BRIEF—Oneness' diabetic foot ulcer treatment approved in Taiwan

Oneness Biotech has received approval from Taiwan Ministry of Health and Welfare for the New Drug Application (NDA) for its plant-based topical cream ON101 to treat diabetic foot ulcers.

ON101 is the first approved DFU treatment in almost two decades, rivaling Smith & Nephew's DFU gel Regranex (becaplermin).

The Taipei-based biotech plans to start Phase III studies in the USA in the second quarter of 2021. It is also in talks with five multinationals about a possible licensing deal.

Oneness' parent company Micro Bio will take charge of the Greater China market (mainland China, Hong Kong and Macau), aiming to get the region's approval by the end of 2021.