BeOne Medicines Ltd. operates as a global oncology company discovering and developing innovative treatments that are more accessible and affordable to cancer patients worldwide.
The company is serial innovators in hematology and has built a differentiated, wholly owned, franchise. This includes a proven best-in-class Bruton’s Tyrosine Kinase inhibitor (‘BTKi’), BRUKINSA, and two late-stage assets, sonrotoclax (‘BCL2i’) and its first-in-class BTK-CDAC, both of which have the potential to be best...
BeOne Medicines Ltd. operates as a global oncology company discovering and developing innovative treatments that are more accessible and affordable to cancer patients worldwide.
The company is serial innovators in hematology and has built a differentiated, wholly owned, franchise. This includes a proven best-in-class Bruton’s Tyrosine Kinase inhibitor (‘BTKi’), BRUKINSA, and two late-stage assets, sonrotoclax (‘BCL2i’) and its first-in-class BTK-CDAC, both of which have the potential to be best-in-class medicines.
Sonrotoclax, the company’s BCL2 inhibitor, is a selective BCL2i designed to have greater potency and selectivity, and potential for better tolerability than venetoclax. The company’s clinical program for sonrotoclax has enrolled over 1,800 patients to date. It is being tested in late-stage clinical trials with BRUKINSA, including as a fixed duration therapy in the Phase 3 CELESTIAL trial of BRUKINSA + sonrotoclax in 1L CLL, which is fully enrolled.
The company’s BTK-CDAC, which is designed to promote the degradation, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease, has enrolled over 500 patients and is the most advanced BTK degrader in the clinic. The company plans to initiate a Phase 3 head-to-head trial in 2025 against pirtobrutinib, consistent with its strategy to develop medicines that have potential to meaningfully improve upon the practice of care.
The company built to address the long-lived challenges to return on investment in the pharmaceutical industry. In 2024 alone, the company advanced 13 differentiated new molecular entities (‘NMEs’) into the clinic, each of which have the potential to be first-in-class or best-in-class. The company’s intention is to build depth in the most prevalent cancers, including breast/gynecologic, lung and gastrointestinal. The company has main PoC catalysts in the next six to eighteen months for key programs, including, its next-generation CDK4 inhibitor and potentially first-in-class B7H4 antibody-drug conjugate (‘ADC’) in breast/gynecologic cancers, potential best-in-class pan-KRAS inhibitor in gastrointestinal (‘GI’) cancer, differentiated mechanism of action (‘MoA’) and first-in-class EGFR-CDAC in lung cancer, as well as the company’s synergistic and potentially best-in-class PRMT5 and MAT2A inhibitors combination in lung cancer. The company also have several exciting early-stage assets, including CDK2i, B7H3 ADC, CEA-ADC, FGFR2b ADC, EGFRxMET TsAb, and IRAK4 CDAC.
The company is a holding company incorporated in the Cayman Islands with operations primarily conducted through its subsidiaries in the U.S., China, the UK, Switzerland, and Australia.
Strategy
The company has built a substantial global clinical team of approximately 3,700 people on six continents, allowing it to run clinical trials predominantly without reliance on CROs. The company has built an oncology research teams with 1,100+ scientists, allowing it to drive serial innovation to enable sustained market leadership.
Commercial and Registration Stage Products
The company commercializes the following internally developed cancer medicines:
BRUKINSA
BRUKINSA is a next-generation, oral, small molecule inhibitor of BTK designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing.
The company is marketing BRUKINSA in the U.S., Europe, China, the UK, Canada, Australia, Japan, Brazil, and other markets.
BRUKINSA has approvals in five indications, including CLL/SLL, WM, R/R MCL, R/R MZL, R/R FL and is approved in more than 70 countries.
In the U.S., BRUKINSA received accelerated approval from the U.S. Food and Drug Administration (‘FDA’) for MCL in adult patients who have received at least one prior therapy in November 2019. It was then approved for patients with WM based on a head-to-head study vs ibrutinib, followed by an accelerated approval in R/R MZL patients who have received at least one anti-CD20-based regimen. In January 2023, BRUKINSA was approved for the treatment of adult patients with CLL or SLL in both the treatment naive and relapsed setting based on two Phase 3 studies. BRUKINSA is the only BTKi to demonstrate progression-free survival (‘PFS’) superiority to ibrutinib in R/R CLL/SLL in all patient segments, including high-risk (17p/TP53). In March 2024, BRUKINSA received accelerated approval from the FDA for R/R FL in combination with obinutuzumab.
In Europe, BRUKINSA received approval from the European Commission (‘EC’) for the treatment of adult patients with WM who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy, as well as for the treatment of patients with R/R MZL and for the treatment of patients with CLL. In November 2023, the EC approved BRUKINSA in combination with obinutuzumab for the treatment of adult patients with R/R FL who have received at least two prior lines of systemic therapy. BRUKINSA is approved to treat more patient populations in Europe than any other BTK inhibitor.
In China, BRUKINSA has received approval from the China National Medical Products Administration (‘NMPA’) for treatment-naïve adults with CLL or SLL, treatment-naïve adults with WM, R/R CLL/SLL, TN & R/R WM, and conditional approval for adult patients with MCL who have received at least one prior therapy. All approved indications for BRUKINSA are included in the updated National Reimbursement Drug List (‘NRDL’) by the China National Healthcare Security Administration (‘NHSA’).
BRUKINSA received approval in Japan for WM and CLL/SLL in December 2024.
TEVIMBRA (tislelizumab)
TEVIMBRA
TEVIMBRA is a humanized IgG4 monoclonal antibody against the immune checkpoint receptor programmed cell death protein 1 (‘PD-1’) that the company specifically designed to minimize binding to Fc receptor gamma, which play an essential role in activating phagocytosis in macrophages, to minimize its negative impact on T effector cells.
The company received regulatory approvals for TEVIMBRA marketing applications in multiple geographies, including the EU (comprising 27 countries plus Iceland and Norway) and 16 countries across North America, Europe, APAC, and other markets.
In-Licensed Products from Amgen
The company is commercializing the following cancer medicines in China under an exclusive license from Amgen:
XGEVA
XGEVA (denosumab) is an antibody-based RANK ligand (‘RANKL’) inhibitor that was approved globally for the prevention of skeletal-related events (‘SREs’) in patients with bone metastases from solid tumors and in patients with multiple myeloma (‘MM’), and for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone (‘GCTB’). XGEVA is approved in over 70 countries worldwide. In China, XGEVA received conditional approval in the GCTB indication in May 2019 (converted to regular approval) and received conditional approval for the SRE indications in November 2020. The company began marketing XGEVA in China in July 2020. In December 2020, the company announced the inclusion of XGEVA in the NRDL for the treatment of GCTB, which was successfully renewed for inclusion in 2023. Beginning in January 2024, the SRE indication was also included in the NRDL.
BLINCYTO
BLINCYTO (blinatumomab), a bispecific CD-19 directed CD3 T-cell engager, is the first and only approved bi-specific T-cell engager (‘BiTE’) immunotherapy. It has been approved in 60 countries for use in patients with acute lymphoblastic leukemia (‘ALL’). In China, BLINCYTO received conditional approval as a treatment for adult patients with R/R ALL in December 2020 (converted to regular approval) and was conditionally approved in April 2022 for pediatric patients with R/R B-cell precursor ALL. The company began commercializing BLINCYTO in August 2021.
KYPROLIS
KYPROLIS (carfilzomib), a proteasome inhibitor, has been approved in over 60 countries for use in patients with R/R MM. It was approved in China as a treatment for patients with R/R MM in July 2021 and the company began commercializing KYPROLIS in January 2022. KYPROLIS was included on the NRDL beginning in March 2023 for its approved indication in China.
In-Licensed Products from BMS
As part of the company’s settlement agreement with BMS, its commercialization of the following cancer medicines licensed from BMS terminates as of February 2025:
REVLIMID (lenalidomide), an oral immunomodulatory medicine
VIDAZA (azacitidine for injection), a pyrimidine nucleoside analog that has been shown to reverse the effects of DNA hypermethylation and promote subsequent gene re-expression.
Other In-Licensed Products
The company commercialize the following medicines in China under an exclusive license from EUSA Pharma:
SYLVANT
SYLVANT (siltuximab), an interleukin-6 (‘IL-6’) antagonist, was approved as a treatment for patients with idiopathic multicentric Castleman disease (‘iMCD’) who are human immunodeficiency virus (‘HIV’) negative and human herpesvirus-8 (‘HHV-8’) negative. SYLVANT was approved in China in December 2021 for the treatment of adult patients with multicentric Castleman disease (‘MCD’) who are HIV negative and HHV-8 negative, also known as iMCD. Beginning in January 2024, Sylvant was included in the NRDL.
QARZIBA
QARZIBA (dinutuximab beta), a mouse-human chimeric monoclonal GD2 antibody, was granted conditional approval by the NMPA for the treatment of high-risk neuroblastoma in patients aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of R/R neuroblastoma with or without residual disease. The company began commercializing QARZIBA in December 2021.
The company commercializes the following product in China under an exclusive license from Bio-Thera:
POBEVCY (BAT1706)
POBEVCY is a biosimilar to Avastin (bevacizumab) developed by Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company located in Guangzhou, China. In China, Avastin is approved for the treatment of patients with metastatic colorectal cancer, NSCLC, glioblastoma, ovarian, fallopian tube or primary peritoneal, and cervical cancers.
POBEVCY was approved by the NMPA in China in November 2021 and launched in late 2021 for the treatment of patients with advanced, metastatic or recurrent NSCLC, metastatic colorectal cancer, recurrent glioblastoma, epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer.
The company acquired the right to develop, manufacture and commercialize POBEVCY in China, including Hong Kong, Macau, and Taiwan.
The company commercializes the following product in China under an exclusive license from Luye Pharma:
BAITUOWEI (goserelin microspheres for injection)
Baituowei (Goserelin Microspheres for Injection), developed by Luye Pharma, is the world’s first and only approved microsphere formulation of Goserelin. With its innovative microsphere formulation, Baituowei is able to ensure efficacy and safety while significantly improving patient experience. Baituowei was approved by the NMPA in China in June 2023 for the treatment of patients with prostate cancer requiring androgen deprivation therapy and included in the NRDL in 2023 and was approved by the NMPA in China in September 2023 for treating breast cancer in premenopausal and perimenopausal women that can be treated with hormones and included in the NRDL in 2024.
Market Access
The company’s sales are largely dependent on the availability and extent of coverage and reimbursement by third party payors. As of December 31, 2024, the company have commercialized its products in over 60 markets.
Several of the company’s medicines are listed on the NRDL. In the latest NRDL list announced in November 2024, the following medicines and indications have been included in the NRDL, effective January 1, 2025:
Tislelizumab in thirteen of its eligible approved indications:
As a first-line treatment for patients with unresectable or metastatic HCC (approved in December 2023 and included in the NRDL at the end of 2024);
In combination with etoposide and platinum chemotherapy as the first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) (approved in June 2024 and included in the NRDL at the end of 2024);
In combination with fluoropyrimidine and platinum chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (approved in April 2024 and included in the NRDL at the end of 2024)1;
In combination with paclitaxel plus platinum- or fluoropyrimidine- and platinum-based chemotherapy, for the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC (approved in May 2023 and included in the NRDL at the end of 2023);
For the treatment of adult patients with locally advanced or metastatic non-squamous NSCLC with EGFR genomic tumor aberrations negative and ALK genomic tumor negative and have progressed after or did nottolerate prior platinum-based chemotherapy; and of adult patients with locally advanced or metastatic squamous NSCLC, with EGFR and ALK negative or unknown, that have progressed after or did not tolerate of prior platinum-based chemotherapy (approved in December 2021 and included in the NRDL at the beginning of 2023);
For the treatment of adult patients with advanced unresectable or metastatic MSI-H or dMMR solid tumors: patients with advanced colorectal cancer (CRC) who had been treated fluoropyrimidines, oxaliplatin and irinotecan; patients with other advanced solid tumors who develop disease progression after prior treatment and have no satisfactory alternative treatment options (approved in March 2022 and included in the NRDL at the beginning of 2023);
For the treatment of patients with locally advanced or metastatic ESCC who have disease progression following or are intolerant to first-line standard chemotherapy (approved in April 2022 and included in the NRDL at the beginning of 2023);
In combination with Gemcitabine and cisplatin, as first-line treatment in patients with recurrent or metastatic NPC (approved in June 2022 and included in the NRDL at the beginning of 2023);
For use in combination with pemetrexed and platinum chemotherapy as a first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous NSCLC, with EGFR genomic tumor aberrations negative and ALK genomic tumor negative (approved in June 2021 and included in the NRDL in 2021);
For the treatment of patients with HCC who have been previously received Sorafenib, Lenvatinib or systemic chemotherapy containing Oxaliplatin (conditionally approved in June 2021 and included in the NRDL in 2021);
For use in combination with paclitaxel and carboplatin as a first-line treatment in patients with unresectable, locally advanced or metastatic squamous NSCLC (approved in January 2021 and included in the NRDL in 2021);
For the treatment of patients with locally advanced or metastatic UC with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (conditionally approved in April 2020 and included in the NRDL in 2020); and
For the treatment of patients with cHL who have received at least two prior therapies (conditionally approved in December 2019 and included in the NRDL in 2020).
BRUKINSA in all four of its approved indications:
In combination with obinutuzumab, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy (approved in May 2024 and included in the NRDL at the end of 2024);
For the treatment of patients with CLL or SLL (approved in April 2023 and included in the NRDL at the end of 2023)1;
For the treatment of patients with WM (approved in April 2023 and included in the NRDL at the end of 2023)2; and
For the treatment of adult patients with MCL who have received at least one prior therapy (conditionally approved in June 2020 and included in the NRDL in 2020).
BAITUOWEI in both of its eligible approved indication:
For the treatment of patients with breast cancer in premenopausal and perimenopausal women that can be treated with hormone therapy (approved in September 2023 and included in the NRDL at the end of 2024);
For the treatment of patients with prostate cancer requiring androgen deprivation therapy (approved in June 2023 and included in the NRDL at the end of 2023).
KYPROLIS successfully renewed its approved indication in October 2024:
In combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two lines of therapy, including proteasome inhibitor and immunomodulator (approved in July 2021 and included in the NRDL at the beginning of 2023).
Commercial- and Clinical-Stage Drug Candidates
A description of the company’s commercial- and clinical-stage drug candidates and clinical data from selected clinical trials is set forth below. Historically, the company have made available, and it intends to continue to make available, clinical data and/or topline results from clinical trials of the company’s drug candidates in its press releases and/or filings with the U.S. Securities and Exchange Commission (‘SEC’), the Stock Exchange of Hong Kong Limited (‘HKEx’), and the Shanghai Stock Exchange (‘SSE’), copies of which are available on the Investors section of its website.
Hematology
BRUKINSA (zanubrutinib), a BTK Inhibitor
The company is evaluating zanubrutinib in a broad pivotal clinical program globally to treat a number of B-cell malignancies. Zanubrutinib has demonstrated sustained 24-hour BTK occupancy in both the peripheral blood, bone marrow and lymph node compartments in patients. Zanubrutinib is the only BTK inhibitor to demonstrate superior progression-free survival in R/R CLL versus IMBRUVICA (ibrutinib), an approved BTK inhibitor.
Clinical Development Updates and Regulatory Status
Based on the clinical data to date, the company believes that BRUKINSA has a best-in-class profile, it has initiated broad global pivotal programs in multiple indications, which led to regulatory approvals of five indications globally. ongoing Phase 3 studies include:
MANGROVE: A Randomized Global Study Comparing Zanubrutinib Plus Rituximab vs. Bendamustine Plus Rituximab in subjects With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation (MCL) (NCT04002297).
MAHOGANY: Zanubrutinib Plus Obinutuzumab vs Lenalidomide plus Rituximab in Relapsed/ Refractory Follicular Lymphoma (FL) (NCT05100862).
The company is also investigating zanubrutinib in several combination studies in MCL, MZL and CLL/SLL, including a Phase 3 trial in combination with sonrotoclax in front-line CLL/SLL. The company continues to examine opportunities for zanubrutinib combinations with both sonrotoclax and its BTK-CDAC (BGB-16673).
The company continues to pursue regulatory approvals for BRUKINSA globally, including regulatory approval of a new tablet formulation, providing patients with more convenience and flexibility.
Sonrotoclax (BGB-11417), a Small Molecule Bcl-2 Inhibitor
The company differentiated BCL2 inhibitor, sonrotoclax, was intentionally designed to have higher potency and selectivity compared to venetoclax, with a shorter half-life and no accumulation.
The company’s first Phase 3 randomized study in TN-CLL, CELESTIAL-TN CLL (NCT06073821), investigating sonrotoclax + BRUKINSA vs. venetoclax + obinutuzumab completed enrollment in Q1 2025.
Solid Tumors
TEVIMBRA (tislelizumab), an anti-PD-1 Antibody
Clinical Development Updates and Regulatory Status
The company has completed more than fourteen registration-enabling clinical trials in lung, liver, lymphoma, urothelial carcinoma, and nasopharyngeal cancer globally, including ten Phase 3 randomized trials and four Phase 2 trials supporting regulatory submissions globally. The company has three active studies in lymphoma, urothelial carcinoma, and solid tumors:
A Phase 3 confirmatory trial in China comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL; NCT04486391).
A Phase 3 confirmatory trial in China in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977).
A Phase 2 trial in China in patients with MSI-H/dMMR solid tumors (NCT03736889).
As of December 2024, the company had enrolled over 14,000 subjects in clinical trials of tislelizumab monotherapy or in combination in more than 35 countries, including 4,700+ subjects outside of China. These studies include eight multi-regional registrational trials that are designed for global regulatory approvals. Data from the company’s trials thus far have suggested that tislelizumab was generally well-tolerated and exhibited anti-tumor activity in a variety of tumor types. In 2024, the company terminated a Phase 3 trial in China of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590).
Lung Cancer
Ociperlimab (BGB-A1217), an anti-TIGIT Antibody
The company have completed patient enrollment in AdvanTIG-302 and will evaluate data when available to inform future development opportunities for ociperlimab.
BG-89894 (SYH2039), a MAT2A Inhibitor
The company licensed this asset from CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd in December 2024.
Gastro-Intestinal Cancer
Zanidatamab, a bispecific HER2-targeted antibody
The company have development and commercial rights to zanidatamab in Asia (excluding Japan), Australia, and New Zealand. The company is participating in one ongoing clinical study with zanidatamab, a global Phase 3 clinical trial (NCT05152147) examining zanidatamab in combination with chemotherapy with and without tislelizumab in HER2-positive gastroesophageal cancer.
The company is also participating with Jazz in a confirmatory study (NCT06282575) for 2L+ BTC. A BLA for the BTC indication is under review by China NMPA as of May 2024 and Orphan Drug Designation (‘ODD’) was issued by Ministry of Food and Drug Safety in South Korea in December 2024.
Preclinical Programs
The company has a proprietary biology research platform that has allowed it to research and develop both small molecules and biologic molecules. In the last decade, this platform has generated more than 30 clinical stage assets, including three internally developed molecules that have been approved by regulatory bodies in the U.S., EU, China, and other markets, with other filings pending globally and planned to be submitted. The platform is a full-process technology system spanning from early discovery to commercialization of oncology medicines based on multiple drug technology platforms that can be applied to oncology and other fields. The company has core technology platforms for the development of small molecule and antibody medicines and the manufacturing of its own and potentially other medicines. The company has over 70 preclinical programs and it believes the majority have best-in-class or first-in-class potential.
The company anticipates advancing many of its preclinical drug candidates into the clinic in the next 12 months. The company believes that it has the opportunity to combine tislelizumab with the company’s preclinical/clinical candidates to target multiple points in the cancer immunity cycle. The company also may seek to develop companion diagnostics that will help identify patients who are most likely to benefit from the use of its medicines and drug candidates.
Manufacturing and Supply
The company manufactures its medicines and drug candidates internally and in some cases with the help CMOs. The company’s manufacturing facilities and the facilities of the CMOs it used to manufacture the company’s medicines and drug candidates operate under good manufacturing practice (‘cGMP’) regulations conditions.
Amgen Collaboration
Collaboration Agreement
On October 31, 2019, the company wholly owned subsidiary, BeiGene Switzerland GmbH (‘BeiGene Switzerland’), entered into a Collaboration Agreement with Amgen, which became effective on January 2, 2020 (as amended, the ‘Amgen Collaboration Agreement’). Pursuant to the terms of the Amgen Collaboration Agreement, the company is responsible for commercializing Amgen’s oncology products XGEVA, BLINCYTO and KYPROLIS in China (excluding Hong Kong, Macao and Taiwan) for a period of five or seven years following each product’s regulatory approval in China, as specified in the Amgen Collaboration Agreement, with the commercialization period for XGEVA commencing following the transition of operational responsibilities for the product. In addition, as specified in the agreement, the company has the option to retain one of the three products to commercialize for as long as the product is sold in China.
Additionally, pursuant to the terms of the Amgen Collaboration Agreement, the company and Amgen have agreed to collaborate on the global clinical development and commercialization of a portfolio of Amgen clinical- and late-preclinical-stage oncology pipeline products.
Intellectual Property
As of February 14, 2025, the company owned 63 issued U.S. patents, 15 issued European patents, 28 issued Japanese patents, 70 issued China patents, a number of pending patent applications in the U.S., Europe, Japan and China, and corresponding issued patents and pending patent applications internationally.
Under the company’s collaboration with Amgen, it has the right to commercialize three medicines in China. The company has one in-licensed medicine in China from Shandong Luye Pharmaceutical Co., Ltd (‘Luye’).
Competition
To the company’s knowledge, Roche, AstraZeneca, Pfizer, and Merck are also developing new therapeutic options with similar mechanisms.
Government Regulation
Any products for which the company receives FDA approval are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, complying with certain electronic records and signature requirements and complying with FDA promotion and advertising requirements.
The company is subject to a variety of PRC laws, rules and regulations affecting many aspects of its business.
Research and Development
The company’s research and development expense included $174.7 millionfor the year ended December 31, 2024.
History
The company was founded in 2010. It was incorporated in the Cayman Islands in 2010. The company was formerly known as BeiGene, Ltd. and changed its name to BeOne Medicines Ltd. in May 2025.
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