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合一生技股份有限公司 / 2023 / FESPIXON, the new drug in treatment of diabetic foot ulcers has been approved by Malaysia NPRA

FESPIXON, the new drug in treatment of diabetic foot ulcers has been approved by Malaysia NPRA

2023-07-14

Published Date:2023-07-14

Original Link:https://www.onenessbio.com/en/news_detail233_2.htm

No 1 Date of announcement 2023/07/14 Time of announcement 20:16:59
Subject FESPIXON, the new drug in treatment of diabetic foot ulcers has been approved by Malaysia NPRA
To which item it meets paragraph 10 Date of events 2023/07/14
Statement
  1. Product:FESPIXON, a new drug for the treatment of diabetic foot ulcers
  2. Mass production date:NA
  3. Effect on company finances and business:
    (1)New drug name or code:FESPIXON (research code: ON101)
    (2)Purpose:
    A.Treatment of diabetic foot ulcers.
    B.Information Website:https://quest3plus.bpfk.gov.my/pmo2/index.php
    (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 informed by the local agent that the DFU new drug, FESPIXON, has been approved by Malaysia National Pharmaceutical Regulatory Agency (NPRA).
    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:
    Marketing and sales of FESPIXON in both Singapore and Malaysia will be jointly planned.
    D.Accumulated investment expenditure incurred:No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies.
    (5)Upcoming development plan:B.Estimate responsibilities:After product commercialization, the company shall pay the licensor a certain percentage of royalties according to the agreement during the validity of licensed patents.
    (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.
  4. Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.):
    (1)FESPIXON has been the first Natural Product with Therapeutic Claim applied with and approved by Malaysia NPRA after the guideline of Natural Products with Therapeutic Claim was published by Malaysia NPRA in 2020. With novel mechanism and significant clinical efficacy, FESPIXON is the only new drug approved by NPRA in the classification to treat diabetic foot ulcer.
    (2)Currently, FESPIXON has been approved in Taiwan, Singapore and Malaysia. The health authorities in China, the Philippines, Vietnam and Indonesia are reviewing the NDA application of FESPIXON.
    (3)According to 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 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.