Oneness was notified that Bonvadis, the wound care topical cream has obtained import license in New Zealand. Regulatory Agent in New Zealand has notified Oneness that Bonvadis, The wound care topical cream has been approved for import of medical device by regulatory authority MEDSAFE in New Zealand, registration number is 230224-WAND-70Q5KB and allowed for market distribution in New Zealand. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: After obtaining official approval or the results (include interim analysis) which are statistically significant, the future strategy: To proceed planning for marketing and distribution.

Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. Upcoming development plan:Ext extensions of indications will be applied. Scheduled completion date: The review timeline is subject to the review process regulated by competent authorities in each country.

Estimate responsibilities: Oneness shall pay the licensor sales royalties according to the licensing contract once the product is put onto the market. Market: Bonvadis has been approved under medical device regulation in New Zealand which is the 2nd approval in advanced countries. The approval in New Zealand, one of the leading countries in APAC region for medical device regulation, will help global market entry and commercialization strategy of Bonvadis.

Oneness implements dual strategies of both medicine products and medical devices for development and marketing of wound care products. Each type of product will comply with corresponding regulatory requirements to get quick access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan and Singapore markets, as well as under the process of pre-market reviews or preparation of submissions for other countries.

Bonvadis topical cream as a medical device has been granted with market approvals for the US, India and New Zealand markets, and planning of market access with medical device submissions at other countries are ongoing.