BeiGene Announces Effective Date of Collaboration and License Agreement with Novartis for Tislelizumab in North America, Europe, and Japan

CAMBRIDGE, Mass. and BEIJING, Feb. 26, 2021 /PRNewswire/ -- BeOne Medicines (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on the global development and commercialization of innovative medicines, announced today that the collaboration and license agreement reached with Novartis on January 11, 2021, has officially taken effect. The agreement covers the development, manufacturing, and commercialization of the anti-PD-1 antibody Baizean in the United States, Canada, Mexico, European Union member states, the United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan.^®(Tislelizumab). Both parties have agreed to [market/distribute] Baizean in the aforementioned countries^®to engage in co-development, wherein Novartis will be responsible for regulatory filings after the transition period and will conduct commercialization activities upon approval. Furthermore, both parties may conduct clinical trials globally to evaluate Baizean^®Potential drug combinations with other anti-cancer therapies; BeOne Medicines may jointly market the products in North America, with part of the operational funding provided by Novartis.

Mr. John V. Oyler, Co-founder, Chairman and Chief Executive Officer of BeOne Medicines, stated: “Since announcing the collaboration with Novartis, our two companies have been actively preparing for the related implementation work, with the aim of bringing Baizean^®to more patients worldwide, whether through Novartis in licensed territories or BeOne Medicines in other regions globally for Baizean^®proceed with commercialization, or both parties will take Brukinsa^®Conduct clinical trials in combination with self-developed drugs or third-party pharmaceuticals. In just over a month since announcing the collaboration with Novartis, Baizean^®The drug has achieved a series of new milestones, beginning with positive primary results from a global Phase 3 clinical trial in patients with previously treated advanced unresectable or metastatic esophageal squamous cell carcinoma, followed by approval in China for use in combination with chemotherapy as first-line treatment for patients with advanced squamous non-small cell lung cancer. “We are pleased to collaborate with Novartis to further unlock the global development potential of this potentially differentiated anti-PD-1 antibody.”

Under the collaboration and license agreement, BeOne Medicines will receive an upfront payment of $650 million and is eligible to receive up to $1.3 billion in payments upon achieving regulatory milestones, $250 million in payments upon achieving sales milestones, as well as royalties on net sales of Baizean^®Royalties on future sales in the licensed territory. Under the agreement, BeOne Medicines will be responsible for the ongoing development of Baizean^®Novartis will fund newly initiated registration-enabling, bridging, or post-marketing studies in the licensed territories, with each party responsible for funding its own activities used to evaluate Baizean.^®Fund clinical trials evaluating the combination of such therapy or third-party drugs. Both parties shall retain their rights to independently develop products in combination with Baizean.^®Global commercialization rights for the drug combination.