Junshi Biosciences Earns Approval in China for Cancer Treatment Trial

China’s National Medical Products Association (NMPA) has given Junshi Biosciences the green light to begin a clinical trial for its anti-BTLA monoclonal antibody for cancer treatment.

The experimental injection, JS004, is the first of its kind approved for trial, the company said. Preclinical studies have shown the treatment can promote tumor-specific T cell proliferation, improve lymphocyte function, lower tumor burden and increase survival rates in a mouse tumor model, the company said.

The FDA approved the drug’s IND for clinical trial in April 2019 for treating patients with advanced unresectable or metastatic solid tumors (including lymphoma) and patients refractory to prior PD-1 antibody treatment.