26 February 2021 - - China-based commercial-stage biotechnology company BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160) has closed collaboration and license agreement with Switzerland-based Novartis Pharma AG (NYSE: NVS), previously reported on January 11, 2021, 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 company said.

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.

Under the collaboration and license agreement, BeiGene will receive an upfront cash payment of USD 650m and is eligible to receive up to USD 1.3bn upon the achievement of regulatory milestones, USD 250m upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory.

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 agents.

Each party retains worldwide rights to commercialize its proprietary products in combination with tislelizumab.

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first medicine from BeiGene's immuno-oncology biologics program and is being developed globally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab has received conditional approval in China as a treatment for patients with cHL who received at least two prior therapies, and for patients with locally advanced or metastatic UC with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

Tislelizumab has also received full approval in China as a first-line treatment for patients with advanced squamous NSCLC in combination with chemotherapy.

In addition, two supplemental new drug applications (sNDAs) for tislelizumab have been accepted in China and are under review -- for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.
Tislelizumab is not approved for use outside of China.