Oneness Biotech : 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
Date of events
2022/03/04
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 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.
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Oneness Biotech Co Ltd. published this content on 04 March 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 March 2022 09:25:05 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 : The Malaysia National Pharmaceutical Regulatory Agency has accepted the NDA application of the diabetic foot ulcer new drug, Fespixon