BeiGene Announces Positive Phase 3 MANGROVE Trial Results for Brukinsa® (Zanubrutinib) as First-Line Treatment in Mantle Cell Lymphoma

MANGROVE is a global, randomized, open-label Phase 3 clinical trial designed to evaluate Brukinsa^®Efficacy and Safety of Zanubrutinib Plus Rituximab Versus Bendamustine Plus Rituximab in Previously Untreated Adult Patients with Mantle Cell Lymphoma. The study enrolled 510 patients across 176 research centers worldwide.

In the experimental arm, patients received zanubrutinib 160 mg orally twice daily in combination with rituximab during the initial treatment phase, followed by zanubrutinib monotherapy until disease progression or unacceptable toxicity. In the control arm, patients received six cycles of bendamustine plus rituximab. The primary endpoint of the study was progression-free survival (PFS) as assessed by an independent review committee (IRC). Overall survival (OS) was the key secondary endpoint. Other secondary endpoints included investigator-assessed PFS, overall response rate (ORR), duration of response (DOR), patient-reported outcomes, and safety.

Brukinsa®^®is an oral small-molecule inhibitor of Bruton's tyrosine kinase (BTK), designed to achieve complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. Compared with other approved BTK inhibitors, Brukinsa^®It features differentiated pharmacokinetic properties. Studies have shown that it can inhibit the proliferation of malignant B cells in multiple disease-related tissues.

Brukinsa^®Global clinical development programs have enrolled more than 8,000 patients across over 45 trials in more than 30 countries and regions to date. Brukinsa^®Approved for at least one indication in 80 markets worldwide, and has been used to treat more than 290,000 patients.

BeOne is a global oncology innovation company dedicated to developing innovative anti-cancer therapies for cancer patients worldwide. The company boasts a robust portfolio in hematology and solid tumors, and continuously accelerates the development of a diverse and innovative drug pipeline through strong in-house R&D capabilities and strategic external collaborations. Currently, BeOne has a growing team across six continents, committed to enhancing the accessibility of innovative medicines and benefiting more patients globally through scientific excellence and operational efficiency. For more information, please visit www.beonemedicines.com.cn or follow the “BeOne” official WeChat account.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including those related to Brukinsa^®Potential Benefits of Combining Rituximab with a Chemotherapy-Free Regimen for Previously Untreated Adult Patients with Mantle Cell Lymphoma (MCL); Brukinsa^®the potential as a cornerstone BTK inhibitor in this disease area, supporting first-line treatment and continuing to expand its leading role in the treatment of B-cell malignancies; the expected timing of clinical and regulatory developments and data readouts; and the plans, commitments, aspirations, and objectives of BeOne mentioned under the heading “About BeOne.” Due to the influence of various important factors, actual results may differ materially from those in the forward-looking statements. These factors include: BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the possibility that clinical results for drug candidates may not support further development or marketing approval; actions by regulatory authorities that may affect the initiation, timeline, and progress of clinical trials as well as drug marketing approvals; the ability of BeOne’s marketed drugs and drug candidates (if approved) to achieve commercial success; BeOne’s ability to obtain and maintain intellectual property protection for its drugs and technologies; BeOne’s reliance on third parties for drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products, and its ability to secure additional working capital to complete the development of drug candidates and to achieve and sustain profitability; and the various risks more fully discussed in the “Risk Factors” section of BeOne’s recent Quarterly Report on Form 10-Q; as well as discussions in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission regarding potential risks, uncertainties, and other important factors. All information in this press release is current only as of the date of issuance, and BeOne has no obligation to update such information unless required by law.