BeOne Medicines Highlights Accelerating Solid Tumor Pipeline with New Data at ASCO 2026

 SAN CARLOS, Calif. - Monday, 01. June 2026 AETOSWire Print 

Oral and poster presentations span three priority programs in breast, gynecologic, and gastrointestinal cancers, advancing rapidly toward pivotal development

Company to host investor webcast showcasing momentum across solid tumor pipeline

(BUSINESS WIRE) -- BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data from its solid tumor pipeline being presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (May 29–June 2, Chicago). These data underscore the significant acceleration across the Company’s high-priority breast, gynecologic and gastrointestinal (GI) cancer development programs.

Data from three differentiated BeOne pipeline assets will be presented, including:

CDK4 inhibitor (BGB-43395) (poster presentation): First disclosure of anti-tumor activity in first-line (1L) HR+/HER2- metastatic breast cancer.

B7-H4 ADC (BG‑C9074) (rapid oral presentation): Phase 1 dose-escalation and safety expansion data in advanced solid tumors.

GPC3x4-1BB (BGB-B2033) bispecific antibody (rapid oral presentation): First clinical data in advanced solid tumors, including hepatocellular carcinoma (HCC), the most common type of liver cancer.

Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said: “2026 is an inflection year for BeOne’s solid tumor portfolio, marked by the encouraging data we are presenting at ASCO combined with upcoming readouts at other major congresses. These programs validate our strategy of pairing the right biology with the right modality, and support advancing several assets in different indications into pivotal trials in 2026.”

Selective CDK4 inhibitor shows promising efficacy and differentiated safety in first-line breast cancer (Poster Presentation: 180; June 1, 2026, 1:30 PM-4:30 PM CDT)

BeOne will present data about its highly selective CDK4 inhibitor, BGB-43395, in 1L HR+/HER2- metastatic breast cancer, in combination with letrozole, showing promising anti-tumor activity and a favorable safety profile, characterized by infrequent low-grade hematologic toxicities and manageable GI events, which were further mitigated when administered with food. Highlights include:

The 240 mg dose of BGB-43395 plus letrozole resulted in a confirmed overall response rate (ORR) of 68.4% (95% CI: 43.4–87.4) and unconfirmed ORR of 73.7% (95% CI: 48.8-90.9).

The 400 mg dose plus letrozole resulted in a confirmed ORR of 63.2% (95% CI: 38.4–83.7) and unconfirmed ORR of 73.7% (95% CI: 48.8-90.9).

Low levels of hematologic treatment-related adverse events (TRAEs) with Grade ≥3 neutropenia reported in 5.3% of patients at the 240 mg dose level and 0% at 400 mg, as well as low frequency of fatigue and asthenia; supports profile and validates the molecule’s high selectivity for CDK4.

GI TRAEs were mitigated when administered with food, all of which were Grade 1.

Median study follow-up was 12.5 (range, 3.1-15.2) months, 12.4 (range, 8.0-15.0) months, and 10.8 (range, 3.2-12.9) months for the 240 mg, 400 mg, and 600 mg dose groups, respectively.

These compelling safety and efficacy findings support the rationale to initiate a global, randomized Phase 3 clinical trial with BGB-43395 in combination with letrozole in 1L HR+/HER2- metastatic breast cancer. The trial, KANDELA-302 (NCT07492641), will begin enrolling patients this month.

B7-H4 ADC demonstrates encouraging efficacy supporting advancement in ovarian cancer (Rapid Oral Abstract: 3013; June 2, 2026, 9:45-11:15 AM CDT)

Data at ASCO from BeOne’s B7‑H4-targeting antibody-drug conjugate (ADC), BG‑C9074, include results from Phase 1 dose‑escalation and safety‑expansion cohorts, demonstrating a combination of early efficacy signals and a favorable tolerability profile. Highlights include:

At doses under consideration for future development, confirmed ORR of 45.5% and unconfirmed ORR of 54.5% in ovarian cancer (OC), and 40.0% in triple-negative breast cancer, with median study follow-up of 6.6 (range, 0.3-20.8) months.

Anti-tumor activity demonstrated in OC regardless of B7-H4 expression level.

Treatment was generally well tolerated with low rates of discontinuation at <5%; 31.5% of patients experienced Grade ≥3 TRAEs, with no Grade ≥3 nausea at 6 mg/kg adjusted ideal body weight (AIBW) and 1.2% at 8 mg/kg AIBW. Grade ≥3 neutropenia rates were 14.8% at 6 mg/kg AIBW and 34.6% at 8 mg/kg AIBW.

AIBW-based dosing used in the ongoing phase 1 study of BG-C9074 effectively reduced pharmacokinetic variability compared with total body weight dosing, as presented in a separate abstract (Poster 166) at ASCO.

These results support continued advancement of the BG‑C9074 development program, with efforts focused on early‑line OC and additional B7‑H4-expressing tumor types.

Potential first-in-class GPC3x4-1BB bispecific demonstrates unprecedented anti-tumor activity in heavily pre-treated HCC patients (Rapid Oral Abstract: 3016; June 2, 2026, 9:45-11:15 AM CDT)

The first clinical data (Phase 1a) for BGB-B2033, a GPC3x4-1BB bispecific antibody, will be presented in a rapid oral session highlighting the first-in-class potential of this program in advanced solid tumors, including heavily pre-treated HCC. BGB-B2033 was rationally designed to target GPC3-expressing tumors, a protein commonly expressed in HCC, the sixth most prevalent cancer and third leading cause of cancer death worldwide,1 with five-year survival rates of only approximately 20%.2

Highlights include:

At doses ≥300 mg, confirmed ORR was 28.9% and unconfirmed ORR was 31.6%, with median study follow-up of 4.8 (range, 0.3-15.5) months.

Treatment was generally well tolerated across all dose levels (1-1000 mg every three weeks [Q3W], N = 61) with no significant dose-dependent increase in rates of treatment-emergent adverse events (TEAEs):

68.9% (42) of patients experienced TEAEs; of these:

47.5% (29) were treatment related

8.2% (5) of patients experienced Grade ≥3 TRAEs

4.9% (3) were treatment-related serious adverse events

TEAE leading to treatment discontinuation occurred in 3.3% (2) of patients

Dose limiting toxicity occurred in 1.6% (1) of patients

TRAEs that occurred in >5% of patients were limited to increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST), both occurring at Grade ≥3 in only 1.6% of patients.

BGB-B2033

300 mg Q3W

(N=14)

600 mg Q3W

(N=14)

1000 mg Q3W

(N=10)

Confirmed ORR (complete response + partial response), n (%)

4 (28.6)

5 (35.7)

2 (20.0)

Unconfirmed ORR (complete response + partial response), n (%)

4 (28.6)

5 (35.7)

3 (30.0)*

*An additional PR (week 36) was reported at 1000 mg, with patient still on treatment, pending confirmation in the next tumor assessment

With ORR levels in heavily pretreated patients on par with the current first-line immunotherapy combination standard of care and a differentiated safety profile, BeOne is moving rapidly to advance clinical development of BGB-B2033. The Company has already announced the initiation of a potentially registration-enabling pivotal study in late-line HCC and planned expansion into earlier lines of therapy and additional tumor types, with the ambition to establish a new standard of care in this difficult-to-treat cancer.

Investor webcast to highlight solid tumor pipeline data at ASCO

BeOne will hold an investor webcast at 7:00 p.m. CDT/8:00 p.m. EDT, today, June 1, 2026. The Company’s leadership team, with clinical commentary by expert physicians, will highlight key solid tumor programs being presented at ASCO, share progress in BeOne’s global R&D portfolio, and outline the strategies and capabilities supporting the Company’s continued growth trajectory.

Webcast access details are available in the Investors section of BeOne’s website at http://ir.beonemedicines.com, https://hkexir.beonemedicines.com, and https://sseir.beonemedicines.com. An archived webcast will be available on the Company’s website.

About BGB-43395, a CDK4 inhibitor

BGB-43395 is an investigational cyclin-dependent kinase (CDK) 4 inhibitor being studied in a global clinical development program in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The program includes KANDELA-302 (NCT07492641), a randomized Phase 3 clinical trial, initiated in Q2 2026 in first-line metastatic HR+/HER2- breast cancer. BGB-43395 is highly potent and selective CDK4 inhibitor and has the potential to reduce the dose-limiting hematologic toxicities that exist with the current CDK4/6 standard of care and may improve tolerability and enable deeper CDK4 inhibition.

About BG-C9074, a B7-H4-targeting ADC

BG-C9074, an investigational topoisomerase I inhibitor ADC that targets the B7-H4 protein, which is broadly expressed in breast and gynecologic cancers, is designed with an innovative drug linker to deliver a potent cancer-killing drug directly to the cancer cells. In a Phase 1 study of BG-C9074 (NCT06233942), patients with advanced solid tumors, irrespective of B7-H4 expression, received BG-C9074 every 3 weeks in escalating doses from 1 to 9 mg/kg. A subsequent safety expansion cohort received BG-C9074 in doses ranging from 4 to 8 mg/kg. Endpoints included safety, recommended dose for expansion, preliminary antitumor activity and pharmacokinetic measures.

About BGB-B2033, a GPC3x4-1BB bispecific antibody

BGB-B2033 is a bispecific antibody targeting GPC3 (glypican 3), a tumor-specific antigen highly expressed in hepatocellular carcinoma (HCC),3 and 4-1BB, a co-stimulatory receptor associated with T-cell activation and tumor reactivity in HCC.4 The molecule has been designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to prevent systemic toxicity. BGB-B2033 is being investigated in a Phase 1 study (NCT06427941) in patients with GPC3-expressing advanced solid tumors with at least one prior line of therapy. Patients received BGB-B2033 every 3 weeks in eight escalating dose levels from 1 to 1000 mg, with various safety and anti-tumor activity endpoints. In December 2025, the FDA granted Fast Track Designation to BGB-B2033 for the treatment of HCC, followed by Orphan Drug Designation in March 2026.

About BeOne

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for 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. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. 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 its solid tumor pipeline; 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 achieve 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.

To access BeOne media resources, please visit our Newsroom site.

   

1 Samant H, Amiri HS, Zibari GB. Addressing the worldwide hepatocellular carcinoma: epidemiology, prevention and management. J Gastrointest Oncol. 2021 Jul;12(Suppl 2):S361-S373. doi: 10.21037/jgo.2020.02.08. PMID: 34422400; PMCID: PMC8343080.

2 National Cancer Institute. Surveillance, Epidemiology, and End Results (SEER) Program. Accessed April 2026.

3 Fanching Lin et al. Novel GPC3-targeting radiopharmaceutical therapy for hepatocellular carcinoma. J Clin Oncol 42, 525-525(2024).DOI:10.1200/JCO.2024.42.3_suppl.525

4 Kim DY et al. 4-1BB Delineates Distinct Activation Status of Exhausted Tumor-Infiltrating CD8+ T Cells in Hepatocellular Carcinoma. Hepatology, VOL. 71, NO. 3, 2020. https://onlinelibrary.wiley.com/doi/pdf/10.1002/hep.30881

 

 

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Contacts

Investor Contact

Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact

Kyle Blankenship

+1 667-351-5176

media@beonemed.com

Kinaxis Appoints Kristin Russel as Chief Marketing Officer

 

(BUSINESS WIRE)--Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, today announced the appointment of Kristin Russel as Chief Marketing Officer (CMO). Russel will lead Kinaxis’ global marketing organization, overseeing marketing strategy, corporate and market positioning, digital and brand marketing, communications and go-to-market initiatives.

Russel will also take the main stage at Kinexions, where she will discuss practical steps organizations can take to move from decisions to outcomes in an increasingly complex operating environment.

A tenured marketing executive and recognized industry leader, Russel brings deep experience scaling technology companies and building high impact brands. She joins Kinaxis from symplr, where she served as Chief Marketing Officer and led the development and execution of the company’s comprehensive marketing strategy across branding, digital and product marketing, public relations, community outreach programs, channel partnerships, and business development.

“Kristin is a proven leader with a track record of building strong brands and connecting strategy to execution,” said Razat Gaurav, Chief Executive Officer of Kinaxis. “As Kinaxis continues to expand its leadership in AI-powered supply chain orchestration and accelerate global growth, Kristin's experience scaling enterprise technology platforms and transforming go-to-market strategy will help strengthen how we engage customers, partners, and the market.”

Russel is widely recognized for her leadership in technology and healthcare marketing. She was named one of PR Daily’s 2023 Top Women in Marketing, recognized among Becker’s Top 100 Women in Healthcare, is a two-time 2023 Stevie Award winner, and was recently named to the 2026 B2B CMO 100, recognizing marketing leaders shaping the future of B2B go-to-market strategy.

“Kinaxis is uniquely positioned at the intersection of AI-powered orchestration, enterprise decision-making and supply chain transformation at a time when organizations are rethinking how they plan and operate in an increasingly complex world,” said Russel. “I’m excited to join the team and help accelerate the company’s next phase of growth as organizations increasingly look to AI-driven technologies to make faster, more confident decisions in the face of constant change.”

Prior to symplr, Russel led marketing at Quest Analytics and Carrot Inc., driving revenue growth through brand building, demand generation, and strategic partnerships. Earlier in her career, she held senior marketing roles at Humana, Cerner, and Omnicell. She is also a successful entrepreneur, having founded the fintech company Anachron, which was later acquired by ING Bank.

About Kinaxis

Kinaxis is a leader in modern supply chain planning and orchestration, powering complex global supply chains, and supporting the people who manage them. Our powerful, AI-infused supply chain orchestration platform, Maestro, combines proprietary technologies and techniques that provide full transparency and agility across the entire supply chain — from multi-year strategic planning to last-mile delivery. We are trusted by renowned global brands to provide the agility and predictability needed to navigate today’s volatility and disruption. For more news and information, please visit kinaxis.com or follow us on LinkedIn.

Source: Kinaxis Inc.

 

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Media Relations

Matt Tatham | Kinaxis

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Investor Relations

Rick Wadsworth | Kinaxis

rwadsworth@kinaxis.com

613-907-7613

Fortegra Completes Acquisition by DB Insurance

 JACKSONVILLE, Fla. -

(BUSINESS WIRE)--The Fortegra Group, Inc. ("Fortegra"), a global specialty insurance company, today announced the completion of its acquisition by DB Insurance Co., Ltd. ("DB"), one of Korea's leading property and casualty insurers. The transaction, announced on September 26, 2025, received all required regulatory and stockholder approvals.

Fortegra will operate independently, maintaining its existing leadership team, distribution relationships, and underwriting discipline. Agents, distribution partners, and customers will continue to experience the service excellence that has defined the Fortegra experience.

Richard Kahlbaugh, Chairman and CEO of Fortegra, said: "Every company eventually changes ownership. That is the nature of business. The closing of this acquisition is a starting point. As part of DB Insurance, Fortegra is positioned to expand our business geographically, enhance our capabilities and deepen our market presence in the US, Europe, the United Kingdom and Asia. Together, DB Insurance and Fortegra intend to build a recognized leader in the global specialty insurance market."

About Fortegra

For more than 45 years, Fortegra, via its subsidiaries, has underwritten risk management solutions that help people and businesses succeed in the face of uncertainty. As a multinational specialty insurer whose insurance subsidiaries have an A.M. Best Financial Strength Rating of A- (Excellent) and an A.M. Best Financial Size Category of ‘X’, we offer a diverse set of admitted and excess and surplus lines insurance products and warranty solutions. For more information: www.fortegra.com.

About DB Insurance

For more than six decades, DB Insurance Co., Ltd. has built a strong foundation as one of Korea’s leading insurers, protecting individuals and businesses while driving the advancement of the nation’s insurance industry. Founded in 1962 as Korea’s first public automobile insurer, the company adopted the name DB Insurance in 2017 to embody its vision of becoming a global insurance group. With an A.M. Best Financial Strength Rating of A+ (Superior) with Financial Size Category of ‘XV’ and S&P Rating A+ (Stable), DB Insurance provides a comprehensive portfolio of general, long-term, and automobile insurance, along with a broad range of financial services through its subsidiaries in life insurance, securities, savings banking, and asset management. For more information: www.idbins.com.

 

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Vijaya Singh

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Katie Butler

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SINOVAC Receives Nasdaq Notification Regarding Late Filing of 2025 Annual Report

 BEIJING - Saturday, 30. May 2026 AETOSWire 

(BUSINESS WIRE)--Sinovac Biotech Ltd. (Nasdaq: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it received a notification letter dated May 20, 2026 (the “Notification Letter”), from Nasdaq Listing Qualifications (“Nasdaq”) stating that as of May 8, 2026, the Company had regained compliance with the periodic filing and interim financial requirements in Nasdaq Listing Rules 5250(c)(1) (the “Periodic Filing Rule”) and 5250(c)(2), as required by the Panel’s decision dated January 21, 2026. As previously disclosed on January 22, 2026, under the Panel’s decision, SINOVAC was required to, on or before May 11, 2026, demonstrate compliance with such Nasdaq Listing Rules by completing filings of its annual report for the year ended December 31, 2024, on Form 20-F and an interim balance sheet and income statement as of the end of its second quarter of 2025 on Form 6-K. The Company timely completed such filings as required by the Panel’s decision.

The Notification Letter also stated that the Company will be subject to a mandatory panel monitor (the “Panel Monitor”) for a period of one year from the date of such letter. If, within that one-year monitoring period, the Nasdaq Listing Qualifications staff (the “Staff”) finds the Company again out of compliance with the Periodic Filing Rule that was the subject of the exception, the Staff will issue a delist determination letter and the Company will have an opportunity to request a new hearing with the initial Panel or a newly convened Panel if the initial Panel is unavailable. The Company will have the opportunity to respond and present to the Panel as provided by Nasdaq Listing Rule 5815(d)(4)(C).

Subsequently, the Company received a delist determination letter (the “Staff Determination”) from Nasdaq dated May 22, 2026, stating that because the Company has not timely filed its annual report on Form 20-F for the year ended December 31, 2025 (the “2025 Annual Report”), the Company no longer complies with the Periodic Filing Rule. Therefore, in accordance with the Panel Monitor, unless the Company timely requests a hearing before the Panel regarding the Staff Determination by May 29, 2026, the Company’s securities would be subject to suspension and delisting.

Accordingly, the Company has today requested a hearing before the Panel. Such hearing request automatically stays the suspension of the Company’s securities for a period of 22 calendar days from the date of the Staff Determination. The Company has also requested a further stay of any suspension action pending the completion of the hearing process.

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based global biopharmaceutical company, with a mission of “supply vaccines to eliminate human diseases”, the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.

The Company’s diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.

SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world’s first inactivated SARS vaccine (Phase I completed), China’s first H5N1 influenza vaccine (Panflu®), the world’s first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the most widely used inactivated COVID-19 vaccine globally.

Beyond its marketed portfolio, the Company is advancing a robust pipeline that includes combination vaccines, recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.

With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the Company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.

For more information, please see the Company’s website at www.sinovac.com.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions, including the Company’s statements related to the timing and actions taken to regain compliance with Nasdaq listing rules. Such statements are based upon the Company’s current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, including without limitation risks, uncertainties and factors related to the completion and filing of the 2025 Annual Report, and actions taken to regain compliance with the Nasdaq listing rules, all of which are difficult to predict and many of which are beyond the Company’s control, which may cause the Company’s actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

 

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BeOne Medicines Establishes Standard for Long-Term Disease Control in CLL with BRUKINSA 78-Month Data at ASCO 2026

  SAN CARLOS, Calif. - Friday, 29. May 2026 AETOSWire  

Data represents the longest reported follow-up for a next-generation BTK inhibitor in CLL, showing sustained disease control and benefit that extends beyond first-line therapy

BRUKINSA plus next-generation BCL2 inhibitor sonrotoclax (ZS) delivered deep, durable, and rapid uMRD responses, raising the bar for potential time-limited treatments in CLL

Data reinforce BeOne’s leadership in CLL and the strength of its foundational hematology franchise

 

(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, is advancing the treatment paradigm in chronic lymphocytic leukemia (CLL) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. With extensive long-term follow-up, the SEQUOIA study of BRUKINSA® (zanubrutinib) reinforces its role as the foundational BTK inhibitor, showing sustained disease control over years of therapy. These findings are further supported by real-world evidence across three large analyses encompassing more than 250,000 patients, underscoring consistent effectiveness and safety in clinical practice. Additionally, BEQALZI™ (sonrotoclax), which was recently approved by the U.S. Food and Drug Administration, and its development in combination with BRUKINSA (ZS) highlight the potential for next-generation, time-limited treatment approaches in CLL.

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:

“CLL is a disease patients live with for years, and the real measure of a therapy is how it performs over the long arc of treatment. Our data at ASCO show that BRUKINSA continues to deliver sustained disease control, which can give physicians and patients confidence to stay the course. Additionally, robust, real-world analyses reinforce its role as a best-in-class BTK inhibitor, with data favoring BRUKINSA over other BTK inhibitors across several efficacy and safety endpoints. With BRUKINSA as the foundation, we are building a broad, differentiated hematology franchise designed to push the field further, including our ZS combination, which achieved deep responses and unprecedented rates of uMRD, and emerging approaches like our BTK degrader, tacabrutideg. Together, these foundational therapies reflect our commitment to redefining what patients should expect from therapy both today and in the future.”

78-month SEQUOIA data highlight the long-term impact of first-line treatment choice in CLL (Poster Presentation: 544; June 1, 2026, 9:00 AM-12:00 PM CDT)

SEQUOIA now provides the longest reported follow-up for a next-generation BTK inhibitor in first-line CLL, enabling a deeper understanding of how treatment outcomes evolve over time. After a median follow-up of 84.01 months (range, 0.0-101.5), BRUKINSA continued to show benefit over bendamustine-rituximab (BR) in patients with treatment-naive CLL/SLL, with progression-free survival (PFS) outcomes that are unprecedented among BTK inhibitors. Key highlights include:

78-month PFS: 71.8% (95% CI, 65.3-77.3) for BRUKINSA vs. 31.0% (95% CI, 24.3-37.9) for BR

78-month COVID-adjusted PFS: 74.6% (95% CI, 68.1-79.9) for BRUKINSA vs. 31.4% (95% CI, 24.7-38.4) for BR

PFS for patients with unmutated IGHV: 70.4% (95% CI, 61.0-77.9) for BRUKINSA vs. 17.4% (95% CI, 9.6-27.1) for BR

PFS for patients with mutated IGHV: 81.8% (95% CI: 72.2-88.4) for BRUKINSA and 45.1% (95% CI: 34.4-55.2) for BR

78-month PFS2: 81.3% (95% CI, 75.6-85.8) for BRUKINSA vs. 74.4% (95% CI, 67.8-79.8) for BR

78-month COVID-adjusted PFS2: 84.7% (95% CI, 79.2-88.8) for BRUKINSA and 76.4% (95% CI, 69.9-81.7) for BR

Of the BRUKINSA-treated patients who progressed (26/241), half received subsequent therapy with BCL2 inhibitor-based salvage therapy and 69.2% had not progressed after more than 3 years of follow-up.

Time to next treatment (TTNT) favored BRUKINSA over BR (HR, 0.24; 95% CI, 0.16-0.35; P<.0001)

Safety: consistent with the results of prior BRUKINSA studies with no new safety signals.

PFS2 captures outcomes beyond first disease progression, measuring time to disease progression on subsequent therapy or death. In CLL, this endpoint provides important insight into how first-line treatment impacts long-term disease control across multiple lines of therapy.

Constantine Tam, M.B.B.S., M.D., Head of Lymphoma Service at Alfred Health and Professor of Haematology at Monash University, said:

“In an indolent disease like CLL, many patients value maintaining disease control over the course of their life, not just in the first year or two of treatment. The continued long-term follow-up from SEQUOIA shows that zanubrutinib can deliver sustained disease control. This is the kind of evidence that allows clinicians and patients to make first-line decisions with real confidence about what lies ahead.”

Real-world efficacy and safety data consistently underscore foundational BRUKINSA as the best-in-class BTKi for TN CLL (Poster Presentations: 545, 543 and 540; June 1, 2026, 9:00 AM-12:00 PM CDT)

In addition to the update from SEQUOIA, BeOne will present data from new analyses of large and robust datasets, which demonstrate consistent and significant real-world benefits of using BRUKINSA over other BTK inhibitors. Key highlights include:

In a real-world analysis of 10,523 Medicare patients, who were diagnosed with CLL/SLL and received frontline treatment with a BTK inhibitor, patients treated with BRUKINSA had a statistically significantly lower risk of death, advancing to next line, or discontinuing treatment, than those on ibrutinib or acalabrutinib. Similar results were observed across age subgroups. (Poster Presentation: 545)

In a separate real-world analysis of Komodo database claims from 16,788 patients with treatment-naïve CLL, BRUKINSA had a longer TTNT (unadjusted HR, 0.88; 95% CI, 0.79-0.97; P=.009) and overall survival (OS; HR, 0.72; 95% CI, 0.62-0.82; P<.001). (Poster Presentation: 543)

A retrospective analysis of 233,362 newly diagnosed CLL patients who initiated treatment with a BTK inhibitor, the atrial fibrillation rate within 1 year was lowest for BRUKINSA at 11% and 13% for acalabrutinib and 16% for ibrutinib (overall P<.0001). (Poster Presentation: 540)

Deep, rapid responses with BRUKINSA plus sonrotoclax (ZS) point to the future of time-limited treatment in CLL, including high-risk disease (Poster Presentation: 541; June 1, 2026, 9:00 AM-12:00 PM CDT)

In the Phase 1/1b study in patients with treatment-naïve CLL/SLL (median follow-up of ~34 months), the all-oral combination of BRUKINSA and next-generation BCL2 inhibitor sonrotoclax (ZS) demonstrated unprecedented rates and kinetics of undetectable minimal residual disease (uMRD), including in patients with high-risk cytogenetics. Key highlights include:

Overall response rate (ORR): 100%, with complete responses in 59.5% of patients

Best uMRD4 rate 98.8%

No patient that achieved uMRD4 reverted to uMRD positivity.

Best uMRD in patients with TP53 mutation/del(17p): 92.9% across 2 dose levels

Median time from combination start to uMRD4: 4.5 months

No disease progression events observed at the recommended Phase 2 dose of 320mg, including patients who electively discontinued therapy

Safety: consistent with previously reported BRUKINSA and sonrotoclax combination studies.

These data will also be presented as encore presentations at the 2026 European Hematology Association (EHA) Congress (June 11–14, Stockholm) along with more than 30 other data sets from BeOne.

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.

With the broadest label globally, BRUKINSA is the foundational BTK inhibitor and is the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing.

The global BRUKINSA clinical development program includes more than 8,000 patients enrolled in over 30 countries and regions across more than 45 trials. BRUKINSA is approved in 80 markets in at least one indication, and more than 290,000 patients have been treated globally.

About BEQALZI™ (sonrotoclax)

BEQALZI™ (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,500 patients have been enrolled across the broad sonrotoclax global development program.

BEQALZI is approved by the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a BTK inhibitor. It is also approved in China for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy, including a BTK inhibitor.

About Tacabrutideg (BGB-16673)

Tacabrutideg is a foundational and potential first-in-class and best-in-class orally available Bruton’s tyrosine kinase (BTK) degrader. With 1,200+ patients dosed to date in an extensive global clinical development program, tacabrutideg is the most advanced BTK degrader in the clinic. This program includes three randomized Phase 3 trials in R/R CLL, including the head-to-head Phase 3 trial versus pirtobrutinib, which began enrolling in Q4 2025. Originating from BeOne’s chimeric degradation activation compound (CDAC) platform, tacabrutideg 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.

The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tacabrutideg 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). Additionally, the European Medicines Agency (EMA) granted tacabrutideg PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.

Select Important Safety Information for BRUKINSA

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.

Select Important Safety Information for BEQALZI™ (sonrotoclax)

Serious and sometimes fatal adverse reactions have occurred with BEQALZI, including tumor lysis syndrome (TLS), serious infections, neutropenia, and embryo-fetal toxicity. BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome.

In the safety population (N=115), tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up. Serious infections occurred in 14% of patients, and Grade 3 or 4 infections occurred in 17% (fatal: 2.6%), with pneumonia (10%) being the most common Grade 3 or greater infection. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%), and febrile neutropenia occurred in 1.7% of all patients. The most common adverse reactions (≥15%) were pneumonia (16%) and fatigue (16%). The most common Grade 3–4 laboratory abnormalities (≥15%) were decreases in lymphocytes (29%) and neutrophils (18%).

Please see full Prescribing 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 that is discovering and developing innovative treatments for 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. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. 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 potential patient benefits of zanubrutinib, sonrotoclax and tacabrutideg; BeOne’s ability to redefine what patients should expect from therapy; 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 achieve 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.

To access BeOne media resources, please visit our Newsroom.

 

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Contacts

 

Investor Contact

Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact

Kyle Blankenship

+1 667-351-5176

media@beonemed.com

AAHI’s SLA-SE Adjuvant Technology Powers Lilly’s Acquisition of Curevo’s Next-Generation Shingles Vaccine

 SLA-SE adjuvant validated as a superior vaccine technology to protect people from infectious disease without debilitating side effects

(BUSINESS WIRE)--The Access to Advanced Health Institute (AAHI), a nonprofit biotech organization dedicated to developing vaccines and technologies for global health, today congratulates Eli Lilly and Company and Curevo Vaccine on Lilly’s acquisition of Curevo.

Curevo’s lead asset, amezosvatein (CRV-101), is a Phase 3-ready subunit vaccine for the prevention of shingles (herpes zoster) that incorporates AAHI’s proprietary SLA-SE adjuvant. The acquisition underscores the growing recognition of next-generation adjuvants that can deliver improved tolerability and strong immune responses.

“SLA-SE represents a significant advancement in adjuvant technology, designed to elicit robust T-cell immunity with a favorable safety profile,” said Keeley Foley, CEO of AAHI. “We are thrilled that this technology, developed at AAHI, is now positioned to reach people through Lilly’s world-class development and commercial capabilities.”

Importantly, AAHI retains rights to license and develop SLA-SE adjuvant for uses outside the shingles (varicella zoster virus) vaccine field. This includes in combination with other antigens for a wide range of infectious diseases, cancer vaccines, and additional indications.

For more information about AAHI and its work, visit www.aahi.org.

About Access to Advanced Health Institute (AAHI)

AAHI is a Seattle-based nonprofit biotech research institute focused on translating high-impact science into affordable, effective, and accessible vaccines. With a global footprint including operations in the United States, England, and South Africa, AAHI collaborates with partners worldwide to combat infectious diseases and improve health equity. For more information, visit https://www.aahi.org/ or contact us at https://www.aahi.org/contact/.

 

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Contacts

 

Media Contact:

Casey Felipe, Director, Operations & Business Development

Access to Advanced Health Institute

Email: info@aahi.org

Phone: 206.381.0883

 

Energy Vault Closes Acquisition of 850 MW Energy Storage Portfolio from BayWa r.e. AG, Establishing Immediate Operational Platform to Capture Growth in Japan

 WESTLAKE VILLAGE, Calif. - 

Acquisition transfers a premium 850 MW Japanese BESS development portfolio and an experienced local development team from BayWa r.e. AG, one of the world’s leading renewable energy independent power producers

Portfolio includes 350 MW of near term, advanced-stage projects expected to reach NTP in 2H 2027, with COD beginning in mid-2028, plus 500 MW of early-stage projects supporting long-term growth and development

Japanese projects are expected to be designed with three-hour duration, generating higher EBITDA per MW than typical shorter-duration BESS projects in Texas.

Transaction brings Energy Vault’s global owned asset portfolio for near term projects underway to 1.1 GW, contributing to $180M+ in expected annual recurring EBITDA as the projects come online

(BUSINESS WIRE)--Energy Vault Holdings, Inc. (NYSE: NRGV) (“Energy Vault” or the “Company”), a global leader in sustainable grid-scale energy storage and AI compute infrastructure solutions, today announced the successful completion of its previously announced acquisition of an 850 MW Battery Energy Storage System (“BESS”) development portfolio in Japan from BayWa r.e. AG, a leading global renewable energy developer and independent power producer.

The closing of the transaction officially establishes Energy Vault’s operational presence in Japan, one of the most attractive and structurally advantaged energy storage markets among developed economies. The acquisition provides Energy Vault with an immediate in-country platform, a premium project pipeline, and a highly experienced local development team with deep expertise in land rights, regulatory permitting, and utility interconnections — capabilities that are essential to scaling successfully in Japan’s complex and rapidly growing energy storage market.

The team and portfolio were carefully selected and originate from BayWa r.e., one of the world’s most sophisticated renewable energy platforms. For Energy Vault, the strategic value of the acquisition extends beyond megawatts alone: it adds proven local execution capability, accelerates market entry, and positions the Company to build a long-term owned-asset platform in a market with strong demand for flexible, reliable, and dispatchable energy storage.

The acquired portfolio includes approximately 350 MW of advanced-stage BESS projects expected to reach Notice to Proceed (“NTP”) in the second half of 2027, with Commercial Operation Dates (“COD”) expected to begin in mid-2028. An additional 500 MW of early-stage projects provides a multi-year development runway and meaningful expansion potential as Energy Vault scales its Japanese platform. Importantly, the advanced-stage projects are expected to be configured with three hours of storage duration. This provides greater energy capacity per MW than shorter-duration BESS projects more commonly seen in other markets, including the United States, and is expected to enhance the long-term revenue potential and asset value of the portfolio. In addition, Japan’s relatively low cost of financing further strengthens project-level economics, making the market particularly attractive for Energy Vault’s asset ownership strategy.

“This acquisition marks a significant step in Energy Vault’s global growth strategy and establishes our direct operating platform in one of the world’s most compelling energy storage markets,” said Robert Piconi, Chairman and Chief Executive Officer of Energy Vault. “By completing this acquisition, we have secured not only a premium BESS development portfolio, but also an experienced local team from one of the most respected renewable energy platforms globally in BayWa Renewables. Japan’s need for flexible, reliable storage is accelerating, and Energy Vault is well positioned to deliver projects at scale while creating long-term, predictable value for our shareholders.”

“Japan is a strategically important market for energy storage, and we are pleased to have successfully transferred this high-quality portfolio to Energy Vault,” said Daniel Gaefke, Group Chief Operating Officer of BayWa r.e. “This transaction reflects BayWa r.e.’s ability to originate, develop, and monetize premium renewable energy assets globally. With its integrated technology platform, execution capability, and asset ownership strategy, Energy Vault is well positioned to advance these projects and support Japan’s energy transition.”

The formal addition of BayWa r.e.’s Japanese portfolio brings Energy Vault’s global owned asset base — including acquired, under-construction, and operating assets — to more than 1 GW across energy storage and AI compute infrastructure. Once fully constructed and operational, this growing owned-asset portfolio is expected to support more than $180M in anticipated annual recurring EBITDA, reinforcing Energy Vault’s transition toward a capital-efficient, recurring revenue business model.

With the acquisition now closed, Energy Vault intends to continue scaling its Japanese presence by advancing the acquired projects, evaluating additional development opportunities, and deploying storage solutions tailored to Japan’s grid needs, safety requirements, and long-term power market dynamics. The Company will also assess next-generation battery chemistries and customized storage configurations designed to maximize value in Japan’s evolving energy landscape.

About Energy Vault

Energy Vault® develops, deploys and operates utility-scale energy storage solutions designed to transform the world’s approach to sustainable energy storage. The Company’s comprehensive offerings include proprietary battery, gravity and green hydrogen energy storage technologies supporting a variety of customer use cases delivering safe and reliable energy system dispatching and optimization. Each storage solution is supported by the Company’s technology-agnostic energy management system software and integration platform. Unique to the industry, Energy Vault’s innovative technology portfolio delivers customized short, long and multi-day/ultra-long duration energy storage solutions to help utilities, independent power producers, and large industrial energy users significantly reduce levelized energy costs while maintaining power reliability. Since 2024, Energy Vault has executed an “Own & Operate” asset management strategy developed to generate predictable, recurring and high margin tolling revenue streams, positioning the Company for continued growth in the rapidly evolving energy storage asset infrastructure market. Please visit www.energyvault.com for more information.

Forward-Looking Statements

This press release includes forward-looking statements that reflect the Company’s current views with respect to, among other things, the Company’s operations and financial performance. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies. These statements often include words such as “anticipate,” “expect,” “contemplate,” “continue,” “suggest,” “plan,” “potential,” “predict,” “believe,” “intend,” “project,” “forecast,” “estimate,” “target,” “project,” “projections,” “should,” “target,” “could,” “would,” “may,” “might,” “will” and other similar expressions. We base these forward-looking statements or projections on our current expectations, plans and assumptions, which we have made in light of our experience in our industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at the time. These forward-looking statements are based on our beliefs, assumptions and expectations of future performance, taking into account the information currently available to us. These forward-looking statements are only predictions based upon our current expectations and projections about future events. These forward-looking statements involve significant risks and uncertainties that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements, including changes in our strategy, expansion plans, customer opportunities, future operations, future financial position, estimated revenues and losses, expected monetization of tax credits, expected financings, projected costs, prospects and plans; the uncertainly of our awards, bookings, backlog and developed pipeline equating to future revenue; the lack of assurance that non-binding letters of intent and other indications of interest can result in binding financings, orders or sales; the possibility of our products or services to be or alleged to be defective or experience other failures; the implementation, market acceptance and success of our business model and growth strategy; our ability to develop and maintain our brand and reputation; developments and projections relating to our business, our competitors, and industry; the impact of macroeconomic uncertainty, including with respect to uncertainty about the future relationship between the United States and other countries with respect to trade policies and tariffs; changes in tax laws and government regulations and the impact of those changes on us, including as a result of the One Big Beautiful Bill Act and its changes to the Internal Revenue Code of 1986, as amended and the clean-energy tax credits established under the Inflation Reduction Act of 2022; investment in development projects that may not achieve commercial operations in our predicted timeframe or at all; our efforts to diversify our supply chain to lessen the impact of tariffs; the ability of our suppliers to deliver necessary components or raw materials for construction of our energy storage systems in a timely manner; our expectations regarding our ability to obtain and maintain intellectual property protection and not infringe on the rights of others; expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012; our future capital requirements and sources and uses of cash; developments in U.S. and global trade policy; the international nature of our operations and the impact of war or other hostilities on our business and global markets; our ability to obtain funding for our operations and future growth; and our business, expansion plans and opportunities, including our expansion into owned and operated projects; our ability to successfully consummate our proposed acquisition in Japan; and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 18, 2026, as such factors may be updated from time to time in its other filings with the SEC, accessible on the SEC’s website at www.sec.gov. New risks emerge from time to time and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Any forward-looking statement made by us in this press release speaks only as of the date of this press release and is expressly qualified in its entirety by the cautionary statements included in this press release. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable laws. You should not place undue reliance on our forward-looking statements.

 

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Contacts

 Energy Vault Contacts:

Investors energyvaultIR@icrinc.com

Media media@energyvault.com

Eskom Media Contact:

Mediadesk@eskom.co.za