BeiGene Enter into Agreement with Novartis
Wednesday, September 20, 2023
BeiGene announced that it has entered into an agreement with Novartis to regain full control over the worldwide development, manufacturing, and commercialisation rights for TEVIMBRA (tislelizumab).
Under the terms of the agreement, Novartis will extend essential transition services and support to BeiGene. This collaborative effort will facilitate the seamless continuation of key components within the TEVIMBRA development and commercialisation plan.
These crucial aspects include manufacturing, regulatory affairs, safety protocols, and clinical support. In return, BeiGene has committed to supplying Novartis with a continuous clinical supply of TEVIMBRA to bolster its ongoing clinical trials.
Under the previous agreement, BeiGene and Novartis had a joint development effort for TEVIMBRA in various countries, including the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. In addition, Novartis will take on responsibility for regulatory submissions and commercialisation rights in these licenced regions once regulatory approval is obtained.
TEVIMBRA, an IgG4 anti-PD-1 monoclonal antibody, designed to minimise its interaction with Fc-gamma (Fcγ) receptors on macrophages. This strategic design aims to enhance the body's immune response against tumours by facilitating the detection and elimination of cancerous cells by immune cells.
