Policy & Regulation
BeiGene regains full rights to anti-PD-1 antibody TEVIMBRA (tislelizumab) from Novartis
19 September 2023 -

Biotechnology company BeiGene (NASDAQ:BGNE) (HKEX:06160) (SSE:688235) said on Tuesday that it has entered into an agreement with Swiss pharmaceutical company Novartis Pharma AG (SIX:NOVN) (NYSE:NVS) to regain worldwide rights for the development, manufacturing and commercialisation of TEVIMBRA (tislelizumab).

TEVIMBRA stands as a cornerstone of BeiGene's solid tumour portfolio and has been a focal point in over 20 potentially registration-enabling trials. Notably, 10 Phase 3 randomised trials and four Phase 2 trials have yielded positive results, affirming TEVIMBRA's potential to deliver substantial improvements in survival benefits and quality of life for numerous cancer patients across various tumour types, often regardless of PD-L1 status. To date, TEVIMBRA has been prescribed to over 750,000 patients, either as a monotherapy or in combination with other treatments.

Under the terms of the new agreement, BeiGene regains full global rights to TEVIMBRA without the obligation of royalty payments to Novartis. Additionally, Novartis will provide transition services and support to BeiGene to facilitate seamless continuity in TEVIMBRA's development and commercialisation, covering key aspects such as manufacturing, regulatory, safety and clinical support. BeiGene, in turn, has committed to providing Novartis with the necessary clinical supply of TEVIMBRA to support its ongoing clinical trials.

This arrangement marks the termination of a previous collaboration and licence agreement that was initiated in January 2021. Under the previous agreement, BeiGene and Novartis had jointly developed TEVIMBRA across several countries, including the United States, Canada, Mexico, EU member states, the UK, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan.

TEVIMBRA is a humanised IgG4 anti-PD-1 monoclonal antibody designed to minimise binding to Fc-gamma receptors on macrophages, enhancing the immune system's ability to detect and fight tumours. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are reviewing TEVIMBRA for various indications, including advanced or metastatic ESCC, locally advanced or metastatic non-small cell lung cancer (NSCLC), and NSCLC in combination with chemotherapy. Tislelizumab has already secured approval for 11 indications in China, where it is the leading PD-1 inhibitor.

BeiGene's extensive tislelizumab development programme encompasses 21 registration-enabling clinical trials in over 30 countries and regions.