Oneness has submitted 510(k) application of Bonvadis for full thickness wound indications to the U.S. FDA

Published Date:2025-04-10

Original Link:https://www.onenessbio.com/en/news_detail352_2.htm

Statement
No	3	Date of announcement	2025/04/10	Time of announcement	16:57:27
Subject	Oneness has submitted 510(k) application of Bonvadis for full thickness wound indications to the U.S. FDA
To which item it meets	Subparagraph 10			Date of events	2025/04/10
1. Date of occurrence of the event:2025/04/10 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 supplemented the required animal study data in accordance with U.S FDA suggestion, and submitted the 510(k) application of Bonvadis for full thickness wound indications to the U.S FDA. (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: Not applicable. (4) Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies. 6. Upcoming development plan: (1) Scheduled completion date: The review timeline is subject to the review process regulated by the competent authority. (2) Estimated responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed. 7. Market situation: According to the statistics of Reportlinker.com, the global market of advanced wound care products will grow at a CAGR of 6.5% and will reach 13.944 billion by 2026. To date, there have been no effective drugs or medical devices for the treatment of chronic wounds. 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 is currently proceeding with the established plan, starting with partial thickness wound indications, and continuously submitting new indication application for key target markets worldwide. At the same time, Oneness is conducting commercial negotiations in multiple countries and regions. (2) 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.