Innovent Biologics, Inc. and Eli Lilly and Company announced that the Center for Drug Evaluation (CDE) of China'sNational Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This is the fifth NMPA-approved indication of TYVYT®. In China, TYVYT® was approved for: the treatment of relapsed or refractory classical Hodgkin's lymphoma in December 2018; the first-line treatment of non-squamous non-small cell lung cancer (NSCLC) in February 2021; and the first-line treatment of squamous NSCLC as well as the first-line treatment of hepatocellular carcinoma in June 2021.

The new approval was based on the interim analysis of ORIENT-15, a global randomized, double-blind, multi-center Phase 3 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 statistically significant improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy regardless of PD-L1 expression status, meeting the pre-defined superior efficacy criteria. Safety profile was consistent with that observed in previously reported studies of sintilimab without new or unexpected safety signals.