The Drug Administration of Vietnam has accepted
the NDA application of the diabetic foot ulcer new drug,
Fespixon
Date of events
2022/07/04
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 new indications under
exploratory studies.
(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 Drug Administration of Vietnam (DAV) 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 3 years after initiation
B.Estimate responsibilities: NA
(6)Market:According to the statistics of the International Diabetes
Federation (IDF), the population with diabetes in Vietnam have been
doubled in the past 10 years and currently, there are nearly 4 million
diabetic patients. The associated complications, including foot ulcers,
amputation, etc. are also on an increasing trend imposing a huge medical
burden.
FESPIXON has been accepted for NDA review by DAV and will be provided
as a novel therapeutic solution to the Vietnamese patients once it is
approved in Vietnam in the future.
4.Any other matters that need to be specified:
(1)The announcement is with regards to the acceptance by Drug Administration
of Vietnam 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)Currently, the health authorities in Singapore, Malaysia, the
Philippines, and Vietnam have accepted the NDA application of Fespixon.
(3)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.
(4)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 04 July 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 July 2022 11:52:09 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. 
