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合一生技股份有限公司 / 2024 / Oneness has received medical device registration approval on Bonvadis Topical Cream for Egypt

Oneness has received medical device registration approval on Bonvadis Topical Cream for Egypt

2024-09-20

Published Date:2024-09-20

Original Link:https://www.onenessbio.com/en/news_detail321_1.htm

No 1 Date of announcement 2024/09/20 Time of announcement 18:46:22
Subject Oneness has received medical device registration approval on Bonvadis Topical Cream for Egypt
To which item it meets paragraph 10 Date of events 2024/09/20
Statement
  1. Date of occurrence of the event: 2024/09/20
  2. New drug name or code: Bonvadis
  3. Indication: Bonvadis wound management medical device
  4. Planned development stages: NA
  5. Current development stage:
    1. (1)File application/approved/disapproved/Each of clinical trials (include interim analysis): Today, the regulatory agent in Egypt has notified Oneness that Bonvadis, the topical cream has been granted medical device importation approval by the Egyptian Drug Authority (EDA) under registration number R170181lrg24V1 and permission for marketing in Egypt.
    2. (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. (3)After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution.
    4. (4)Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies.
  6. Upcoming development plan:
    1. (1)Scheduled completion date: Subsequent applications for broader indications will be submitted, and review timelines will be subject to the review processes regulated by the regulatory authorities.
    2. (2)Estimated responsibilities: Oneness shall pay the licensor sales royalties at a certain percentage according to the licensing contract once the product is commercialized.
  7. Market situation: Egypt has a population of approximately 108 million, with a diabetic population of about 11 million. There is significant potential in the wound care market.
  8. 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 a dual regulatory strategy, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025. Oneness continues to progress the market access and collaboration in the major target markets according to the plan.
    2. (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.
  9. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.: