The National Medical Products Administration (NMPA) of China has approved the new drug application of CStone’s anti-PD-L1 monoclonal antibody Cejemly (sugemalimab) in combination with chemotherapy for treatment-naïve metastatic (stage IV) non-small cell lung cancer.

Globally, the incidence of lung cancer continues to rise, and it is still the leading cause of cancer death worldwide, with huge unmet medical needs.

Dr. Frank Jiang, Chairman and CEO of CStone, said: "Cejemly is our third approved new drug in China this year. This further demonstrates CStone's ability and track record in developing and commercializing high-quality new drugs. As a drug supported by China's national science innovation program, Cejemly is a globally leading anti-PD-L1 monoclonal antibody. We will work closely with Pfizer to leverage resources and advantages of both sides to accelerate commercialization so that more Chinese patients can benefit from this innovative therapy soon."

Dr. Jason Yang, Chief Medical Officer of CStone, said, "We are thrilled that Cejemly has been approved in Mainland China. It took only four years for Cejemly to obtain the first NDA approval in lung cancer from the initiation of the phase I clinical trial in humans. It comprehensively showcased CStone's robust clinical strategy, innovative trial design and rapid execution, while once again demonstrating the 'CStone Speed'. We will continue to work with our partner to pursue regulatory discussions for Cejemly on the NDAs of stage III and stage IV NSCLC with regulators in multiple countries and regions, including the U.S. Food and Drug Administration, and bring this innovative immunotherapy to more lung cancer patients soon. We will also continue to advance the registrational studies of Cejemly in esophageal squamous cell carcinoma, gastric cancer, relapsed/refractory extranodal natural killer/T-cell lymphoma, to benefit more cancer patients."

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients. Compared with placebo plus chemotherapy, Cejemly plus chemotherapy lowered the risk of disease progression or death by 52%, significantly prolonged the patients' PFS and an encouraging trend in overall survival was observed. The clinical benefit was irrespective of NSCLC pathologies and PD-L1 expression levels. Cejemly has a well-tolerated safety profile, and no new safety signals were found.