NMPA approves CStone’s Cejemly for lymphoma treatment
CStone Pharmaceuticals has announced that the National Medical Products Administration (NMPA) of China has approved its anti-PD-L1 antibody Cejemly (sugemalimab) for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL).
This approval makes Cejemly the world’s first anti-PD-1/PD-L1 monoclonal antibody approved specifically for the treatment of R/R ENKTL.
Cejemly’s approval follows data from the GEMSTONE-201 study which assessed the efficacy and safety of the drug as a monotherapy for this indication. Results demonstrated that the drug significantly improved the objective response rate (ORR) compared to historical controls.
Cejemly was also generally well-tolerated with no new safety signals being observed.
Dr Jason Yang, chief executive officer of CStone, commented: “We are excited to obtain approval of sugemalimab for R/R ENKTL from the NMPA of China. This marks another milestone for sugemalimab following the prior approvals for stage 3 and 4 NSCLC and years of intensive effort and innovation by CStone’s research and development team on this rare disease. We have always believed that the unmet medical needs of patients with cancer should not be overlooked just because of a small population. In addition to lung cancer, sugemalimab also covers other large indications in the first-line setting, such as gastric cancer and esophageal cancer, and the biologics license applications are currently under review by NMPA. We are also maintaining close communications with the US Food and Drug Administration (FDA) to accelerate the registration of sugemalimab in the US.”
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