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合一生技股份有限公司 / 2023 / The National Agency of Drug and Food Control(Badan Pengawas Obat dan Makanan; BPOM) has accepted the NDA application of the diabetic foot ulcer new drug, Fespixon

The National Agency of Drug and Food Control(Badan Pengawas Obat dan Makanan; BPOM) has accepted the NDA application of the diabetic foot ulcer new drug, Fespixon

2023-06-06

Published Date:2023-06-06

Original Link:https://www.onenessbio.com/en/news_detail224_3.htm

No 1 Date of announcement 2023/06/06 Time of announcement 18:12:22
Subject The National Agency of Drug and Food Control(Badan Pengawas Obat dan Makanan; BPOM) has accepted the NDA application of the diabetic foot ulcer new drug, Fespixon
To which item it meets paragraph 10 Date of events 2023/06/06
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 the 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 consultant company that the Indonesia BPOM 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 investment expenditure at the moment in consideration of 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 3-4 years after initiation.
    B.Estimate responsibilities:NA
    (6)Market:
    According to the data from International Diabetes Federation (IDF), there are approx. 19.5 million DM patients in Indonesia and will increase to 28.6 million in 2045. The associated complications, including foot ulcers, amputation, etc. are also on an increasing trend imposing a huge medical burden.
    FESPIXON has been approved in Taiwan and Singapore, and it has been accepted for NDA review by Malaysia NPRA, Philippines PFDA, Vietnam DAV and Indonesia BPOM. This will be provided as a novel therapeutic solution to the Indonesian patients once it is approved in Indonesia in the future.
  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)The announcement is with regards to the acceptance by BPOM in Indonesia 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)Currently, FESPIXON has been approved in Taiwan and Singapore. The health authorities in Malaysia, the Philippines, Vietnam and Indonesia have accepted the NDA application of Fespixon.
    (3)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.
    (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.