BeOne Medicines Announces Voluntary Agreement with U.S. Government to Expand Access to Innovative Cancer Medicines

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Agreement advances patient access and strengthens BeOne's long-term commitment to U.S. innovation and manufacturing

SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines, Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced a voluntary agreement with the U.S. Government to expand access to innovative cancer medicines for American patients while strengthening our U.S manufacturing footprint and further expanding the capabilities needed to deliver medicines at scale. The agreement builds on BeOne's longstanding commitment to patient access and investment in research and scientific innovation.

John V. Oyler, Co-Founder, Chairman and CEO, BeOne Medicines, said:
“At BeOne, we believe every patient should benefit from innovative cancer therapies. We appreciate the Trump Administration’s commitment to advancing solutions that broaden access and scientific progress for American patients. This agreement reflects our purpose to reach more patients as we expand our U.S. investment in additional research, development, and manufacturing to deliver breakthrough cancer treatments worldwide.”

Improved access to oncology medicines for patients
This announcement reflects BeOne’s participation in the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model and the company’s commitment to pricing future FDA-approved products in line with other key developed markets.

Increased manufacturing and investment
Through continued investments in U.S. manufacturing, BeOne is enhancing supply continuity and manufacturing flexibility while supporting patient access to innovative medicines.

• BeOne entered into an onshoring agreement with the U.S. government, securing an exemption from Section 232 pharmaceutical tariffs that recognizes the company’s significant and ongoing investments in US. manufacturing.

• The company recently announced a $300 million onshoring investment in its flagship clinical and commercial-stage manufacturing and research and development facility in Hopewell, NJ, bringing total U.S. manufacturing investment to more than $1 billion. The expansion will add small-molecule manufacturing capacity, create approximately 120 full-time jobs and enhance BeOne’s ability to manufacture medicines in the states and advance its oncology pipeline of more than 35 clinical- and commercial-stage assets.

The U.S. is an important hub for BeOne's scientific, clinical and manufacturing operations. BeOne employs more than 2,000 U.S. colleagues within a global team of more than 12,000 across six continents. In 2025, the company generated nearly $2 billion in direct U.S. economic impact and invested $1 billion in U.S. research and development. BeOne is also advancing one of oncology's broadest pipelines through 93 clinical trials at approximately 1,100 sites across 45 states and one territory, supported by more than 650 investigators.

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 BeOne helping more eligible patients in the U.S. access innovative cancer medicines while supporting continued investment in U.S. research, manufacturing and scientific innovation; BeOne reaching patients around the world faster, more reliably and at greater scale; BeOne pricing future FDA-approved products in line with other key developed markets; BeOne’s commitment to continued investment in U.S. manufacturing, stronger supply chain resilience, and support of patient access to innovative medicines; 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260831047788/en/

Investor Contact
Liza Heapes
+1 857-302-5663
ir@beonemed.com

Media Contact
Kyle Blankenship
+ 1 667-351-5176
media@beonemed.com

Source: BeOne Medicines, Ltd.