Core Insights - BeOne Medicines Ltd. announced new data on sonrotoclax, a next-generation BCL2 inhibitor, showing significant clinical benefits as both a monotherapy and in combination therapies for B-cell malignancies, particularly at the 67th American Society of Hematology Annual Meeting [1][2] Summary by Category Clinical Data - Sonrotoclax demonstrated an overall response rate (ORR) of 52.4% in patients with relapsed/refractory mantle cell lymphoma (MCL), with a complete response (CR) rate of 15.5% in a Phase 1/2 study [3] - The median duration of response (DOR) was 15.8 months, with a median time to response (TTR) of 1.9 months and a median progression-free survival (PFS) of 6.5 months [4] - In combination therapies, sonrotoclax plus zanubrutinib achieved a 100% ORR in 135 efficacy-evaluable patients, with a CR/CRi rate of 55% [7] Safety and Tolerability - Treatment with sonrotoclax monotherapy was generally well tolerated, with manageable adverse events; the most common grade 3 treatment-emergent adverse events included neutropenia (19.1%), infections (16.5%), and pneumonia (10.4%) [5] - The combination therapies also showed good tolerability, with no treatment-emergent adverse events leading to death or significant complications [13][14] Regulatory Status - Sonrotoclax is under Priority Review by the U.S. Food and Drug Administration (FDA) for potential accelerated approval, having received Breakthrough Therapy Designation and Fast Track Designation for MCL and other conditions [5][17] Market Potential - Sonrotoclax could become the first BCL2 inhibitor approved for relapsed/refractory MCL in the U.S., with the potential to transform treatment outcomes for patients with limited options [3][6]

SAN CARLOS, Calif.--(BUSINESS WIRE)---- $ONC #BeOne--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton's tyrosine kinase (BTK) inhibitor. "Sonrotoclax i ...

Core Insights - BeOne Medicines showcases its leadership in B-cell malignancies at the ASH 2025 conference, presenting extensive new data from its hematology portfolio, including BRUKINSA, sonrotoclax, and BGB-16673 [1][3][4] Group 1: BRUKINSA (Zanubrutinib) - BRUKINSA demonstrates sustained overall survival of 84% and 88% after COVID adjustment, with a landmark progression-free survival (PFS) superiority of 74% at 6 years in treatment-naïve chronic lymphocytic leukemia (CLL) [5] - Long-term data from the SEQUOIA and ALPINE studies confirm BRUKINSA's role as the backbone of CLL therapy, with continuous treatment showing clinically meaningful benefits [6][11] - BRUKINSA is positioned as the preferred BTK inhibitor due to its manageable side effect profile, including lower incidences of fatigue and pain compared to other treatments [8] Group 2: Sonrotoclax - Sonrotoclax, a next-generation BCL2 inhibitor, shows promising clinical activity in B-cell malignancies, with early trials indicating rapid undetectable minimal residual disease (uMRD) rates in treatment-naïve CLL patients [22][23] - The FDA has granted Breakthrough Therapy Designation for sonrotoclax in relapsed or refractory mantle cell lymphoma (MCL) and Fast Track Designation for MCL and Waldenström macroglobulinemia [24] Group 3: BGB-16673 - BGB-16673 is a potential first-in-class BTK protein degrader, with nearly 800 patients dosed in clinical trials, including three Phase 3 trials in relapsed/refractory CLL [25][26] - The drug is designed to degrade both wildtype and mutant forms of BTK, addressing resistance issues seen in patients with progressive disease [25] Group 4: Clinical Presentations and Data - Nearly 50 abstracts accepted for presentation at ASH 2025, including six oral presentations highlighting the efficacy and safety of BeOne's hematology assets [1][4] - Presentations will include real-world evidence and modeling approaches to refine understanding of treatment outcomes with BTK inhibitors [7][20] Group 5: Company Overview - BeOne Medicines is a global oncology company focused on developing innovative treatments for cancer, with a commitment to improving access to medicines for patients worldwide [32][33]

Summary of BeOne Medicines FY Conference Call Company Overview - **Company**: BeOne Medicines (NasdaqGS:BGNE) - **Industry**: Biotechnology - **Key Achievement**: First year of profitability and recognized as one of the fastest-growing large biotech companies [3][4] Competitive Advantages - **Integrated Development**: Fully integrated CRO-free clinical development organization with over 3,600 professionals [4] - **Product Pipeline**: Deep product pipeline with 10 internally developed New Molecular Entities (NMEs) entering the clinic in 2024 and 16 to date [3] - **Cost Efficiency**: 70% of the cost to develop medicines is in clinical development; BeOne aims to reduce this through its integrated approach [4] Product Performance - **Brukinsa**: - Leading market share in the BTK inhibitor market with 47% year-over-year growth in the U.S. and 71% growth in Europe [6][8] - Demonstrated durable progression-free survival (PFS) with 74% landmark PFS at 72 months [6][7] - Significant real-world impact and prescription growth globally [8][9] Market Dynamics - **Fixed Duration Treatments**: - BeOne supports finite treatments that meet four criteria: deep response, sustained PFS, acceptable safety profile, and convenience [10][11] - Current market dynamics show continuous use BTK inhibitors capturing about 50% of the market, with opportunities for growth through fixed-duration offerings [11][12] Pipeline Developments - **Sonrotoclax**: - Designed to be more potent and selective than venetoclax, with a half-life of five hours [14][15] - Breakthrough designation in relapsed refractory MCL, with plans for global filing based on upcoming data [30] - Phase 3 study planned for multiple myeloma, targeting the translocation 11;14 population [32][33] - **BDK CDAC**: - A degrader molecule with a different mechanism, potentially effective against mutations that standard inhibitors cannot target [24][25] - Phase 2 cohort fully enrolled, with data expected in the first half of next year [26] Competitive Landscape - **Comparison with Competitors**: - BeOne's zanubrutinib shows superior response rates compared to pirtobrutinib and acalabrutinib in specific patient populations [20][21] - Ongoing head-to-head studies to validate BeOne's offerings against competitors [16][17] Future Outlook - **Clinical Trials**: - Upcoming data presentations at ASH for various products, including BDK CDAC and sonrotoclax [28][29] - Commitment to advancing solid tumor pipeline, particularly CDK4/6 inhibitors, with a focus on first-line breast cancer [34][36] Conclusion - BeOne Medicines is positioned strongly within the biotechnology sector with a robust product pipeline, innovative clinical development strategies, and a commitment to addressing patient needs through differentiated therapies. The company is actively pursuing growth opportunities in both hematology and solid tumors while maintaining a competitive edge against established players in the market.

Company Overview - BeOne Medicines Ltd. is a global oncology company based in Switzerland, focused on discovering and developing innovative cancer treatments that are more accessible to patients worldwide [2] - The company has a diverse pipeline of novel therapeutics targeting both hematology and solid tumors, supported by internal capabilities and collaborations [2] - BeOne has a workforce of over 11,000 employees across six continents, emphasizing its commitment to improving access to medicines for cancer patients [2] Upcoming Events - BeOne Medicines will participate in two investor conferences: the Guggenheim Second Annual Healthcare Innovation Conference on November 10, 2025, and the Jefferies Global Healthcare Conference in London on November 17, 2025 [5] - Live webcasts of these events will be available on the company's investor relations website, with archived replays accessible afterward [1][5] Financial Information - BeOne Medicines is scheduled to announce its third quarter 2025 financial results on November 6, 2025, before the financial markets open [8] - Following the financial results release, the company will host a live webcast with management at 8:00 a.m. ET [8] Recent Developments - BeOne presented new data on its PD-1 inhibitor, TEVIMBRA, at the European Society of Medical Oncology 2025 Congress, showcasing benefits from two pivotal Phase 3 trials [9][10] - The U.S. FDA granted Breakthrough Therapy Designation for sonrotoclax, a next-generation BCL2 inhibitor, for treating adult patients with relapsed or refractory mantle cell lymphoma [11]

Core Insights - BeOne Medicines Ltd. has received Breakthrough Therapy Designation from the FDA for sonrotoclax, a next-generation BCL2 inhibitor aimed at treating adult patients with relapsed or refractory mantle cell lymphoma [1] Company Summary - BeOne Medicines Ltd. is a global oncology company focused on developing innovative treatments for cancer [1] - The FDA's acceptance of BeOne's request indicates a significant step forward in the development of sonrotoclax for a challenging patient population [1]