Oneness BiotECH Co., Ltd. announced that U.S. FDA notified Oneness that Bonvadis for partial thickness wounds, closed post-surgical wounds, and burns (1st and superficial 2nd degrees) is 510(k) cleared. New drug name or code: Bonvadis. Indication: Bonvadis wound management medical device.

Planned development stages: In accordance with U.S FDA suggestion, the company will continue supplementing the required animal study data and submit the 510(k) for Bonvadis for use in full thickness chronic wounds. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): U.S. FDA notified Oneness that partial thickness wounds, closed post-surgical wounds, and burns (1st and superficial 2nd degrees) is 510(k) cleared. After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: To plan for marketing and distribution.

Accumulated investment expenditure incurred:No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors. Upcoming development plan: Scheduled completion date: i) In accordance with U.S. FDA suggestion, the company will submit the 510(k) for Bonvadis for use in full-thickness chronic wounds in 2024 second half after supplementing the required animal study data. ii) For countries that accept the simplified registration through the US FDA 510(k), applications for multiple new indications will be submitted for market approval in 2024/25, with the goal of expanding Bonvadis?

indications in global markets. Estimate responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed. Oneness implements dual strategies of both medicinal product and medical device for development and marketing of wound care products.

Each type of product will comply with corresponding regulatory requirements to get earlier access to the markets. New drug Fespixon Cream has been approved as new drug in Taiwan, Singapore, Malaysia, and China markets. Bonvadis as a medical device has been cleared for acute wound management in the US, India, New Zealand, South Africa and Thailand.

It is cleared for scar management in European Union. In order to expand the intended indications, the company submitted 510(k) in accordance with the U.S. FDA's review requirements in 2023 Fourth Quarter for partial and full thickness chronic wounds (including diabetic ulcer, pressure ulcer, and venous ulcer), post-surgical wounds, and burns, etc. The company submitted technical documents in April 2024 (review deadline set for May 22, 2024), the U.S. FDA held a conference call at May 16, 2024 and provided two suggestions: i) Given the request for additional animal study data, it is suggested for the company voluntarily withdraw the submission and resubmit it after providing supplementary animal study data.

Or ii) Direct notification of rejection will be issued based on the current review results. In addition to agreeing to voluntarily withdrawal of the submission as per FDA suggestion, the company proactively submitted the requested documents to the FDA (not indicating new animal study data). The company received notification from the FDA that Bonvadis for partial thickness wounds, closed post-surgical wounds, and burns (1st and superficial 2nd degrees) is 510(k) cleared).

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.