Pulmogine, a vibrating mesh nebulizer developed by HCmed, was included in the Australian Register of Therapeutic Goods (ARTG) on April 2022. With the approval granted, HCmed would be able to assist more pharmaceutical companies to conduct clinical trials focused on the development of inhalation drugs in Australia.
According to statistics, the global inhalation drug market is expected to reach 41 billion US dollars in 2026. The COVID-19 pandemic has driven demand growth for respiratory treatment drugs during the past two years. Moreover, different forms of inhalation drugs have pushed the demand for more efficient drug delivery platforms, with vibrating mesh nebulizers attracting the market’s attention as they are able to aerosolize biologic therapeutics such as protein drugs and RNA. Pulmogine has already received CE marking and approvals from Taiwan’s TFDA, Brazil’s INMETRO/ANVISA, China’s NMPA and US FDA 510(k).
HCmed’s CEO, Jason Cheng, mentioned, “Australia has a simple and efficient regulatory pathway for clinical trials and is recognized for the high quality of its scientific and medical research. Moreover, the Australian government offers generous incentives that encourage more investments in clinical trials. These qualities of the Australian environment make the country an ideal place to conduct clinical trials. HCmed is currently under discussions with some potential partners that are planning to conduct Phase I study in Australia." Besides providing a platform that is CE marked and FDA cleared for Pulmogine, HCmed expects the latest inclusion in the ARTG to strengthen the relationship with its partners and attract more pharmaceutical companies that are interested in developing inhaled formulations.
