Drugmaker with rare disease work · based in Basel, Switzerland · ticker ONC · beonemedicines.com
BeOne Medicines Ltd. works on 6 rare diseases we track, including Acute Myeloid Leukemia, Mantle Cell Lymphoma and 4 more. It has 27 active clinical trials, and 20 are looking for volunteers now. It also has 2 FDA-approved rare disease drugs.
BeOne Medicines, called BeiGene until May 2025, is a cancer drug company with its legal home in Basel, Switzerland. Its best-known medicine is Brukinsa (zanubrutinib), a BTK inhibitor pill approved for Waldenström's macroglobulinemia, chroniclymphocytic leukemia and small lymphocytic lymphoma, and for mantle cell, marginal zone and follicular lymphoma in certain settings.
BeOne Medicines Ltd. pipeline
Each row lists the diseases BeOne Medicines Ltd. is studying at that stage, from the ones closest to approval down to the earliest work.
These are BeOne Medicines Ltd. trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.
20 trials looking for volunteers now
Looking for volunteersPhase 2Recently updatedNCT06839053
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
This phase II trial studies the side effects of an escalated ramp-up of sonrotoclax following initial debulking with zanubrutinib or rituximab in treating patients with chroniclymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) that is newly diagnosed, has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Rituximab is a monoclonal antibody that binds to a protein called CD20, which is found on B-cells, and may kill tumor cells. Zanubrutinib may stop the growth of tumor cells by blocking a protein called Bruton's tyrosine kinase (BTK), which is needed for tumor cell growth. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (BCL-2). This protein helps certain types of blood tumor cells to survive and grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. Giving an increased dose of sonrotoclax over a shorter period of time in combination with zanubrutinib or rituximab may be safe and tolerable in treating patients with newly diagnosed, relapsed or refractory CLL, SLL, and MCL.
Looking for volunteersPhase 3Recently updatedNCT06742996
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
Looking for volunteersPhase 1/2Recently updatedNCT04973605
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed/refractory (R/R) multiple myeloma (MM) and chromosomal translocation t(11;14).
The study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.
This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
This study will evaluate the safety and preliminary effectiveness of sonrotoclax combined with azacitidine in adults aged 18-70 years with newly diagnosed myelodysplastic neoplasms with increased blasts-2 (MDS-IB2).
Sonrotoclax blocks BCL-2, a protein that helps cancer cells survive. Combining sonrotoclax with azacitidine may improve disease control. This study aims to determine whether the combination can induce remission with an acceptable safety profile, facilitate allogeneic stem cell transplantation in suitable patients, and improve long-term clinical outcomes.
This multicenter, open-label study has two sequential parts. Phase Ib will evaluate different sonrotoclax doses and identify the recommended dose for phase II. Phase II will further assess remission rates and safety at the selected dose. All participants will receive sonrotoclax plus azacitidine; there is no randomizedcontrol group.
Participants will undergo regular blood tests, bone marrow examinations, and monitoring for side effects. Suitable participants may proceed to transplantation based on disease response and clinical condition. Those who are not proceeding to transplantation and continue to benefit may continue treatment according to the protocol. Follow-up will assess the duration of remission, disease progression, subsequent treatment, survival, and quality of life.
The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma.
Looking for volunteersPhase 1/2Recently updatedNCT05006716
A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies
TestsTacabrutideg
For B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma and Waldenström Macroglobulinemia
Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapydose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
Follow a condition BeOne Medicines Ltd. is studying
Pick a condition. One email when a new trial opens, a trial changes or the FDA decides, from any company, not only BeOne Medicines Ltd.. Unsubscribe anytime.
You'll get, for Acute Myeloid Leukemia:
Trial Alerts, when a new trial opens or a trial changes
Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
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On May 13, 2026 the FDA granted accelerated approval to Beqalzi (sonrotoclax), a BCL2 inhibitor, for adults with mantle cell lymphoma after at least 2 lines of treatment including a BTK inhibitor. In rare blood cancers it is also testing sonrotoclax in AML, MDS and multiple myeloma, and a BTK degrader, BGB-16673 (tacabrutideg), in Waldenström's and other B-cell cancers.
Where BeOne Medicines Ltd. trials take place
The trials above run at 869 study sites in 33 countries. Tap a country to see its states, cities and hospitals.
China
199▼
United States
166▼
Australia
60▼
France
58▼
United Kingdom
52▼
Italy
41▼
Japan
39▼
Brazil
38▼
Spain
35▼
Germany
28▼
Poland
20▼
Canada
20▼
Rare diseases BeOne Medicines Ltd. works on
Each disease page lists every open trial, not only BeOne Medicines Ltd.'s, plus approved treatments.
Acute myeloid leukemia (AML) is a fast-growing cancer of the bone marrow in which immature white blood cells called blasts crowd out normal blood cells, causing fatigue, infections and bleeding...
How common: The National Cancer Institute's SEER program estimates 22,720 new US cases and 11,500 deaths in 2026, about 1.1% of new cancers, and 83,311 people were living with AML in 2023
Membranous nephropathy is a rare autoimmune kidney disease where the body's own antibodies attack proteins in the kidney's filtering units (glomeruli).
How common: About 12 new cases per million people each year in the U.S.; roughly 40,000-50,000 Americans living with the disease
Multiple myeloma is a cancer of plasma cells, the white blood cells that make antibodies.
How common: About 36,000 new US diagnoses expected in 2026 and roughly 203,000 people living with it, which puts myeloma right at the edge of the US rare disease threshold; it is 1.7% of all new cancers (NCI SEER)
Waldenström Macroglobulinemia is a rare blood cancer in which malignant B-lymphocytes produce excessive amounts of a protein called macroglobulin (immunoglobulin M or IgM).
How common: Approximately 1,500 new cases per year in the United States; median age of diagnosis is 68 years
Where to get support
Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. BeOne Medicines Ltd.'s own site is beonemedicines.com, and our help paying for treatment page lists drugmaker programs and charity funds.
Brukinsa (zanubrutinib): a BTK inhibitor taken as 160mg twice a day or 320mg once a day, approved for Waldenström macroglobulinemia, CLL and SLL, and in certain settings mantle cell, marginal zone and follicular lymphoma. See the Brukinsa page.
Beqalzi (sonrotoclax): a BCL2 inhibitor that received FDA accelerated approval on May 13, 2026 for adults with mantle cell lymphoma after at least 2 lines of treatment including a BTK inhibitor. In its single-arm trial of 103 adults, 52% responded.
Source: ClinicalTrials.gov, checked November 2, 2026.
BeOne Medicines Ltd. has active programs across 6 rare diseases: Acute Myeloid Leukemia, Mantle Cell Lymphoma, Membranous Nephropathy, Multiple Myeloma, Myelodysplastic Syndromes, Waldenström Macroglobulinemia. Each disease page on Trial Friend shows the latest recruiting trials, FDA-approved treatments, and patient resources.
The clinical trials section on this page shows active and recruiting rare disease trials sponsored by BeOne Medicines Ltd., pulled live from ClinicalTrials.gov. Each trial card includes the study phase, recruitment status, conditions being studied, number of trial sites, and a direct link to the full study record. You can also explore individual disease pages to see trials from all sponsors for a specific condition.
To explore enrollment, find a recruiting trial in the clinical trials list on this page and click "View full study" to see the full ClinicalTrials.gov record, which includes eligibility criteria, study locations, and contact information for each trial site. Your doctor can also help determine if a specific trial is appropriate for your condition. Not all trials are open at every location, so check the site list for one near you.
BeOne Medicines Ltd. has 2 FDA-approved drugs with a rare disease use that we track, as of November 2026.
Medicare and Medicaid: drugmaker copay cards are limited to private insurance, so people with government coverage usually look to a free medicine program or a charity fund, both on the help paying page.
Eligibility is decided by each program, so call the number listed before a prescription is filled.