#China #Suzhou #CStone Pharmaceuticals #Sugemalimab #Non-Small Cell Lung Cancer

CStone Pharmaceuticals Advances Sugemalimab Application to EMA

CStone Pharmaceuticals, a leading biopharmaceutical firm based in China, has recently taken a significant step in the fight against lung cancer by submitting a Type II variation application to the European Medicines Agency (EMA). This application seeks approval for Sugemalimab, an innovative treatment specifically aimed at patients suffering from unresectable stage III non-small cell lung cancer (NSCLC) who have not experienced disease progression after undergoing concurrent or sequential platinum-based chemoradiotherapy (CRT).

This marks CStone’s second regulatory submission regarding Sugemalimab to the EMA, following its initial approval in 2024 for treating metastatic squamous and non-squamous NSCLC. The new indication is particularly crucial as it seeks to fill a significant treatment gap in the European market, where only one PD-L1 antibody has received approval for stage III NSCLC. If granted approval, Sugemalimab would not only provide a new treatment option for patients with stage III disease but also position itself as a critical immunotherapy option for lung cancer generally, given its proven efficacy in both stage III and IV conditions.

The basis for this application is firmly rooted in the encouraging results from the GEMSTONE-301 Phase III trial, a multicenter, randomized, double-blind study that evaluated the efficacy of Sugemalimab as a consolidation therapy post-CRT for patients with unresectable stage III NSCLC. The findings, published in the prestigious journal The Lancet Oncology, revealed a significant reduction of 36% in the risk of disease progression or death, showcasing markedly improved progression-free survival (PFS) outcomes. In addition, a remarkable 56% reduction in the risk of mortality was observed, displaying a strong positive trend towards an overall survival (OS) benefit.

Notably, the clinical benefits of Sugemalimab were consistent across various patient subgroups, regardless of the prior CRT modality utilized, highlighting its broad applicability and favorable safety profile, with no new safety signals identified during the trial.

Dr. Jason Yang, the CEO and President of Research and Development at CStone, elaborated on the company's commitment to expanding Sugemalimab's indications. He mentioned that following the drug's success for stage IV NSCLC in Europe, CStone is closely collaborating with EMA to extend its utility to earlier-stage cancers. “With the impressive efficacy and safety profile of Sugemalimab, we are confident that it will meet the critical needs of patients facing stage III NSCLC. Our goal remains to enhance global access through strategic partnerships and collaborations with regulatory bodies, striving to ensure that patients worldwide can benefit from this innovative therapy,” emphasized Dr. Yang.

Sugemalimab, a fully human monoclonal antibody targeting PD-L1, was developed using CStone’s unique OmniRat® transgenic animal platform, which is designed to produce fully human antibodies in a single step. This development process aims to mitigate the common risks of immunogenicity and toxicity associated with similar drugs, offering patients a potentially safer treatment option.

The approval history of Sugemalimab is impressive. The drug is already supported by the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in conjunction with platinum-based chemotherapy for first-line treatment of metastatic NSCLC absent sensitive EGFR mutations, ALK, ROS1, or RET genomic aberrations. Moreover, the National Medical Products Administration (NMPA) in China has approved Sugemalimab for multiple indications, including:

• - Combination therapy for first-line treatment of metastatic squamous and non-squamous NSCLC without EGFR or ALK genomic aberrations
• - Treatment of patients with unresectable stage III NSCLC post-Chemoradiotherapy
• - Treatment of relapsed or refractory extranodal NK/T-cell lymphoma
• - Combination with fluorouracil and platinum-based chemotherapy for unresectable locally advanced, recurrent, or metastatic ESCC
• - First-line treatment for unresectable locally advanced or metastatic gastric cancer with specific PD-L1 expression criteria.

Founded in late 2015, CStone Pharmaceuticals has established itself as a pioneering biopharmaceutical entity focused on cutting-edge oncology therapies. The firm has achieved significant milestones including the successful rollout of four novel therapeutics and attaining 16 regulatory approvals across nine different indications. Their robust pipeline features 16 promising candidates, encompassing both first-in-class and best-in-class options, showcasing a diverse portfolio that includes antibody-drug conjugates (ADCs), multispecific antibodies, and immunotherapies.

For further insights, visit CStone Pharmaceuticals.

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