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合一生技股份有限公司 / 2023 / Oneness has submitted medical device registration application of Bonvadis for wound care to the Saudi Food and Drug Authority (SFDA) in Kingdom of Saudi Arabia.

Oneness has submitted medical device registration application of Bonvadis for wound care to the Saudi Food and Drug Authority (SFDA) in Kingdom of Saudi Arabia.

2023-12-25

Published Date:2023-12-25

Original Link:https://www.onenessbio.com/en/news_detail259_1.htm

No 1 Date of announcement 2023/12/25 Time of announcement  18:06:04
Subject Oneness has submitted medical device registration application of Bonvadis for wound care to the Saudi Food and Drug Authority (SFDA) in Kingdom of Saudi Arabia.
To which item it meets paragraph 10 Date of events 2023/12/25
Statement
  1. Product:Bonvadis for wound care
  2. Mass production date:NA
  3. Effect on company finances and business:

    1. (1)New drug name or code:Bonvadis

      (2)Purpose:Wound Dressing

      (3)Planned development stages：NA

      (4)Current development stage:

      1. File application/approved/disapproved/Each of clinical trials (include interim analysis):Oneness received a notification by regulatory agent in Kingdom of Saudi Arabia, today we have submitted a medical device registration application of Bonvadis for wound care to the Saudi Food and Drug Authority (SFDA).
      2. 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
      3. 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
      4. Accumulated investment expenditure incurred:No disclosure in considerations of future marketing strategies.

      (5)Upcoming development plan:

      1. Scheduled completion date:The review timeline is subject to the review process regulated by the competent authority in each country.
      2. 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 the FMS (Future Market Insight) 2023 analysis report, the chronic wound market in the GCC Arab countries is expected to reach a market size of US$271.8 million in 2024, and Saudi Arabia is the most populous and largest economy in the GCC Arab countries. Saudi Arabia population in 2020 was estimated to be about 35 million, accounting for 54% of all GCC countries. Its per capita GDP reaches US$55,000, ranking second among the GCC countries; thus, the chronic wound market size would be expected to be huge.

  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. (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, 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, and South Africa as well as 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 for chronic wound to the U.S. FDA, and will be followed by the submission of market access applications in countries where we plan to market the medical 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.