BeOne Medicines strengthens clinical-centered role

Expands inegrated Phase 1/2 development... accelerating combination and biomarker strategies

Expandis domestic clinical research... aims to add solid tumor pipeline

BeOne Medicines is accelerating its research through an early-stage clinical-focused anticancer development strategy. As the paradigm of anticancer drug development shifts toward biomarker-based precision medicine, integrated Phase 1/2 development and simultaneous verification of multiple treatment strategies are becoming increasingly common.

In particular, the company is strengthening combination therapy strategies and patient-selection-based development from the early stages while also focusing on expanding its domestic clinical network. According to the company, rather than simply competing on development speed, the focus is on rapidly delivering effective therapies while maintaining patient safety and data integrity.

On the 19th, BeOne Medicines held a media forum in Gwanghwamun, Seoul under the theme “Latest Trends in Oncology Clinical Research and the Current Status and Outlook of Domestic Clinical Trials.” The event was organized ahead of Clinical Trials Day on the 20th.

Presentations highlighted recent changes in oncology clinical research trends, the strengths and challenges of Korea’s clinical trial environment, and the need to expand early-stage clinical research.

Eui-kyung Lee, Regional Communication and Patient Engagement Lead at BeOne Medicines, said, “From the company’s founding stage, BeOne Medicines aimed to create a structure that more rapidly and comprehensively connects drug discovery, clinical development, regulatory approval, and commercialization. In fact, since our in-house clinical team directly manages most of our trials, the time required until database lock is approximately 30% faster than the industry average

She added, “We invest more in clinical research than we generate in sales. Guided by the philosophy that only innovation that reaches patients is true innovation, we are conducting oncology research focused on improving patient accessibility.”

According to BeOne Medicines, the company currently has more than 180 ongoing global clinical trials, with over 40 studies already in Phase III or regulatory review stage. Approximately 30,000 patients are participating in these global trials.

“Boundary between Phase 1 and 2 Is blurring”…Combination and frontline treatment validation begins earlier

Hye-sun Kim, Associate Director, Scientific Site Engagement Lead, Clinical operations at BeOne Medicines Korea

Hye-sun Kim, Associate Director of Clinical Operations at BeOne Medicines Korea, explained that oncology clinical trials are increasingly moving away from traditional phased development structures.

Kim said, “In the past, the process was sequential: determining dose in Phase I, confirming efficacy in Phase II, and then proceeding to confirmatory Phase III trials. Recently, however, integrated Phase I/II designs that simultaneously evaluate multiple patient groups and combination strategies have become increasingly common.”

She continued, “While it was previously common to first obtain approval for monotherapy in later-line treatments before moving it to earlier-line settings, the trend is now shifting toward evaluating c combinations involving chemotherapy, immuno-oncology agents, and targeted therapies from the early stages.”

She also emphasized the growing importance of biomarkers.

Kim stated, “Biomarkers are evolving beyond mere tools for identifying targets to serve as a language that explains outcomes. Today’s clinical trials must simultaneously consider patient selection, risk management, treatment timing, and combination strategies, making their design and operation far more complex than in the past.”

She also noted that the rapid expansion of antibody-drug conjugates (ADCs), bispecific antibodies, and multi-target therapies is increasing the burden of clinical trial design.

“In the past, therapies targeted a single mechanism, but now development involves simultaneously controlling two or more targets or utilizing immune cells. This is an era in which drug-drug interactions, toxicity management, and optimal dose adjustment all need to be considered.”

She added, “Simply moving quickly does not in itself constitute innovation. The key is to rapidly deliver effective treatments to patients who truly need them while maintaining patient safety and data integrity.”

Korea’s strength in early-stage clinical trials highlighted

Jihye Cha, Senior Manager and Scientific Site Engagement Lead at BeOne Medicines Korea

Jihye Cha, Senior Manager and Scientific Site Engagement Lead at BeOne Medicines Korea, said Korea still maintains strong competitiveness in the global oncology clinical trial landscape.

According to Cha, Korea ranked fourth globally in 2023 and sixth in 2024 in terms of company-sponsored clinical trial registration data, particularly maintaining strength in early-stage clinical trials.

Cha said, “Korea’s strengths include rapid patient enrollment, high data reliability, and strong global communication capabilities among investigators. The university hospital-centered healthcare system also enables highly efficient clinical trial execution.”

She added, “The direction of global clinical development is shifting beyond simple trial execution toward involvement from the strategic development stage itself. Investigators and institutions, therefore, need to expand their roles in early-stage clinical research.”

BeOne Medicines is also accelerating the expansion of early-stage clinical trials in Korea, leveraging the domestic clinical environment.

According to the company, it has conducted or is conducting 55 clinical trials domestically, including 20 Phase I, 15 Phase II, and 20 Phase III trials. Currently, 27 studies are ongoing, involving more than 1,300 registered patients in Korea. Solid tumors account for approximately 75% of the company’s domestic clinical portfolio.

In particular, various target- and modality-based pipelines beginning with immuno-oncology therapies are entering Korean clinical trials, and key candidates targeting breast cancer, lung cancer, liver cancer, and gynecologic cancers are preparing to advance into subsequent clinical phases.

Cha explained, “Over the past three years, we have been one of the companies conducting the largest number of Phase 1 clinical trials in Korea. We are expanding clinical opportunities so that as many investigators and institutions as possible can gain experience with promising novel therapies.”

She added, “People sometimes ask why more anticancer drugs are needed when so many already exist, but from the patient perspective, that is absolutely not the case. Even within the same cancer type, biomarkers and treatment responses differ greatly between patients, so more treatment options are still needed.”

BeOne Medicines also stated that it is expanding discussions with Korean biotech companies regarding combination therapies and collaborative research.

A company representative said, “We have held approximately 30 meetings with Korean biotech companies. We are focusing on systematically expanding domestic R&D synergies primarily through licensing-in opportunities.”