Interview with Beigene: Partnering with Korea for Innovative Cancer Treatment

A company that has rapidly established itself in the oncology sector within just a decade, competing among global big pharma with decades of history, is BeiGene, a global leader in the development of new cancer treatments.

BeiGene has successfully developed and commercialized treatments for both solid and blood cancers, such as the anti-PD-1 immunotherapy "Tislelizumab" and the BTK inhibitor "Zanubrutinib," expanding its global influence.

BeiGene began to show serious interest in the Korean market in 2019, establishing a local branch that year and launching clinical research in 2021. In 2022, BeiGene opened its office and has since conducted over 37 clinical trials in Korea, demonstrating vigorous research activity.

In this context, the company participated in the BIO KOREA 2024 event held in Seoul on June 8, where it showcased its R&D capabilities, key pipelines, and ongoing partnership efforts. Beyond the presentation, the company also discussed collaboration opportunities through partnership meetings with South Korean pharmaceutical and biotech companies.

Hit News interviewed Mark C. Lanasa, Vice President and Chief Medical Officer of BeiGene's Solid Tumor Division, at the event. The discussion covered the objectives and expected outcomes of the partnership meetings, the future role of Tislelizumab, which is rapidly progressing through the domestic reimbursement process, and other related topics.

"2024 is a monumental year for BeiGene as ten substances from our R&D pipeline are entering the clinical stage. In this regard, I believe South Korea is a very important country for BeiGene's continued new drug development.

In fact, it has been less than three years since we established our Korean subsidiary, and we already have 37 clinical programs underway in South Korea.

The reasons for this are South Korea's excellent healthcare system, proactive government support, high-quality hospital facilities and services for clinical research, and the world-class capabilities of its researchers.

BeiGene has gained significant insights from Korean medical professionals, from the design to the execution of clinical studies conducted in South Korea.

Additionally, we have identified unmet medical needs among real patients suffering from upper gastrointestinal or esophageal cancers, which are prevalent in East Asia. We design studies with excellent Korean researchers and share rich interpretations of the data obtained from these studies.

In summary, South Korea is a crucial partner for BeiGene throughout the entire cycle of our clinical trial development program, from early Phase I to late Phase III stages."

"About 100 South Korean companies applied for the partnering meetings, and we had one-on-one meetings with 11 of them. These companies possessed a variety of platform technologies, including small molecules, antibody-drug conjugates (ADCs), monoclonal antibodies (mAbs), and bispecific antibodies (bsAbs).

Typically, partnerships between companies tend to focus on commercialization after development. However, BeiGene is more focused on the R&D stage. We are looking for companies that share the same 'values' as us.

BeiGene already has a well-developed and rich pipeline. Some might ask if there is a need to seek new partnerships externally. However, BeiGene believes in the philosophy of 'doing everything we can to provide more beneficial treatments to patients' and views no pipeline as perfect at its current level.

BeiGene takes great pride in expanding access to excellent medicines globally. This expansion of access means developing and disseminating substances that achieve the highest level of innovation, not just creating similar existing medicines. We are looking for companies that can collaborate with us to expand global access based on the most innovative science.

For example, we evaluate the potential of substances or products by analyzing their biological properties, mechanisms, types of technological platforms used, and the quality of clinical data.

It is also important that the substances, targets, and mechanisms complement our pipeline portfolio. We are particularly interested in substances with high potential for combination therapies.

However, we do not have a limited perspective based on specific criteria. We are interested in any new technology or mechanism that complements our current targets or key areas of focus."

"Tevimbra is designed with differences in antigen binding properties and response kinetics compared to earlier drugs like Keytruda (pembrolizumab) and Opdivo (nivolumab). Currently, in South Korea, it is approved for second-line treatment of adult patients with esophageal squamous cell carcinoma (ESCC).

Tevimbra is a monoclonal antibody (mAb, IgG4) that binds to the PD-1 immune checkpoint receptor. Studies have shown that it more effectively blocks the binding of PD-1 to PD-L1, maintaining binding 30 to 80 times longer than competing products.

While it is true that the approved indications of immunotherapies often overlap, the robust data and recognition from oncology specialists for Tevimbra give us a great deal of pride.

To highlight data from the key RATIONALE-302 clinical trial, Tevimbra showed over two months of survival benefit in the overall survival (OS) primary efficacy endpoint compared to the monotherapy group with cytotoxic chemotherapy. These results were both statistically and clinically significant.

Additionally, health-related quality of life (HRQOL) is an important evaluation metric, and Tevimbra was rated better due to fewer side effects compared to the control group.

The results of the RATIONALE-306 study, evaluating the safety and efficacy of Tevimbra as a first-line treatment, are set to be presented at this year’s American Society of Clinical Oncology (ASCO) meeting. Given the highly significant results, we plan to submit approval applications and undergo review processes in major countries.

Moreover, a Phase III trial is underway, with patient enrollment completed, to assess the combination therapy of Tevimbra and the TIGIT inhibitor Ociperlimab in patients with high PD-L1 expression."

“As mentioned earlier, South Korea offers a highly favorable environment for global clinical research and product development. In terms of submitting regulatory review materials, South Korea was one of our top-priority countries.

Additionally, the prevalence of ESCC is higher in East Asia compared to North America and Europe. Tevimbra has already been well-received in China, where it has been widely prescribed with high satisfaction from both healthcare providers and patients, establishing itself as a market leader.

We believe that Tevimbra can also become the best treatment option in South Korea, which led us to swiftly decide to pursue approval here."

"BeiGene does not consider the development of a specific immunotherapy as the final point. We view it as a foundational step towards further developing various combination therapies in key cancer types. Our ultimate goal is to achieve best-in-class status by combining our immunotherapies with other developing treatments, such as ADCs.

Our hematologic cancer pipelines are slightly closer to commercialization compared to our solid tumor programs. 'Sonrotoclax,' a BCL2 inhibitor, has shown promising efficacy in both preclinical and early clinical studies, aiming to achieve best-in-class status like Brukinsa.

Sonrotoclax is currently in a Phase III clinical trial for first-line treatment of chronic lymphocytic leukemia (CLL) in combination with Brukinsa. It is also being studied for acute myeloid leukemia (AML) and multiple myeloma.

Additionally, we are developing BTK-CDAC for patients whose disease has progressed after BTK inhibitor therapy. CDAC degrades target proteins through ubiquitination, offering an ideal approach to overcome various mutations.

BeiGene has unique capabilities in the R&D of ADCs, as well as their manufacturing and production. This is a distinct characteristic even among global pharmaceutical companies.

We are also interested in mRNA and are conducting direct research, along with research programs through partnerships. While it is difficult to disclose specific targets at this stage, we anticipate starting clinical research around next year."

"In the future of cancer research, the degrader field is expected to be significantly important. In this diverse field, BeiGene aims to lead in related research.

Additionally, mRNA will be a means to target previously inaccessible areas.

Furthermore, immune-conjugates or T-cell-like molecules will act similarly to immune cells, stimulating the immune system overall or specific parts to achieve meaningful therapeutic benefits.

Although it is uncertain whether these areas will reach the clinical stage, we believe it is crucial to explore all possibilities and review various targets and mechanisms."

"We are deeply grateful for the opportunity to engage in discussions with potential partners in South Korea through this partnering session and meetings.

BeiGene seeks to form partnerships with companies that have innovative mechanisms and targets. If there are companies aiming to develop best-in-class and first-in-class medicines, we believe we would be a very attractive partner candidate.

BeiGene's ultimate goal is to contribute to as many patients as possible. We aim to be a trustworthy partner for companies that share this goal. Additionally, we hope to contribute to the Korean market by developing and launching our key products in a timely manner.

To achieve all of this successfully, we believe that building strong personal relationships is crucial. Therefore, we look forward to having many conversations with members of the Korean industry in the future."