The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of CStone’s sugemalimab, an anti-PD-L1 monoclonal antibody (mAb), for first-line treatment of metastatic non-small cell lung cancer (NSCLC).
CStone’s sugemalimab has been recommended in combination with chemotherapy as a first-line treatment for NSCLC.
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The endorsement could mark the first anti-PD-L1 monoclonal antibody approved for both squamous and non-squamous NSCLC, irrespective of PD-L1 expression, in Europe.
The CHMP’s positive opinion is based on the GEMSTONE-302 study, a multi-centre, randomised, double-blind, Phase 3 clinical trial showing significant improvements in progression-free survival (PFS) and overall survival (OS) when sugemalimab is combined with chemotherapy in previously untreated stage IV NSCLC patients.
CStone CEO, executive director and research and development president Dr Jason Yang stated: “The positive opinion from EMA CHMP normally indicates an upcoming approval for market authorisation by the European Commission, marking a significant milestone not only for sugemalimab but also for CStone and the entire pharmaceutical industry in China.
“The CHMP recommendation brings us closer to delivering this innovative treatment to European patients with lung cancer, and it also highlights a major milestone in CStone’s global strategy.”
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By GlobalDataCStone has already secured approval for sugemalimab in China for five cancer indications.
In China, the National Medical Products Administration (NMPA) has approved sugemalimab for stage III and IV NSCLC, extranodal NK/T-cell lymphoma, oesophageal squamous cell carcinoma and gastric cancer.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is undertaking a marketing authorisation application review for sugemalimab for metastatic NSCLC.
CStone is in discussions with the EMA, the UK Medicines and Healthcare products Regulatory Agency, and the US Food and Drug Administration for additional indications.
It is looking at development and commercialisation partnerships in countries and regions worldwide.
