Bonvadis® topical cream received medical device marketing authorization approval for all indications in wounds by AMMPS Morocco.

Date of occurrence of the event:2026/04/10
New drug name or code: Bonvadis^® Topical Cream
Indication: Wound Dressing
Planned development stages: NA
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 AMMPS registration certificate number 37034/2025/1080-2026/IMP/DM/AMMPS and with permission to be marketed in Morocco.
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 considerations of future marketing strategies.
Upcoming development plan:
1. Scheduled completion date: Not applicable.
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.
Market situation: Morocco’s advanced wound care market is growing steadily, driven by rising chronic wounds and diabetes. As of 2025, 2.88 million people live with diabetes (IDF Diabetes Atlas 11th Edition). With increasing diabetes prevalence, expanding healthcare infrastructure, and a growing trend toward home care, demand for advanced wound care products in both clinical and home settings continues to rise.
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, 1^st and 2^nd 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.
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.
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.