BeiGene

BeiGene, Ltd. is a China-based drug developer. It specializes in the development of drugs for cancer treatment. Founded in 2010 by chief executive officer John V. Oyler and Xiaodong Wang, the multinational company headquartered in Cambridge, Massachusetts has offices in North America, Europe, South America, Asia and Australia. BeiGene has a large presence in Chinese market. BeiGene has developed several pharmaceuticals, including tislelizumab, a checkpoint inhibitor, and zanubrutinib, a Bruton's tyrosine kinase inhibitor.

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.

One of BeiGene's internally developed medicines is tislelizumab (BGB-A317), a PD-1 antibody or PD-L1 inhibitor that prevents cancer tumors from evading the immune system. Tislelizumab is being developed as a monotherapy and for use in combination with other therapies for several types of cancer. In December 2019, it was approved by National Medical Products Administration in China for the treatment of Hodgkin lymphoma. In April 2020, tislelizumab was also approved in China to treat urothelial carcinoma. In September 2021, the U.S. Food and Drug Administration (FDA) accepted a biologics license application for tislelizumab to treat unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma that has previously been treated with systemic therapy.

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. In November 2019, zanubrutinib became the first cancer drug developed in China to gain FDA approval; it received accelerated approval for the treatment of mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin lymphoma. In June 2020, the drug was also approved in China for the treatment of MCL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL); it was then approved for the treatment of CLL and SLL by the European Commission in November 2022 and by the FDA for the same indications in January 2023. In September 2021, the FDA approved zanubrutinib to treat adults with Waldenström's macroglobulinemia, a rare non-Hodgkin lymphoma, 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.

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. Brukinsa is the only BTK inhibitor to demonstrate PFS supriority in a head-to-head comparison of BTK inhibitors. 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.

History
BeiGene was founded in late 2010 by John V. Oyler, an American entrepreneur who serves as the company's chief executive officer and chairman, alongside Xiaodong Wang, A Chinese American biochemist. Oyler and Wang envisioned a global multinational biopharmaceutical company focusing on cancer treatment. Xiaodong Wang is former Howard Hughes Medical Investigator at the University of Texas Southwestern Medical Center. The company initially primarily operated in China.

John Oyler provided part of the initial seed money and also received early backing from the American pharmaceutical company Merck & Co.. BeiGene established offices in Philadelphia and at Zhongguancun Life Science Park near the  where Wang serves as director. Merck invested $20 million in BeiGene in 2011.

On February 2, 2016, BeiGene had its first initial public offering (IPO) of 6.6 million shares priced at $24 on the Nasdaq Stock Market under the ticker symbol BGNE. The company raised $182 million. The IPO, managed by Goldman Sachs and Morgan Stanley, was backed by Baker Brothers and Hillhouse BGN Holdings, which together planned to purchase half the shares offered. In a March 2018 follow-on offering, BeiGene raised another $758 million. In August 2018, the company had another IPO when it offered a secondary listing of its shares on the Hong Kong Stock Exchange, raising $903 million in the process.

In July 2017, BeiGene entered into a partnership with Celgene to continue the development and commercialization of the cancer drug BGB-A317, also known as tislelizumab. 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. 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. 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. Celgene returned the rights to the drug in June 2019 along with a payment of $150 million to conclude the deal.

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.

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. 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. Novartis returned the rights to tislelizumab to BeiGene in September 2023. In March 2024, tislelizumab (Tevimbra) received FDA approval for the treatment of advanced or metastic esophageal squamous cell carcinoma after prior chemotherapy. 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. 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, although it conducted its first research in the country in 2014. The company has become one of the largest clinical research organizations in Australia. In fact, all first-in-human phase 1 trials of internally discovered assets at BeiGene are conducted in Australia.