Published Date:2021-02-24
Original Link:https://www.onenessbio.com/en/news_detail28_4.htm
| No | 1 | Date of announcement | 2021/02/24 | Time of announcement | 08:42:18 |
|---|---|---|---|---|---|
| Subject | Oneness received the letter from MOHW informing that ON101 for DFUs has obtained the new drug approval and its drug certificate will be notified for receipt. | ||||
| To which item it meets |
paragraph 10 | Date of events | 2021/02/24 | ||
| Statement | |||||
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1.Product:ON101 2.Mass production date:NA 3.Effect on company finances and business: (1)New drug name or code:ON101 (2)Purpose:Treatment of Diabetic foot ulcer. (3)Planned development stages:The second phase 3 clinical trial (ON101CLCT04)in the US, and other exploratory studies for new indications. (4)Current development stage: A.File application/approved/disapproved/Each of clinical trials (include interim analysis): New drug approval is obtained from The Ministry of Health and Welfare Food and Drug Administration (TFDA) and its official drug certificate will be notified for receipt. 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 interimanalysis) of statistically significant sense, the future strategy: Product launch for commercialization is proceeding including drug listing plan in hospitals, sales training and strategic collaboration with medical associations and societies. D.Accumulated investment expenditure incurred:No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies to protect the company and investors interests. (5)Upcoming development plan: A.Scheduled completion date:2-3 years after initiation of the second phase 3 trial in the US. B.Estimate responsibilities:After product commercialization, the company shall pay the licenser a certain percentage of royalties according to the agreement. (6)Market:According to the statistics of the International Diabetes Federation, the total number of diabetic patients worldwide was 425 million and will reach 629 million in 2045. Among those patients, 19–34% will encounter a foot ulcer during their lifetime. Some of the patients would end up with amputation and the 5-year survival of the amputees is about 60%, which indicates DFU is a serious complication causing death and disability in diabetes patients. According to the 2018 Diabetes Clinical Care Guidelines, there are about 22,000 diabetic foot patients being hospitalized in Taiwan per year, of which about 6,700 proceeded to amputation. Further, based on a retrospective analysis of an international journal, Diabetes Care in May 2020 (Diabetes Care. 2020;43 (8):1732-1740), the average annual treatment cost for a DFU in Taiwan is NT$140,000, and the average annual cost of an amputation is about NT$390,000. It shows that the medical burden caused by DFU is tremendous that not only affects patients and their families, but also imposes a heavy burden on the government and society. 4.Any other matters that need to be specified: (1)According to Article 2 under 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. (2)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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