【Health Korea News / Reporter Seo Jung-pil】 Korea is emerging as a key clinical development hub in Asia for Australian contract research organizations (CROs). The trend reflects a combination of external factors, including the rapid growth of China's biotechnology sector and U.S.-China decoupling, along with Korea's strong clinical trial infrastructure.

Korea has accumulated extensive experience in multinational clinical trials, supported by broad patient access, specialized clinical research professionals, and well-established clinical trial center (CTC) capabilities. These strengths are positioning Korea as a critical link in the global development pathway for China-originated drug candidates. These factors are driving growing interest among Australian CROs in the Korean market.

Avance Clinical Establishes Asian Operations Hub in Seoul

According to industry sources, Avance Clinical is currently one of the Australian CROs showing the strongest interest in Korea. The company has already established an Asian operations headquarters in Seoul and built a multinational clinical trial network connecting China, Taiwan, Korea, and North America.

Avance Clinical's strategy is to rapidly conduct early-stage clinical trials in Australia for drug candidates discovered in China and other Asian markets, before expanding patient-based clinical trials to major Asian countries, including Korea and Taiwan. The company aims to shorten the global development pathway from early safety evaluation to later-stage development.

Ben Edwards, chief operating officer (COO) of Avance Clinical, said ahead of his participation in 'BIO Asia–Taiwan 2026' that "for drug candidates discovered in Shanghai and Beijing, we will rapidly complete first-in-human (FIH) studies in Australia and then conduct multinational patient trials across Korea and Taiwan, utilizing Seoul as a central hub."

At the BIO International Convention held last month, Edwards also stated that Avance Clinical plans to utilize its Seoul office not simply as a clinical execution branch, but as a control tower coordinating patient trials and development stages across Asia.

Novotech Expands Clinical Trial Network Across Korea

Novotech, regarded as one of the leading full-service CROs in the Asia-Pacific region, is also accelerating the expansion of its clinical trial network in Korea. Based at its Seoul office, the company is strengthening domestic clinical trial capabilities by expanding partnerships with major hospitals in the Seoul metropolitan area as well as regional tertiary hospitals.

Patient recruitment speed is one of the key factors biotech companies consider when selecting a CRO. To improve recruitment efficiency, Novotech established a strategic partnership with Wonju Severance Christian Hospital in March, creating a framework for rapid clinical trial initiation when needed.

The company is also working to build a "one-stop clinical trial pipeline" connecting early- and late-stage development. Through its subsidiary clinical trial support organization (SMO) Acrostar, Novotech signed a three-party agreement with Kyungpook National University Hospital in March 2025.

Under the model, early safety studies are completed at an advanced clinical trial center operated by its Australian headquarters, followed immediately by late-stage clinical trials at Kyungpook National University Hospital and Chilgok Kyungpook National University Hospital. The strategy is designed to reduce the time and cost required to establish new clinical trial sites at each stage of development.

In June, Novotech further expanded its Korean clinical network by strengthening research cooperation with Asan Medical Center for high-difficulty early-phase clinical trials (Phase 1/2).

China Biotech Growth and U.S.-China Tensions Reshape Global Clinical Trial Landscape

The growing interest of Australian CROs in Korea is closely linked to the rapid growth of China's biotechnology sector and changes in the global drug development environment driven by U.S.-China tensions.

Chinese biotech companies have recently produced a growing number of competitive drug candidates. However, as U.S.-China tensions intensify, relying solely on clinical data generated in China has become increasingly challenging when seeking approvals from global regulators such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

As a result, Korea, which is geographically close to China and has internationally recognized clinical development capabilities, is emerging as an alternative hub connecting China-originated drug candidates with global development programs.

World-class digital clinical infrastructure is another key factor driving Australian CROs to seek opportunities in Korea. Korea is among the fastest countries in the world in adopting electronic medical record (EMR) data standardization and decentralized clinical trials (DCTs). When combined with the structured clinical trial center (CTC) infrastructure of major hospitals, these capabilities are expected to further improve the quality of clinical data submitted to global regulatory authorities such as the FDA and EMA.

Industry analysts expect the trend of overseas CROs expanding their presence in Korea to accelerate as the pipeline of China-originated drug candidates grows and demand for high-quality global clinical trials increases.