No | 1 | Date of announcement | 2023/09/25 | Time of announcement | 18:30:26 |
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Subject | Oneness has submitted medical device registration application for Bonvadis to the Egyptian Drug Authority (EDA). | ||||
To which item it meets | paragraph 10 | Date of events | 2023/09/25 | ||
Statement | |||||
1.Product:Bonvadis for wound care 2.Mass production date:NA 3.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):Oneness received a notification by regulatory agent in Egypt, today we have submitted a medical device registration application for Bonvadis to the Egyptian Drug Authority (EDA). B.Once disapproved by competent authority or each stage of clinical trials(including interim analyses) results in a less than statisticallysignificant sense, the risks and the associated measures the Company may face:NA C.After obtaining official approvals, the results of clinical trials (include interim analyses) which are statistically significant, anoccurrence of other newly impacted development of a medicinal product or the future strategy of the management direction of the company:NA D.Accumulated investment expenditure incurred:No disclosure in considerations of future marketing strategies. (5)Upcoming development plan: A.Scheduled completion date:The review timeline is subject to the review process regulated by the competent authority in each country. B.Estimated responsibilities:Oneness shall pay the licensor sale royalties according to the licensing contract once the product is put onto the market. (6)Market:Egypt belongs to the Middle East and North Africa (MENA) region, with a population of approximately 108 million people, accounting for 28% of the total population of the MENA region. The wound care market holds great potential in this region. 4.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 earlier access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, and Malaysia markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device has been approved with medical device licenses for wound management in the US,India, New Zealand, and South Africa for scar management in European Union. In order to expand the intended patient population and add multiple indications, we have submitted a 510(k) application to the U.S. FDA, and will be followed by the submission of market access applications in countries where we plan to market the medical device. Meanwhile, we are continuously expanding our international business negotiations and clinical trials, collecting feedback from target markets and authoritative physicians to strengthen our foothold in the global market. (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 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. (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. 1.Product:Bonvadis for wound care 2.Mass production date:NA 3.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):Oneness received a notification by regulatory agent in Egypt, today we have submitted a medical device registration application for Bonvadis to the Egyptian Drug Authority (EDA). B.Once disapproved by competent authority or each stage of clinical trials (including interim analyses) results in a less than statistically significant sense, the risks and the associated measures the Company may face:NA C.After obtaining official approvals, the results of clinical trials (include interim analyses) which are statistically significant, an occurrence of other newly impacted development of a medicinal product or the future strategy of the management direction of the company:NA D.Accumulated investment expenditure incurred:No disclosure in considerations of future marketing strategies. (5)Upcoming development plan: A.Scheduled completion date:The review timeline is subject to the review process regulated by the competent authority in each country. B.Estimated responsibilities:Oneness shall pay the licensor sale royalties according to the licensing contract once the product is put onto the market. (6)Market:Egypt belongs to the Middle East and North Africa (MENA) region, with a population of approximately 108 million people, accounting for 28% of the total population of the MENA region. The wound care market holds great potential in this region. 4.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 earlier access of the markets. New drug Fespixon Cream has been approved with medicine licenses for Taiwan, Singapore, and Malaysia markets, as well as under the process of pre-market reviews or preparation of submissions for other countries. Bonvadis as a medical device has been approved with medical device licenses for wound management in the US, India, New Zealand, and South Africa for scar management in European Union. In order to expand the intended patient population and add multiple indications, we have submitted a 510(k) application to the U.S. FDA, and will be followed by the submission of market access applications in countries where we plan to market the medical device. Meanwhile, we are continuously expanding our international business negotiations and clinical trials, collecting feedback from target markets and authoritative physicians to strengthen our foothold in the global market. (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 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. (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. |