智通财经网·2025-08-19 09:24Core Insights - Rongchang Biopharma's novel bispecific antibody RC148 has been officially included in the list of breakthrough therapy drugs by the Center for Drug Evaluation (CDE) in China, 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) demonstrating superior efficacy and manageable safety of RC148 combined with docetaxel compared to standard treatments in patients with treatment-resistant NSCLC [1] Group 1: Breakthrough Therapy Designation - Breakthrough therapy drugs are defined as innovative or modified drugs used to treat serious or life-threatening diseases with no effective treatment options or those showing significant clinical advantages over existing therapies [2] - The CDE will prioritize resources for drugs designated as breakthrough therapies, significantly shortening the time to market for new drugs [2] Group 2: Clinical Study Results - The primary endpoint of the clinical study was the objective response rate (ORR), which indicated that RC148 combined with docetaxel showed better efficacy than similar drugs or standard treatments in patients who had previously failed PD-1/PD-L1 inhibitors and platinum-based chemotherapy [1] - The safety profile of the combination treatment was reported to be controllable and well-tolerated, suggesting a new treatment option for this patient population [1]