Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that its market approval filing for the investigational product SCT-I10A, a programmed-death 1 (PD-1) monoclonal antibody (mAb), has been accepted for review by the National Medical Products Administration (NMPA). The filed indication is for the treatment of head and neck squamous cell carcinoma (HNSCC).
The PD-(L)1 inhibitor market in China is highly competitive, with a total of 10 such products currently on the market. These include BMS’s Opdivo (nivolumab), MSD’s Keytruda (pembrolizumab), Junshi Bio’s toripalimab, Innovent Bio’s Tyvyt (sintilimab), Gloria Pharma’s zimberelimab, Henlius’s serplulimab, and Lepu Bio’s pucotenlimab. Additionally, there are PD-L1 products such as AstraZeneca’s Imfinzi (durvalumab), Roche’s Tecentriq (atezolizumab), Alphamab Oncology’s envafolimab, CStone Pharma’s Cejemly (sugemalimab), and Jiangsu Hengrui’s adebrelimab. Among these, only Opdivo and Keytruda have indications covering HNSCC.- Flcube.com