By Fineline Cube 
RemeGen Co., Ltd. (SHA: 688331, HKG: 9995), a China-based biotech company, announced that its novel bispecific antibody, RC148, has received Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This designation is for RC148 in combination with docetaxel for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with negative driver mutations. These patients have previously been treated with PD-1/PD-L1 inhibitors and platinum-based chemotherapy, either in combination or sequentially.
Drug Profile
RC148 is a bispecific antibody developed from RemeGen’s HiBody platform. It has shown potential in treating a variety of solid tumors. The Breakthrough Therapy Designation was granted based on results from a multi-center, open-label Phase I/II clinical study (RC148-C001) conducted in China.
Clinical Trial Results
In patients with advanced NSCLC who had previously received PD-1/PD-L1 inhibitors and platinum-based chemotherapy, RC148 in combination with docetaxel demonstrated superior efficacy compared to similar drugs or standard treatments. The combination therapy also exhibited a manageable safety profile and was well-tolerated, highlighting its potential as a new treatment option for this patient population.-Fineline Info & Tech