Beijing Biostar Pharmaceuticals (HKG:2563) received approval from the U.S. Food and Drug Administration (FDA) for its international multi-center Phase II/III registration clinical study for Utidelone Capsules, according to a Thursday filing with the Hong Kong bourse.
UTD2 with capecitabine and oxaliplatin for first-line treatment of advanced or metastatic gastric cancer in PD-L1-negative patients, the filing added.