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合一生技股份有限公司 / 2022 / US FDA notified today that 510(k) Premarket Notification of Bonvadis, the wound care topical cream was substantially equivalent.

US FDA notified today that 510(k) Premarket Notification of Bonvadis, the wound care topical cream was substantially equivalent.

2022-08-20

Published Date:2022-08-20

Original Link:https://www.onenessbio.com/en/news_detail174_2.htm

No 2 Date of announcement 2022/08/20 Time of announcement 19:13:32
Subject US FDA notified today that 510(k) Premarket Notification of Bonvadis, the wound care topical cream was substantially equivalent.
To which item it meets paragraph 10 Date of events 2022/08/20
Statement
  1. Product:Bonvadis topical cream 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):US FDA has notified today that 510(k) Premarket Notification of Bonvadis, the wound care topical cream has been determined substantially equivalent and may be legally marketed.
    B.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur:NA
    C.After obtaining official approval or the results of statistically significant sense, the future strategy:To be marketed in the US
    D.Accumulated investment expenditure incurred:No disclosure in consideration of the future marketing strategies.
    (5)Upcoming development plan:Apply the medical device registration to the countries where US FDA 510(k) can be accepted as reference to accelerate the global market entry of Bonvadis.
    A.Scheduled completion date:The review timeline is subject to the review process regulated by competent authority in each country.
    B.Estimate responsibilities:Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed.
    (6)Market:According to the statistics of Reportlinker.com, the global market of advanced wound care products will grow at a CAGR of 6.5% and will reach 13.944 billion by 2026.
  4. Any other matters that need to be specified:
    (1)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.
    (2)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.