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合一生技股份有限公司 / 2023 / Oneness 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.

Oneness 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.

2023-08-31

Published Date:2023-08-31

Original Link:https://www.onenessbio.com/en/news_detail241_2.htm

No 1 Date of announcement 2023/08/31 Time of announcement  21:42:45
Subject Oneness 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.
To which item it meets paragraph 10 Date of events 2023/08/31
Statement
  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 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
    B.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
    C.After obtaining official approval or the results (include interim analysis) which are statistically significant, the future strategy: 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 competent authorities in each country.
    B.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 the statistics of Reportlinker.com, the global advanced wound care products market is projected to achieve a compound annual growth rate (CAGR) of 6.4%, reaching an estimated $16.2 billion by 2030.
  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 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 we plan to market the medical device. Meanwhile, we are continuously expanding our international business negotiations and human 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 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.