Why Australia Became a 'Clinical Heaven'... What Is the Reason?

Possible Direct Entry to US and Europe Without Separate FDA Approval
Stepping Stone to Global Expansion

Clinical Trials in Multiethnic Countries Covering Multiple Races at Once
Faster Clinical Progress and Tax Benefits

[Asia Economy Reporter Chunhee Lee] Australia is emerging as a global hub for clinical trials. Thanks to the government's active support in establishing optimal conditions for clinical trials, it also offers attractive elements for entering the global market. Domestic companies are conducting various clinical trials in Australia to expand globally.

According to ClinicalTrials, a global clinical trial information site, there are currently 1,624 clinical trials recruiting patients in Australia.

Last year, more than 1,800 clinical trials were conducted, with 95,000 participants. Australia holds the second largest share in the global clinical trial outsourcing market, following the United States.

The biggest reason Australia is gaining popularity as a clinical trial location is that it serves as a stepping stone for global expansion. Clinical trials conducted in Australia allow direct access to the US and Europe. Without separately applying for Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA), clinical data from trials conducted in Australia can be used to apply directly for approval from the FDA and the European Medicines Agency (EMA).

Recruitment of clinical trial patients is also conducive to globalization. When trials are conducted only in Korea, most participants are East Asians, so separate trials targeting other races such as Caucasians are required for global expansion.

However, Australia is a multiethnic country composed of Caucasians, Blacks, East Asians, Hispanics, and Indigenous Australians, allowing clinical trials involving diverse ethnic groups to be conducted simultaneously. If necessary, trials can also be conducted exclusively on homogeneous groups such as Korean or Chinese descendants.

The speed of clinical trial progress is also fast. Approval takes only about 4 to 5 weeks, and the Human Research Ethics Committee (HREC) review takes an average of 21 days. Speed is a crucial factor in new drug development, where time is life and money. Additionally, biopharmaceutical research and development (R&D) tax incentives provide up to 45% tax rebates.

Based on this background, New South Wales, where Sydney is located, and Victoria, home to Melbourne, have recently emerged as international clinical trial hubs. Domestic companies are actively conducting clinical trials in Australia and increasingly establishing local subsidiaries.

Daewoong Pharmaceutical recently completed Phase 1 clinical trials of the long-acting injectable hair loss treatment ‘IVL3001’, developed in collaboration with InventiGel, in Australia. Furthermore, its new drug development subsidiary, iNt Therapeutics, is conducting Phase 1 trials of the non-opioid osteoarthritis pain treatment drug ‘iN1011-N17’. In April, they announced interim results confirming safety, tolerability, and pharmacokinetic excellence.

Hyundai Bioscience recently established its local subsidiary, ‘Hyundai Bioscience Australia’. Through this, they plan to advance global clinical trials for ‘Polytaxel’, which applies drug delivery system (DDS) technology to the existing anticancer drug ‘Docetaxel’, targeting pancreatic cancer.

Ilias Biologics also leveraged Australia’s clinical environment to become the first domestic exosome company to enter overseas clinical trials in Australia. The Phase 1 clinical trial for the acute kidney injury treatment ‘ILB-202’ after cardiac surgery was approved by the Australian HREC in April.

A Daewoong Pharmaceutical official explained, "Among various countries, Australia is the closest Caucasian country to Korea, and it also offers the advantage of utilizing clinical trials involving diverse ethnic groups," adding, "The procedures are simplified, and it is convenient to conduct clinical trials, which seems to be preferred."

This content was produced with the assistance of AI translation services.