CStone Secures EU Approval for PD-L1 Inhibitor Cejemly in First-Line NSCLC

CStone Pharmaceuticals announced that the European Commission has approved Cejemly (sugemalimab) for the first-line treatment of both squamous and non-squamous non-small-cell lung cancer (NSCLC), excluding cases involving sensitising EGFR mutations, or aberrations in ALK, ROS1, or RET. This milestone represents the first international approval of a domestically developed Chinese PD-L1 inhibitor and the first of its class to gain EU clearance as a front-line treatment option in combination with chemotherapy for this indication.

This approval is based on results from the Phase III GEMSTONE-302 study. The trial demonstrated that Cejemly combined with chemotherapy significantly extended progression-free survival and overall survival compared to a placebo plus chemotherapy in 479 patients who had not received prior treatment for metastatic NSCLC. CStone Pharmaceuticals noted that more long-term data on treatment efficacy and survival will be presented at the forthcoming European Society for Medical Oncology (ESMO) annual meeting.

CStone had initially partnered with EQRx for the development and commercialization of Cejemly outside of Greater China. However, CStone retained the rights to the drug outside China after EQRx faced financial difficulties and was acquired by Revolution Medicines last year. In China, where Cejemly is approved for five indications, Pfizer holds the marketing rights through its 9.9% stake in CStone.

CStone Pharmaceuticals has also formed a partnership with Ewopharma to commercialize Cejemly in Central and Eastern Europe, as well as Switzerland. Furthermore, CStone is actively seeking partnerships in Western Europe, Latin America, the Middle East, Africa, Southeast Asia, and Canada to expand the drug's availability.

CEO Jason Yang described Cejemly’s international approval as a significant achievement in CStone's 'Pipeline 1.0' strategy. He noted that the company's 'Pipeline 2.0' plan will prioritize the development of other promising drugs with potential to be first-in-class or best-in-class. Yang also mentioned that Cejemly will be explored further in combination with antibody-drug conjugates and bi-/tri-specific antibodies.

The company is preparing for additional EU approvals of Cejemly in Stage III NSCLC, first-line gastric and oesophageal cancers, and relapsed/refractory NK/T-cell lymphoma. Additionally, the drug is under review in the UK for first-line treatment of metastatic NSCLC in combination with chemotherapy.