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合一生技股份有限公司 / 2026 / EU NB issued the EU market approval for Bonvadis that grants marketing authorization across all 27 EU member states for acute and chronic wounds, and scar management.

EU NB issued the EU market approval for Bonvadis that grants marketing authorization across all 27 EU member states for acute and chronic wounds, and scar management.

2026-03-12

 

No 1 Date of announcement 2026/03/12 Time of announcement 23:33:33
Addresser Shu-Ling Cheng Addresser’s Position President Addresser’s Phone Number 02-26558860
Subject EU NB issued the EU market approval for Bonvadis that grants marketing authorization across all 27 EU member states for acute and chronic wounds, and scar management.
To which item it meets Subparagraph 10 Date of events 2026/03/12
Statement
  1. Date of occurrence of the event: 2026/03/12
  2. New drug name or code: Bonvadis Topical Cream
  3. Indication: wound management medical device
  4. Planned development stages: NA
  5. Current development stage:
    (1.)File application/approved/disapproved/Each of clinical trials (include interim analysis) results/occurrence of other major events affecting new-drug research and development: Today Oneness received EU Notified Body (ECM) issued EU Quality Management System Certificate (EU market approval) (Certificate No. ECM26MDR002) that grants marketing authorization across all 27 EU member states for Bonvadis used for acute and chronic wounds and scar management.
    (2.)Once disapproved by competent authority, having each of clinical trials (include interim analysis) results less than statistically significant sense, or occurrence of other major events affecting new-drug research and development, the risks and the associated measures the Company may occur: NA
    (3.)After obtaining official approval from competent authority, the results (include interim analysis) of statistically significant sense, or the occurrence of other major events affecting new-drug research and development, the future strategy: To plan for marketing and distribution.
    (4.)Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies.
  6. Upcoming development plan:
    (1.)Scheduled completion date: NA
    (2.)Estimated responsibilities: Oneness shall pay the licensor sales royalties at a certain percentage within the prescribed period according to the licensing contract once the product is commercialized.
  7. Market situation: Global healthcare expenditure in the wound care market has reached $300 billion, with the U.S., EU, and China serving as the primary markets. Notably, there remains a significant unmet medical need for chronic non-healing wounds, for which no truly effective drugs or medical devices currently exist.
  8. Any other matters that need to be specified (If an event occurs or is resolved by a company that is publicly offered or above, 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 a dual regulatory strategy for drug and medical device market access for the wound care product globalization and commercialization.
    (2.) The indications for use of Bonvadis for this EU market approval 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.) The EU market approval of all applied indications completes a vital piece of the global market puzzle for Bonvadis. This achievement serves as a powerful catalyst for our ongoing international commercialization efforts.
    (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.