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BeiGene
Company typePublic
Founded2010; 14 years ago (2010) in Beijing, China
Founder
HeadquartersCambridge, Massachusetts, U.S.; Beijing, China; Basel, Switzerland[1]
RevenueDecrease $309 million (2020) [2]
Increase $428 million (2019)[2]
$–1.658 billion (2020)[3]
$–960 million (2019)[3]
Number of employees
10,000

BeiGene is a global biotechnology company that 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 has offices in North America, Asia, Australia and Europe. 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. Successful formulas would either be sold to or co-developed with larger drugmakers who could fund the late-stage trials.[5]

In the years since, BeiGene has shifted toward an integrated approach to research and development, investing in in-house clinical development and trials[6] rather than partnering with contract research organizations to run trials. The company has built up the capacity to run clinical trials in several regions simultaneously,[7] helping provide larger numbers of patients with more diversity. According to BeiGene, this approach has reduced trial costs by 30% and reduced the time trials take.[8] The company also focuses on developing medicines that are affordable and accessible to cancer patients in all regions,[9] including implementing parity pricing in some cases, setting prices in line with in-class comparators.[10] As of 2022, BeiGene had trial sites in 45 countries.[11]

From 2019 to 2022, BeiGene's internal research team of preclinical scientists grew from 200 to more than 800 people.[12] In 2022, the company identified four next-gen technologies on which it was focusing its research: mRNA, antibody-drug conjugates, CAR-NK cells and bispecific monoclonal antibodies.[13] BeiGene is also conducting research on the use of TIGIT inhibitors, including developing anti-TIGIT antibody ociperlimab,[12] which was licensed to Novartis in 2021.[14] Novartis returned the rights for ociperlimab to BeiGene in 2023.[15]

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.[8] BeiGene has favored head-to-head clinical trials to validate the benefits of medicines,[7] including two large global phase 3 clinical trials comparing zanubrutinib to ibrutinib between 2017 and 2023.[8]

Medicines

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Zanubrutinib

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BeiGene 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] As of June 2023, zanubrutinib was approved in more than 65 markets worldwide.[23]

BeiGene is also testing zanubrutinib as a treatment for COVID-19.[24] In September 2021, the FDA approved zanubrutinib to treat adults with Waldenström's macroglobulinemia, a rare non-Hodgkin lymphoma,[25] 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.[26] The Galien Foundation recognized Brukinsa in the cancer category of the 2022 Prix Galien USA Awards.[27][28] Also in 2022, the National Institute for Health and Care Excellence recommended zanubrutinib for the treatment of Waldenström macroglobulinemia.[29]

Tislelizumab

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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.[30] Tislelizumab is being developed as a monotherapy and for use in combination with other therapies for several types of cancer.[31] In December 2019, it was approved by National Medical Products Administration in China for the treatment of Hodgkin lymphoma.[32] In April 2020, tislelizumab was also approved in China to treat urothelial carcinoma.[33] 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.[34] The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion of tislelizumab for the treatment of unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy in July 2023.[35] The European Commission approved tislelizumab for the same indication in September 2023.[36]

History

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Founding, early operations, and IPO

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BeiGene was founded in late 2010 by John V. Oyler, an American entrepreneur who serves as the company's chief executive officer and chairman,[37] and Dr. Xiaodong Wang,[5] a member of the National Academy of Sciences.[38] Wang and Oyler envisioned a biopharmaceutical company with a global presence focusing on cancer treatment, with research and development in Changping, Beijing, and clinical operations in Philadelphia.[8]

The founders provided part of the initial seed money and also received early backing from the American pharmaceutical company Merck & Co.[5] BeiGene established offices at the Zhongguancun Life Science Park near the National Institute of Biological Sciences, Beijing [zh],[39] where Wang serves as director.[5]

On February 2, 2016, BeiGene had its first initial public offering (IPO) of 6.6 million shares priced at $24[40] on the Nasdaq Stock Market under the ticker symbol BGNE.[41] The company raised $182 million.[42] The IPO, managed by Goldman Sachs and Morgan Stanley, was backed by Hillhouse BGN Holdings and Baker Brothers, which together planned to purchase half the shares offered.[41] In a March 2018 follow-on offering, BeiGene raised another $758 million.[43] 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.[44]

Manufacturing and growth

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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.[45] BeiGene also opened a new office in Sydney, Australia, in 2022,[46] although it conducted its first research in the country in 2014. The company has become one of the largest clinical research organizations in Australia.[47] In fact, all first-in-human phase 1 trials of internally discovered assets at BeiGene are conducted in Australia.[48] In addition, Australia and New Zealand have more than 100 unique BeiGene clinical trial sites with more than 50 clinical studies underway with more than 2,900 patients.[citation needed]

In 2023, the company opened an office in São Paulo, Brazil, as part of its expansion in Latin America. The office hosts administrative, commercial, and clinical operations. The company has stated that its plans for future Latin American expansion include Argentina, Mexico, Chile, Colombia, Uruguay, and other countries.[49]

In addition, as of 2023, BeiGene was constructing a $700 million investment site for biologics manufacturing and research and development. Located in Hopewell, New Jersey, the Princeton West Innovation Campus is scheduled to open in 2024.[50]

Partnerships

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Talk About It

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In November 2022, BeiGene began offering a program to help patients better manage mental health issues associated with cancer, called "Talk About It".[51][52] BeiGene partnered with the Cancer Support Community to conduct research on the mental health needs of cancer patients[53] and formed an advisory panel of experts to inform the work.[52] BeiGene also partnered with the Association of Community Cancer Centers, the Association of Oncology Social Workers and the American Psychosocial Oncology Society to host a national summit on cancer and mental health.[54] In September 2023, BeiGene received the Nancy and Marty Dowd Spirit of Hope Award from Crossroads4Hope to recognize the company's efforts in supporting community work to address the psychosocial needs of cancer patients.[55]

Max Foundation

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The non-profit BeiGene Foundation[56] partnered with the health equity non-profit Max Foundation in 2023 to make Brukinsa available for free to patients in 29 countries over the following three years.[57]

Collaborations

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Amgen

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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 $1.25 billion toward their research.[58] Amgen invested another $421 million in BeiGene in July 2020.[59]

Asieris Pharmaceuticals

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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.[60]

Celgene

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In July 2017, BeiGene entered into a partnership with Celgene to continue the development and commercialization of the cancer drug BGB-A317,[30] 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.[61] 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.[62] 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.[63]

DualityBio

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In July 2023, BeiGene acquired an exclusive license from DualityBio for an investigational antibody-drug conjugate for the treatment of certain solid tumors. DualityBio will continue research for the drug and support future Investigational New Drug applications.[64]

Novartis

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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.[65] The two companies announced late-stage trial results in April 2023 indicating that tislelizumab in conjunction with chemotherapy helped prolong survival for patients with types of gastric cancer, both with or without PD-L1 expression in their tumors.[66]

Strand Therapeutics

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In January 2021, BeiGene partnered with Strand Therapeutics to develop mRNA-based treatments for tumors. As part of the partnership, BeiGene invested $5 million in Strand.[67]

Zymeworks

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In November 2018, BeiGene began a license and collaboration agreement with biotech company Zymeworks.[68] In December 2021, the two companies began a phase 3 clinical trial of zanidatamab, a bispecific antibody.[69]

References

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  1. ^ "Meet the most innovative and inventive pharmaceutical companies of 2021". Fortune. April 16, 2021. Archived from the original on 2021-04-16. Retrieved 2021-06-21.
  2. ^ a b "BeiGene Revenue 2014–2021". Macrotrends. Retrieved June 21, 2021.
  3. ^ a b "BeiGene Operating Income 2014–2021". Macrotrends. Retrieved June 21, 2021.
  4. ^ Liu, Angus (29 April 2022). "BeiGene CEO touts 'strategic asset' in flagship US site and a fix to stock delisting risk". FiercePharma.
  5. ^ a b c d Loo, Daryl (2011-07-07). "BeiGene Brings Biotech to China". Bloomberg. Retrieved 2020-08-04.
  6. ^ Borgs, Mieke; Eckardt, Nils (2 May 2023). "Why R&D innovation holds the key to greater patient impact". European Pharmaceutical Review. Retrieved 13 September 2023.
  7. ^ a b Henderson, Lisa (29 March 2023). "A Vision of Affordability". PharmExec. Retrieved 14 September 2023.
  8. ^ a b c d "A New Force in the Fight Against Cancer: Beigene's Disruptive Innovation". Harvard Business Review. September 2023.
  9. ^ "BeiGene president on why the company chooses 'disruption'". BioPharmaDispatch. 17 March 2023. Retrieved 14 September 2023.
  10. ^ Kansteiner, Fraiser (10 April 2023). "With Brukinsa launch, BeiGene seeks to avoid protracted pricing squabbles in Europe: exec". Fierce Pharma. Retrieved 14 September 2023.
  11. ^ Flannery, Russell (11 August 2022). "Curing Cancer Takes A Global Village: Cancer Moonshot Pathways". Forbes. Retrieved 14 September 2023.
  12. ^ a b Liu, Simu (6 July 2022). "BeiGene's R&D chief knows PD-1 is crowded. But TIGIT, combos and a Novartis partnership put asset in play". Fierce Biotech. Retrieved 23 August 2023.
  13. ^ Taylor, Nick Paul (6 July 2022). "Doubling down on mRNA, BeiGene taps rising Hong Kong star to create targeted therapies". Fierce Biotech. Retrieved 12 September 2023.
  14. ^ Armstrong, Annalee (20 December 2021). "Novartis brings on first TIGIT drug in massive billion-dollar biobucks deal with BeiGene". Fierce Biotech. Retrieved 12 September 2023.
  15. ^ Waldron, James (11 July 2023). "Novartis retreats from TIGIT, handing $300M candidate back to BeiGene". Fierce Biotech. Retrieved 19 September 2023.
  16. ^ a b c Robbins, Rebecca (2019-02-13). "For BeiGene, Bristol-Celgene deal is poised to have big ripple effects". STAT. Retrieved 2020-08-04.
  17. ^ "FDA Approves First Chinese Cancer Drug for U.S. Patient Use". Bloomberg. 2019-11-15. Retrieved 2020-08-05.
  18. ^ Mathias, Tamara; Maddipatla, Manojna (2019-11-14). "China's BeiGene gets FDA approval for drug to treat rare form of lymphoma". Reuters. Retrieved 2020-08-05.
  19. ^ Columbus, Gina (2020-06-03). "Zanubrutinib Gains Approval in China for Relapsed/Refractory CLL/SLL and MCL". OncLive. Retrieved 2020-08-05.
  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. ^ "BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma". BeiGene (Press release). 15 June 2023. Retrieved 19 September 2023.
  24. ^ Vardi, Nathan (2020-04-16). "BeiGene Launching Brukinsa Trial In Later-Stage COVID-19 Patients". Forbes. Retrieved 2020-08-05.
  25. ^ Mulcahy, Nick (September 2, 2021). "FDA Approval for Zanubrutinib in Waldenström's Macroglobulinemia". Medscape. Archived from the original on 2021-09-02. Retrieved 2021-12-08.
  26. ^ Park, Brian (September 15, 2021). "Brukinsa Gets Accelerated Approval for Marginal Zone Lymphoma". MPR. Retrieved 2021-12-08.
  27. ^ Buntz, Brian (15 August 2022). "Pharma50: The 22 Most Innovative Biotech Products of 2022 | Drug Discovery & Development". Drug Discovery and Development. Retrieved 14 September 2023.
  28. ^ Genetzky, Dr Petra (1 June 2023). "Prix Galien Suisse für Brukinsa". Medical Tribune Schweiz (in Swiss High German). Retrieved 14 September 2023.
  29. ^ Jeffries, Fleur (21 September 2022). "BeiGene's Brukinsa gets green light from NICE as Waldenström's macroglobulinemia treatment". PMLive. Retrieved 14 September 2023.
  30. ^ a b Grover, Divya; Pratap, Bhanu (2017-07-05). "Celgene signs deal with BeiGene for tumor cancer treatment". Reuters. Retrieved 2020-08-04.
  31. ^ 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.
  32. ^ 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.
  33. ^ "BeiGene's Tislelizumab Approved by China's NMPA for PD-L1 Elevated Bladder Cancer". Precision Oncology News. 2020-04-13. Retrieved 2020-08-05.
  34. ^ Park, Brian (2021-09-13). "Tislelizumab Under Review for Esophageal Squamous Cell Carcinoma". MPR. Archived from the original on 2021-09-13. Retrieved 2021-12-08.
  35. ^ "Meeting highlights from the Committee for Medicinal Products Human Use (CHMP) 17-20 July 2023". European Medicines Agency. 17 July 2023. Retrieved 19 September 2023.
  36. ^ Ryan, Chris (19 September 2023). "Tislelizumab Approved in Europe for Advanced ESCC After Platinum-Based Chemotherapy". OncLive. Retrieved 6 October 2023.
  37. ^ Lovelace, Jr., Berkeley (2019-10-31). "Amgen takes 20% stake in Chinese biotech BeiGene for $2.7 billion". CNBC. Retrieved 2020-08-04.
  38. ^ "Xiaodong Wang". National Academy of Sciences. Retrieved 6 October 2023.
  39. ^ Yoffee, Lynn (2013-11-22). "John Oyler Aims To Build China's Genentech via Beigene". BioWorld. Retrieved 2020-08-04.
  40. ^ "BeiGene raises $158.4 mln in second U.S. IPO to price in 2016". Reuters. 2016-02-03. Retrieved 2020-08-04.
  41. ^ a b Picker, Leslie (2016-02-03). "Editas Medicine and BeiGene Gain in Market Debuts". The New York Times. ISSN 0362-4331. Retrieved 2020-08-04.
  42. ^ Ng, Eric (2020-07-13). "BeiGene seals jumbo deal as US investors eye China's pharma market". South China Morning Post. Retrieved 2020-08-04.
  43. ^ Micklus, Amanda (2018-03-14). "Deals In Depth: January 2018". In Vivo. Informa. Retrieved 2020-08-04.
  44. ^ Lau, Fiona; Zhu, Julie (2018-08-02). "Chinese biotech BeiGene raises $903 million in HK's first secondary listing under new rules: sources". Reuters. Retrieved 2020-08-04.
  45. ^ Arthur, Rachel (17 May 2022). "BeiGene opens regional office in Basel to strengthen European presence". BioPharma-Reporter. Retrieved 3 October 2023.
  46. ^ "BeiGene opens first Aust office 13.12.22 AM". Pharma in Focus. 13 December 2022. Retrieved 3 October 2023.
  47. ^ Koehn, Emma (2 May 2022). "'Invest bravely': Cancer-fighting giant sets sights on Australia". The Sydney Morning Herald. Retrieved 14 September 2023.
  48. ^ "BeiGene hits Major Milestone with First PBS Approved Cancer Treatment". Mirage News. 1 March 2022. Retrieved 3 October 2023.
  49. ^ "BeiGene expanding presence in Latin America". The Pharma Letter. 13 April 2023. Retrieved 3 October 2023.
  50. ^ Flannery, Russell (22 March 2023). "BeiGene Expects To Finish Construction At $700 Million New Jersey Site In 2024". Forbes. Retrieved 22 August 2023.
  51. ^ Adams, Ben (17 November 2022). "BeiGene delves into cancer care's mental health impact, launching 'Talk About It' to treat patients beyond their disease". Fierce Pharma. Retrieved 30 June 2023.
  52. ^ a b Renfrow, Jacqueline (10 February 2023). "BeiGene boosts mental health resources for cancer patients as it doubles down on 'Talk About It' campaign". Fierce Pharma. Retrieved 30 June 2023.
  53. ^ Snyder Bulik, Beth (3 February 2023). "BeiGene reveals mental health and cancer care gap in study, debuts digital resources". Endpoints News. Retrieved 30 June 2023.
  54. ^ Bires, Jennifer (8 August 2023). "Psychosocial Care in Oncology: The Impact of Social Determinants of Health". Association of Community Cancer Centers. Retrieved 3 October 2023.
  55. ^ "Crossroads4Hope, A Network of Cancer Support". LinkedIn. 2 October 2023. Retrieved 3 October 2023.
  56. ^ "BRIEF—BeiGene to offer Brukinsa access in poorer countries". The Pharma Letter. 17 May 2023. Retrieved 22 August 2023.
  57. ^ Liu, Angus (17 May 2023). "BeiGene, Max Foundation team up to provide free Brukinsa to CLL patients in 29 low-income countries". Fierce Pharma. Retrieved 22 August 2023.
  58. ^ Armstrong, Drew; Lyu, Dong (2019-10-31). "Amgen to Take $2.7 Billion Stake in BeiGene for China Growth". Bloomberg. Retrieved 2020-08-04.
  59. ^ Crescenzo, Sarah de (15 July 2020). "Amgen invests further $421m in China's Beigene - Bioprocess Insider". BioProcess International. Retrieved 22 August 2023.
  60. ^ "Asieris and BeiGene to Test Combination Therapy for Bladder Cancer". Chinabio Today. 6 May 2021. Archived from the original on 2021-05-10. Retrieved 7 May 2021.
  61. ^ Taylor, Nick Paul (6 July 2017). "Celgene bags Beigene PD-1 drug for $263M up front". Fierce Biotech. Retrieved 16 August 2023.
  62. ^ Feuerstein, Adam (2017-07-06). "Celgene now owns a checkpoint inhibitor for solid tumors, but is Beigene deal too late for cancer immunotherapy race?". STAT. Retrieved 2020-08-04.
  63. ^ Armstrong, Drew (2019-06-17). "Celgene Hands Cancer Drug Back to BeiGene, Plus $150 Million". Bloomberg. Retrieved 2020-08-04.
  64. ^ Lynch, Connor (10 July 2023). "BeiGene Ups ADC Investment with $1.3B DualityBio Licensing Deal". BioSpace. Retrieved 22 August 2023.
  65. ^ "Novartis Licenses BeiGene's Anti-PD-1 Agent Tislelizumab in North America, Europe, Japan". Precision Oncology News. 2021-02-26. Retrieved 2021-06-21.
  66. ^ Liu, Angus (20 April 2023). "BeiGene, Novartis' tislelizumab stages comeback with broader stomach cancer trial win". Fierce Pharma. Retrieved 22 August 2023.
  67. ^ Javeed, Mohammad Shayan (11 January 2021). "BeiGene, Strand Therapeutics to co-develop mRNA-based cancer therapies". S&P Global. Retrieved 6 October 2023.
  68. ^ Taylor, Nick Paul (27 November 2018). "BeiGene bags Asian rights to Zymeworks' HER2 bispecifics". Fierce Biotech. Retrieved 30 June 2023.
  69. ^ Buntz, Brian (9 December 2021). "Zymeworks and its partner BeiGene expand zanidatamab pivotal trial in Asia". Drug Discovery and Development. Retrieved 30 June 2023.
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