| No | 1 | Date of announcement | 2025/05/09 | Time of announcement | 16:15:39 |
|---|---|---|---|---|---|
| Subject | The medical device registration application of Bonvadis for all indications in wounds has been accepted by India CDSCO. | ||||
| To which item it meets | Subparagraph 10 | Date of events | 2025/05/09 | ||
| Statement | |||||
| 1. Date of occurrence of the event:2025/05/09 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 medical device registration application of Bonvadis for all indications has been accepted by CDSCO in India. (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 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 Invest India, the country’s medical device market is valued at approximately USD 11 billion and is one of the fastest-growing among emerging markets. With a projected 15% CAGR — 2.5 times the global average — the market is expected to reach USD 50 billion by 2030. 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) Bonvadis obtained commercial approval for the indication of acute wounds in February 2023. 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 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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