January 11, 2021: “Novartis has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China, accelerating the potential for Novartis to enter the large and growing checkpoint inhibitor field.
Tislelizumab is an 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.
Under the terms of the agreement, Novartis will obtain the development and commercialization rights to tislelizumab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan in exchange for an upfront payment of USD 650 million plus royalties and milestone payments.
BeiGene will retain the rights to tislelizumab in China and other countries. The transaction has been approved by the Boards of Directors of both companies.
More than 7,700 patients have been enrolled in 15 potentially registration-enabling clinical trials with tislelizumab in a dozen indications, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma, gastric cancer and nasopharyngeal carcinoma.
The first ex-China regulatory filing is expected in 2021.
In addition, Novartis and BeiGene have identified multiple tislelizumab plus Novartis therapy combination clinical trial opportunities in solid tumors.
“Novartis has a bold ambition to reimagine medicine and find new cures for cancer and blood disorders.
This agreement expands on our strategy as the only company pursuing four different approaches to treating cancer: targeted therapy, radioligand therapy, cell and gene therapy, and immunotherapy.
No other company has this range of therapeutic approaches, and the opportunity to combine them to offer the best outcomes for each patient,” said Susanne Schaffert, PhD, President, Novartis Oncology.
“We are excited about collaborating with BeiGene, a leading global biotechnology company with roots in China, to bring tislelizumab to patients around the world, and pair it with our extensive portfolio and pipeline to develop transformative combination therapies for patients.”
Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for certain patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma.
In addition, BeiGene has filed three supplemental new drug applications for tislelizumab in China for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable HCC.
Closing of the transaction is subject to expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.”
