Zhi Tong Cai Jing·2025-08-19 09:23Core Insights - Rongchang Biopharma's novel bispecific antibody RC148 has been officially included in the list of breakthrough therapy drugs by the China National Medical Products Administration (NMPA) [1][2] - The indication for RC148 is for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has failed prior PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The inclusion is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) demonstrating superior efficacy and manageable safety compared to similar drugs or standard treatments [1] Group 1 - RC148's inclusion as a breakthrough therapy highlights its significant clinical value and development potential [2] - The drug aims to provide a new treatment option for patients with advanced NSCLC who have limited alternatives [1][2] - The NMPA's designation will expedite the clinical development process and potentially shorten the time to market for RC148 [2] Group 2 - Breakthrough therapy drugs are defined as innovative or modified drugs that address serious or life-threatening diseases with no effective treatment options or demonstrate significant clinical advantages over existing therapies [2] - The NMPA will prioritize resource allocation for drugs recognized as breakthrough therapies, facilitating faster access for patients [2]