CStone Pharmaceuticals announced that the National Medical Products Administration ("NMPA") of China has approved the new drug application ("NDA") of anti-PD-L1 monoclonal antibody Cejemly (sugemalimab) in combination with chemotherapy for treatment-naïve metastatic (stage IV) non-small cell lung cancer ("non-small cell lung caner" or "NSCLC") patients. 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. According to statistics, there were 2.21 million new lung cancer cases worldwide in 2020. NSCLC accounts for about 85% of all lung cancer cases, and about 66% of patients are diagnosed with stage III/IV NSCLC. According to IQVIA's Global Oncology Trends, the size of global oncology drug market is estimated to reach US$269 billion by 2025, of which immuno-oncology drugs will contribute about 20%. 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 ("OS") 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. Apart from the approved indication, the NMPA accepted the NDA of Cejemly as consolidation therapy in patients with unresectable stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy in September 2021. The product has the potential to become an anti-PD-L1 monoclonal antibody approved to cover stage III and stage IV NSCLC in all-comer settings.