China's NMPA accepts Innovent application for sintilimab combo

Innovent Biologics has received acceptance from China's NMPA to review its sintilimab and GC101 combination for advanced melanoma. The submission seeks approval for patients with unresectable or metastatic melanoma following at least two previous systemic treatments. The regulatory filing relies on findings from MIZAR-003, a Phase II trial assessing GC101 with sintilimab against chemotherapy. Credit: Asian Isolated / Shutterstock.com. Innovent Biologics has received acceptance from China’s National Medical Products Administration (NMPA) to review its sintilimab and Nolgileucel injection (GC101) combination for advanced melanoma. The submission seeks approval for patients diagnosed with unresectable or metastatic melanoma whose condition has progressed following…

Source: Pharmaceutical Technology