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Novartis Licenses BeiGene's Anti-PD-1 Agent Tislelizumab in North America, Europe, Japan

NEW YORK – Novartis said on Friday that it has licensed the anti-PD-1 antibody tislelizumab from BeiGene for development and commercialization in North America, Europe, and Japan.

The drug, which is specifically designed to minimize binding to FcγR on macrophages, has garnered regulatory approvals in multiple indications from China's National Medical Products Administration, including for patients with PD-L1-elevated bladder cancer.

Merck will pay BeiGene $650 million upfront. Beijing-headquartered BeiGene is also eligible to receive up to $1.3 billion in regulatory milestones, $250 million for sales milestones, and royalties on tislelizumab sales in Novartis' territory.

Under the terms of the licensing agreement, Novartis and BeiGene will continue to jointly develop tislelizumab in the US, Canada, Mexico, member countries of the European Union, the UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. Novartis will be responsible for regulatory submissions and subsequent commercialization following any approvals, though BeiGene has the option to co-detail the product North America.

BeiGene will remain responsible for funding ongoing studies of tislelizumab, and is currently evaluating tislelizumab in 15 potentially registration-enabling clinical trials, both in China and globally. Among these trials is a Phase II tumor-agnostic clinical trial enrolling patients with microsatellite instability-high or mismatch repair-deficient solid tumors.

Novartis will also pay for any new registrational, bridging, or post-marketing studies in the licensed territories, and BeiGene and Novartis will fund any clinical trials that evaluate tislelizumab in combination with their own agents or third-party agents. According to a statement from Novartis, the company has already identified several opportunities to develop tislelizumab in combination with other agents in its pipeline. The company was not able to share additional details on which combinations would be included in the tislelizumab development plan.