NEWS

  1. Product:Bonvadis for wound care
  2. Mass production date:NA
  3. Effect on company finances and business:
     (1) New drug name or code:Bonvadis
     (2) Purpose:Wound Dressing
     (3) Planned development stages：NA
     (4) Current development stage:
         A. File application/approved/disapproved/Each of clinical trials (include interim analysis):Oneness received a notification by regulatory agent inThailand, today we have submitted a medical device registration application of Bonvadis for wound care to the Thai Food and Drug Administration (Thai FDA).
         B. Once disapproved by competent authority or each stage of clinical trials (including interim analyses) results in a less than statistically significant sense, the risks and the associated measures the Company may
         face:NA
         C. After obtaining official approvals, the results of clinical trials (include interim analyses) which are statistically  significant, an occurrence of other newly impacted development of a medicinal product or the future  strategy of the management direction of the company:NA
         D. Accumulated investment expenditure incurred:No disclosure in considerations of future marketing strategies.
    (5) Upcoming development plan:
         A. Scheduled completion date:The review timeline is subject to the review process regulated by the competent authority in each country.
         B. Estimated responsibilities:Oneness shall pay the licensor sale royalties according to the licensing contract once the product is put onto the market.
     (6) Market:According to a research report by Future Market Insight, the estimated sales in the wound care market  in Thailand for the year 2023 are expected to reach US$119 Million, with a projected compound annual growth rate (CAGR) of 7.9 from 2023 to 2033.
 4. Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7,  subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.):
    (1) Oneness implements dual strategies of both medicine products and medical devices for development and  marketing of our 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, we 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 we plan to market the medica device.Meanwhile, we are continuously  expanding our international business negotiations and clinical trials, collecting feedback from target markets  and authoritative physicians to strengthen our foothold in the  global  market.
     (2)  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.
     (3) 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.