Oneness has submitted medical device registration application of Bonvadis for wound care to the Thai Food and Drug Administration (Thai FDA) in Thailand. Effect on company finances and business: (1) New drug name or code: Bonvadis, (2) Purpose: Wound Dressing, (3)Planned development stages-GNA. 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 earlier access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, and Malaysia 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, and South Africa for scar management in European Union.

In order to expand the intended patient population and add multiple indications, have submitted a 510(k) application to the U.S. FDA, and will be followed by the submission of market access applications in countries where plan to market the medical device. Meanwhile, are continuously expanding international business negotiations and clinical trials, collecting feedback from target markets and authoritative physicians to strengthen foothold in the global market. 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 a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/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.