China’s National Medical Products Administration (NMPA) has approved CStone Pharmaceuticals’ sugemalimab (Cejemly) for unresectable stage III non-small cell lung cancer (NSCLC) treatment.
According to a company statement, sugemalimab was approved for use on unresectable stage III NSCLC patients without disease progression after concurrent or sequential platinum-based chemoradiotherapy.
NMPA approved sugemalimab after assessing the results of the GEMSTONE-301 trial that studied the efficacy and safety of sugemalimab as a consolidation therapy in such patients.
The study results showed that sugemalimab significantly improved patients’ progression-free survival (PFS) reducing the risk of disease progression or death by 36%. It was also well-tolerated in patients.
With this approval, CStone has secured eight new drug application (NDA) approvals for four drugs.
CStone CEO Dr Frank Jiang said: “We appreciate the NMPA for granting the new approval which is an important milestone in our journey to lead the treatment of lung cancer as China steps up efforts to support innovative therapies and address unmet needs.
“As a leading biopharma company in fostering precision medicines and immuno-oncology therapies, CStone has been spearheading multiple medical breakthroughs. With this approval, it will provide a new treatment option for stage III NSCLC patients, while demonstrating our prowess in advancing lung cancer treatments and bringing forward transformative drugs to the market.”
CStone discovered the anti-PD-L1 monoclonal antibody sugemalimab leveraging OmniRat transgenic animal platform. The company also entered into strategic collaboration with Pfizer to develop and commercialise sugemalimab in mainland China.
Pfizer Biopharmaceutical Group China president Jean-Christophe Pointeau said: “After the approval of Stage IV NSCLC indication a few months ago, Cejemly achieved immediate commercialisation across China, offering hopes to Chinese NSCLC patients with improved diagnosis and treatment solutions.
“We firmly believe that the approval of the new indication will allow more patients to benefit from this drug, bridge the gap and fulfil the unmet needs, especially the needs of unresectable Stage III NSCLC patients for immune consolidation therapy after sequential chemoradiotherapy.”