Welcome to our dedicated page for BeOne Medicines Ltd. news (Ticker: ONC), a resource for investors and traders seeking the latest updates and insights on BeOne Medicines Ltd. stock.
BeOne Medicines Ltd. (ONC) generates a steady flow of oncology news that reflects its focus on hematology and solid tumors. As a Switzerland‑domiciled global oncology company with listings on NASDAQ, the Hong Kong Stock Exchange and the STAR Market in Shanghai, BeOne regularly issues updates on clinical data, regulatory milestones, financial performance and corporate developments.
Investors and healthcare professionals following ONC news will see frequent announcements related to B‑cell malignancies, especially chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). The company highlights new data for its BTK inhibitor BRUKINSA, including long‑term results from Phase 3 trials such as SEQUOIA and ALPINE, as well as patient‑reported outcomes and guideline updates. News also covers sonrotoclax, an investigational BCL2 inhibitor, with items on FDA Breakthrough Therapy Designation, Priority Review for relapsed or refractory MCL, and clinical results in CLL and other B‑cell cancers. Updates on BTK degrader BGB‑16673 from the CaDAnCe clinical program appear alongside these hematology releases.
On the solid tumor side, BeOne’s news includes Phase 3 trial results for ZIIHERA (zanidatamab) plus TEVIMBRA (tislelizumab) and chemotherapy in first‑line HER2‑positive gastroesophageal adenocarcinoma, as well as regulatory plans based on these data. Additional releases describe TEVIMBRA’s expanding indications and BGB‑B2033’s FDA Fast Track Designation in hepatocellular carcinoma. Financial news items provide quarterly revenue, product sales trends for BRUKINSA and TEVIMBRA, cash flow metrics and updated guidance, while corporate updates cover conference presentations, research milestones and agreements such as the IMDELLTRA royalty purchase arrangement with Royalty Pharma.
For users tracking ONC, this news stream offers insight into BeOne’s evolving hematology and solid tumor portfolios, its regulatory interactions in major markets and its stated goal of broadening patient access to cancer therapies. Bookmarking the ONC news page on Stock Titan allows readers to follow company press releases, clinical milestones and financial disclosures in one place.
BeOne Medicines (NASDAQ: ONC) will present fireside chats at four investor conferences in March 2026: TD Cowen (Mar 2), Leerink Global Healthcare (Mar 9), Citizens Life Sciences (Mar 10) and Barclays Global Healthcare (Mar 10).
Live webcasts and archived replays will be available via the investors section of the company website.
BeOne Medicines (NASDAQ: ONC) will report fourth quarter and full year 2025 financial results on Thursday, February 26, 2026 before markets open. A live webcast with management will follow at 8:00 a.m. ET, accessible from the company's investor website, with an archived replay available.
Participants are advised to register at least 15 minutes before the webcast to ensure timely connection.
BeOne Medicines (NASDAQ: ONC) presented at the 44th Annual J.P. Morgan Healthcare Conference on Jan. 13, 2026, highlighting leadership in B-cell malignancies, a global "development superhighway," and financial strength. Key clinical highlights include 6-year SEQUOIA results for BRUKINSA showing 74% PFS vs 32% for BR and OS at 72 months of 84% vs 80%. Sonrotoclax received its first global regulatory approvals on Dec. 30. BGB-16673 showed 86% ORR and 79% 12-month PFS in heavily pretreated CLL. The company reported >$350 million free cash flow in Q3 2025 and >$4 billion cash on hand, and disclosed advancing 15 NMEs into the clinic in the last 18 months with plans for 8–10 NMEs per year starting 2026.
BeOne Medicines (NASDAQ:ONC) reported Phase 3 HERIZON-GEA-01 results showing ZIIHERA (zanidatamab) plus chemotherapy, with and without TEVIMBRA (tislelizumab), met the dual primary endpoint of PFS and showed strong survival signals.
The ZIIHERA+TEVIMBRA+chemo arm showed mOS 26.4 months (HR=0.72; P=0.0043), a 28% reduction in risk of death and >7-month mOS improvement; both experimental arms achieved mPFS 12.4 months vs 8.1 months control. ORR was ~70% and median DOR reached 20.7 months with the triple regimen. Safety was consistent with known class effects; Grade ≥3 TRAEs were 71.8% (triple arm).
BeOne plans regulatory submissions for TEVIMBRA and ZIIHERA based on these data.
BeOne Medicines (NASDAQ: ONC) will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 with a presentation scheduled for 7:30 am PST.
Live webcasts and archived replays will be available on the company’s investor websites: https://ir.beonemedicines.com, https://hkexir.beonemedicines.com, and https://sseir.beonemedicines.com.
BeOne Medicines (NASDAQ: ONC) announced that on December 18, 2025 the U.S. FDA granted Fast Track Designation for BGB-B2033, a bispecific antibody targeting GPC3 and 4-1BB for treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression after prior systemic therapy. The designation highlights the program's potential in an area of high unmet need.
BeOne is conducting a global, multi-center Phase 1 trial (NCT06427941) to evaluate safety and anti-tumor activity of BGB-B2033 as monotherapy and in combination with PD-1 inhibitor TEVIMBRA (tislelizumab).
BeOne Medicines (NASDAQ: ONC) presented long‑term CLL data at ASH 2025 showing BRUKINSA (zanubrutinib) achieved an estimated 74% 6‑year PFS versus 32% for bendamustine+rituximab in treatment‑naïve CLL/SLL (SEQUOIA).
Other key BRUKINSA results: 72‑month OS ~84% (88% COVID‑adjusted), durable benefit in del(17p) patients, BRUKINSA+venetoclax 36‑month PFS 87% with sustained uMRD, and ALPINE long‑term BRUKINSA median PFS 52.5 months. NCCN now lists zanubrutinib+venetoclax as a preferred first‑line option.
Investigational BTK degrader BGB‑16673 showed deep responses in heavily pretreated R/R CLL: overall ORR 85.3%, RP2D ORR 94.4%, and 12/18‑month PFS of 73.5%/65.9%.
BeOne Medicines (NASDAQ: ONC) reported ASH 2025 data showing the investigational BCL2 inhibitor sonrotoclax produced durable monotherapy responses in relapsed/refractory mantle cell lymphoma (R/R MCL) and relapsed/refractory CLL/SLL, and rapid, deep uMRD rates in treatment‑naive CLL when combined with BTK inhibitor and anti‑CD20 agents.
Key figures include ORR 52.4% in R/R MCL (n=103), median DOR 15.8 months (follow‑up 14.2 months), ORR 100% for sonrotoclax+zanubrutinib (320 mg cohort) and uMRD4 91% at 48 weeks. FDA and NMPA accelerated‑approval reviews are underway.
BeOne Medicines (Nasdaq: ONC) announced the U.S. FDA has accepted and granted Priority Review to the NDA for sonrotoclax, a next‑generation BCL2 inhibitor for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after prior BTK inhibitor therapy.
The NDA is supported by a global Phase 1/2 single‑arm study of 125 patients that met its primary endpoint of overall response rate (IRC‑assessed) and showed promising CR, DOR, and PFS results with a manageable safety profile. Full data will be presented at ASH 2025 (oral, Dec 7).
BeOne plans Project Orbis participation and submissions to other regulators including EMA and China NMPA.
BeOne Medicines (NASDAQ:ONC) will present nearly 50 abstracts at ASH 2025 (Dec 6-9), including six orals across three hematology programs: BTK inhibitor BRUKINSA (zanubrutinib), BCL2 inhibitor sonrotoclax, and BTK degrader BGB-16673. Key disclosed metrics: SEQUOIA reports an estimated 74% PFS at 6 years in treatment‑naïve CLL/SLL and sustained overall survival of 84% (88% after COVID adjustment); ALPINE long‑term extension reports up to 6 years follow‑up. New sonrotoclax and BGB-16673 data include rapid, deep responses, uMRD findings, and multi‑malignancy activity.