BeiGene announced a collaboration and license agreement with Novartis Pharma AG to develop, manufacture and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan.

The Companies have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals. In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and BeiGene has an option to co-detail the product in North America, funded in part by Novartis.

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved and marketed by BeiGene in China in two indications, classical Hodgkin’s lymphoma (cHL) following at least two prior therapies and locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression. In addition, three supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and are under review. These indications are first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable hepatocellular carcinoma.

“We are excited to collaborate with Novartis to further explore the potential of tislelizumab in multiple combinations and indications. Novartis is a well-recognized leader in oncology with a unique portfolio of cancer treatments and pipeline agents,” said John V. Oyler, Co-Founder, CEO, and Chairman of BeiGene. “This important collaboration stands on a strong foundation of tislelizumab’s broad global development program, which has delivered two approvals in China, currently spans 15 potentially registration-enabling clinical trials, and has enrolled over 7,700 patients to date, including approximately 2,500 patients in more than 20 countries and regions outside of mainland China. We look forward to working with Novartis to fulfill the global opportunity of this potentially differentiated anti-PD-1 antibody.”

Under the agreement BeiGene will receive an upfront cash payment of $650 million from Novartis. BeiGene is eligible to receive up to $1.3 billion upon the achievement of regulatory milestones, $250 million upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory. Under the terms of the agreement, BeiGene will be responsible for funding ongoing clinical trials of tislelizumab, Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party will be responsible for funding clinical trials evaluating tislelizumab in combination with its own or third party products. Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.

Closing of the transaction is subject to the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.