Summary of the Article: South Korean Biotech Firms Increasingly Favor Overseas Clinical Trials
This article details a growing trend of South Korean biotechnology and pharmaceutical companies conducting clinical trials outside of Korea, primarily in the US and Australia, despite wanting to eventually market their products domestically.Here’s a breakdown of the key points:
Why the Shift?
High Regulatory Barriers in Korea: The Korean FDA (KFDA) requires extensive pre-clinical data (animal toxicity, safety, effectiveness) before allowing clinical trials to begin. This is a notable hurdle.
FDA & EMA Adaptability: The US FDA and European Medicines Agency (EMA) allow clinical trials to start with less initial data, with the option to submit further facts as the trial progresses. They also have specialized review systems for advanced therapies.
KFDA’s Repeated Requests: companies report facing constant requests for supplementary data from the KFDA, even after initial clinical plans are accepted.Examples of Companies & Treatments:
kolon Life Science: Focusing US trials for spinal indications and neuropathy pain gene treatment (KLS-2031) after facing difficulties in Korea following a license cancellation in 2019.
Gobioslab: Conducting Phase II psoriasis trials in the US and Australia.
Bionia & Olix: Running Phase 1 trials for pulmonary fibrosis and hair loss treatments, respectively, in Australia.
TPD (Protein Decomposition System) Companies: Seeking FDA approval before domestic entry.
Challenges of Overseas Trials:
Patient Recruitment: Difficult to find and enroll local patients.
Complex Processes: Clinical analysis is more complicated in foreign countries.
High Costs: Contracting with global Clinical Research Organizations (CROs) is expensive (e.g., 30 billion won for 40 patients in the US).
Technology Transfer Issues: Lack of Korean clinical/approval history can hinder technology transfer deals.
Impact on Korea’s Position:
Falling Global Trial Share: Korea’s ranking in global clinical trial share has dropped from 4th to 6th in the last year.
Seoul’s Ranking Threatened: While Seoul is still a major clinical trial hub, its second-place ranking is threatened by Beijing, China.
Loss of Benefit: Taxpayer-funded drug progress is ultimately leading to approvals and commercialization outside of Korea.
the article paints a picture of a Korean biotech industry frustrated by domestic regulations and increasingly looking to international markets to advance their drug development programs. The author emphasizes the urgent need for regulatory reform in Korea to attract and retain clinical trials and foster a thriving domestic biotech sector.
