The Food and Drug Administration–Philippines (PFDA) has accepted the NDA application of the diabetic foot ulcer new drug, Fespixon

 The Food and Drug Administration-Philippines (PFDA)
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 consultant company
     that the Philippines FDA 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:Diabetes mellitus has been ranked the fourth leading cause of
   death in Philippines in 2020, following ischemic heart diseases, cancer,
   and cerebrovascular diseases. According to the data from International
   Diabetes Federation, there are approx. 4.3 million DM patients in
   Philippines and will increase to 5.45 million in 2030. Among patients
   with diabetic foot ulcers, more than 30% of them will end up with
   amputation. If FESPIXON approved by PFDA, it would be a new option for
   treatment of diabetic foot ulcer for the patients.
4.Any other matters that need to be specified:
(1)The announcement is with regards to the acceptance by PFDA in Philippines
   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.