The Food and Drug Administration-Philippines (PFDA)
has accepted the NDA application of the diabetic foot
ulcer new drug, Fespixon
Date of events
2022/04/18
To which item it meets
paragraph 10
Statement
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.
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Oneness Biotech Co Ltd. published this content on 18 April 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 April 2022 11:13:03 UTC.
ONENESS BIOTECH CO., LTD. is a Taiwan-based company principally engaged in the research, development, production and sales of health products. The Company's main products include health supplies, health food and healthy food. The Company is also involved in the development of new drugs for the treatment of wound healing in chronic diabetic foot ulcers, as well as the development of new anticancer drugs. The Company distributes its products in domestic market.
ONENESS BIOTECH CO., LTD. 
