BeiGene

Last updated

BeiGene, Ltd.
Company type Public
Founded2010;14 years ago (2010)
Founders
Headquarters Cambridge, Massachusetts, U.S.; Beijing, China; Basel, Switzerland [1]
RevenueIncrease2.svg US$2.459 billion (2023)
Increase Negative.svgUS$−1.21 billion (2023)
Increase Negative.svgUS$−882 million (2023)
Total assets Decrease2.svgUS$5.805 billion (2023)
Total equity Decrease2.svgUS$3.537 billion (2023)
Number of employees
10,600 (2024)
Website www.beigene.com OOjs UI icon edit-ltr-progressive.svg
Footnotes /references
[2]

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]

Contents

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]

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. [12] Tislelizumab is being developed as a monotherapy and for use in combination with other therapies for several types of cancer. [13] In December 2019, it was approved by National Medical Products Administration in China for the treatment of Hodgkin lymphoma. [14] In April 2020, tislelizumab was also approved in China to treat urothelial carcinoma. [15] 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. [16]

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]

History

BeiGene was founded in late 2010 by John V. Oyler, [11] an American entrepreneur who serves as the company's chief executive officer and chairman, [30] alongside Xiaodong Wang, a Chinese American biochemist. Oyler and Wang envisioned a global multinational biopharmaceutical company focusing on cancer treatment. [11] Xiaodong Wang is former Howard Hughes Medical Investigator at the University of Texas Southwestern Medical Center. [31] [32] The company initially primarily operated in China. [11]

John Oyler provided part of the initial seed money and also received early backing from the American pharmaceutical company Merck & Co.. [11] BeiGene established offices in Philadelphia [33] [34] and at Zhongguancun Life Science Park near the National Institute of Biological Sciences, Beijing  [ zh ] where Wang serves as director. [11] [35] Merck invested $20 million in BeiGene in 2011. [35]

On February 2, 2016, BeiGene had its first initial public offering (IPO) of 6.6 million shares priced at $24 [36] on the Nasdaq Stock Market under the ticker symbol BGNE. [37] The company raised $182 million. [38] 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. [37] In a March 2018 follow-on offering, BeiGene raised another $758 million. [39] 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. [40]

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]

Related Research Articles

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<span class="mw-page-title-main">Chronic lymphocytic leukemia</span> Bone marrow cancer in which lymphocytes are overproduced

Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes. Early on, there are typically no symptoms. Later, non-painful lymph node swelling, feeling tired, fever, night sweats, or weight loss for no clear reason may occur. Enlargement of the spleen and low red blood cells (anemia) may also occur. It typically worsens gradually over years.

<span class="mw-page-title-main">Amgen</span> American multinational biopharmaceutical company

Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, As of 2022, Amgen has approximately 24,000 staff in total.

<span class="mw-page-title-main">Rituximab</span> Biopharmaceutical drug

Rituximab, sold under the brand name Rituxan among others, is a monoclonal antibody medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and Epstein–Barr virus-positive mucocutaneous ulcers. It is given by slow intravenous infusion.

<span class="mw-page-title-main">Cancer immunotherapy</span> Artificial stimulation of the immune system to treat cancer

Cancer immunotherapy (immuno-oncotherapy) is the stimulation of the immune system to treat cancer, improving the immune system's natural ability to fight the disease. It is an application of the fundamental research of cancer immunology (immuno-oncology) and a growing subspecialty of oncology.

<span class="mw-page-title-main">Bruton's tyrosine kinase</span> Kinase that plays a role in B cell development

Bruton's tyrosine kinase, also known as tyrosine-protein kinase BTK, is a tyrosine kinase that is encoded by the BTK gene in humans. BTK plays a crucial role in B cell development.

Richter's transformation (RT), also known as Richter's syndrome, is the conversion of chronic lymphocytic leukemia (CLL) or its variant, small lymphocytic lymphoma (SLL), into a new and more aggressively malignant disease. CLL is the circulation of malignant B lymphocytes with or without the infiltration of these cells into lymphatic or other tissues while SLL is the infiltration of these malignant B lymphocytes into lymphatic and/or other tissues with little or no circulation of these cells in the blood. CLL along with its SLL variant are grouped together in the term CLL/SLL.

<span class="mw-page-title-main">Phosphoinositide 3-kinase inhibitor</span>

Phosphoinositide 3-kinase inhibitors are a class of medical drugs that are mainly used to treat advanced cancers. They function by inhibiting one or more of the phosphoinositide 3-kinase (PI3K) enzymes, which are part of the PI3K/AKT/mTOR pathway. This signal pathway regulates cellular functions such as growth and survival. It is strictly regulated in healthy cells, but is always active in many cancer cells, allowing the cancer cells to better survive and multiply. PI3K inhibitors block the PI3K/AKT/mTOR pathway and thus slow down cancer growth. They are examples of a targeted therapy. While PI3K inhibitors are an effective treatment, they can have very severe side effects and are therefore only used if other treatments have failed or are not suitable.

<span class="mw-page-title-main">Ibrutinib</span> Medication used in cancer treatment

Ibrutinib, sold under the brand name Imbruvica among others, is a small molecule drug that inhibits B-cell proliferation and survival by irreversibly binding the protein Bruton's tyrosine kinase (BTK). Blocking BTK inhibits the B-cell receptor pathway, which is often aberrantly active in B cell cancers. Ibrutinib is therefore used to treat such cancers, including mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström's macroglobulinemia. Ibrutinib also binds to C-terminal Src Kinases. These are off-target receptors for the BTK inhibitor. Ibrutinib binds to these receptors and inhibits the kinase from promoting cell differentiation and growth. This leads to many different side effects like left atrial enlargement and atrial fibrillation during the treatment of Chronic Lymphocytic Leukemia.

<span class="mw-page-title-main">Idelalisib</span> Chemical compound

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<span class="mw-page-title-main">Venetoclax</span> Medication

Venetoclax, sold under the brand names Venclexta and Venclyxto, is a medication used to treat adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or acute myeloid leukemia (AML).

<span class="mw-page-title-main">Acalabrutinib</span> Chemical compound

Acalabrutinib, sold under the brand name Calquence, is a medication used to treat various types of non-Hodgkin lymphoma, including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic Lymphoma (CLL/SLL). It may be used both in relapsed as well as in treatment-naive settings.

<span class="mw-page-title-main">Duvelisib</span> PI3K inhibitor

Duvelisib, sold under the brand name Copiktra, is a medication used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma after other treatments have failed. It is taken by mouth. It is a PI3 kinase inhibitor.

<span class="mw-page-title-main">Tislelizumab</span> Monoclonal antibody

Tislelizumab, sold under the brand name Tevimbra among others, is a humanized monoclonal antibody directed against programmed death receptor-1. It is being developed by BeiGene.

<span class="mw-page-title-main">Umbralisib</span> Chemical compound

Umbralisib, sold under the brand name Ukoniq, is an anti-cancer medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). It is taken by mouth.

Verastem, Inc., doing business as Verastem Oncology, is an American pharmaceutical company that develops medicines to treat certain cancers. Headquartered and founded in Boston, Massachusetts, the firm is a member of NASDAQ Biotechnology Index.

<span class="mw-page-title-main">Zanubrutinib</span> Chemical compound

Zanubrutinib, sold under the brand name Brukinsa, is an anticancer medication used for the treatment of mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic lymphocytic leukemia (CLL). Zanubrutinib is classified as a Bruton's tyrosine kinase (BTK) inhibitor. It is given by mouth.

<span class="mw-page-title-main">Orelabrutinib</span> Drug for treatment of cancer

Orelabrutinib is a drug for the treatment of cancer.

<span class="mw-page-title-main">Lisaftoclax</span> Chemical compound

Lisaftoclax is an investigational new drug being developed by Ascentage Pharma for the treatment of hematological malignancies, particularly chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is a selective inhibitor of the B-cell lymphoma 2 (BCL-2) protein, designed to restore the normal process of programmed cell death (apoptosis) in cancer cells. As of 2024, lisaftoclax is undergoing multiple Phase 3 clinical trials, including studies in combination with BTK inhibitors for relapsed/refractory CLL/SLL.

<span class="mw-page-title-main">Sonrotoclax</span> Chemical compound

Sonrotoclax is an investigational new drug that is being evaluated for the treatment of hematologic malignancies, particularly chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is a potent and selective BCL2 inhibitor that can overcome resistance associated with BCL2 mutations, such as the G101V variant, which limits the effectiveness of first-generation inhibitors like venetoclax.

References

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  9. ↑ Beasley, Deena (October 31, 2019) Amgen takes 20.5% stake in BeiGene to sell cancer drugs in China Reuters
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