TEVIMBRA® Approved in Israel for Post-Chemotherapy OSCC Treatment

HERZLIYA, Israel – BeiGene, Ltd., a global oncology company listed on NASDAQ, HKEX, and SSE, has announced that the Israeli Ministry of Health has approved TEVIMBRA® (tislelizumab) for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (OESCC) after prior systemic chemotherapy.

Itzik Mizrahi, Country General Manager of BeiGene Israel, noted, "Cancer incidence in Israel is on the rise, particularly for solid tumors, which pose a significant health challenge. The approval of Tevimbra offers a new and innovative treatment option for patients suffering from esophageal squamous cell carcinoma (ESCC), bringing renewed hope and potentially better outcomes."

BeiGene is committed to increasing access to Tevimbra in Israel. The company has submitted applications for its use in first- and second-line treatments for both squamous and non-squamous non-small cell lung cancer (NSCLC) and is planning future applications for first-line OESCC and gastric cancer (GC).

The company has initiated over 17 trials that could lead to registration of TEVIMBRA, including 11 Phase 3 randomized trials and four Phase 2 trials, which have already yielded positive results. Through these trials, TEVIMBRA has shown the potential to provide significant survival benefits and improve the quality of life for cancer patients across various tumor types, often regardless of PD-(L)1 status, both as a standalone treatment and in combination with other therapies. To date, TEVIMBRA has been prescribed to more than 900,000 patients globally.

In 2023, the European Commission approved tislelizumab for advanced or metastatic ESCC after prior chemotherapy. Additionally, in February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) gave a positive opinion on its use for non-small cell lung cancer across three indications.

About TEVIMBRA® (tislelizumab):
Tislelizumab is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody. It possesses high affinity and binding specificity to PD-1 and is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. This design helps immune cells in the body to better detect and combat tumors.

About BeiGene:
BeiGene is a global oncology company that focuses on discovering and developing innovative treatments to make them more affordable and accessible to cancer patients worldwide. The company has a broad portfolio and is accelerating the development of its diverse pipeline of innovative therapies through internal capabilities and collaborations. BeiGene is committed to significantly improving access to medicines for a larger number of patients. The company has a global team of over 10,000 colleagues across five continents.