Oneness Biotech Co., Ltd. has submitted a 510(k) application to the U.S. FDA to expand the intended patient population and add multiple chronic wound indications for Bonvadis. 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.

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 as a medical device for wound management has been granted with market approvals for the US, India, and New Zealand, and for scar management in European Union. This 510(k) application to the U.S. FDA to expand the intended patient population and add multiple indications, will be followed by the submission of market access applications in countries where the company plan to market the medical device. According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application.

It takes considerable time and expenses to develop a new drug of which success can't be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions.