BeOne Medicines Gets Global Oncology Innovation Leadership Award at BIOHK 2025

BeOne’s R&D spans both hematologic and solid tumours:

• BTK inhibitor: BeOne’s first independently developed innovative drug, and the only treatment worldwide in its class to have completed head-to-head clinical trials in both Chronic Lymphocytic Leukaemia (CLL) and Waldenström’s Macroglobulinemia (WM)¹. It has been approved in more than 75 markets and was honoured with the prestigious Prix Galien Suisse in 2023²..
• PD-1 inhibitor (immunotherapy): Approved in Hong Kong for six indications, including non-small cell lung cancer, oesophageal cancer, and gastric cancer, with expansion to nasopharyngeal carcinoma and lung cancer — two of the most prevalent cancer types in Asia. This therapy is marketed in 47 countries and regions, including the United States, European Union, China, and Japan, with over 60 indication-approval applications submitted to expand its global coverage.

Fast-to-proof-of-concept (PoC) strategy to accelerate innovation delivery
BeOne’s integrated development approach combines robust R&D capabilities, a PoC-driven strategy and a wide portfolio of assets. With over 40 Phase 3-ready or registration-potential clinical trials and more than 40 R&D assets in clinical and commercialisation stages, BeOne maintains leadership across multiple technology platforms, including multi-specific antibodies, chimeric degradation activating compounds (CDACs), and antibody-drug conjugates (ADCs).

Through the PoC strategy, BeOne concentrates on highly differentiated and promising molecule candidates. The company has successfully pushed through the clinical development for 20 drug molecules and obtained regulatory approvals across six continents, demonstrating its outstanding R&D efficiency and globalisation strategy.

Globalisation to strengthen sustainable supply
BeOne has established three major R&D and manufacturing bases in the United States and China, encompassing the entire industry chain from research and development to manufacturing and commercialisation.

Notably, the Guangzhou campus spans 1.3 million ft and features advanced manufacturing capabilities to produce large-molecule drugs, serving as a core supply hub in the Greater Bay Area, including Hong Kong. This footprint ensures a stable drug supply and enhances accessibility for patients in the region.

As one of the world’s top 20 leading oncology patent holders and listed as one of the “World’s Top 10 Most Inventive Pharmaceutical Companies” by IDEA Pharma in 2025, BeOne will continue to devote its efforts to researching hematologic and solid tumours.

Leveraging Hong Kong as a strategic bridge between Asia and the international community, BeOne is committed to accelerating the development and delivery of innovative therapies, collaboratively driving a new paradigm for cancer care regionally and globally.

Prof. Albert Yu, Chairman of Hong Kong Biotechnology Organisation, remarked, “BeOne’s leadership in oncology is fully evident in its innovative drug development, globalisation strategy, and significant improvements in quality of life for cancer patients locally and worldwide.

“Grounded in rigorous scientific research, BeOne aligns clinical needs with accessibility considerations across various markets to launch multiple self-developed innovative medicines to the global stage. The company’s efforts represent scientific excellence and a profound commitment to cancer patients, deserving of the Global Oncology Leadership Award.”

This press release contains forward-looking statements, and actual results may differ from those expressed or implied in these statements. All information provided herein is as of the date of this release, and unless required by law, BeOne has no obligation to update or revise any such information.

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 benefits of sonrotoclax.

BeOne’s expectations regarding sonrotoclax’s clinical development, regulatory milestones, submissions and approvals; BeOne’s plans to present the full data at an upcoming medical meeting; and BeOne’s plans, commitments, aspirations and goals under the caption “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, commercialisation, and other services;

BeOne’s limited experience in obtaining regulatory approvals and commercialising pharmaceutical products.

BeOne’s 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.