BeOne Medicines Korea said Korea should seek a larger role in global oncology drug development as cancer trials become faster, more complex and increasingly centered on biomarkers, early-stage research and patient access.
At a media forum in Seoul on Tuesday, executives from the global oncology company said Korea remains one of the world’s leading countries for company-sponsored cancer trials, but warned that the country must move beyond simply executing studies and become more involved in development strategy from the early stages.
Lee Eui-kyung, regional communication and patient engagement lead at BeOne Medicines Korea, said the company invests more in clinical research than it generates in sales, underscoring its focus on oncology development.
“We are often asked what percentage of sales we invest in clinical trials, but we are investing a larger amount than our sales in clinical research,” Lee said. “That shows how serious we are about oncology research.”
Lee said BeOne Medicines was founded with the goal of making cancer drug development more integrated and faster, challenging the conventional sequential and fragmented process of clinical development. The company is pursuing oncology research under what it calls a “3G” strategy, with a focus on speed, global development and patient access.
She said most of the company’s clinical studies are run by internal clinical teams, allowing BeOne to improve trial speed, patient recruitment and communication with investigators. According to Lee, BeOne’s timeline from clinical trial initiation to data lock is about 30 percent faster than the industry average.
“Because clinical research costs account for a large part of the price of oncology drugs, this structure provides a foundation for offering new drugs at a more reasonable price,” Lee said.
The company currently has more than 40 clinical trials in phase 3 or under regulatory review, more than 180 global clinical trials underway and about 30,000 patients participating in studies worldwide. Its global R&D team has about 5,000 employees.
Kim Hye-seon, associate director and scientific site engagement lead for clinical operations at BeOne Medicines Korea, speaks on the changing design of oncology clinical trials, where patient selection, safety monitoring and biomarker-based evidence are becoming increasingly important, at a media forum in Seoul on Tuesday. (Credit: Korea Biomedical Review)
Kim Hye-seon, associate director and scientific site engagement lead for clinical operations at BeOne Medicines Korea, said oncology trials differ fundamentally from non-oncology trials because they begin with patients from phase 1.
Kim, a thoracic surgeon who previously treated lung and esophageal cancer patients at Korean hospitals, said many non-oncology phase 1 studies are conducted in healthy volunteers to determine dosing. In oncology, however, investigational drugs are usually tested in patients from the beginning because many cancer drugs carry substantial toxicity and are being developed for serious diseases with urgent treatment needs.
Kim said this means oncology trials often combine research and therapeutic purposes from the earliest stage.
“In oncology, phase 1 is not just a study to determine dose,” Kim said. “It also has a therapeutic purpose from the beginning because it is conducted in patients who need treatment.”
She said the traditional stepwise model of phase 1, phase 2 and phase 3 development is also becoming less clear in oncology. Many studies now combine phase 1 and early phase 2 components, use multiple cohorts and test different patient groups, combinations and treatment settings within a single protocol.
Kim said the change reflects a shift in clinical trial design. In the past, trials mainly asked whether a drug worked. Now, they increasingly ask which patients should receive the drug, at what point in treatment and in what combination.
This has made trial design more complicated, particularly as oncology drugs have evolved from cytotoxic chemotherapy to targeted therapies, immune checkpoint inhibitors, antibody-drug conjugates (ADCs), bispecific antibodies and emerging multi-target approaches.
Kim noted that ADCs opened the way for drugs that act through more than one mechanism, while bispecific and trispecific antibodies are further blurring the line between single-agent therapy and combination-like mechanisms. As drugs target multiple pathways at once, she said, developers must anticipate overlapping toxicities, pharmacokinetic interactions and unexpected safety issues from the earliest stage.
“Fast development alone cannot be called innovation,” Kim said. “Because these studies are conducted in patients, patient safety is the most important factor. Development must be fast, but it also has to be based on sufficient evidence.”
Kim also said endpoints in oncology trials are becoming more diverse. While progression-free survival and overall survival remain central to regulatory decision-making, developers now need to evaluate why a trial succeeds or fails, how each component of a regimen contributes to outcomes and which biomarkers explain patient responses.
Biomarkers, she said, are no longer only tools to confirm whether a patient has a target for a specific drug. They are now used for diagnosis, prediction, prognosis, monitoring and interpretation of trial results.
The expansion of biomarker-based treatment has also changed the role of systemic therapy. Treatments once used mainly in advanced or palliative settings are moving earlier into neoadjuvant and adjuvant settings, where they are combined with surgery or used to improve the chances of curative treatment.
However, Kim warned that earlier use of systemic therapy requires stricter patient selection and ethical consideration. Some patients who could have undergone curative surgery may lose that opportunity if preoperative treatment causes serious toxicity. In such settings, surrogate endpoints such as pathological complete response are increasingly used, but trial results must still be interpreted carefully to separate the effects of preoperative treatment, surgery and postoperative therapy.
Cha Ji-hye, senior manager and scientific site engagement lead at BeOne Medicines Korea, presents Korea’s oncology clinical trial landscape and BeOne Medicines Korea’s local research activities at a media forum in Seoul on Tuesday. (Credit: Korea Biomedical Review)
Cha Ji-hye, senior manager and scientific site engagement lead at BeOne Medicines Korea, said Korea has maintained a strong position in global oncology trials but faces growing competition from other countries.
Citing company-sponsored clinical trial registration data, Cha said Korea ranked fourth globally in 2023 and sixth in 2024. In 2024, Korea conducted 116 oncology trials, a level similar to France and higher than Japan in phase 2 studies, she said.
Lung cancer accounted for the largest share of oncology trials in Korea, followed by breast cancer, biliary tract cancer and colorectal cancer. Korea’s relatively high share of gastric cancer trials is a distinctive feature compared with many Western countries, where prostate cancer and brain and central nervous system cancers account for larger portions of oncology research.
Cha said Korea’s position is especially strong when measured against its population size. However, she added that the country needs to think more strategically about what it can offer global companies and what it wants to gain from participation in global development.
“Korea is already a country that performs clinical research very well,” Cha said. “But global clinical research is changing from simple execution toward participation from the development strategy stage.”
Cha said Korea’s strengths include high medical accessibility, concentration of cancer care in large university hospitals, experienced investigators, strong data quality and the ability of many Korean researchers to communicate in English at global academic and clinical levels.
BeOne Medicines Korea has conducted or is conducting 55 clinical trials in Korea, including 27 ongoing studies. More than 1,300 patients have been enrolled in the company’s Korean studies. Solid tumors account for about three-quarters of the trials.
By phase, the company has conducted 20 phase 1 trials, 15 phase 2 trials and 20 phase 3 trials in Korea. Cha said BeOne has been one of the most active sponsors of phase 1 oncology trials in Korea over the past three years.
The company has 135 employees in Korea, including more than 90 R&D-related staff. Over the past four years, BeOne has invested more than 150 billion won in R&D in Korea, Cha said.
However, she said Korea still faces structural challenges. Large hospitals are concentrated in Seoul and the surrounding metropolitan area, which improves efficiency but raises questions about balanced patient access. Early-stage trials also require substantial time, resources and risk-taking from investigators and institutions.
Cha said Korea needs an environment where skilled professionals at hospitals, research institutions and regulatory bodies can continue building experience without leaving the field.
“To keep Korea strong in global clinical research, researchers and institutions need the capacity to work with companies from the early clinical development stage,” Cha said. “At the same time, practical issues must be addressed so that time and resources can be used efficiently.”
Lee Han-soo
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