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== History ==
== History ==
BeiGene was founded in late 2010 by John V. Oyler,<ref name=":0">{{Cite web|last=Loo|first=Daryl|date=2011-07-07|title=BeiGene Brings Biotech to China|url=https://www.bloomberg.com/news/articles/2011-07-07/beigene-brings-biotech-to-china|access-date=2020-08-04|website=Bloomberg}}</ref> an American entrepreneur who serves as the company's [[chief executive officer]] and chairman.<ref>{{Cite web|last=Lovelace Jr.|first=Berkeley|date=2019-10-31|title=Amgen takes 20% stake in Chinese biotech BeiGene for $2.7 billion|url=https://www.cnbc.com/2019/10/31/amgen-takes-20percent-stake-in-chinese-biotech-beigene-for-2point7-billion.html|access-date=2020-08-04|website=CNBC|language=en}}</ref> Oyler and Wang envisioned a global multinational biopharmaceutical company focusing on cancer treatment.<ref name=":0" />. [[Xiaodong Wang (biochemist)|Xiaodong Wang]], is an internationally renowned biochemist and former [[Howard Hughes Medical Institute|Howard Hughes Medical Investigator]] at the [[University of Texas Southwestern Medical Center]].<ref>https://www.hhmi.org/scientists/xiaodong-wang</ref><ref>{{Cite web |title=Wang lauded as ‘one of the most highly original, bold and creative scientists’ |url=https://www.asbmb.org/asbmb-today/people/022312/wang-wins-asbmb-merck-award |access-date=2024-03-28 |website=www.asbmb.org |language=en}}</ref>
BeiGene was founded in late 2010 by John V. Oyler,<ref name=":0">{{Cite web|last=Loo|first=Daryl|date=2011-07-07|title=BeiGene Brings Biotech to China|url=https://www.bloomberg.com/news/articles/2011-07-07/beigene-brings-biotech-to-china|access-date=2020-08-04|website=Bloomberg}}</ref> an American entrepreneur who serves as the company's [[chief executive officer]] and chairman.<ref>{{Cite web|last=Lovelace Jr.|first=Berkeley|date=2019-10-31|title=Amgen takes 20% stake in Chinese biotech BeiGene for $2.7 billion|url=https://www.cnbc.com/2019/10/31/amgen-takes-20percent-stake-in-chinese-biotech-beigene-for-2point7-billion.html|access-date=2020-08-04|website=CNBC|language=en}}</ref> Oyler and Wang envisioned a global multinational biopharmaceutical company focusing on cancer treatment.<ref name=":0" /> [[Xiaodong Wang (biochemist)|Xiaodong Wang]], is an internationally renowned biochemist and former [[Howard Hughes Medical Institute|Howard Hughes Medical Investigator]] at the [[University of Texas Southwestern Medical Center]].<ref>https://www.hhmi.org/scientists/xiaodong-wang</ref><ref>{{Cite web |title=Wang lauded as ‘one of the most highly original, bold and creative scientists’ |url=https://www.asbmb.org/asbmb-today/people/022312/wang-wins-asbmb-merck-award |access-date=2024-03-28 |website=www.asbmb.org |language=en}}</ref>


John Oyler provided part of the initial [[seed money]] and also received early backing from the American pharmaceutical company [[Merck & Co.]]<ref name=":0" /> BeiGene established offices at the [[Zhongguancun Life Science Park]] near the {{Interlanguage link|National Institute of Biological Sciences, Beijing|lt=National Institute of Biological Sciences, Beijing|zh|北京生命科學研究所}} complemented with offices in Philadelphia<ref>{{Cite web |date=2023-03-29 |title=A Vision of Affordability |url=https://www.pharmexec.com/view/a-vision-of-affordability |access-date=2024-03-28 |website=PharmExec |language=en}}</ref>,<ref>{{Cite web|last=Yoffee|first=Lynn|date=2013-11-22|title=John Oyler Aims To Build China's Genentech via Beigene|url=https://www.bioworld.com/articles/384456-john-oyler-aims-to-build-china-s-genentech-via-beigene?v=preview|access-date=2020-08-04|website=BioWorld|language=en}}</ref> where Wang serves as director.<ref name=":0" /> <ref name=":4">{{Cite news |last=Wright |first=Rob |date=November 1, 2019 |title=How — And Why — John Oyler Built BeiGene |url=https://www.lifescienceleader.com/doc/how-and-why-john-oyler-built-beigene-0001 |work=Life Science Leader}}</ref>. Merck invested $20 million in BeiGene in 2011. <ref name=":4" />
John Oyler provided part of the initial [[seed money]] and also received early backing from the American pharmaceutical company [[Merck & Co.]]<ref name=":0" /> BeiGene established offices at the [[Zhongguancun Life Science Park]] near the {{Interlanguage link|National Institute of Biological Sciences, Beijing|lt=National Institute of Biological Sciences, Beijing|zh|北京生命科學研究所}} complemented with offices in Philadelphia<ref>{{Cite web |date=2023-03-29 |title=A Vision of Affordability |url=https://www.pharmexec.com/view/a-vision-of-affordability |access-date=2024-03-28 |website=PharmExec |language=en}}</ref>,<ref>{{Cite web|last=Yoffee|first=Lynn|date=2013-11-22|title=John Oyler Aims To Build China's Genentech via Beigene|url=https://www.bioworld.com/articles/384456-john-oyler-aims-to-build-china-s-genentech-via-beigene?v=preview|access-date=2020-08-04|website=BioWorld|language=en}}</ref> where Wang serves as director.<ref name=":0" /><ref name=":4">{{Cite news |last=Wright |first=Rob |date=November 1, 2019 |title=How — And Why — John Oyler Built BeiGene |url=https://www.lifescienceleader.com/doc/how-and-why-john-oyler-built-beigene-0001 |work=Life Science Leader}}</ref> Merck invested $20 million in BeiGene in 2011. <ref name=":4" />


On February 2, 2016, BeiGene had its first [[initial public offering]] (IPO) of 6.6 million shares priced at $24<ref>{{Cite news|date=2016-02-03|title=BeiGene raises $158.4 mln in second U.S. IPO to price in 2016|language=en|work=Reuters|url=https://www.reuters.com/article/beigene-ipo-idUSL2N15I049|access-date=2020-08-04}}</ref> on the [[Nasdaq|Nasdaq Stock Market]] under the [[ticker symbol]] BGNE.<ref name=":2">{{Cite news|last=Picker|first=Leslie|date=2016-02-03|title=Editas Medicine and BeiGene Gain in Market Debuts|language=en-US|work=The New York Times|url=https://www.nytimes.com/2016/02/04/business/dealbook/editas-medicine-and-beigene-gain-in-market-debuts.html|access-date=2020-08-04|issn=0362-4331}}</ref> The company raised $182 million.<ref>{{Cite web|last=Ng|first=Eric|date=2020-07-13|title=BeiGene seals jumbo deal as US investors eye China's pharma market|url=https://www.scmp.com/business/companies/article/3092962/beigene-once-target-short-sellers-attracts-jumbo-deal-amgen|access-date=2020-08-04|website=South China Morning Post|language=en}}</ref> 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.<ref name=":2" /> In a March 2018 [[follow-on offering]], BeiGene raised another $758 million.<ref>{{Cite news|last=Micklus|first=Amanda|date=2018-03-14|title=Deals In Depth: January 2018|work=In Vivo|publisher=[[Informa]]|url=https://invivo.pharmaintelligence.informa.com/IV005291/Deals-In-Depth-January-2018|access-date=2020-08-04}}</ref> In August 2018, the company had another IPO when it offered a [[Cross listing|secondary listing]] of its shares on the [[Hong Kong Stock Exchange]], raising $903 million in the process.<ref>{{Cite news|last1=Lau|first1=Fiona|last2=Zhu|first2=Julie|date=2018-08-02|title=Chinese biotech BeiGene raises $903 million in HK's first secondary listing under new rules: sources|language=en|work=Reuters|url=https://www.reuters.com/article/us-beigene-listing-idUSKBN1KN0E1|access-date=2020-08-04}}</ref> BeiGene has been a large accelerated domestic filer on the Nasdaq since fiscal 2017 and is audited by Ernst & Young LLP in Boston, Massachusetts.
On February 2, 2016, BeiGene had its first [[initial public offering]] (IPO) of 6.6 million shares priced at $24<ref>{{Cite news|date=2016-02-03|title=BeiGene raises $158.4 mln in second U.S. IPO to price in 2016|language=en|work=Reuters|url=https://www.reuters.com/article/beigene-ipo-idUSL2N15I049|access-date=2020-08-04}}</ref> on the [[Nasdaq|Nasdaq Stock Market]] under the [[ticker symbol]] BGNE.<ref name=":2">{{Cite news|last=Picker|first=Leslie|date=2016-02-03|title=Editas Medicine and BeiGene Gain in Market Debuts|language=en-US|work=The New York Times|url=https://www.nytimes.com/2016/02/04/business/dealbook/editas-medicine-and-beigene-gain-in-market-debuts.html|access-date=2020-08-04|issn=0362-4331}}</ref> The company raised $182 million.<ref>{{Cite web|last=Ng|first=Eric|date=2020-07-13|title=BeiGene seals jumbo deal as US investors eye China's pharma market|url=https://www.scmp.com/business/companies/article/3092962/beigene-once-target-short-sellers-attracts-jumbo-deal-amgen|access-date=2020-08-04|website=South China Morning Post|language=en}}</ref> 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.<ref name=":2" /> In a March 2018 [[follow-on offering]], BeiGene raised another $758 million.<ref>{{Cite news|last=Micklus|first=Amanda|date=2018-03-14|title=Deals In Depth: January 2018|work=In Vivo|publisher=[[Informa]]|url=https://invivo.pharmaintelligence.informa.com/IV005291/Deals-In-Depth-January-2018|access-date=2020-08-04}}</ref> In August 2018, the company had another IPO when it offered a [[Cross listing|secondary listing]] of its shares on the [[Hong Kong Stock Exchange]], raising $903 million in the process.<ref>{{Cite news|last1=Lau|first1=Fiona|last2=Zhu|first2=Julie|date=2018-08-02|title=Chinese biotech BeiGene raises $903 million in HK's first secondary listing under new rules: sources|language=en|work=Reuters|url=https://www.reuters.com/article/us-beigene-listing-idUSKBN1KN0E1|access-date=2020-08-04}}</ref> BeiGene has been a large accelerated domestic filer on the Nasdaq since fiscal 2017 and is audited by Ernst & Young LLP in Boston, Massachusetts.
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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.<ref name=":1" /> In November 2019, zanubrutinib became the first cancer drug developed in China to gain FDA approval;<ref>{{Cite web|date=2019-11-15|title=FDA Approves First Chinese Cancer Drug for U.S. Patient Use|url=https://www.bloomberg.com/news/articles/2019-11-15/fda-approves-first-chinese-cancer-drug-for-u-s-patient-use|access-date=2020-08-05|website=Bloomberg}}</ref> it received accelerated approval for the treatment of [[mantle cell lymphoma]] (MCL), a rare and aggressive form of [[non-Hodgkin lymphoma]].<ref>{{Cite news|last1=Mathias|first1=Tamara|last2=Maddipatla|first2=Manojna|date=2019-11-14|title=China's BeiGene gets FDA approval for drug to treat rare form of lymphoma|language=en|work=Reuters|url=https://www.reuters.com/article/us-beigene-fda-idUSKBN1XO2UI|access-date=2020-08-05}}</ref> In June 2020, the drug was also approved in China for the treatment of MCL, [[chronic lymphocytic leukemia]] (CLL), and small lymphocytic lymphoma (SLL);<ref>{{Cite web|last=Columbus|first=Gina|date=2020-06-03|title=Zanubrutinib Gains Approval in China for Relapsed/Refractory CLL/SLL and MCL|url=https://www.onclive.com/view/zanubrutinib-gains-approval-in-china-for-relapsedrefractory-cllsll-and-mcl|access-date=2020-08-05|website=OncLive}}</ref> it was then approved for the treatment of CLL<ref>{{cite news |title=BeiGene's Brukinsa receives EC approval for chronic lymphocytic leukaemia |url=https://www.pmlive.com/pharma_news/beigenes_brukinsa_receives_ec_approval_for_chronic_lymphocytic_leukaemia_1481254 |access-date=30 June 2023 |work=PMLive |date=21 November 2022 |language=en}}</ref> and SLL by the [[European Commission]] in November 2022<ref>{{cite news |last1=Liu |first1=Angus |title=ASH: AbbVie, J&J's Imbruvica under serious threat as BeiGene's Brukinsa delivers head-to-head trial win |url=https://www.fiercepharma.com/pharma/abbvie-jjs-imbruvica-under-serious-threat-beigenes-brukinsa-delivers-all-around-head-head |access-date=30 June 2023 |work=Fierce Pharma |date=22 November 2022}}</ref> and by the FDA for the same indications in January 2023.<ref>{{cite news |last1=Killmurray |first1=Conor |title=FDA Approves Zanubrutinib in Adult Patients with CLL/SLL |url=https://www.targetedonc.com/view/fda-approves-zanubrutinib-in-adult-patients-with-cll-sll |access-date=30 June 2023 |work=Targeted Oncology |date=19 January 2023 |language=en}}</ref> In September 2021, the FDA approved zanubrutinib to treat adults with [[Waldenström's macroglobulinemia]], a rare non-Hodgkin lymphoma,<ref>{{Cite web|last=Mulcahy|first=Nick|date=September 2, 2021|title=FDA Approval for Zanubrutinib in Waldenström's Macroglobulinemia|url=http://www.medscape.com/viewarticle/958058|url-status=live|access-date=2021-12-08|website=Medscape|language=en|archive-url=https://web.archive.org/web/20210902170846/https://www.medscape.com/viewarticle/958058 |archive-date=2021-09-02 }}</ref> 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.<ref>{{Cite news|last=Park|first=Brian|date=September 15, 2021|title=Brukinsa Gets Accelerated Approval for Marginal Zone Lymphoma|work=MPR|url=https://www.empr.com/home/news/brukinsa-gets-accelerated-approval-for-marginal-zone-lymphoma/|access-date=2021-12-08}}</ref>
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.<ref name=":1" /> In November 2019, zanubrutinib became the first cancer drug developed in China to gain FDA approval;<ref>{{Cite web|date=2019-11-15|title=FDA Approves First Chinese Cancer Drug for U.S. Patient Use|url=https://www.bloomberg.com/news/articles/2019-11-15/fda-approves-first-chinese-cancer-drug-for-u-s-patient-use|access-date=2020-08-05|website=Bloomberg}}</ref> it received accelerated approval for the treatment of [[mantle cell lymphoma]] (MCL), a rare and aggressive form of [[non-Hodgkin lymphoma]].<ref>{{Cite news|last1=Mathias|first1=Tamara|last2=Maddipatla|first2=Manojna|date=2019-11-14|title=China's BeiGene gets FDA approval for drug to treat rare form of lymphoma|language=en|work=Reuters|url=https://www.reuters.com/article/us-beigene-fda-idUSKBN1XO2UI|access-date=2020-08-05}}</ref> In June 2020, the drug was also approved in China for the treatment of MCL, [[chronic lymphocytic leukemia]] (CLL), and small lymphocytic lymphoma (SLL);<ref>{{Cite web|last=Columbus|first=Gina|date=2020-06-03|title=Zanubrutinib Gains Approval in China for Relapsed/Refractory CLL/SLL and MCL|url=https://www.onclive.com/view/zanubrutinib-gains-approval-in-china-for-relapsedrefractory-cllsll-and-mcl|access-date=2020-08-05|website=OncLive}}</ref> it was then approved for the treatment of CLL<ref>{{cite news |title=BeiGene's Brukinsa receives EC approval for chronic lymphocytic leukaemia |url=https://www.pmlive.com/pharma_news/beigenes_brukinsa_receives_ec_approval_for_chronic_lymphocytic_leukaemia_1481254 |access-date=30 June 2023 |work=PMLive |date=21 November 2022 |language=en}}</ref> and SLL by the [[European Commission]] in November 2022<ref>{{cite news |last1=Liu |first1=Angus |title=ASH: AbbVie, J&J's Imbruvica under serious threat as BeiGene's Brukinsa delivers head-to-head trial win |url=https://www.fiercepharma.com/pharma/abbvie-jjs-imbruvica-under-serious-threat-beigenes-brukinsa-delivers-all-around-head-head |access-date=30 June 2023 |work=Fierce Pharma |date=22 November 2022}}</ref> and by the FDA for the same indications in January 2023.<ref>{{cite news |last1=Killmurray |first1=Conor |title=FDA Approves Zanubrutinib in Adult Patients with CLL/SLL |url=https://www.targetedonc.com/view/fda-approves-zanubrutinib-in-adult-patients-with-cll-sll |access-date=30 June 2023 |work=Targeted Oncology |date=19 January 2023 |language=en}}</ref> In September 2021, the FDA approved zanubrutinib to treat adults with [[Waldenström's macroglobulinemia]], a rare non-Hodgkin lymphoma,<ref>{{Cite web|last=Mulcahy|first=Nick|date=September 2, 2021|title=FDA Approval for Zanubrutinib in Waldenström's Macroglobulinemia|url=http://www.medscape.com/viewarticle/958058|url-status=live|access-date=2021-12-08|website=Medscape|language=en|archive-url=https://web.archive.org/web/20210902170846/https://www.medscape.com/viewarticle/958058 |archive-date=2021-09-02 }}</ref> 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.<ref>{{Cite news|last=Park|first=Brian|date=September 15, 2021|title=Brukinsa Gets Accelerated Approval for Marginal Zone Lymphoma|work=MPR|url=https://www.empr.com/home/news/brukinsa-gets-accelerated-approval-for-marginal-zone-lymphoma/|access-date=2021-12-08}}</ref>


As of 2023, the company had a portfolio of 17 medicines from its internal pipeline as well as partnerships, in addition to 23 development programs and over 60 discovery programs<ref>{{Cite web |title=XBRL Viewer |url=https://www.sec.gov/ix?doc=/Archives/edgar/data/1651308/000165130824000014/bgne-20231231.htm |access-date=2024-03-28 |website=www.sec.gov |language=en}}</ref>. BeiGene has used head-to-head clinical trials to validate the benefits of medicines<ref name=":5">{{Cite news |last=Henderson |first=Lisa |date=March 29, 2023 |title=A Vision of Affordability |url=https://www.pharmexec.com/view/a-vision-of-affordability |work=Pharma Exec}}</ref>, including two large global phase 3 clinical trials comparing zanubrutinib to [[ibrutinib]] between 2017 and 2023. BeiGene currently conducts global clinical trials in Australia, Italy, Spain, and Poland.<ref name=":5" />
As of 2023, the company had a portfolio of 17 medicines from its internal pipeline as well as partnerships, in addition to 23 development programs and over 60 discovery programs.<ref>{{Cite web |title=XBRL Viewer |url=https://www.sec.gov/ix?doc=/Archives/edgar/data/1651308/000165130824000014/bgne-20231231.htm |access-date=2024-03-28 |website=www.sec.gov |language=en}}</ref> BeiGene has used head-to-head clinical trials to validate the benefits of medicines,<ref name=":5">{{Cite news |last=Henderson |first=Lisa |date=March 29, 2023 |title=A Vision of Affordability |url=https://www.pharmexec.com/view/a-vision-of-affordability |work=Pharma Exec}}</ref> including two large global phase 3 clinical trials comparing zanubrutinib to [[ibrutinib]] between 2017 and 2023. BeiGene currently conducts global clinical trials in Australia, Italy, Spain, and Poland.<ref name=":5" />


== References ==
== References ==

Revision as of 03:26, 28 March 2024

BeiGene, Ltd.
Company typePublic
Founded2010; 14 years ago (2010) in Beijing, China
Founders
HeadquartersBeijing, China, and Cambridge, Massachusetts, U.S., Basel, Switzerland,[1]
RevenueIncrease US$2.459 billion (2023)
Negative increase US$−1.21 billion (2023)
Negative increase US$−882 million (2023)
Total assetsDecrease US$5.805 billion (2023)
Total equityDecrease US$3.537 billion (2023)
Number of employees
10,600 (2024)
Websitewww.beigene.com Edit this at Wikidata
Footnotes / references
[2]

BeiGene, Ltd. is a global oncology company[3] that specializes in the development of drugs for cancer treatment.[4] Founded in 2010 chief executive officer by John V. Oyler and Xiaodong Wang, the multinational company headquartered in Cambridge, Massachusetts has offices in North America, Europe, South America, Asia and Australia.[5][6][7][8] BeiGene has developed several pharmaceuticals, including tislelizumab, a checkpoint inhibitor, and zanubrutinib, a Bruton's tyrosine kinase inhibitor. 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. [9] [10] Brukinsa is the only BTK inhibitor to demonstrate PFS supriority in a head-to-head comparison of BTK inhibitors.[11] 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.[12]

Global Multinational Company

In 2024, Fast Company recognized BeiGene, headquartered in Cambridge, Massachusetts, as one of the Most Innovative Companies across 606 organizations that are reshaping industries.[13]

History

BeiGene was founded in late 2010 by John V. Oyler,[14] an American entrepreneur who serves as the company's chief executive officer and chairman.[15] Oyler and Wang envisioned a global multinational biopharmaceutical company focusing on cancer treatment.[14] Xiaodong Wang, is an internationally renowned biochemist and former Howard Hughes Medical Investigator at the University of Texas Southwestern Medical Center.[16][17]

John Oyler provided part of the initial seed money and also received early backing from the American pharmaceutical company Merck & Co.[14] BeiGene established offices at the Zhongguancun Life Science Park near the National Institute of Biological Sciences, Beijing [zh] complemented with offices in Philadelphia[18],[19] where Wang serves as director.[14][20] Merck invested $20 million in BeiGene in 2011. [20]

On February 2, 2016, BeiGene had its first initial public offering (IPO) of 6.6 million shares priced at $24[21] on the Nasdaq Stock Market under the ticker symbol BGNE.[22] The company raised $182 million.[23] 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.[22] In a March 2018 follow-on offering, BeiGene raised another $758 million.[24] 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.[25] BeiGene has been a large accelerated domestic filer on the Nasdaq since fiscal 2017 and is audited by Ernst & Young LLP in Boston, Massachusetts.

In July 2017, BeiGene entered into a partnership with Celgene to continue the development and commercialization of the cancer drug BGB-A317,[26] also known as tislelizumab.[27] 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.[28] 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.[29] 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.[27] Celgene returned the rights to the drug in June 2019 along with a payment of $150 million to conclude the deal.[30]

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.[31]

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.[32] 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.[33] Novartis returned the rights to tislelizumab to BeiGene in September 2023.[34] In March 2024, tislelizumab (Tevimbra) received FDA approval for the treatment of advanced or metastic esophageal squamous cell carcinoma after prior chemotherapy.[35] This FDA approval marked BeiGene's second for an internally developed medicine.

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.[14]

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.[26] Tislelizumab is being developed as a monotherapy and for use in combination with other therapies for several types of cancer.[36] In December 2019, it was approved by National Medical Products Administration in China for the treatment of Hodgkin lymphoma.[37] In April 2020, tislelizumab was also approved in China to treat urothelial carcinoma.[38] 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.[39]

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.[27] In November 2019, zanubrutinib became the first cancer drug developed in China to gain FDA approval;[40] it received accelerated approval for the treatment of mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin lymphoma.[41] In June 2020, the drug was also approved in China for the treatment of MCL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL);[42] it was then approved for the treatment of CLL[43] and SLL by the European Commission in November 2022[44] and by the FDA for the same indications in January 2023.[45] In September 2021, the FDA approved zanubrutinib to treat adults with Waldenström's macroglobulinemia, a rare non-Hodgkin lymphoma,[46] 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.[47]

As of 2023, the company had a portfolio of 17 medicines from its internal pipeline as well as partnerships, in addition to 23 development programs and over 60 discovery programs.[48] BeiGene has used head-to-head clinical trials to validate the benefits of medicines,[49] including two large global phase 3 clinical trials comparing zanubrutinib to ibrutinib between 2017 and 2023. BeiGene currently conducts global clinical trials in Australia, Italy, Spain, and Poland.[49]

References

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