Cai Jing Wang·2025-08-20 21:14Core Viewpoint - Rongchang Biopharmaceutical has received a breakthrough therapy designation from the China National Medical Products Administration (NMPA) for its innovative bispecific antibody RC148, aimed at treating non-small cell lung cancer (NSCLC) [1][2]. Group 1: Breakthrough Therapy Designation - The bispecific antibody RC148 has been officially included in the list of breakthrough therapies by the NMPA, targeting the indication of RC148 in combination with docetaxel for patients who have previously failed PD-1/PD-L1 inhibitors [2]. - The designation is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China, which demonstrated superior efficacy of RC148 combined with docetaxel compared to similar drugs or standard treatments in advanced NSCLC patients who failed prior treatments [2]. Group 2: Clinical Value and Development Potential - The breakthrough therapy designation signifies the significant clinical value and development potential of RC148, which will facilitate accelerated clinical development and resource allocation by the NMPA [2]. - Breakthrough therapies are defined as innovative drugs or modified drugs that provide substantial clinical advantages over existing treatment methods for serious or life-threatening diseases, where no effective treatment options are available [2].