Oneness was notified today that Bonvadis, the wound care topical cream has obtained import license in New Zealand.

Published Date:2023-03-14

Original Link:https://www.onenessbio.com/en/news_detail207_4.htm

Statement
No	1	Date of announcement	2023/03/14	Time of announcement	18:26:55
Subject	Oneness was notified today that Bonvadis, the wound care topical cream has obtained import license in New Zealand.
To which item it meets	paragraph 10			Date of events	2023/03/14
Product:Bonvadis topical cream for wound care Mass production date:NA Effect on company finances and business: (1)New drug name or code:Bonvadis (2)Purpose:Wound Dressing (3)Planned development stages：NA (4)Current development stage: A.File application/approved/disapproved/Each of clinical trials (include interim analysis):Regulatory Agent in New Zealand has notified Oneness today that Bonvadis, the wound care topical cream has been approved for import of medical device by regulatory authority MEDSAFE in New Zealand, registration number is 230224-WAND-70Q5KB and allowed for market distribution in New Zealand. B.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 C.After obtaining official approval or the results (include interim analysis) which are statistically significant, the future strategy:To proceed planning for marketing and distribution. D.Accumulated investment expenditure incurred:No disclosure in considerations of future marketing strategies. (5)Upcoming development plan:Extensions of indications will be applied. A.Scheduled completion date:The review timeline is subject to the review process regulated by competent authorities in each country. B.Estimate responsibilities:Oneness shall pay the licensor sales royalties according to the licensing contract once the product is put onto the market. (6)Market:Bonvadis has been approved under medical device regulation in New Zealand which is the 2nd approval in advanced countries. The approval in New Zealand, one of the leading countries in APAC region for medical device regulation, will help global market entry and commercialization trategy of Bonvadis. 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 dual strategies of both medicine products and medical devices for development and marketing of our wound care products. Each type of product will comply with corresponding regulatory requirements to get quick access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan and Singapore markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis topical cream as a medical device has been granted with market approvals for the US, India and New Zealand markets, and planning of market access with medical device submissions at other countries are ongoing. (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 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. (3)It takes considerable time and expenses to develop a new drug of which success can’t be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions.