Oneness Biotech Co., Ltd. announced that the Bonvadis, the wound care topical cream has been approved for import of medical device by Thai Food and Drug Administration (Thai FDA) in Thailand with registration number 67-2-2-2-0000197 and permission for market distribution in Thailand. After obtaining official approval or the results the future strategy is to proceed planning for marketing and distribution. Upcoming development plan: Extensions of indications will be applied.

A. Scheduled completion date: The review timeline is subject to the review process regulated by competent authorities in each country. B. Estimate responsibilities: Oneness shall pay the licensor sales royalties according to the licensing contract once the product is put onto the market. Oneness implements dual strategies of both medicinal products and medical devices for development and marketing of wound care products.

Each type of product will comply with corresponding regulatory requirements to get earlier access to the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, Malaysia, and China markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device has been approved with medical device licenses for wound management in the US, India, New Zealand, South Africa and Thailand as well as for scar management in European Union.