BeiGene announces Novartis collaboration on antibody

China-based biotechnology company BeiGene Ltd held a media conference in Beijing on Tuesday to announce its collaboration and license agreement with Swiss pharmaceutical company Novartis Pharma AG for development and commercialization of the cancer treatment tislelizumab.

The two companies have agreed to jointly develop BeiGene's anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, the European Union, the United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan.

Novartis will be responsible for regulatory submissions after a transition period and for commercialization after regulatory approval in these licensed countries. 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.

BeiGene will receive an upfront cash payment of $650 million from Novartis and is eligible to receive up to $1.3 billion upon the achievement of regulatory milestones, and $250 million upon the achievement of sales milestones, in addition to royalties on future sales of tislelizumab in licensed territories.

Under the terms of the agreement, BeiGene will be responsible for funding ongoing clinical trials of tislelizumab, and Novartis has agreed to fund new registration, bridging or post-marketing studies in its territory. 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 proprietary products in conjunction with tislelizumab.

Tislelizumab received approval from the China National Medical Products Administration last April as a treatment for patients with locally advanced or metastatic urothelial carcinoma, the most common type of bladder cancer, following the therapy's initial approval in classical Hodgkin's lymphoma by the NMPA in December 2019.

Three supplemental new drug applications for tislelizumab have been accepted by the NMPA and are under review. They are first-line treatment of patients with advanced squamous non-small cell lung cancer in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable hepatocellular carcinoma.

John V. Oyler, co-founder, CEO and chairman of BeiGene, said the company looks forward to working with Novartis to fulfill the global opportunity of the potentially differentiated anti-PD-1 antibody.

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.

Apart from the two conditional approvals it has received in China, the drug currently spans 15 potentially registration-enabling clinical trials globally, and has enrolled over 7,700 patients to date, including approximately 2,500 patients in more than 20 countries and regions outside the Chinese mainland.