CStone’s sugemalimab gains CHMP recommendation for NSCLC treatment


CStone Pharmaceuticals has reached a pivotal milestone in its global strategy, with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of sugemalimab, an innovative anti-PD-L1 monoclonal antibody, for the treatment of metastatic non-small cell lung cancer (NSCLC). This approval positions sugemalimab to be the first such therapy in Europe for both squamous and non-squamous NSCLC, irrespective of PD-L1 expression.

Strategic Achievement in Oncology

The positive opinion from CHMP not only advances sugemalimab towards market authorization by the European Commission but also highlights CStone’s emergence as a leader in the oncology field, particularly from China to global markets. Sugemalimab, developed using the OmniRat transgenic animal platform, showcases a unique molecular design that reduces immunogenicity risks and enhances safety, distinguishing it from other drugs in its class.

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Clinical Trial Insights

The CHMP’s recommendation is based on results from the GEMSTONE-302 study, a Phase 3 trial that demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) with sugemalimab plus chemotherapy compared to placebo plus chemotherapy in previously untreated stage IV NSCLC patients. These findings have been recognized in prestigious publications including The Lancet Oncology and Nature Cancer, and highlighted in various international medical conferences.

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Comments from Leadership

Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, expressed optimism about the future, stating, “The positive opinion from EMA CHMP normally indicates an upcoming approval for market authorization by the European Commission, marking a significant milestone not only for sugemalimab but also for CStone and the entire pharmaceutical industry in China.”

Expanding Global Footprint

Following this recommendation, CStone is poised to extend sugemalimab’s reach beyond China, having already secured approvals for multiple indications within the country. The drug is currently under review by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and discussions are ongoing with other regulatory bodies including the EMA and the U.S. Food and Drug Administration (FDA).

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The CHMP’s positive opinion is a testament to the potential of sugemalimab in transforming the treatment landscape for NSCLC, a leading cause of cancer-related death globally. This development not only emphasizes the efficacy of sugemalimab in treating complex oncological diseases but also signifies a major leap in CStone’s commitment to addressing unmet medical needs worldwide.

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