Henlius Plans to File for China NDA Approval of PD-1 Inhibitor

Shanghai Henlius Biotech will file for China approval of its PD-1 inhibitor after successful Phase II trials of the candidate. Henlius said HLX10 met its endpoints in a Phase II trial, but it will release the data at a future medical conference. Later this year, it plans to file a China NDA for HLX10 plus chemotherapy as a first-line treatment for sqNSCLC. The Phase II trial tested HLX10 in patients with advanced microsatellite instability-high or mismatch repair-deficient solid tumors that don't respond to standard therapies. More details.... Stock Symbol: (HK: 2696) Share this with colleagues: // //