| Subject |
Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds for Saudi Arabia |
- Date of occurrence of the event: 2024/11/04
- New drug name or code: Bonvadis
- Indication: Wound Dressing
- Planned development stages: NA
- Current development stage:
- (1)File application/approved/disapproved/Each of clinical trials (include interim analysis): Oneness was notified by the agent for registration submission with Saudi Food and Drug Authority (SFDA) today that Bonvadis topical cream received medical device marketing authorization approval for all indications in wounds under authorization number MDMA-2-2024-3084 and with permission to be marketed in the Kingdom of Saudi Arabia.
- (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: To plan for marketing and distribution.
- (4)Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies.
- Upcoming development plan:
- (1)Scheduled completion date: NA
- (2)Estimated responsibilities: Oneness shall pay the licensor sales royalties at a certain percentage according to the licensing contract once the product is commercialized.
- Market situation: According to the International Diabetes Federation (IDF), the population of Saudi diabetic patients are more than 4 million people. The number of DFU patients is approximately 500,000. Current treatments in Saudi Arabia are mostly traditional remedies, and the incidences of ulcer infection and amputation are relatively high.
- 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 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 by the Saudi FDA is for all indications of wounds, including acute wounds, chronic wounds, and scars. Indications for acute wounds include minor skin lacerations, abrasions, cuts, and burns; indications for chronic wounds include partial and full thickness wounds, first and second degree burns, pressure ulcers, diabetic ulcers, venous ulcers, and post-surgical wounds with reduced scar formation by creating the moist environment in the wounds.
- (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.
- 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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