Zanubrutinib

Jiangsu Hengrui Pharmaceuticals has quietly become a top 25 biopharma company in the world by market value. Once virtually unknown outside of China, the company has made its name overseas via an R&D engine that has not only spawned over 20 approved drugs in China, but also new startups — including a billion-dollar obesity biotech — and expansive deals with Western drugmakers. But there’s still one big item on its bucket list: selling its own treatments outside of China. After all, it’s the capability to sell drugs, not just make them, that gives pharma companies their stature — and profits. “We have the ambition one day to have our own global development capabilities and therefore commercialization capabilities ex-China,” Hengrui chief strategy officer Frank Jiang said at Endpoints News ’ JPM event in January. In a separate interview, he crystallized the ultimate goal: “To have Hengrui-branded products sold in the US, the EU.” Hengrui is the largest and best example of a homegrown Chinese company mapping out a potential future as a large multinational drugmaker. With a valuation of about $61.2 billion, Hengrui is now larger than Takeda and Bayer. While it’s by no means alone — Innovent Biologics and Fosun Pharma , among others, show similar aspirations — Hengrui has become the player to watch because it’s so much larger than the others and is already shaking up the industry’s status quo. It won’t be an easy path, and it may still be years before any of them market their drugs outside China on their own, if ever. One potential obstacle lies in geopolitics. US regulators and lawmakers in particular are wary of opening the floodgates to Chinese drugs. Even so, some of the biggest names in pharma concede that momentum may be on China’s side. Just as Europe and later the US developed as centers of discovery in medicine, “the one country that is coming closest to now recreating that ecosystem is China,” Merck CEO Rob Davis told the Galien Forum in New York City in October. The nation is funding academic research, has “an ecosystem of small biotech, and they’re very quickly trying to drive the large pharma model.” “They’re not where we are yet, but they’re moving very quickly,” Davis said. Hengrui started over 50 years ago as a generic drugmaker. It’s only been in the past two decades or so that the company began focusing on researching and making new medicines, reflecting China’s big push to transform itself into an innovation hub. Today, Hengrui has more than 100 experimental treatments being studied across some 400-plus clinical trials. “What is our strength? Today it’s still R&D and efficiency,” Jiang said on stage at Endpoints’ event. “The timeline that we do science is very different from our competitors.” Speed, particularly in the early stages of drug development, has become a hallmark of China biotech’s rise. That’s helped the nation’s biotechs begin to outpace competitors in areas such as cancer and genetic medicines. Hengrui has a multipronged plan to expand outside of China. Partnerships with Merck and GSK are centered around big indications like lung or heart diseases that Hengrui might not have the resources to advance outside of China on its own. Another approach involves working with investment firms to set up new companies abroad, such as Kailera Therapeutics, the obesity startup Hengrui founded alongside Bain Capital. The Kailera model gives Hengrui a way to get assets abroad while providing “great learning,” Jiang told Endpoints. Hengrui is also working on getting FDA approvals on its own, though right now those efforts are limited to experimental drugs that require only “relatively modest” clinical trials and patient populations, Jiang said. But it hasn’t all been smooth sailing. The FDA has twice rejected Hengrui’s checkpoint drug for liver cancer over manufacturing problems, though the company and its partner Elevar Therapeutics resubmitted their application to the agency last week. The company last year hired Yu Liu, a former oncology VP at Bristol Myers Squibb, as its chief medical officer, international to help expand clinical development efforts in the US and outside of China. While there is a precedent for Hengrui’s push to spring from China as a large multinational pharma player selling its own treatments, that example comes with asterisks. The company now known as BeOne Medicines won FDA approval of a cancer treatment called Brukinsa in 2019, marking the first US approval of a cancer drug from China. But the drugmaker has worked to distance itself from its China roots, most notably by renaming itself last year from BeiGene, which was a wordplay on “Beijing.” BeOne, now domiciled in Switzerland, says it was “never formally headquartered in China” and currently doesn’t “​​claim a global headquarters.” Much has changed in the years since BeiGene emerged, and the path may not be so straightforward for Chinese companies sharing global ambitions, according to Qiang Lu, chairman of Shanghai-based GenFleet Therapeutics. “The globalization, the friendly capital environment, and also this kind of a regulatory picture is no longer there,” he said on a panel at an investor event on the sidelines of JPM. Tense geopolitical relations between the US and China loom large. US lawmakers in December passed a weakened version of the Biosecure Act, which was aimed at restricting Chinese biopharma suppliers deemed national security threats. It’s unclear if and how regulators and lawmakers would respond to a Chinese drugmaker trying to market its treatments in the US on its own. “Five years ago, people were saying Chinese companies were more innovative and were going to go overseas,’’ Bernstein analyst Rebecca Liang, who covers China biopharma, said in an interview with Endpoints. “But it’s not that easy. We’ve had more failures than successes.” Though there are few instances of drugs discovered in China making it big, aside from BeOne’s Brukinsa and Legend Biotech’s myeloma cell therapy Carvykti, last year’s deluge of deals between China biotechs and US companies means that is likely to change in the coming years. There are several thousand biotechs in China, so expect to see a “full spectrum” of the types of companies that will develop there, according to Fangning Zhang, a McKinsey partner who leads the consulting firm’s life sciences practice in Greater China. For both small and large drug developers in China alike, accessing the far more lucrative external markets via deals or other lanes is key. Out of all these companies, however, only a few including Hengrui have the prospects to truly become multinational. Another such aspirant is Innovent. “We have ambitions to become a global company,” Innovent CEO Michael Yu told Endpoints on the sidelines of the JPM conference. Innovent has an office in California and has been growing its clinical and research teams in the US. “There are a couple companies that are starting to become more thoughtful and intentional when they strike partnerships with Western players around assets,” Zhang said in an interview at JPM. Co-development and co-commercialization deals, rather than a “simple out-licensing transaction,” allow China-based biotechs to “learn from the best in industry.” For instance, Innovent reached a $1.2 billion upfront deal with Takeda last year to jointly develop and commercialize an immunotherapy for cancer. The companies started a Phase 3 trial of the treatment in lung cancer at the end of last year. But for now, with its size and all the “fanfare” about its pipeline, Hengrui is “one of a kind,” Bernstein’s Liang said. “The ambition is there. They want to be big, they want to be global.” Even so, much of the company’s assets are at an early stage, she said, and “that moment is yet to come.” Drew Armstrong, Jared Whitlock and Kyle LaHucik contributed reporting to this story.

Company outlines foundational hematology leadership, multiple 2026 data catalysts, a unique global clinical development superhighway, and continued financial excellence SAN CARLOS, Calif.--(BUSINESS WIRE)-- $ONC #BeOne -- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will outline the pillars of its growing global oncology leadership during its presentation today at the 44 th Annual J.P. Morgan Healthcare Conference in San Francisco. John V. Oyler, Co-Founder, Chairman, and CEO at BeOne, will highlight the Company’s transformative leadership in treating B-cell malignancies. The presentation will feature BRUKINSA ® , the global leader among Bruton’s tyrosine kinase (BTK) inhibitors, as well as foundational hematology assets: sonrotoclax, a next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor that received its first global regulatory approvals on December 30, and BGB-16673, a potentially first-in-class and best-in-class BTK chimeric degradation activation compound (CDAC). In addition, Mr. Oyler will share further information on BeOne’s global development superhighway, which encompasses global, wholly internal, and competitively advantaged clinical capabilities that can greatly reduce the cost and time to develop a new medicine, thereby increasing the speed of access to innovation for patients around the world. “BeOne is emerging as the world’s leading oncology company with established leadership in the treatment of B-cell malignancies, an industry-leading pipeline and a unique set of internal capabilities to address tremendous unmet patient need around the world,” Mr. Oyler said. “BRUKINSA has entrenched itself as the best-in-class, foundational BTK inhibitor and global revenue leader with an unparallelled long-term efficacy and safety pro all approved indications. The investigational combination of BRUKINSA and BCL2 inhibitor sonrotoclax has the potential to change the fixed-duration treatment landscape for CLL with best-in-class rates and kinetics of minimal residual disease. BGB-16673 is the most advanced BTK degrader in the clinic and continues to emerge as a potential first-in-class and best-in-class treatment. Combining one of the industry’s most innovative research teams with our vertically integrated clinical development capabilities puts us in a strong position for our next phase of growth with a solid financial pro a growing global footprint.” Key themes from BeOne’s presentation (7:30 a.m. PT, Tuesday, Jan. 13, 2026) at the J.P. Morgan Healthcare Conference include: BeOne is the only company with potentially best-in-class, foundational medicines in three key MOAs in CLL BeOne is the leading company in the treatment of chronic lymphocytic leukemia (CLL) with three approved or clinical-stage foundational medicines addressing all patient subtypes. BRUKINSA is now the global revenue leader in the BTKi class and the only BTKi to demonstrate superior progression-free survival (PFS) and cardiac safety pro ibrutinib in a Phase 3 head-to-head trial. At the American Society of Hematology (ASH) Annual Meeting in December, the Company presented landmark six-year results from the global, Phase 3 SEQUOIA trial of BRUKINSA versus bendustamine plus rituximab (BR) in treatment-naïve CLL or small lymphocytic lymphoma with an estimated 74% PFS compared with 32% PFS for BR. The overall survival (OS) at 72 months was 84% for BRUKINSA and 80% with BR. After adjusting for COVID-19, the OS rates were 88% and 82%, respectively. BeOne is rapidly advancing the investigational combination of BRUKINSA and sonrotoclax as a potential best-in-class fixed-duration regimen for the treatment of first-line CLL with clinical results showing potential best-in-class rates of undetectable minimal residual disease (uMRD) at the earliest time as exploratory endpoints. The Company anticipates uMRD results from the Phase 3 CELESTIAL trial of zanubrutinib plus sonrotoclax (ZS) versus venetoclax plus obinutuzumab (VO) in 2026. In addition, the Company continues to advance BGB-16673 as a potentially first-in-class and best-in-class targeted degrader of BTK with Phase 1 trial results in heavily pretreated CLL patients at a median follow-up of 18 months demonstrating an overall response rate of 86% and 12-month progression-free survival of 79%. The Company anticipates potentially pivotal Phase 2 trial results for BGB-16673 in R/R CLL in 2026. BeOne’s peerless global development superhighway combined with an industry-leading oncology R&D team drives faster development, accelerated regulatory registrations, and broader global patient access BeOne is leveraging one of the largest oncology research teams in the industry alongside nearly 6,000 clinical development and manufacturing colleagues supporting the Company’s wholly internal, strategically advantaged global development superhighway to rapidly bring our medicines to cancer patients around the world. The Company’s dedicated team of research scientists holds deep expertise in designing innovative small-molecule inhibitors, biologics, targeted protein degraders, multispecific antibodies and antibody drug conjugates. In the past 18 months, the Company has advanced 15 New Molecular Entities (NME) into the clinic across a broad range of modalities and expects to deliver an additional eight to 10 NMEs per year into the clinic starting in 2026. BeOne plans to share updates for the following programs, each of which has achieved clinical proof of concept and presents a significant market opportunity: CDK4 inhibitor, B7-H4 ADC, PRMT5 inhibitor, GPC3x41BB bispecific antibody, and CEA ADC. A strong financial pro investment for BeOne’s future growth BeOne’s strong financial position enables the Company to achieve greater global scale while maintaining profitability in 2026 and beyond. The Company generated more than $350 million in free cash flow in the third quarter of 2025 with more than $4 billion in cash on hand. BeOne will continue to invest in driving innovation across its hematology and solid tumor pipelines to maximize long-term value for patients and shareholders while pursuing value-creating business development, including opportunities to leverage the Company’s global development superhighway. Live webcast of BeOne’s presentation can be accessed from the investors section of the Company’s website at . Archived replays will be available on the Company’s website. About BeOne Medicines BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to 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 of nearly 12,000 colleagues 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 and follow us on LinkedIn , X , Facebook and Instagram . Forward-Looking Statements 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’s anticipated presentation at the 44 th Annual J.P. Morgan Healthcare Conference; the potential of sonrotoclax to be a best-in-class BCL2 inhibitor and BGB-16673 to be a first-in-class BTK CDAC; BeOne’s internal capabilities to drive innovation to address unmet patient need around the world; the potential of the combination of BRUKINSA and sonrotoclax to treat CLL; BeOne’s positioning for growth; anticipated timing of results from BeOne’s clinical trials of ZS versus VO and BGB-16673; BeOne’s expectations with respect to advancing NMEs into the clinic; BeOne’s ability to achieve greater global scale while maintaining profitability; BeOne’s plans to continue to invest in commercial assets and geographies that drive profitable growth; 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, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing 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. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Contacts Investor Contact Liza Heapes +1 857-302-5663 ir@beonemed.com Media Contact Kyle Blankenship +1 667-351-5176 media@beonemed.com