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BeiGene, Ltd. is a multinational oncology company.[3] It specializes in the development of drugs for cancer treatment.[4] Founded in 2010 by chief executive officer John V. Oyler and Xiaodong Wang, the company is headquartered in Cambridge, Massachusetts and has offices in North America, Europe, South America, Asia and Australia.[5][6][7][8] BeiGene has a large presence in the Chinese market.[9] BeiGene has developed several pharmaceuticals, including tislelizumab, a checkpoint inhibitor, and zanubrutinib, a Bruton's tyrosine kinase inhibitor. On 14 November, 2024 the company announced its intention to rebrand as BeOne Medicines.[10]
Research and development
In addition to clinical research, BeiGene's early business model involved obtaining the rights to experimental medicines shelved by other pharmaceutical companies and taking them through early clinical trials at Chinese medical schools and hospitals. Successful formulas would either be sold to or co-developed with larger drugmakers who could fund the late-stage trials.[11]
BeiGene also developed zanubrutinib, a Bruton's tyrosine kinase inhibitor for the treatment of cancer, from a formula its scientists created in Beijing in 2012.[17] In November 2019, zanubrutinib became the first cancer drug developed in China to gain FDA approval;[18] it received accelerated approval for the treatment of mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin lymphoma.[19] In June 2020, the drug was also approved in China for the treatment of MCL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL);[20] it was then approved for the treatment of CLL[21] and SLL by the European Commission in November 2022[22] and by the FDA for the same indications in January 2023.[23] In September 2021, the FDA approved zanubrutinib to treat adults with Waldenström's macroglobulinemia, a rare non-Hodgkin lymphoma,[24] and separately granted an accelerated approval for use of the drug in the treatment of relapsed or refractory marginal zone B-cell lymphoma in patients who have been treated with an anti-CD20 regimen.[25]
In 2023, Brukinsa, the Bruton's tyrosine kinase inhibitor crossed blockbuster threshold to hit 1.3 billion dollars in full-year sales with the majority of product sales originating in the United States and Europe. [26][27] Brukinsa is the only BTK inhibitor to demonstrate PFS supriority in a head-to-head comparison of BTK inhibitors.[28] The FDA approved a label update for Brukinsa in 2023 which includes superior PFS results from the Phase 3 ALPINE head-to-head trial versus Imbruvica in relapsed/refractory CLL.[29]
In July 2017, BeiGene entered into a partnership with Celgene to continue the development and commercialization of the cancer drug BGB-A317,[12] also known as tislelizumab.[17] BeiGene also acquired Celgene's operations in China as well as the rights to commercialize Abraxane, Revlimid and Vidaza, Celgene's approved drugs in China.[41] As part of the deal, Celgene made a $150 million equity investment in BeiGene and acquired the rights for the sale of tislelizumab overseas for $263 million, with another $980 million plus royalties contingent on future sales.[42] The deal stipulated that, if Celgene began work on a competitor drug, BeiGene could buy back the rights to tislelizumab. In January 2019, Celgene was acquired by Bristol-Myers Squibb, which is developing a similar cancer immunotherapy drug, Opdivo, allowing BeiGene to regain its overseas rights to tislelizumab.[17] Celgene returned the rights to the drug in June 2019 along with a payment of $150 million to conclude the deal.[43]
In 2019, Amgen Inc. acquired 20.5% of BeiGene in a deal valued at $2.7 billion, and gained a seat on BeiGene's board of directors. In turn, BeiGene acquired the rights to commercialize three Amgen pharmaceuticals, Xgeva, Kyprolis, and Blincyto, as well as 20 others in development, investing up to $1.25 billion toward their research.[44]
In January 2021, BeiGene announced a collaboration and license agreement with Novartis to develop and commercialize tislelizumab in Canada, member countries of the European Union, Switzerland, Iceland, Japan, Liechtenstein, Mexico, Norway, Russia, United Kingdom, and the U.S.[45] In May 2021, BeiGene and Asieris Pharmaceuticals worked together to assess the efficacy and quality of Asieris's MetAP2 inhibitor and BeiGene's PD-L1 inhibitor for bladder cancer patients.[46] Novartis returned the rights to tislelizumab to BeiGene in September 2023.[47] In March 2024, tislelizumab (Tevimbra) received FDA approval for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy.[48] This FDA approval marked BeiGene's second for an internally developed medicine.
BeiGene opened several new offices around the world in 2022, including a regional office in Basel, Switzerland, which serves as a hub for the company's operations in Europe.[49] As of 2022, the company had enrolled patients from more than 45 countries, including 25 European countries, in clinical trials. BeiGene also opened a new office in Sydney, Australia, in 2022,[50] although it conducted its first research in the country in 2014. The company has become one of the largest clinical research organizations in Australia.[51] In fact, all first-in-human phase 1 trials of internally discovered assets at BeiGene are conducted in Australia.[52]
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