Sonrotoclax

BeOne doesn’t expect any meaningful impact this year from U.S. tariffs on pharmaceuticals because of the natural flow of inventory, the company’s CFO Aaron Rosenberg said. After beating AstraZeneca’s Calquence in quarterly revenue for the first time at the end of 2024, BeOne Medicines’ Brukinsa has pulled further ahead.Brukinsa’s second-quarter sales reached $950 million, which topped analysts’ expectations by about 5%. That compares with $872 million for Calquence during the same three-month stretch.The $78 million difference between the two newer BTK inhibitors marked an expansion from the $30 million advantage that Brukinsa had on Calquence in the first quarter of this year.“With our strengthening market position, we have seen competition aggressively discounted,” BeOne CFO Aaron Rosenberg said on an investor call Wednesday. “Despite this, given our broad access strategy and having protected class status, the vast majority of patients have unfettered access to Brukinsa and an even greater number achieve access upon appeal.”Despite its competitor’s discount strategy, BeOne expects stable Brukinsa U.S. net pricing for the rest of 2025, Matt Shaulius, general manager of North America, said on the call.“What we were conveying today is we are well aware of the environment,” Rosenberg said in an interview with Fierce Pharma after the investor call. “Our priorities are ensuring open access, but doing it in a way that recognizes the value of our innovations.”Brukinsa’s differentiated profile has been driving volume growth in the market, Rosenberg said.The medicine’s performance helped BeOne generate net income of $94 million during the second quarter after the company became profitable for the first time under GAAP standards in the first three months of 2025.BeOne officially changed its name from BeiGene and redomiciled from the Cayman Islands to Switzerland in May.The move was about the maturity of the company, Rosenberg said, describing Switzerland as a welcoming environment for the biopharma industry with its reliable trade and tax treaties.BeOne’s relocation comes as the entire biopharma industry braces for U.S. tariffs on pharmaceutical imports. During a CNBC interview Tuesday, President Donald Trump said the administration will install a small tariff on pharmaceuticals initially, growing to 150% in a year or a year and a half before eventually reaching 250%. The rate will be announced “within the next week or so,” he said. BeOne’s guidance, including an upgraded outlook of a gross margin in the mid- to high-80% range for 2025, already incorporates what’s known today about tariffs, Rosenberg said on the investor call.“That impact has largely been mitigated by how we’ve globalized and regionalized our supply chain,” the CFO said, pointing to the company’s U.S. production for Brukinsa and a new biologics facility in Hopewell, New Jersey, for potential commercial supply of Tevimbra and future medicines.BeOne currently partners with contractors to handle Brukinsa drug production and packaging in the U.S., but it does need to import active pharmaceutical ingredients, Rosenberg told Fierce. The company has two FDA-approved sources for Brukinsa API in the EU and China, and it’s looking to add another source in Europe.Meanwhile, the BeOne leadership team is monitoring the upcoming results from the Trump administration’s Section 232 investigation into the national security implications of pharmaceutical imports. But Rosenberg said the firm doesn’t expect any meaningful impact this year because of the natural flow of inventory.“We’ll assess what the results of those investigations and policy that comes from it,” Rosenberg said. “Like everything in our business, we’ll be agile and make sure we’re being as financially efficient as we can be, and most important, that we have a supply chain that can serve patients around the world.”In another potential regulatory uncertainty in the U.S., President Trump recently upped the ante on the implementation of the “most favored nation” drug pricing policy that aims to match the costs of prescription drugs in the U.S. to the lowest price offered in other developed countries.Companies like Novo Nordisk, Eli Lilly and Pfizer/Bristol Myers Squibb have rolled out direct-to-consumer models offering some of their medicines at lower costs directly to patients, and Roche has said it’s considering this approach.BeOne is studying the DTC model, but Rosenberg said it’s hard to say how suited it is to cancer drugs, including Brukinsa.“I think there potentially is applicability,” Rosenberg said. “Like anything in our business, we will assess it. And if there’s value there, and it helps patients, [it’s] something we’ll look at seriously."Meanwhile, additional competition is brewing for Brukinsa.Last week, Eli Lilly announced that its noncovalent BTK inhibitor Jaypirca matched up to AbbVie and Johnson & Johnson’s first-to-market covalent BTK drug Imbruvica in overall response rate in front-line chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The Lilly med also showed a nominal superiority, although the trial design didn’t give this analysis statistical power. But Lilly’s positive Bruin CLL-314 readout for Jaypirca is “highly unlikely to be practice-changing,” BeOne’s R&D chief, Lai Wang, Ph.D., said on the call.For one, the Lilly study has not reported progression-free survival data, which Lai said is the gold standard in first-line CLL/SLL. In addition, Jaypirca should be compared with Brukinsa, Wang argued, because BeOne’s medicine is the true standard now in the treatment-naïve setting. What’s more, given that CLL is a chronic disease, and because Lilly’s proposing continuous treatment, the company needs a longer follow-up to truly convince people of Jaypirca’s therapeutic benefit, Wang said.Because Jaypirca is currently the only noncovalent BTK that can be used sequentially after failure on a covalent BTK inhibitor, Wang expects doctors will reserve the Lilly drug for second-line treatment based on existing data.During Wednesday’s call, Wang again shrugged off first-line CLL competition from AstraZeneca’s fixed-duration option of two Calquence combinations, which have been approved in the EU and are under review at the FDA. On the fixed-duration front, BeOne is advancing its phase 3 Celestial 301 trial that pairs Brukinsa with the company’s BCL-2 inhibitor sonrotoclax. Editor's Note: The story was updated with the correct information on the source of BeOne's Brukinsa API supplies.

SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will present new clinical data from three cornerstone hematology assets at the European Hematology Association (EHA) Congress. Four oral presentations highlight the promising clinical activity of BeOne’s next-generation BCL2 inhibitor sonrotoclax, BTK protein degrader BGB-16673, and the backbone of our hematology franchise, BTK inhibitor BRUKINSA (zanubrutinib), which has the broadest label globally of any approved BTK inhibitor. These data reinforce the company’s strategic vision to redefine the standard of care for B-cell malignancies. “The data presented at EHA 2025 underscore the strength of BeOne’s comprehensive hematology pipeline, built on the success of BRUKINSA, the only BTK inhibitor to demonstrate superior progression-free survival over ibrutinib in a Phase 3 trial,1” said Lai Wang, Ph.D. Global Head of R&D at BeOne. “With our potentially best-in-class BCL2 inhibitor, sonrotoclax, and first-in-class BTK degrader, BGB-16673, we are advancing innovative therapies aimed at addressing resistance mechanisms and improving outcomes for patients with B-cell malignancies.” The data presented at EHA 2025 support the ongoing advancement of sonrotoclax and BGB-16673 into Phase 3 studies and lay the groundwork for BeOne’s first regulatory submissions for these programs. The company’s integrated development approach—anchored in differentiated mechanisms and translational science—positions its programs to address key areas of unmet need in hematologic oncology. “While existing therapies have improved outcomes in CLL and related malignancies, many patients still relapse or develop resistance and continue to face limited options,” said Stephan Stilgenbauer, Professor of Medicine and Medical Director of the Comprehensive Cancer Center Ulm (CCCU), Head of the Early Clinical Trials Unit (ECTU), and Head of the Division of CLL Dept. of Internal Medicine III at Ulm University. “The updated data presented at EHA underscore the potential of novel approaches, including BTK degradation and BCL2-based combinations, to overcome known mechanisms of resistance and expand treatment options for patients.” Sonrotoclax + BRUKINSA Demonstrates Deep Responses in CLL and MCL BeOne’s data will highlight the emerging potential of its next-generation assets to address the unmet needs of patients with B-cell malignancies. Updated results from Phase 1 studies evaluating sonrotoclax in combination with BRUKINSA in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and with R/R mantle cell lymphoma (MCL) demonstrated consistent, deep responses and a manageable safety profile. Sonrotoclax is well-positioned to improve key aspects of the BCL2 inhibitor class and has demonstrated robust and durable antitumor activity and a tolerable safety profile across all dose levels. R/R CLL/SLL ( Oral Presentation S159 ): Overall response rate (ORR): 96%; complete response (CR): 52% across all dose levels Undetectable minimal residual disease (uMRD) was achieved in 82% of patients overall, with responses deepening over time No tumor lysis syndrome (TLS) or febrile neutropenia observed Overall response rate (ORR): 96%; complete response (CR): 52% across all dose levels Undetectable minimal residual disease (uMRD) was achieved in 82% of patients overall, with responses deepening over time No tumor lysis syndrome (TLS) or febrile neutropenia observed R/R MCL ( Oral Presentation S234 ): ORR: 79%; CR rate: 66%, with 84% of responders in ongoing response at data cutoff No TLS or atrial fibrillation/flutter reported; the most common grade ≥3 adverse event was neutropenia (19.6%) ORR: 79%; CR rate: 66%, with 84% of responders in ongoing response at data cutoff No TLS or atrial fibrillation/flutter reported; the most common grade ≥3 adverse event was neutropenia (19.6%) Robust Early Results in CLL and WM with Potentially First-in-Class BTK Degrader As the most clinically advanced BTK degrader, BGB-16673 continues to show potential in patients with various hematological malignancies. Updated data from the ongoing Phase 1 CaDAnCe-101 study of BGB-16673 in R/R CLL/SLL and R/R Waldenström macroglobulinemia (WM) showed substantial antitumor activity and a tolerable safety profile across heavily pretreated populations. R/R CLL/SLL ( Oral Presentation S158 ): ORR: 84.8% across all dose levels and 93.8% at the recommended phase 2 dose of 200mg Patients were heavily pretreated, with most previously treated with BTK and BCL2 inhibitors. The median number of prior therapies was four. Responses deepened over time Grade ≥3 adverse events included neutropenia (24%) and pneumonia (11%); no reported deaths were attributed to study drug ORR: 84.8% across all dose levels and 93.8% at the recommended phase 2 dose of 200mg Patients were heavily pretreated, with most previously treated with BTK and BCL2 inhibitors. The median number of prior therapies was four. Responses deepened over time Grade ≥3 adverse events included neutropenia (24%) and pneumonia (11%); no reported deaths were attributed to study drug R/R Waldenström Macroglobulinemia ( Oral Presentation S231 ): ORR: 84.4%; major response rate: 75.0%; very good partial response rate (VGPR): 31.3% Rapid onset of response (median: 1.0 month), with continued deepening over time Efficacy observed across genetic backgrounds and prior BTKi exposure Most common grade ≥3 TEAE was neutropenia/neutrophil count decreased (31%); no reported atrial fibrillation or febrile neutropenia. ORR: 84.4%; major response rate: 75.0%; very good partial response rate (VGPR): 31.3% Rapid onset of response (median: 1.0 month), with continued deepening over time Efficacy observed across genetic backgrounds and prior BTKi exposure Most common grade ≥3 TEAE was neutropenia/neutrophil count decreased (31%); no reported atrial fibrillation or febrile neutropenia. BRUKINSA Monotherapy Showed Sustained OS and PFS Benefit Data from Arm D of the SEQUOIA Phase 3 trial will also be presented at the meeting (Abstract PS1566), demonstrating that treatment with BRUKINSA plus venetoclax has the potential to drive progression-free survival and overall deep and durable responses across the frontline CLL patient spectrum, including patients with high-risk mutational status. SEQUOIA Arm D investigated BRUKINSA plus venetoclax in 114 patients with treatment-naïve (TN) CLL / SLL with or without del(17p) and/or TP53 high-risk mutations. At a median follow-up of 31.2 months, the combination induced a high 24-month progression-free survival (PFS) rate of 92% (95% CI, 85-96%) and an impressive overall response rate (ORR) of 97%. The 24-month overall survival (OS) rate was 96% (95% CI, 90%-98%). Notably, these benefits were observed regardless of del(17p)/TP53 mutational status. The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. Arm C of the SEQUOIA study investigated BRUKINSA monotherapy in patients with TN CLL / SLL and del(17p) mutations, representing the largest prospective cohort of CLL/SLL patients with del(17p), will be presented at EHA (Abstract: PS1565). At a median follow-up of over 5.5 years (65.8 months), most patients remained progression-free. Notably, at 60 months, 72.2% of patients who received BRUKINSA remained progression-free (95% CI, 62.4, 79.8). When adjusted for the impact of the COVID-19 pandemic, 73.0% of patients in the cohort remained progression-free (95% CI, 63.3, 80.6) at 60 months. The 60-month OS rate was 85.1% (95% CI, 76.9, 90.6) and 87.0% (95% CI, 79.0, 92.1) when adjusted for COVID-19. At the time of data cut-off, the ORR was 97.3%, and 62.2% of patients were still receiving treatment with BRUKINSA. The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. BeOne will host an investor R&D Day on June 26 at 8:30 am ET covering our deep and broad global innovation pipeline and platforms, as well as the Company's vision, differentiated capabilities, and value creation drivers. The live webcast can be accessed from the investors section of BeOne’s website at https://ir.beonemedicines.com/, https://hkexir.beonemedicines.com/, or https://sseir.beonemedicines.com/. An archived replay will be available to investors for 90 days following the event. About Sonrotoclax (BGB-11417) Sonrotoclax is designed to block the B-cell lymphoma 2 (BCL2) protein, which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a potent and specific inhibitor of BCL2 with a short half-life and no accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and more than 1,900 patients have been enrolled to date across the global development program. The U.S. Food and Drug Administration (FDA) granted sonrotoclax Fast Track Designation for the treatment of adult patients with mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM). About BGB-16673 BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting protein degrader from BeOne’s chimeric degradation activation compound (CDAC) platform. BGB-16673 is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease. BGB-16673 is the most advanced BTK protein degrader in the clinic, with an extensive global clinical development program. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). About BRUKINSA® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (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. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate PFS superiority to a first-generation BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved for at least one indication in more than 75 markets, and more than 200,000 patients have been treated globally. Select Important Safety Information Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury). In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Please see full U.S. Prescribing Information including U.S. Patient Information. The information provided in this press release is intended for a global audience. Product indications vary by region. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the strength of BeOne’s hematology pipeline; BeOne’s ability to advance innovative therapies and improve outcomes for patients with B-cell malignancies; the ability of BeOne’s assets to address unmet needs of patients with B-cell malignancies and areas of hematologic oncology; the ability of sonrotoclax to improve the BCL2 inhibitor class and the asset’s future capabilities; the future potential of BGB-16673 in patients with hematological malignancies; the ability for BTK degradation and BCL2-based combinations to expand treatment options for patients; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. 1 Brown, Jennifer R et al. “Sustained benefit of zanubrutinib vs ibrutinib in patients with R/R CLL/SLL: final comparative analysis of ALPINE.” Blood vol. 144,26 (2024): 2706-2717. doi:10.1182/blood.2024024667