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•2026-02-22
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Bonvadis® topical cream received medical device marketing authorization approval for all indications in wounds by INVIMA Colombia.

Bonvadis® > News > Bonvadis® topical cream received medical device marketing authorization approval for all indications in wounds by INVIMA Colombia.
  1. Date of occurrence of the event:2026/02/27
  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 agent that the Bonvadis® topical cream received medical device marketing authorization approval for all indications in wounds under INVIMA imported registration license number INVIMA2026DM-0032092 and with permission to be marketed in the Colombia. This marks the first time Bonvadis® topical cream has obtained medical device marketing authorization for all indications in wounds in Latin American countries.
    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: Not applicable.
    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: 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 International Diabetes Federation (IDF) Diabetes Atlas 2025, 11th Edition, in Colombia, approximately 3.0 million adults currently live with diabetes, representing a prevalence rate of 8.4%, with projections indicating the number will climb to 4.3 million by 2050. Market data further show that Colombia’s advanced wound care (AWC) markets are growing steadily. In Colombia, the AWC market was valued at approximately USD 61.7 million in 2023 and is projected to reach USD 92.4 million by 2030, with a CAGR of 5.9%.
  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 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.
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