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合一生技股份有限公司 / 2024 / The EU MDR application of Bonvadis for acute and chronic wounds and scar management has been accepted by EU Notified Body for QMS and product certification.

The EU MDR application of Bonvadis for acute and chronic wounds and scar management has been accepted by EU Notified Body for QMS and product certification.

2024-07-22

Published Date:2024-07-22

Original Link:https://www.onenessbio.com/en/news_detail305_2.htm

No 1 Date of announcement 2024/07/22 Time of announcement 20:44:43
Subject The EU MDR application of Bonvadis for acute and chronic wounds and scar management has been accepted by EU Notified Body for QMS and product certification.
To which item it meets paragraph 10 Date of events 2024/07/22
Statement
  1. Date of occurrence of the event: 2024/07/22
  2. New drug name or code: Bonvadis
  3. Indication: wound management medical device
  4. Planned development stages: Not applicable.
  5. Current development stage:
    1. (1)File application/approved/disapproved/Each of clinical trials (include interim analysis): Oneness has received notification from the overseas consultant company that the EU MDR application of Bonvadis for acute and chronic wounds and scar management, has been accepted by EU Notified Body for quality management system (QMS) and product certification.
    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: Not applicable.
    3. (3)After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable.
    4. (4)Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies.
  6. Upcoming development plan:
    1. (1)Scheduled completion date: The review timeline is subject to the review process regulated by the competent authority in each country.
    2. (2)Estimate responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed.
  7. Market situation: According to Grand View Research Market Analysis Report, global market of wound care in 2023 reached US$22.2 billion, at CAGR of 4.15%. It is expected to reach US$29.5 billion by 2030. To date, there are no effective drugs or medical devices for the treatment of chronic hard-to-heal wounds.
  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 dual strategies of both medicinal product and medical device 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 as new drug in Taiwan, Singapore, Malaysia, and China markets. Bonvadis as a medical device has been cleared for acute wound management, partial thickness wounds, closed post-surgical wounds, and 1st and superficial 2nd degree burns in the US. India, New Zealand, South Africa and Thailand have been cleared for acute wound management.
    2. (2)The indications for use of Bonvadis for this EU MDR application cover acute wounds, chronic wounds, and scar management. Acute wounds include minor skin lacerations, abrasions, cuts, and minor burns. Chronic wounds include partial and full-thickness wounds, 1st and 2nd degree burns, pressure ulcers, diabetic ulcers, venous stasis ulcers, and post-surgical wounds. Creating a moist wound environment may help in the reduction of scar formation (this is included in the approved scar management indications in Europe).
    3. (3)This application represents a key objective for our company’s global market access for chronic wound products. The EU Notified Body has formally accepted Bonvadis for use in acute, chronic wounds, and scar management. This significantly contributes to achieving Bonvadis’ global market access.
    4. (4)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.
  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.