Human PD-1 Monoclonal Antibody (YR0095)

Camrelizumab Biosimilar uses the same protein sequences as the therapeutic antibody camrelizumab.Camrelizumab is an IgG4κ humanized monoclonal antibody being investigated for hepatocellular carcinoma. It targets programmed cell death protein 1 (PD-1), a protein on the surface of cells, also known as CD279 (cluster of differentiation 279). Camrelizumab is being evaluated in the Phase 2/3 (NCT02989922) of patients with advanced hepatocellular carcinoma (HCC) in second-line after failure or intolerance to prior systemic treatment. The study has 2 arms in which patients will be intravenous administered 3 mg/kg SHR-1210 on day 1 every 2 weeks or every 3 weeks. The primary outcome measures are the overall response rate (ORR) and overall survival (OS) rates at 6 months with duration of response and OS at 2 years as secondary endpoints. The estimated enrollment is 220 patients, and the estimated primary completion date is December 2018. A randomized, open-label Phase 3 study (NCT03099382) is evaluating the efficacy of camrelizumab treatment compared to standard-of-care treatment (docetaxel or irinotecan) in patients with esophageal carcinoma. Patients are randomly assigned to receive either SHR-1210 (200 mg every 2 weeks) or the standard of care (docetaxel 75 mg/m2 on day 1 every 3 weeks or irinotecan 180 mg/m2 on day 1 every 2 weeks). This Phase 3 study has an estimated enrollment of 438 and an estimated primary completion date of June 2018.