Tevimbra will be available in the U.S. in the second half of 2024. The approval represents the first indication in the U.S. for Tevimbra.

The approval is based on the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population with a statistically significant and clinically meaningful survival benefit for Tevimbra compared with chemotherapy. 

In the ITT population, the median overall survival (OS) in the Tevimbra arm was 8.6 months compared to 6.3 months in the chemotherapy arm.

Also Read: JP Morgan’s Bullish View On This Chinese Biotech, Says Pullback Creates Entry Point.

Tislelizumab received approval from the European Commission for advanced or metastatic ESCC after prior chemotherapy in 2023 and a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in February 2024 as a treatment for non-small cell lung cancer across three indications.

The FDA is also reviewing Biologics License Applications for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. 

The target action dates are July and December 2024, respectively.

Price Action: BGNE shares are up 0.26% at $169.34 on the last check Friday.