REMEGEN (09995) announced that its proprietary novel bispecific antibody RC148 has been officially granted breakthrough therapy drug designation by China's Center for Drug Evaluation (CDE) under the National Medical Products Administration. The designated indication is: RC148 in combination with docetaxel for the treatment of driver gene-negative locally advanced or metastatic non-small cell lung cancer (NSCLC) that has failed treatment with PD-1/PD-L1 inhibitors and platinum-containing chemotherapy (combination or sequential).

This breakthrough therapy designation by the CDE is based on a multi-center, open-label Phase I/II clinical study (RC148-C001) conducted in China. The clinical study explores the efficacy and safety of RC148 combined with docetaxel in treating NSCLC patients who have failed previous treatment with PD-1/PD-L1 inhibitors and platinum-containing chemotherapy (combination or sequential), with objective response rate (ORR) as the primary endpoint.

Study results demonstrate that in advanced NSCLC patients who failed treatment with PD-1/PD-L1 inhibitors and platinum-containing chemotherapy (combination or sequential), RC148 combined with docetaxel showed superior efficacy compared to similar drugs or standard treatments. The combination therapy demonstrated manageable safety profile with good tolerability, potentially providing a new treatment option for this patient population.

Breakthrough therapy drugs refer to innovative drugs or improved drugs used to prevent or treat diseases that seriously threaten life or severely affect quality of life, where no effective prevention or treatment methods exist, or where there is sufficient evidence demonstrating significant clinical advantages compared to existing treatment methods. For innovative drugs granted breakthrough therapy designation, the CDE will prioritize resource allocation, significantly shortening the time for new drug approval.

This breakthrough therapy designation underscores RC148's significant clinical value and development potential, which will help accelerate RC148's clinical development process and benefit patients more quickly.