1.Product:The diabetic foot ulcer new drug developed by the Company has been granted new drug approval. The trade name of the new drug is Fespixon cream which has been approved by the Ministry of Health and Welfare for drug license collection
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 granted.
   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) of statistically significant sense, the future strategy:  Strategic planning for global commercialization is proceeding, including new drug application or required clinical trials by different countries and regions for market entries, determining collaboration partners, product education training and marketing, as well as academic researches.
   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 hase 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 during the validity of licensed patents.
(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, 12%~15% 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 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 or new drug application to domestic or overseas regulatory receiving approval or disapproval, obtaining the statistical date of endpoints authorities, 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.