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合一生技股份有限公司 / 2023 / Oneness received new drug approval by Singapore HSA on its DFU new drug, FESPIXON.

Oneness received new drug approval by Singapore HSA on its DFU new drug, FESPIXON.

2023-01-31

Published Date:2023-01-31

Original Link:https://www.onenessbio.com/en/news_detail198_5.htm

No 1 Date of announcement 2023/01/31 Time of announcement 18:16:51
Subject Oneness received new drug approval by Singapore HSA on its DFU new drug, FESPIXON.
To which item it meets paragraph 10 Date of events 2023/01/31
Statement
  1. Product:FESPIXON, a new drug for the treatment of diabetic foot ulcer
  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 ulcer.
     B.Information Website: www.hsa.gov.sg
    (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 Singapore Health Sciences Authority (HSA).
     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:Plan for future commercialization and marketing.
     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 expected to be completed in 2025.
     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:According to the statistics of the International Diabetes Federation, the prevalence of diabetes mellitus in Singapore was 11.6% in 2021. According to International Wound Journal published in 2021 (International Wound Journal 2021;18:375–386), the mean cost per patient-year was US $3,368 (ulcer-only),US $10,468 (minor amputation), and US $30,131 (major amputation). It shows the medical burden caused by DFU that not only affects patients and their families, but also imposes a heavy burden on the government and society.
  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 is a new drug with novel mechanism of action by inhibiting inflammation and activating specific chemokines to change the polarization of macrophages in chronic wounds. It can transit the M1-macrophage dominant wound microenvironment to be M2-macrophage dominant one. This can attenuate the wound inflammation and transfer to proliferation to promote ulcer healing.
    (2)Singapore HSA is a regulatory indicator in ASEAN countries. The new drug approval on FESPIXON is an important milestone to ASEAN market entry.
    (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.