12 January 2021 - - Chinese biotechnology company BeiGene, Ltd. (NASDAQ: BGNE) (HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, has forged a collaboration and license agreement with Swiss pharmaceutical company Novartis Pharma AG (NYSE: NVS) 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.

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 following at least two prior therapies and locally advanced or metastatic urothelial carcinoma with PD-L1 high expression.

In addition, three supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation of the China National Medical Products Administration 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.

Under the agreement BeiGene will receive an upfront cash payment of USD 650m from Novartis. BeiGene 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.

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.

Tislelizumab (BGB-A317) 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 drug 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 received conditional approval from the China NMPA 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.

In addition, three sNDAs for tislelizumab have been accepted by the CDE of the NMPA and are under review, for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable HCC.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and two pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.


BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide.

Its 5,000+ employees are in China, the United States, Australia, Europe, and elsewhere.