General manager of Oneness Biotech, Ms Chih-Hui Cheng, said yesterday that the FDA 510K approval for wound care topical creamm represents the success of the dual strategyto enter the U.S., and is also of great significance to global market access. As for the drug, the original plan is to apply for a new drug application (NDA) in 2025. As for the authorisation, although the North American draft agreement was obtained at the end of last year, the partner hopes to receive written confirmation from the FDA on the NDA requirements first, so the objective of one-NDA-per-year will not be achieved.

The company's earnings call indicated that its products have now been expanded to six items, including five new drugs and one medical device. In the third quarter, the clinical trials of FB825 and FB704A were affected by Covid-19, and in order to avoid affecting the trial results, the pace of recruitment was deliberately slowed down.

However, Bonvadis, a topical cream for the treatment of diabetic foot ulcers, received 510K approval from the FDA in late August, which is the first step towards the dual strategy in the US market and is of even greater significance for global market access. The first stage of application will be made to New Zealand, India, South Africa and Australia. Oneness is currently analysing the regulatory and examination process of each country and will submit the application after confirmation.

In response to the impact of the global pandemic and the FDA's recommendations on NDAs, the number of trial centres will increase to 30 in the first half of 2023, accelerating the receipt of cases and meeting the original 2025 NDA submission schedule. For the market in China, Oneness is in the final stages of the process and have already submitted sufficient documentation to meet all requirements on a scientific basis.

The company has also communicated with the FDA several times, but the one-year licensing cannot be completed.

As for the new nucleic acid drug SN812, it was finally approved for Phase I clinical trial in the US this month and the final subject visits are targeted to be completed in January next year. After the first intake of healthy persons, an application will be submitted to the FDA for use in patients. After consent is granted, a new treatment group 1c will be added to observe the clinical effects of the drug in Covid-19 infected persons.