| No | 1 | Date of announcement | 2025/10/03 | Time of announcement | 17:06:49 |
|---|---|---|---|---|---|
| Subject | The medical device registration application of Bonvadis for all indications in wounds has been accepted by ThaiFDA. | ||||
| To which item it meets | Subparagraph 10 | Date of events | 2025/10/03 | ||
| Statement | |||||
| 1.Date of occurrence of the event:2025/10/03 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):Oneness has received notification from the agent today that the medical device registration application of Bonvadis for all indications has been accepted by ThaiFDA in Thailand. (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: NA (3)After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: NA (4)Accumulated investment expenditure incurred:No disclosure in consideration of future marketing strategies. 6.Upcoming development plan: (1)Scheduled completion date:The review timeline will be determined based on the regulatory authority's review process. (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 International Diabetes Federation (IDF), there are approximately 6.36 million people with diabetes in Thailand. However, due to the lack of effective and cost-effective drugs or medical devices for chronic wounds, the annual burden of wound care is currently estimated to exceed USD 700 million (Int Wound J. 2023 Nov 14;20(10): 3935–3938). 8.Any other matters that need to be specified(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 diabetic countries and regions by 2025/2026. Oneness continues to progress the market access and collaboration in the major target markets according to the plan. (2)Bonvadis obtained commercial approval for the indication of acute wounds in January 2024. For extending the indications of Bonvadis, the application of 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 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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