BeiGene Secures Commercial Rights to Five Novartis Oncology Products in China's Vast Market

On March 16, BeOne Medicines announced that it had completed the licensing-in transaction for five approved anti-cancer products from Novartis that have been included in the National Reimbursement Drug List (NRDL), and will market, promote, and sell these products in designated regions within China (referred to as the "vast market").

These five products include the BRAF inhibitor Tafinlar® (dabrafenib), the MEK inhibitor Mekinist® (trametinib), the VEGFR inhibitor Votrient® (pazopanib), the mTOR inhibitor Afinitor® (everolimus), and the ALK inhibitor Zykadia® (ceritinib).

China’s “vast market” includes approximately 13,000 hospitals across various cities, districts, and counties, covering around 500,000 cancer patients. BeOne Medicines’ self-developed and licensed products already hold a significant market share in these regions.

Currently, BeOne Medicines has 16 approved anti-tumor drugs in China and has built a scientific commercialization team of over 3,100 people.

In January 2021, BeOne Medicines and Novartis announced a collaboration granting Novartis the rights to develop, manufacture, and commercialize BeOne Medicines' anti-PD-1 antibody drug, BeiGene's Tislelizumab (trade name: Baizean®), in North America, Europe, and Japan. Since the effectiveness of the cooperation agreement, the two parties have achieved milestone progress, including the submission of a Biologics License Application (BLA) for tislelizumab outside of China, which was accepted by the U.S. Food and Drug Administration (FDA) for the treatment of patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic therapy. Additionally, the two parties are closely collaborating and preparing as planned for other BLA submissions for tislelizumab, exploring combination therapies of tislelizumab with their respective product portfolios and pipelines.

Based on the progress of cooperation between the two companies and their shared commitment to bringing new therapies to more patients, in December 2021, both parties jointly signed an Option, Collaboration, and License Agreement to collaborate on the development, manufacturing, and commercialization of BeOne Medicines' TIGIT inhibitor ociperlimab. Meanwhile, according to the commercial development agreement signed by both parties, BeOne Medicines has the right to market and sell five Novartis-approved drugs that have been included in the National Reimbursement Drug List within designated regions in China (referred to as the "vast market").