China-based CStone Pharmaceuticals (HKG: 2616) has announced filing for another indication approval for its anti-programmed death-ligand 1 (PD-L1) inhibitor sugemalimab (trade name: Cejemly) with the European Medicines Agency (EMA). The application seeks approval for sugemalimab’s use in patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent or sequential platinum-based chemoradiotherapy (CRT). This follows last year’s approval of sugemalimab for the treatment of first-line metastatic squamous and non-squamous NSCLC in Europe.
Sugemalimab’s Development and Approval
Sugemalimab, developed by CStone using the OmniRat transgenic animal platform, has already received approval from the European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA). It is approved for use in combination with platinum-based chemotherapy for first-line metastatic NSCLC patients with no sensitizing EGFR mutations or ALK, ROS1, or RET genomic tumor aberrations.
Commercialization Partnerships
CStone licensed the commercialization rights for sugemalimab to European firm Ewopharma in Switzerland and the 18 Central and Eastern European Countries (CEECs) in May 2024. This strategic partnership underscores CStone’s commitment to expanding the reach of sugemalimab and providing treatment options for patients with NSCLC across Europe.-Fineline Info & Tech
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