The board of directors of Innovent Biologics, Inc. announced that the National Medical Products Administration (the " NMPA ") has accepted the supplemental New Drug Application (" sNDA ") for TYVYT ® (sintilimab injection) in combination with chemotherapy (cisplatin plus paclitaxel/cisplatin plus 5-fluorouracil) for the first-line treatment of esophageal squamous cell carcinoma ("ESCC"). The sNDA application is based on the interim analysis of the global randomized, double-blind, multi-center Phase 3 ORIENT-15 clinical trial - which evaluated sintilimab in combination with chemotherapy compared to placebo in combination with chemotherapy as first-line therapy for ESCC. Based on the interim analysis conducted by the Independent Data Monitoring Committee ("IDMC"), sintilimab in combination with chemotherapy demonstrated a significant improvement in the primary endpoint of overall survival ("OS") of patients compared to placebo in combination with chemotherapy, regardless of PD-L1 expression status. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified. The results of ORIENT-15 were presented at the European Society for Medical Oncology Congress 2021. Esophageal cancer is the fifth most commonly diagnosed cancer and the fourth leading cause of death from cancer in China, and squamous cell carcinoma is the predominant histologic type. There is a huge unmet clinical need for the first-line treatment of advanced or metastatic ESCC given the limited OS benefit of chemotherapy treatment. The results of ORIENT-15 demonstrated that sintilimab plus chemotherapy (cisplatin plus paclitaxel/cisplatin plus 5-fluorouracil) significantly improved OS and progression-free survival compared to chemotherapy. The Company hopes to bring the new regimen to Chinese patients with ESCC as quickly as possible. ORIENT-15 is a global randomized, double-blind, multicenter Phase 3 clinical study evaluating sintilimab in combination with chemotherapy (cisplatin plus paclitaxel/cisplatin plus 5-fluorouracil), compared to placebo in combination with chemotherapy (cisplatin plus paclitaxel/cisplatin plus 5-fluorouracil), for the first-line treatment of unresectable locally advanced, recurrent or metastatic ESCC (ClinicalTrials.gov, NCT03748134). At the time of interim analysis, a total of 659 eligible patients were enrolled and randomly assigned into the experimental group or control group in a 1:1 ratio. The primary endpoints were OS in all randomized patients and OS in PD-L1 positive (defined as CPS 10) patients.