BeiGene regains full rights from Novartis for anti-PD-1 antibody Tevimbra (tislelizumab).

"We are excited to regain the global rights to Tevimbra, which enables us to build out our in-house solid tumor commercial capabilities and complements our deep pipeline presented at our recent R&D Day. With more than 12,000 patients enrolled in our Tevimbra global clinical trial program, we plan to rapidly accelerate our regulatory and development plans across a wider range of tumor types,” said John V. Oyler, Co-Founder, Chairman and CEO of BeiGene. “BeiGene will continue to work with Novartis on development, regulatory and manufacturing priorities. Novartis will manufacture Tevimbra for many markets worldwide and explore its potential in combination with their oncology assets.”

The parties mutually agreed to terminate the previous collaboration and license agreement entered into on January 11, 2021, and, pursuant to the new agreement, BeiGene regained full global rights to Tevimbra with no royalty payments due to Novartis. In addition, Novartis will provide transition services and support to BeiGene to enable key aspects of the Tevimbra development and commercialization plan to proceed without disruption, including manufacturing, regulatory, safety and clinical support. BeiGene has agreed to provide Novartis with ongoing clinical supply of Tevimbra to support its clinical trials.

Tevimbra is currently under review by the FDA and the European Medicines Agency (EMA) for advanced or metastatic ESCC after prior chemotherapy. The EMA is reviewing a marketing authorization application for Tevimbra as a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated locally advanced or metastatic NSCLC. Regulatory submissions for Tevimbra are also under review by authorities in the U.K., Australia, China, New Zealand, Brazil, Korea, Switzerland, Israel and Indonesia. Tislelizumab is approved as a treatment in 11 indications in China and is the leading PD-1 inhibitor in the country.