Cai Jing Wang·2025-08-20 21:35Group 1 - The core viewpoint of the news is that 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] - RC148 is specifically indicated for use in combination with docetaxel for patients with locally advanced or metastatic NSCLC who have failed prior treatment with PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The designation is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China, which demonstrated superior efficacy and manageable safety of RC148 combined with docetaxel compared to similar drugs or standard treatments in patients with advanced NSCLC [1] Group 2 - Breakthrough therapy drugs are defined as innovative or modified drugs that are used to treat serious life-threatening diseases with no effective treatment options or those that show significant clinical advantages over existing therapies [2] - The inclusion of RC148 in the breakthrough therapy category highlights its substantial clinical value and development potential, which will facilitate faster clinical development and quicker access for patients [2]