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BeiGene

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BeiGene, Ltd.
Company typePublic
Founded2010; 14 years ago (2010)
Founders
HeadquartersCambridge, Massachusetts, U.S.; Beijing, China; 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 China-based drug developer.[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.

Research and development

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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.[10]

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

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.[16] In November 2019, zanubrutinib became the first cancer drug developed in China to gain FDA approval;[17] it received accelerated approval for the treatment of mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin lymphoma.[18] In June 2020, the drug was also approved in China for the treatment of MCL, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL);[19] it was then approved for the treatment of CLL[20] and SLL by the European Commission in November 2022[21] and by the FDA for the same indications in January 2023.[22] In September 2021, the FDA approved zanubrutinib to treat adults with Waldenström's macroglobulinemia, a rare non-Hodgkin lymphoma,[23] 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.[24]

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. [25] [26] Brukinsa is the only BTK inhibitor to demonstrate PFS supriority in a head-to-head comparison of BTK inhibitors.[27] 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.[28]

History

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BeiGene was founded in late 2010 by John V. Oyler,[10] an American entrepreneur who serves as the company's chief executive officer and chairman,[29] alongside Xiaodong Wang, a Chinese American biochemist. Oyler and Wang envisioned a global multinational biopharmaceutical company focusing on cancer treatment.[10] Xiaodong Wang is former Howard Hughes Medical Investigator at the University of Texas Southwestern Medical Center.[30][31] The company initially primarily operated in China.[10]

John Oyler provided part of the initial seed money and also received early backing from the American pharmaceutical company Merck & Co..[10] BeiGene established offices in Philadelphia[32][33] and at Zhongguancun Life Science Park near the National Institute of Biological Sciences, Beijing [zh] where Wang serves as director.[10][34] Merck invested $20 million in BeiGene in 2011.[34]

On February 2, 2016, BeiGene had its first initial public offering (IPO) of 6.6 million shares priced at $24[35] on the Nasdaq Stock Market under the ticker symbol BGNE.[36] The company raised $182 million.[37] 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.[36] In a March 2018 follow-on offering, BeiGene raised another $758 million.[38] 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.[39]

In July 2017, BeiGene entered into a partnership with Celgene to continue the development and commercialization of the cancer drug BGB-A317,[11] also known as tislelizumab.[16] 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.[40] 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.[41] 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.[16] Celgene returned the rights to the drug in June 2019 along with a payment of $150 million to conclude the deal.[42]

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.[43]

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.[44] 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.[45] Novartis returned the rights to tislelizumab to BeiGene in September 2023.[46] In March 2024, tislelizumab (Tevimbra) received FDA approval for the treatment of advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy.[47] 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.[48] 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,[49] although it conducted its first research in the country in 2014. The company has become one of the largest clinical research organizations in Australia.[50] In fact, all first-in-human phase 1 trials of internally discovered assets at BeiGene are conducted in Australia.[51]

References

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  1. ^ "Meet the most innovative and inventive pharmaceutical companies of 2021". Fortune. 16 April 2021. Archived from the original on 16 April 2021. Retrieved 21 June 2021.
  2. ^ "2023 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. 26 February 2024.
  3. ^ Leo, Leroy (14 July 2022). "FDA delays decision on BeiGene's cancer drug on China COVID curbs". Reuters.
  4. ^ Liu, Angus (29 April 2022). "BeiGene CEO touts 'strategic asset' in flagship US site and a fix to stock delisting risk". FiercePharma.
  5. ^ "BeiGene Expands Presence in Latin America With Opening of Brazil Office – BeiGene LTD". hkexir.beigene.com. Retrieved 28 March 2024.
  6. ^ "BeiGene expanding presence in Latin America". www.thepharmaletter.com. Retrieved 28 March 2024.
  7. ^ MEA, Channel 360 (26 October 2023). "BeiGene establishes UAE office to expand MENA operations". Channel 360 MEA. Retrieved 28 March 2024.{{cite web}}: CS1 maint: numeric names: authors list (link)
  8. ^ Flannery, Russell. "BeiGene Expects To Finish Construction At $700 Million New Jersey Site In 2024". Forbes. Retrieved 28 March 2024.
  9. ^ Beasley, Deena (October 31, 2019) Amgen takes 20.5% stake in BeiGene to sell cancer drugs in China Reuters
  10. ^ a b c d e f Loo, Daryl (7 July 2011). "BeiGene Brings Biotech to China". Bloomberg. Retrieved 4 August 2020.
  11. ^ a b Grover, Divya; Pratap, Bhanu (5 July 2017). "Celgene signs deal with BeiGene for tumor cancer treatment". Reuters. Retrieved 4 August 2020.
  12. ^ Desai, Jayesh; Deva, Sanjeev; Lee, Jong Seok; Lin, Chia-Chi; Yen, Chia-Jui; Chao, Yee; Keam, Bhumsuk; Jameson, Michael; Hou, Ming-Mo; Kang, Yoon-Koo; Markman, Ben (June 2020). "Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors". Journal for ImmunoTherapy of Cancer. 8 (1): e000453. doi:10.1136/jitc-2019-000453. ISSN 2051-1426. PMC 7295442. PMID 32540858.
  13. ^ Lee, Sang Hyung; Lee, Hyun Tae; Lim, Heejin; Kim, Yujin; Park, Ui Beom; Heo, Yong-Seok (June 2020). "Crystal structure of PD-1 in complex with an antibody-drug tislelizumab used in tumor immune checkpoint therapy". Biochemical and Biophysical Research Communications. 527 (1): 226–231. doi:10.1016/j.bbrc.2020.04.121. PMID 32446372. S2CID 218874092.
  14. ^ "BeiGene's Tislelizumab Approved by China's NMPA for PD-L1 Elevated Bladder Cancer". Precision Oncology News. 13 April 2020. Retrieved 5 August 2020.
  15. ^ Park, Brian (13 September 2021). "Tislelizumab Under Review for Esophageal Squamous Cell Carcinoma". MPR. Archived from the original on 13 September 2021. Retrieved 8 December 2021.
  16. ^ a b c Robbins, Rebecca (13 February 2019). "For BeiGene, Bristol-Celgene deal is poised to have big ripple effects". STAT. Retrieved 4 August 2020.
  17. ^ "FDA Approves First Chinese Cancer Drug for U.S. Patient Use". Bloomberg. 15 November 2019. Retrieved 5 August 2020.
  18. ^ Mathias, Tamara; Maddipatla, Manojna (14 November 2019). "China's BeiGene gets FDA approval for drug to treat rare form of lymphoma". Reuters. Retrieved 5 August 2020.
  19. ^ Columbus, Gina (3 June 2020). "Zanubrutinib Gains Approval in China for Relapsed/Refractory CLL/SLL and MCL". OncLive. Retrieved 5 August 2020.
  20. ^ "BeiGene's Brukinsa receives EC approval for chronic lymphocytic leukaemia". PMLive. 21 November 2022. Retrieved 30 June 2023.
  21. ^ Liu, Angus (22 November 2022). "ASH: AbbVie, J&J's Imbruvica under serious threat as BeiGene's Brukinsa delivers head-to-head trial win". Fierce Pharma. Retrieved 30 June 2023.
  22. ^ Killmurray, Conor (19 January 2023). "FDA Approves Zanubrutinib in Adult Patients with CLL/SLL". Targeted Oncology. Retrieved 30 June 2023.
  23. ^ Mulcahy, Nick (2 September 2021). "FDA Approval for Zanubrutinib in Waldenström's Macroglobulinemia". Medscape. Archived from the original on 2 September 2021. Retrieved 8 December 2021.
  24. ^ Park, Brian (15 September 2021). "Brukinsa Gets Accelerated Approval for Marginal Zone Lymphoma". MPR. Retrieved 8 December 2021.
  25. ^ "BeiGene Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates – NASDAQ (US) Website". ir.beigene.com. Retrieved 28 March 2024.
  26. ^ Liu, Angus (26 February 2024). "BeiGene grows global workforce by 1,000-plus as Brukinsa surges, Tevimbra launches outside China". Fierce Pharma.
  27. ^ "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)". OncLive. 20 December 2023. Retrieved 28 March 2024.
  28. ^ "FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL) – NASDAQ (US) Website". ir.beigene.com. Retrieved 28 March 2024.
  29. ^ Lovelace Jr., Berkeley (31 October 2019). "Amgen takes 20% stake in Chinese biotech BeiGene for $2.7 billion". CNBC. Retrieved 4 August 2020.
  30. ^ "Xiaodong Wang, PhD | Former Investigator Profile | 1997-2010". www.hhmi.org. Retrieved 28 March 2024.
  31. ^ "Wang lauded as 'one of the most highly original, bold and creative scientists'". www.asbmb.org. Retrieved 28 March 2024.
  32. ^ "A Vision of Affordability". PharmExec. 29 March 2023. Retrieved 28 March 2024.
  33. ^ Yoffee, Lynn (22 November 2013). "John Oyler Aims To Build China's Genentech via Beigene". BioWorld. Retrieved 4 August 2020.
  34. ^ a b Wright, Rob (1 November 2019). "How — And Why — John Oyler Built BeiGene". Life Science Leader.
  35. ^ "BeiGene raises $158.4 mln in second U.S. IPO to price in 2016". Reuters. 3 February 2016. Retrieved 4 August 2020.
  36. ^ a b Picker, Leslie (3 February 2016). "Editas Medicine and BeiGene Gain in Market Debuts". The New York Times. ISSN 0362-4331. Retrieved 4 August 2020.
  37. ^ Ng, Eric (13 July 2020). "BeiGene seals jumbo deal as US investors eye China's pharma market". South China Morning Post. Retrieved 4 August 2020.
  38. ^ Micklus, Amanda (14 March 2018). "Deals In Depth: January 2018". In Vivo. Informa. Retrieved 4 August 2020.
  39. ^ Lau, Fiona; Zhu, Julie (2 August 2018). "Chinese biotech BeiGene raises $903 million in HK's first secondary listing under new rules: sources". Reuters. Retrieved 4 August 2020.
  40. ^ Taylor, Nick Paul (6 July 2017). "Celgene bags Beigene PD-1 drug for $263M up front". Fierce Biotech. Retrieved 16 August 2023.
  41. ^ Feuerstein, Adam (6 July 2017). "Celgene now owns a checkpoint inhibitor for solid tumors, but is Beigene deal too late for cancer immunotherapy race?". STAT. Retrieved 4 August 2020.
  42. ^ Armstrong, Drew (17 June 2019). "Celgene Hands Cancer Drug Back to BeiGene, Plus $150 Million". Bloomberg. Retrieved 4 August 2020.
  43. ^ Armstrong, Drew; Lyu, Dong (31 October 2019). "Amgen to Take $2.7 Billion Stake in BeiGene for China Growth". Bloomberg. Retrieved 4 August 2020.
  44. ^ "Novartis Licenses BeiGene's Anti-PD-1 Agent Tislelizumab in North America, Europe, Japan". Precision Oncology News. 26 February 2021. Retrieved 21 June 2021.
  45. ^ "Asieris and BeiGene to Test Combination Therapy for Bladder Cancer". Chinabio Today. 6 May 2021. Archived from the original on 10 May 2021. Retrieved 7 May 2021.
  46. ^ Bonanos, Paul (19 September 2023). "As Novartis PD-1 deal ends, BeiGene sees U.S., EU as gateways to global access". BioCentury. Retrieved 27 November 2023.
  47. ^ "BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy – NASDAQ (US) Website". ir.beigene.com. Retrieved 28 March 2024.
  48. ^ "BeiGene opens regional office in Basel to strengthen European presence". 17 May 2022.
  49. ^ "BeiGene opens first Aust office 13.12.22 AM".
  50. ^ "'Invest bravely': Cancer-fighting giant sets sights on Australia". 2 May 2022.
  51. ^ "BeiGene hits Major Milestone with First PBS Approved Cancer Treatment".
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