The Malaysia National Pharmaceutical Regulatory Agency has accepted the NDA application of the diabetic foot ulcer new drug, Fespixon

 The Malaysia National Pharmaceutical Regulatory
Agency has accepted the NDA application of the diabetic
foot ulcer new drug, Fespixon

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 National Pharmaceutical Regulatory Agency
     of Malaysia 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 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: 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
   B.Estimate responsibilities: NA
(6)Market:The prevalence of diabetes mellitus (DM) in Malaysia is the
   highest among the ASEAN countries. According to the systematic review
   published on Int. J. Environ. Res. Public Health, 2020, the annual
   medical costs on DM is US$600 million per year and one of the most costly
   complications is amputation which brings a huge medical burden. FESPIXON
   has been accepted for NDA review by NPRA and will fulfill the local unmet
   medical need once it is approved in Malaysia in the future.
4.Any other matters that need to be specified:
(1)The announcement is with regards to the acceptance by NPRA in Malaysia
   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.