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合一生技股份有限公司 / 2024 / Oneness was notified today that Bonvadis, the wound care topical cream has obtained import license in Thailand.

Oneness was notified today that Bonvadis, the wound care topical cream has obtained import license in Thailand.

2024-01-18

Published Date:2024-01-18

Original Link:https://www.onenessbio.com/en/news_detail261_5.htm

No 1 Date of announcement 2024/01/18 Time of announcement 17:34:50
Subject Oneness was notified today that Bonvadis, the wound care topical cream has obtained import license in Thailand.
To which item it meets paragraph 10 Date of events 2024/01/18
Statement
  1. Product:Bonvadis topical cream 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):The regulatory Agent in Thailand has notified Oneness today that 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.
      2. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA
      3. After obtaining official approval or the results (include interim analysis) which are statistically significant, the future strategy: To proceed planning for marketing and distribution.
      4. Accumulated investment expenditure incurred:No disclosure in considerations of future marketing strategies.

      (5) Upcoming development plan:Extensions of indications will be applied.

      1. Scheduled completion date:The review timeline is subject to the review process regulated by competent authorities in each country.
      2. Estimate responsibilities:Oneness shall pay the licensor sales 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. (1) Oneness implements dual strategies of both medicinal 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 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. 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 the 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 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.

      (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.