BeOne

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.{{Cite journal |last1=Desai |first1=Jayesh |last2=Deva |first2=Sanjeev |last3=Lee |first3=Jong Seok |last4=Lin |first4=Chia-Chi |last5=Yen |first5=Chia-Jui |last6=Chao |first6=Yee |last7=Keam |first7=Bhumsuk |last8=Jameson |first8=Michael |last9=Hou |first9=Ming-Mo |last10=Kang |first10=Yoon-Koo |last11=Markman |first11=Ben |date=June 2020 |title=Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors |url= |journal=Journal for ImmunoTherapy of Cancer |language=en |volume=8 |issue=1 |pages=e000453 |doi=10.1136/jitc-2019-000453 |issn=2051-1426 |pmc=7295442 |pmid=32540858}} In December 2019, it was approved by National Medical Products Administration in China for the treatment of Hodgkin lymphoma.{{Cite journal |last1=Lee |first1=Sang Hyung |last2=Lee |first2=Hyun Tae |last3=Lim |first3=Heejin |last4=Kim |first4=Yujin |last5=Park |first5=Ui Beom |last6=Heo |first6=Yong-Seok |date=June 2020 |title=Crystal structure of PD-1 in complex with an antibody-drug tislelizumab used in tumor immune checkpoint therapy |url=https://linkinghub.elsevier.com/retrieve/pii/S0006291X20308615 |journal=Biochemical and Biophysical Research Communications |language=en |volume=527 |issue=1 |pages=226–231 |doi=10.1016/j.bbrc.2020.04.121 |pmid=32446372 |s2cid=218874092}} In April 2020, tislelizumab was also approved in China to treat urothelial carcinoma.{{Cite web |date=2020-04-13 |title=BeiGene's Tislelizumab Approved by China's NMPA for PD-L1 Elevated Bladder Cancer |url=https://www.precisiononcologynews.com/regulatory-news-fda-approvals/beigenes-tislelizumab-approved-chinas-nmpa-pd-l1-elevated-bladder |access-date=2020-08-05 |website=Precision Oncology News |language=en-us}} 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.{{Cite web |last=Park |first=Brian |date=2021-09-13 |title=Tislelizumab Under Review for Esophageal Squamous Cell Carcinoma |url=https://www.empr.com/home/news/drugs-in-the-pipeline/tislelizumab-under-review-for-esophageal-squamous-cell-carcinoma/ |url-status=live |archive-url=https://web.archive.org/web/20210913170634/https://www.empr.com/home/news/drugs-in-the-pipeline/tislelizumab-under-review-for-esophageal-squamous-cell-carcinoma/ |archive-date=2021-09-13 |access-date=2021-12-08 |website=MPR |language=en-US}}

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;{{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}} it received accelerated approval for the treatment of mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin lymphoma.{{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 |url=https://www.reuters.com/article/us-beigene-fda-idUSKBN1XO2UI |access-date=2020-08-05 |work=Reuters |language=en}} In June 2020, the drug was also approved in China for the treatment of MCL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL);{{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}} it was then approved for the treatment of CLL{{cite news |date=21 November 2022 |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 |language=en}} and SLL by the European Commission in November 2022{{cite news |last1=Liu |first1=Angus |date=22 November 2022 |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}} and by the FDA for the same indications in January 2023.{{cite news |last1=Killmurray |first1=Conor |date=19 January 2023 |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 |language=en}} In September 2021, the FDA approved zanubrutinib to treat adults with Waldenström's macroglobulinemia, a rare non-Hodgkin lymphoma,{{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 |archive-url=https://web.archive.org/web/20210902170846/https://www.medscape.com/viewarticle/958058 |archive-date=2021-09-02 |access-date=2021-12-08 |website=Medscape |language=en}} 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.{{Cite news |last=Park |first=Brian |date=September 15, 2021 |title=Brukinsa Gets Accelerated Approval for Marginal Zone Lymphoma |url=https://www.empr.com/home/news/brukinsa-gets-accelerated-approval-for-marginal-zone-lymphoma/ |access-date=2021-12-08 |work=MPR}}

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. {{Cite web |title=BeiGene Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates – NASDAQ (US) Website |url=https://ir.beigene.com/news/beigene-reports-fourth-quarter-and-full-year-2023-financial-results-and-business-updates/e8b7556f-f159-4875-9522-d636c85d1cfa/ |accessdate=28 March 2024 |website=ir.beigene.com}} {{Cite news |last=Liu |first=Angus |date=Feb 26, 2024 |title=BeiGene grows global workforce by 1,000-plus as Brukinsa surges, Tevimbra launches outside China |url=https://www.fiercepharma.com/pharma/beigene-added-1400-staffers-brukinsa-surges-tevimbra-launches-outside-china |work=Fierce Pharma}} Brukinsa is the only BTK inhibitor to demonstrate PFS supriority in a head-to-head comparison of BTK inhibitors.{{Cite web |date=2023-12-20 |title=Extended Follow-up of ALPINE Randomized Phase 3 Study Confirms Sustained Superior Progression-free Survival of Zanubrutinib Versus Ibrutinib for Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (R/R CLL/SLL) |url=https://www.onclive.com/view/extended-follow-up-of-alpine-randomized-phase-3-study |access-date=2024-03-28 |website=OncLive |language=en}} 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.{{Cite web |title=FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL) – NASDAQ (US) Website |url=https://ir.beigene.com/news/fda-approves-label-update-for-brukinsa-zanubrutinib-in-chronic-lymphocytic-leukemia-cll/49b1ba2a-1f61-4034-9371-292f81d2ca57/ |access-date=2024-03-28 |website=ir.beigene.com |language=en}}

BeiGene was founded in late 2010 by John V. Oyler,{{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}} an American entrepreneur who serves as the company's chief executive officer and chairman,{{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}} 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.{{Cite web|url=https://www.hhmi.org/scientists/xiaodong-wang|title=Xiaodong Wang, PhD | Former Investigator Profile | 1997-2010|website=www.hhmi.org|accessdate=28 March 2024}}{{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}} 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{{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}}{{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}} and at 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}} where Wang serves as director.{{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}} 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{{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}} on the Nasdaq Stock Market under the ticker symbol BGNE.{{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}} The company raised $182 million.{{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}} 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.{{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}} 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.{{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}}

In July 2017, BeiGene entered into a partnership with Celgene to continue the development and commercialization of the cancer drug BGB-A317,{{Cite news|last1=Grover|first1=Divya|last2=Pratap|first2=Bhanu|date=2017-07-05|title=Celgene signs deal with BeiGene for tumor cancer treatment|language=en|work=Reuters|url=https://www.reuters.com/article/us-beigene-stake-celgene-idUSKBN19R04J|access-date=2020-08-04}} also known as tislelizumab.{{Cite web|last=Robbins|first=Rebecca|date=2019-02-13|title=For BeiGene, Bristol-Celgene deal is poised to have big ripple effects|url=https://www.statnews.com/2019/02/13/for-a-chinese-cancer-drug-developer-bristol-celgene-deal-is-poised-to-have-big-ripple-effects/|access-date=2020-08-04|website=STAT|language=en-US}} 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.{{cite news |last1=Taylor |first1=Nick Paul |title=Celgene bags Beigene PD-1 drug for $263M up front |url=https://www.fiercebiotech.com/biotech/celgene-bags-beigene-pd-1-drug-for-263m-upfront |access-date=16 August 2023 |work=Fierce Biotech |date=6 July 2017}} 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.{{Cite web|last=Feuerstein|first=Adam|date=2017-07-06|title=Celgene now owns a checkpoint inhibitor for solid tumors, but is Beigene deal too late for cancer immunotherapy race?|url=https://www.statnews.com/2017/07/06/celgene-now-owns-checkpoint-inhibitor-solid-tumors-beigene-deal-late-cancer-immunotherapy-race/|access-date=2020-08-04|website=STAT|language=en-US}} 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.{{Cite web|last=Armstrong|first=Drew|date=2019-06-17|title=Celgene Hands Cancer Drug Back to BeiGene, Plus $150 Million|url=https://www.bloomberg.com/news/articles/2019-06-17/celgene-hands-cancer-drug-back-to-beigene-plus-150-million?sref=AhlHBrWD|access-date=2020-08-04|website=Bloomberg}}

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.{{Cite web|last1=Armstrong|first1=Drew|last2=Lyu|first2=Dong|date=2019-10-31|title=Amgen to Take $2.7 Billion Stake in BeiGene for China Growth|url=https://www.bloomberg.com/news/articles/2019-10-31/amgen-to-take-2-7-billion-stake-in-beigene-for-china-expansion|access-date=2020-08-04|website=Bloomberg}}

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.{{Cite web|date=2021-02-26|title=Novartis Licenses BeiGene's Anti-PD-1 Agent Tislelizumab in North America, Europe, Japan|url=https://www.precisiononcologynews.com/cancer/novartis-licenses-beigenes-anti-pd-1-agent-tislelizumab-north-america-europe-japan|access-date=2021-06-21|website=Precision Oncology News|language=en}} 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.{{Cite web|date=6 May 2021|title=Asieris and BeiGene to Test Combination Therapy for Bladder Cancer|url=http://www.chinabiotoday.com/articles/asieris-beigene-combination|url-status=live|access-date=7 May 2021|website=Chinabio Today|archive-url=https://web.archive.org/web/20210510142957/http://www.chinabiotoday.com/articles/asieris-beigene-combination |archive-date=2021-05-10 }} Novartis returned the rights to tislelizumab to BeiGene in September 2023.{{cite news |last1=Bonanos |first1=Paul |title=As Novartis PD-1 deal ends, BeiGene sees U.S., EU as gateways to global access |url=https://www.biocentury.com/article/649278/as-novartis-pd-1-deal-ends-beigene-sees-u-s-eu-as-gateways-to-global-access |access-date=27 November 2023 |work=BioCentury |date=19 September 2023}} In March 2024, tislelizumab (Tevimbra) received FDA approval for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy.{{Cite web |title=BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy – NASDAQ (US) Website |url=https://ir.beigene.com/news/beigene-receives-fda-approval-for-tevimbra-for-the-treatment-of-advanced-or-metastatic-esophageal-squamous/20eb032c-15ce-456a-a852-39c88a28d811/ |access-date=2024-03-28 |website=ir.beigene.com |language=en}} 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.{{cite web | url=https://www.biopharma-reporter.com/Article/2022/05/17/BeiGene-opens-regional-office-in-Switzerland-to-strengthen-European-presence# | title=BeiGene opens regional office in Basel to strengthen European presence | date=17 May 2022 }} 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,{{cite web | url=https://pharmainfocus.com.au/news_m.asp?newsid=20478 | title=BeiGene opens first Aust office 13.12.22 AM }} although it conducted its first research in the country in 2014. The company has become one of the largest clinical research organizations in Australia.{{cite web | url=https://www.smh.com.au/business/entrepreneurship/invest-bravely-cancer-fighting-giant-sets-sights-on-australia-20220429-p5ah8j.html | title='Invest bravely': Cancer-fighting giant sets sights on Australia | date=2 May 2022 }} In fact, all first-in-human phase 1 trials of internally discovered assets at BeiGene are conducted in Australia.{{cite web | url=https://www.miragenews.com/beigene-hits-major-milestone-with-first-pbs-733278/ | title=BeiGene hits Major Milestone with First PBS Approved Cancer Treatment }}

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Category:2016 initial public offerings

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Category:Chinese companies established in 2010

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Category:Pharmaceutical companies established in 2010

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