BeOne Resolves AbbVie Patent Dispute as Brukinsa Powers First Profit and Swiss Rebrand
BeOne,, formerly BeiGene, resolves AbbVie’s patent dispute over Brukinsa®, achieves first-ever quarterly profit, and finalizes Swiss rebrand, signaling its evolution from China-based biotech to global oncology player.
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) — formerly BeiGene, Ltd. — announced that AbbVie has withdrawn its U.S. patent litigation against Brukinsa® (zanubrutinib), ending a high-profile legal battle over the fast-growing BTK inhibitor. The resolution comes as BeOne posts its first profitable quarter and completes a corporate rebrand anchored in Switzerland.
Patent Dispute Resolved
AbbVie’s subsidiary Pharmacyclics opted not to appeal the U.S. Patent and Trademark Office (USPTO) ruling invalidating all challenged claims of U.S. Patent No. 11,672,803. On September 30, 2025, both parties filed a joint stipulation to dismiss the related U.S. district court litigation with prejudice, fully resolving the matter.
The patent covered a method-of-use claim for BTK inhibitors in CLL/SLL, specifically dosing until disease progression or unacceptable toxicity while excluding lymphocytosis as a progression criterion. Its invalidation removes a major legal overhang for Brukinsa, which continues to gain market share versus AbbVie and J&J’s Imbruvica®.
Brukinsa: BeOne’s Growth Engine
Brukinsa is BeOne’s flagship BTK inhibitor and top-selling product. In 2024, U.S. sales exceeded $1.57 billion, with global revenue surpassing $2 billion.
| Product | Period | Sales (USD millions) | YoY Growth |
|---|---|---|---|
| Brukinsa | Q2 2025 | 621 | +101% vs Q2 2024 |
| FY 2024 US | 1,570 | +12% vs FY 2023 | |
| Q2 2024 | 308 | — | |
| Imbruvica | Q2 2025 | 812 | -6% vs Q2 2024 |
| Q2 2024 | 862 | — |
Source: Company filings, industry reports
Insight: Brukinsa shows a strong upward trajectory, doubling quarterly revenue YoY, while Imbruvica is experiencing a modest decline, highlighting BeOne’s accelerating market capture.
First-Ever Profit in Q2 2025
Driven by the continued momentum of Brukinsa® (zanubrutinib) and steady growth of Tevimbra® (tislelizumab), BeOne reported net income of ~$94.3 million in Q2 2025, marking the company’s first GAAP-profitable quarter in its history.
- Brukinsa®: Delivered global sales of approximately $950 million in Q2 2025, representing nearly 50% year-over-year growth, and remained the company’s primary growth engine.
- Tevimbra®: Contributed $194 million in Q2 2025 sales, up 22% YoY, providing additional support to profitability.
This milestone underscores BeOne’s transition from a historically R&D-driven, loss-making biotech to a commercially sustainable global oncology company.
Pipeline Momentum
- Sonrotoclax (BGB-11417, BCL-2 inhibitor): Positive topline results in mantle cell lymphoma (MCL), advancing toward pivotal trials and Brukinsa-based combinations.
- BGB-16673 (BTK degrader): Early clinical development targeting BTK-resistant cancers.
- TEVIMBRA® (tislelizumab, PD-1 antibody): EMA’s CHMP recently recommended for perioperative NSCLC; approved in multiple global markets.
- Imdelltra® (DLL3 T-cell engager, Amgen-partnered): BeOne monetized ex-China royalties via a $885 million upfront deal with Royalty Pharma, retaining China rights.
Competitive Landscape in BTK Inhibitors
| Drug | Developer | Key Indications / Notes | Line of Therapy |
|---|---|---|---|
| Brukinsa (zanubrutinib) | BeOne | CLL/SLL, MCL, WM | First-line & relapsed/refractory (R/R); strong global growth |
| Imbruvica (ibrutinib) | AbbVie/J&J | CLL/SLL, MCL, WM, MZL | First-line & R/R; market pioneer but declining due to safety/tolerability |
| Calquence (acalabrutinib) | AstraZeneca | CLL/SLL, MCL | First-line & R/R; cleaner safety profile, steady growth |
| Jaypirca (pirtobrutinib) | Eli Lilly | CLL/SLL, MCL | Mostly R/R, especially after prior covalent BTK therapy |
| Orelabrutinib | InnoCare/Biogen | CLL/SLL, MCL | Smaller-scale global presence; mostly China; R/R and select first-line |
Insight: While all these BTK inhibitors target overlapping indications (primarily CLL/SLL and MCL), Brukinsa stands out with head-to-head superiority vs Imbruvica in both first-line and R/R settings, while Jaypirca specifically addresses BTK-resistant populations. Calquence maintains strong uptake due to its safety profile, but Brukinsa is currently trending ahead in global market share.
From BeiGene to BeOne: Swiss Redomiciliation
BeOne, originally founded in China as BeiGene, has completed its redomiciliation from the Cayman Islands to Switzerland, formally adopting the new name. With headquarters now in Beijing, Cambridge (MA), and Basel, the company positions itself as a global oncology multinational. Major shareholders include Amgen Inc., which owns approximately 17.2%, and Baker Bros. Advisors LP, holding around 16.7% of the company. CEO John Oyler highlighted that the rebrand reflects both commercial success with Brukinsa and ambition to advance a pipeline of over 50 investigational assets, bridging its Chinese origins with a global presence.
Outlook
The convergence of:
- AbbVie’s legal withdrawal
- Brukinsa’s commercial surge
- BeOne’s first profit
- A diversified pipeline
- Swiss rebrand
…positions BeOne at a transformational inflection point. Once seen primarily as China’s leading biotech, BeOne now signals its ambition to compete among global oncology leaders.
Sources
- BeOne Medicines corporate filings and earnings reports
- Industry market research on BTK inhibitors
- Press releases regarding patent litigation and corporate rebrand
- Analyst reports on oncology market trends
Disclaimer
This article is for informational purposes only and does not constitute investment advice. Readers should perform their own research or consult a financial advisor before making investment decisions.