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Oneness was notified today that Bonvadis, the wound care topical cream has obtained import license in South Africa. |
- 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 South Africa has notified Oneness today that Bonvadis, the wound care topical cream has been approved for import of medical device by South African Health Products Regulatory Authority (SAHPRA) in South Africa, registration number is 00003007MD and allowed for market distribution in South Africa.
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: South African market is one of the largest economies in Africa, getting medical device access is an important strategy of African economies market entry. According to the analysis of Taipei Liaison Office in the Republic of South Africa, private healthcare system is well-developed, middle class is growing up and numbers of public-private partnership hospitals is increasing. 95% of medical devices in South Africa is imported, the medical device market has the highest potential.
- 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, 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 for wound management has been granted with market approvals for the US, India, New Zealand, and South Africa, and for scar management in European Union. The subsequent market access plan with medical device submissions in other countries are ongoing. Meanwhile, we will continue to expand our international business negotiations and human trials, collecting feedback from target markets and authoritative physicians, in order 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 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.
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