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合一生技股份有限公司 / 2022 / 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

2022-03-04

Published Date:2022-03-04

Original Link:https://www.onenessbio.com/en/news_detail147_3.htm

No 1 Date of announcement 2022/03/04 Time of announcement 17:13:42
Subject The Malaysia National Pharmaceutical Regulatory Agency has accepted the NDA application of the diabetic foot ulcer new drug, Fespixon
To which item it meets paragraph 10 Date of events 2022/03/04
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.