markets with this bispecific antibody candidate. This regulatory clearance allows the company to advance its clinical development program beyond its initial Chinese market focus and potentially accelerate the path toward broader global availability.
Strategic Implications for Bispecific Antibody Development
The FDA's clearance of RC148 demonstrates the regulatory acceptance of RemeGen's bispecific antibody technology platform and validates the company's approach to developing innovative cancer therapeutics. The ability to target both PD-1 and VEGF pathways simultaneously may offer potential advantages over single-target therapies in treating advanced malignant solid tumors.
With clinical trials now authorized in both China and the United States, RemeGen is positioned to generate comprehensive clinical data across different patient populations and regulatory environments, potentially supporting future global registration strategies for RC148.
