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合一生技股份有限公司 / 2023 / The CEA of Fespixon based on its significant clinical efficacy showed its cost-effectiveness for treating DFUs. The manuscript was published by JAMA Network Open

The CEA of Fespixon based on its significant clinical efficacy showed its cost-effectiveness for treating DFUs. The manuscript was published by JAMA Network Open

2023-01-13

Published Date:2023-01-13

Original Link:https://www.onenessbio.com/en/news_detail195_5.htm

No 1 Date of announcement 2023/01/13 Time of announcement 15:16:40
Subject The CEA of Fespixon based on its significant clinical efficacy showed its cost-effectiveness for treating DFUs. The manuscript was published by JAMA Network Open
To which item it meets paragraph 53 Date of events 2023/01/13
Statement
  1. Date of occurrence of the event:2023/01/13
  2. Company name:ONENESS BIOTECH CO., LTD.
  3. Relationship to the Company (please enter ”head office” or ”subsidiaries”):head office
  4. Reciprocal shareholding ratios:NA
  5. Cause of occurrence:Fespixon (research code: ON101) is a first-in-class macrophage-regulating new drug for topical use that accelerates wound healing by rebalancing M1 and M2 macrophages to improve the immune environment of DFUs. The superior efficacy of Fespixon has been demonstrated in an international Phase III clinical trial. This article is the first in the world to investigate the cost-effectiveness of a macrophage-regulating drug compared with the current standard care for treating diabetic foot ulcers (DFUs). The results demonstrated that Fespixon has a breakthrough effect with cost-effectiveness and can be cost-saving in the patients with hard-to-heal risk factors. The health economic data supported Fespixon being a highly cost-effective option as a future standard care from national healthcare sector’s perspective. The manuscript has been accepted and published by JAMA Network Open, an international renowned SCI journal (Impact factor: 13.37)
  6. Countermeasures:None
  7. Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 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 significant clinical efficacy in wound healing. The international Phase III clinical trial results and novel mechanism have been published in JAMA Network Open, a global leading journal as well as in JID Innovations, an SCI journal issued by Society for Investigative Dermatology (SID) and European Society for Dermatological Research (ESDR). A review article was also published in Pharmaceutics. These demonstrated the superior efficacy and scientific evidence of Fespixon. This recently published cost-effectiveness article illustrates that the breakthrough by macrophage-regulating new drug in treating diabetic foot ulcers can be cost-effective or cost-saving. With the advantages in having superior efficacy and cost-effectiveness, Fespixon will bring changes to the future standard care and can comprehensively reduce the burden of the country, society, healthcare professionals and patients.
    (2)Oneness continues to increase the scientific values and international exposure of the new drug pipelines via publication on leading SCI journals.
    (3)The article is available online on JAMA Network Open: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800276?resultClick=3