The second Phase III clinical study was approved by US Food and Drug Administration (FDA) on 3rd March 2018 for the new drug ON101 which is indicated for the chronic diabetic foot ulcer and developed by Oneness Biotech. ON101 is the first new drug in Taiwan with two Phase III clinical studies approved by US FDA.
Oneness Biotech stated that two phase III clinical trials must be carried out in accordance with the USA guideline of marketing authorization of new drug. ON101 has been researched and developed since 2008 and it is the first drug in Taiwan with two Phase III clinical studies approved by US FDA.
The interim analysis of the first phase III clinical study conducted in Taiwan had been completed and the results has reached a significant efficacy index. It is preparing to apply for a new drug registration (NDA) to the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare. At the same time, a Phase III clinical study has been approved by the State Food and Drug Administration (CFDA). The patient population for this phase III clinical study is mainly Asian ethnicity.
Oneness Biotech pointed out that the second phase III clinical study approved by US FDA is also a multi-regional clinical trial design (MRCT). The same protocol will be submitted to the EU for review. Oneness will conduct this Phase III clinical study in the US and EU simultaneously to accelerate the launch of ON101 new drugs on the global market.