Ge Long Hui A P P·2025-08-19 09:25Group 1 - The core point of the news is that Rongchang Biologics' new bispecific antibody RC148 has been officially included in the list of breakthrough therapy drugs by the CDE, targeting locally advanced or metastatic non-small cell lung cancer (NSCLC) that has failed previous treatments [1][2] - The inclusion is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China, which evaluates the efficacy and safety of RC148 in combination with docetaxel for NSCLC patients who have failed PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The study results indicate that RC148 combined with docetaxel shows superior efficacy compared to similar drugs or standard treatments, with manageable safety and good tolerability, potentially providing a new treatment option for this patient population [1] Group 2 - Breakthrough therapy drugs are defined as innovative or modified drugs used to treat serious life-threatening diseases with no effective treatment options or those that demonstrate significant clinical advantages over existing therapies [2] - The inclusion of RC148 as a breakthrough therapy highlights its substantial clinical value and development potential, which will help accelerate its clinical development process and benefit a larger patient population more quickly [2]