|No||1||Date of announcement||2021/12/17||Time of announcement||17:37:36|
|Subject||The Singapore Health Science Authority has accepted the NDA application of the diabetic foot ulcer new drug, Fespixon|
|To which item it meets||paragraph 53||Date of events||2021/12/17|
1.Product:ON101 Diabetic foot ulcer new drug
2.Mass production date:NA
3.Effect on company finances and business:
(1)New drug name or code:FESPIXON CREAM
(2)Purpose:Treatment of diabetic foot ulcers.
(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):Oneness has been notified by the Singaporean consultant company that the Health Science Authority of Singapore has accepted the NDA application of FESPIXON, the diabetic foot ulcer new drug.
B.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur:NA
C.After obtaining official approval or the results of statistically significant sense, the future strategy:NA
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:The second phase 3 trial in the US is scheduled to complete in 2 to 3 years after initiation.
(6)Market:Singapore is an indicative country in ASEAN in terms of the drug evaluation regulations. The expenditures on health per capita in Singapore is the highest among ASEAN countries. The NDA application acceptance by HSA will be helpful for future market entry application with other ASEAN countries.
4.Any other matters that need to be specified:
(1)The announcement is with regards to the acceptance by HSA in Singapore on NDA application of FESPIXON, the diabetic foot ulcer new drug. The application will be under regulatory and scientific review and shall not be regarded as an approval.
(2)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 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.