CStone's sugemalimab gains second EU approval for stage III lung cancer

CStone Pharmaceuticals announced that the European Commission has approved sugemalimab as monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC). This approval is for patients with PD-L1 expression on ≥1% of tumor cells, no sensitizing EGFR mutations, or ALK, ROS1 genomic aberrations, and whose disease has not progressed following platinum-based chemoradiotherapy. This marks the second EC approval for sugemalimab, expanding its indication spectrum across Europe.

Dr. Jason Yang, chief executive and president of R&D at CStone, highlighted that this approval follows the initial EC approval for first-line metastatic NSCLC, broadening the treatment option for a wider patient population. Dr. Qingmei Shi, chief medical officer, added that sugemalimab is now the second PD-(L)1 antibody approved in Europe for stage III NSCLC, addressing a critical unmet medical need.

Sugemalimab was developed using the OmniRat® transgenic animal platform, allowing for the creation of fully human antibodies. This fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody aims to reduce the risk of immunogenicity and toxicity for patients. The National Medical Products Administration of China has already approved sugemalimab for five indications.