Matt Shaulis, General Manager for North America at BeOne Medicines, discusses the company’s rapid rise as a global oncology leader and its growing impact in the US. He explains how BeOne’s fully integrated research, development, and manufacturing model is transforming the way new cancer therapies are discovered and delivered. Shaulis also highlights the success of Brukinsa, the company’s leading BTK inhibitor, the early momentum behind its first immuno-oncology therapy, Tevimbra, and BeOne’s deep pipeline of next-generation treatments across multiple cancer types.
Bringing extensive leadership experience across speciality pharma and large multinationals, with a strong background in oncology, what attracted you to join a relatively new player in global pharma such as BeOne Medicines?
It was really a combination of factors that made joining BeOne Medicines an easy decision. First and foremost, the company has visionary leadership. Our co-founder, chairman and CEO, John V. Oyler, has established a highly differentiated business model. BeOne is a fully integrated global oncology leader – driven by scientific excellence and exceptional speed. We are built around strong internal research and discovery capabilities that allow us to be highly innovative, move quickly, operate with a cost advantage, and bring more molecules to proof of concept. Importantly, we generate rich data at that stage, which then enables more informed decisions about which molecules are likely to be winners.
When a molecule shows promise and advances into development, it is supported by our global clinical development organisation, which operates largely CRO-free and spans the US, Europe, Australia, China, and other global sites. This structure gives us the confidence to pursue bold approaches, like superiority trial designs, in a way that many competitors may not attempt. Our global medical affairs and commercial teams are also designed to move with speed and precision, delivering maximum impact. That integrated model and innovative ambition were major draws for me.
I have spent more than two decades leading cross-functional and commercial teams across organisations such as Pfizer, Teva, Cephalon, and J&J. More recently, I served as President of the US and Chief Commercial Officer at Hansa Biopharma, a commercial-stage biopharmaceutical company. Before that, I held the roles of President of Immunology for Europe and Asia, and eventually, President of North American Oncology at Pfizer. Across large pharma, mid-sized companies, and biotech, I have seen great science and excellent execution, and I believe BeOne sits in the sweet spot between them. We have the capital and scale to do things right while remaining agile and entrepreneurial enough to move quickly.
On a personal note, I also have a deep connection to oncology. My mother was diagnosed with stage IV metastatic breast cancer, HER2-positive, and was treated with trastuzumab. Thanks to that innovation, we had nine more years with her. That experience reinforced for me the real and lasting impact that scientific progress can have on patients and their families. I’m excited to be part of the clear focus on oncology and the commitment to doing things differently that BeOne has.
As General Manager for North America, what is the significance of the US within BeOne’s global operations across commercial, R&D, and manufacturing activities?
We are deeply committed to serving patients not only globally but also here in the US, which is our largest and fastest-growing market. North America plays a central role in BeOne’s overall operations, with nearly 2,000 colleagues contributing to a global team of nearly 12,000. Across the region, we are addressing some of the most challenging cancers across blood, lung, breast, and gastrointestinal areas. While we operate regionally, we remain very much part of a unified global organisation focused on delivering impact for patients.
In the US, our footprint spans coast to coast, from our biologics and clinical R&D hub in Hopewell, New Jersey, to our biomarker laboratory in San Carlos, California. These facilities allow us to advance research, development, and innovation while also strengthening our domestic supply chains.
A great example of this integration is our end-to-end US manufacturing for our flagship blood cancer medicine, Brukinsa. It is produced in Kentucky and Missouri and packaged in Illinois and Pennsylvania. This illustrates just how central our US operations are to BeOne’s global network and to ensuring reliable access to innovative therapies for patients everywhere.
As BeOne’s fastest-growing brand, can you tell us about Brukinsa and the breadth of its impact on patients?
Our integrated R&D model has truly delivered on innovation, and Brukinsa is a prime example of that success. As an internally discovered, next-generation medicine, Brukinsa was designed to transform the standard of care for patients with B-cell malignancies in the US. It has become the number one prescribed Bruton’s tyrosine kinase (BTK) inhibitor in the US and the fastest-growing brand in its class, serving as the backbone of our haematology franchise.
Its best-in-class profile has driven rapid adoption, and it has become the leading BTK inhibitor in the US. We continue to expand our value and market share leadership despite competing with well-established products from major pharmaceutical companies. We are incredibly proud of the trust we have earned from physicians and patients alike, and of the fact that Brukinsa is the only BTK inhibitor approved by the FDA across five haematology-oncology indications, reaching more than 240,000 patients worldwide.
Marking BeOne’s entry into immuno-oncology in the US, how has the 2024 launch of Tevimbra progressed so far?
Tevimbra is another great example of BeOne entering a highly competitive market with a molecule that stands out through our unique scientific and clinical development model. It is the first medicine to emerge from our in-house immuno-oncology program and a differentiated PD-1 inhibitor. Tevimbra is now approved in 48 markets, including three FDA approvals in the US within one year. Globally, Tevimbra has reached more than 1.8 million patients.
In the US, we are seeing strong early momentum, with 22% sales growth last quarter and more than a thousand vials delivered as oncologists continue to learn about its scientific differentiation and clinical value. Looking ahead, we are focused on solidifying Tevimbra’s position in the early-line setting and advancing both monotherapy and combination approaches. We see this PD-1 inhibitor as a foundational therapy signifying BeOne’s long-term commitment to oncology and playing a key role in our broader solid tumour pipeline.
BeOne has an impressively broad portfolio of more than 40 clinical and commercial-stage assets. Which late-stage programs are you most excited to bring to the US in the near future?
Our capabilities are enabling us to advance one of the industry’s deepest oncology pipelines, creating more opportunities to bring new treatments to patients. We now have over 1,200 scientists and more than 45 clinical and commercial stage assets spanning blood, lung, breast, gastrointestinal, and rare cancers.
In haematology, Brukinsa is just the beginning. We are building a long-term, multi-product CLL leadership franchise designed to deliver best-in-class or first-in-class treatment options across lines of therapy and patient risk groups. A key part of that strategy is sonrotoclax, an investigational, next-generation BCL2 inhibitor that recently received FDA Breakthrough Therapy designation. The data show potential for sonrotoclax to become the first BCL2 inhibitor approved for the treatment of a specific type of rare B-cell lymphoma. It is a more selective and faster-acting molecule than first-generation BCL2s, which could potentially simplify monitoring, streamline dosing schedules, and favourably impact safety.
We are also evaluating sonrotoclax in combination with Brukinsa in Phase III studies. This is an approach that we believe has the potential to positively impact frontline care for patients with B-cell malignancies.
I am also excited about our BTK degrader, one of the most advanced in clinical development. It has the potential to be both first- and best-in-class, designed to overcome treatment-emergent resistance mutations and offer mechanistic advantages over existing non-covalent BTK inhibitors.
Looking ahead, both of these molecules represent major opportunities for us. In the near term, sonrotoclax is expected to be the next to reach the market.
CEO John V. Oyler has championed an approach of “fast breakthroughs and broader access,” emphasising that where patients live should not determine what medicines they can access. How do you translate this philosophy into practice in the US, where payer dynamics and access barriers are particularly complex?
Pursuing patient access looks different in every country and region, and just as elsewhere, ensuring broad access within the US remains central to who we are. We firmly believe that every patient deserves high-quality, impactful medicines, regardless of where they live or their circumstances.
Our commercial strategy goes well beyond simply launching breakthrough therapies. We work closely with healthcare systems and partners across the US to identify and remove barriers to treatment, accelerating access and ensuring that our global mission translates into real, measurable impact for patients here at home.
A good example of this is our myBeOneSupport program, which can help eligible patients in North America address access challenges. This program can help guide patients through their care journeys and help them manage financial, educational, and emotional support needs.
We also recognise the importance of partnerships in advancing broad access. We collaborate with more than 60 US patient advocacy groups, including Blood Cancer United, CLL Society, Lymphoma Research Foundation and many more. These partnerships serve to expand education, promote biomarker testing, and ensure that innovation reaches the patients who need it most.
What is your approach to building a culture within the North American organisation that positions BeOne as both a credible healthcare partner and a patient-focused innovator?
Our name, BeOne, reflects both our purpose and our culture. “Be” represents our commitment to helping patients live free from cancer. Meanwhile, “One” symbolises our belief in bringing together multiple stakeholders across the organisation and the broader healthcare ecosystem to work collectively towards that goal.
A major part of our culture is fostering cross-functional collaboration within the organisation and building strong partnerships across the wider cancer community. This means working closely with academic experts, community oncologists, nurses, patient advocates, and policy leaders. Together, we are all united by a shared focus on improving outcomes for patients.
We are proud to be seen as a trusted partner within the healthcare ecosystem, and we have strategic collaborations with leading companies such as Amgen, Pfizer, and Novartis that share our patient-centric vision and commitment to transformational science.
Last year alone, we delivered 13 new medicines into the clinic. We’ve conducted more than 170 trials and reached over 1.8 million patients globally with our medicines. These achievements demonstrate how our collaborative culture directly translates into real-world impact, and this is only the beginning.
As General Manager during this exciting period of growth and development for BeOne Medicines, what are your priorities in the US and North America for the coming years?
We are at a truly exciting inflexion point for BeOne Medicines. After 15 years of sustained investment in research, development, and manufacturing, we are now reaching full scale. The goals for the next three to five years look very different from those of the past. We are highly focused on growth, expansion, and impact.
We will continue to scale our operations while targeting some of the world’s deadliest cancers in blood, lung, breast, and gastrointestinal areas. The coming years will bring further investment in domestic manufacturing, more clinical trials, expanded partnerships, and a continued commitment to ensuring that every patient, no matter where they live, can access our medicines.
I am incredibly energised by our team, our science, and the momentum we have built. We are advancing one of the industry’s deepest pipelines, including next-generation modalities such as bispecific antibodies, protein degraders, and ADCs. These are the innovations which will play a defining role in shaping the future of oncology. We are now in the position to see the full benefit of the last 15 years of foundational investments translate into an even greater scale of impact for patients.
What final message would you like to share with the US and global healthcare and life sciences community on behalf of BeOne?
We are at an extraordinary moment in cancer treatment innovation. The data emerging from new therapies, technologies, and targets show greater potential than ever before to improve patient outcomes. But none of us can do this alone. Cancer is far too complex for any single company or country to solve in isolation. It takes the entire ecosystem of patients, providers, policymakers, and partners, all moving together with urgency and purpose.
At BeOne, we see ourselves as part of this broader community of scientists, advocates, manufacturers, and healthcare leaders working to deliver life-changing medicines to more patients. That is what drives us every day. Bold science, deep partnerships, and a shared belief that, together, we can redefine what is possible for people living with cancer.
