CStone Pharmaceuticals announced that the registrational clinical study (GEMSTONE-201) of sugemalimab in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) met the primary endpoint. Results showed that sugemalimab significantly enhanced the objective response rate (ORR), as assessed by the Independent Radiology Review Committee (IRRC), compared with historical control. The investigator-assessed ORR was consistent with the evaluation by IRRC.

Sugemalimab also demonstrated a well-tolerated safety profile in patients with R/R ENKTL, and no new safety signals were observed. CStone plans to submit a new drug application (NDA) in the near term to the National Medical Products Administration (NMPA) of China for sugemalimab as the treatment of R/R ENKTL and will present the topline results at an upcoming international academic conference. The NMPA of China has approved the NDA of sugemalimab in combination with chemotherapy for treatment-naïve metastatic (stage IV) NSCLC patients.

In addition, another NDA of sugemalimab in stage III NSCLC is under regulatory review. Sugemalimab is expected to provide a new treatment option for both stage III and stage IV NSCLC patents in the future. Sugemalimab has also demonstrated the tremendous potential with its unique mechanism of action and attractive clinical data in the treatment of lung cancer, lymphoma and other tumors.