Korea key to Gilead’s new drug development

From single-tablet and curative therapies to ADCs and CAR-Ts targeting unmet needs

Partnerships with Yuhan and Samsung Biologics span manufacturing...Efforts also focus on treatment access and public awareness

Korea takes part in 6 out of every 10 global oncology clinical trials conducted by Gilead.

Marking its 15th anniversary, Gilead’s Korean affiliate plans to expand the participation of Korean investigators and patients in clinical research while continuing to build partnerships needed to bring new medicines to patients.

Gilead Sciences Korea held a press conference on Sept. 22 to review its achievements in Korea and outline its future R&D direction. The company said its focus is on developing new options for diseases where existing treatments fall short and improving patient access to treatment.

From Hepatitis and HIV to Oncology...Targeting areas with limited treatment options

Since its establishment in 2011, Gilead Sciences Korea has introduced 12 treatments in Korea across liver diseases, HIV, fungal infections and oncology. Its R&D efforts, which began with viral diseases, have expanded into oncology, while development is also underway in inflammatory diseases with limited treatment options.

In HIV, the shift from regimens requiring multiple medications taken at different doses and times to single-tablet regimens was highlighted as an advance that has reduced the treatment burden.

Joo-yeon Lee, Country Medical Director at Gilead Sciences Korea, said, “Patients faced a considerable burden because they had to take multiple medications, each according to its own dose, administration instructions and schedule, HIV, which was once a life-threatening disease, is now regarded as a manageable chronic condition.”

Excerpt from Gilead Sciences Korea presentation

In hepatitis, the company highlighted the advent of curative treatment for hepatitis C and advances in overcoming drug resistance and reducing the risk of long-term complications in hepatitis B.

Lee said, “In the past, treatment goals for hepatitis B centered on changes in liver function markers or serum markers. Today, treatment has evolved toward reducing liver-related events such as liver cancer.”

In oncology, the company highlighted triple-negative breast cancer and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In triple-negative breast cancer, antibody-drug conjugates (ADCs) have opened the way for a new targeted approach that delivers anticancer agents directly to cancer cells.

For DLBCL, CAR-T therapy was presented as offering a new treatment opportunity for patients whose disease has relapsed or failed to respond to existing therapies.

Lee said, “With a single administration, we can even hope to achieve a cure, We cannot say that every patient will be cured, but this represents a change that has improved the potential for cure and survival compared with what was previously possible.”

Korea takes part in drug development and supply...emphasizes clinical trials and manufacturing partnerships

Jae-yeon Choi, General Manager of Gilead Sciences Korea, identified tackling diseases with limited treatment options and changing existing standards of care as key drivers of the company’s growth. She also described improving the treatment environment for patients and people living with infectious diseases, as well as their families and communities, as part of the company’s role.

Choi said, “We made a commitment to break through in some of the most challenging therapeutic areas, where treatment options are most limited. We have continued to take on the challenge of going beyond existing therapies and changing the standard of care.”

The Korean affiliate has steadily expanded its participation in Gilead’s global drug development programs. According to company figures, Korea participates in about 43% of Gilead’s global clinical trials, enabling Korean investigators and patients to take part in new drug research from the development stage.

Excerpt from Gilead Sciences Korea presentation

Choi said, “More than 40% of our workforce of fewer than 100 employees consists of professionals dedicated to R&D. In oncology, Korea participates in 60% of our clinical trials.”

Manufacturing partnerships in Korea predate the establishment of the local affiliate. According to Choi, Gilead has worked with Yuhan in the active pharmaceutical ingredient (API) field for more than 30 years, while Samsung Biologics supplies antibodies used in the production of oncology ADCs.

The company also emphasized collaboration with healthcare professionals and patient communities in getting treatments to patients after development and manufacturing. The aim is not simply to supply medicines, but also to address the challenges patients and their families face throughout the treatment journey.

Jae-yeon Choi, General Manager of Gilead Sciences Korea

Choi said, “Even after all the work that goes into developing a treatment, bringing it to patients requires partnerships across many fronts. We have long contemplated how we can create a better treatment environment, from the families of patients and people living with infectious diseases to the broader community.”

The company’s publication of a children’s book for children with family members undergoing cancer treatment also grew out of these efforts. The initiative is intended to ease the anxiety and emotional difficulties children may experience during a family member’s treatment and help families and their broader communities navigate the treatment journey together.

In HIV, the company identified changing public perceptions of people living with HIV as another priority. Gilead continues to work with multiple partners on its Red Period campaign, aimed at reducing misconceptions and stigma surrounding people living with HIV.

Choi said, “If the past 15 years were about expanding what is possible in treatment through scientific innovation and collaboration with a wide range of partners, the next 15 years will be about more firmly translating the benefits of that innovation into better treatment and meaningful changes in the lives of more patients.”