Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds for Australia.

Published Date:2025-05-21

Original Link:https://www.onenessbio.com/en/news_detail359_1.htm

Statement
No	1	Date of announcement	2025/05/21	Time of announcement	20:42:12
Subject	Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds for Australia.
To which item it meets	Subparagraph 10			Date of events	2025/05/21
1. Date of occurrence of the event: 2025/05/21 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 today that the Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds under ARTG certificate number DV-2025-MC-09357-1 and with permission to be marketed in the Australia. (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: The demand for wound care products in Australia continues to grow steadily. According to the International Diabetes Federation Diabetes Atlas, 11th Edition (2025), the number of people living with diabetes in Australia has reached 1.69 million, reflecting a continuous rise in prevalence. As diabetes-related complications increase, the incidence of diabetic foot ulcers (DFUs) is also climbing, further driving the demand for advanced wound care solutions. A recent study published in the International Wound Journal (Int Wound J. 2024 Jan 31;21(2):e14709) estimates that Australia’s annual expenditure on wound care has exceeded USD 6 billion, making it the tenth-highest in the world. This growth is primarily driven by an aging population, a rising burden of chronic diseases, and increasing demand for high-quality healthcare. These factors highlight the significant medical and economic burden associated with chronic wound management in Australia. 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, marketing the wound care product as both a drug and a medical device so that it may receive approval for commercialization in major countries and regions by 2025. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. (2) The clearance on Bonvadis is 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.