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•2026-05-11
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Bonvadis® topical cream received medical device marketing authorization approval for all indications in wounds by Health Canada.

Bonvadis® > News > Bonvadis® topical cream received medical device marketing authorization approval for all indications in wounds by Health Canada.
  1. Date of occurrence of the event:2026/05/08
  2. New drug name or code: Bonvadis®
  3. Indication: Wound Dressing
  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: Oneness has received notification from the Canada authority, Health Canada, that the Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds under approval certification No. 115377, with permission to be marketed in the Canada.
    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. After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution.
    4. Accumulated investment expenditure incurred: No disclosure in considerations of future marketing strategies.
  6. Upcoming development plan:
    1. Scheduled completion date: Not applicable.
    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: According to the forecast report of Data Bridge Market Research, the North America is the largest market of global advanced wound care market. The CAGR is 6.4% in the forecast period from 2020 to 2027, and it is expected to reach 4.6 billion dollars by 2027.
  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. Bonvadis obtained commercial approval for all indications of wounds, including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic foot ulcers, venous ulcers, and post-surgical wounds; other indications are to remain the moisture in wounds and reduce scar formation.
    3. 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.
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