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合一生技股份有限公司 / 2024 / Fespixon, the new drug in treatment of diabetic foot ulcers has been approved by Indonesia BPOM and the drug license will be collected

Fespixon, the new drug in treatment of diabetic foot ulcers has been approved by Indonesia BPOM and the drug license will be collected

2024-08-06

Published Date:2024-08-06

Original Link:https://www.onenessbio.com/en/news_detail308_2.htm

No 1 Date of announcement 2024/08/06 Time of announcement 21:25:12
Subject Fespixon, the new drug in treatment of diabetic foot ulcers has been approved by Indonesia BPOM and the drug license will be collected
To which item it meets paragraph 10 Date of events 2024/08/06
Statement
  1. Date of occurrence of the event: 2024/08/06
  2. New drug name or code: Fespixon (ON101)
  3. Indication:
    1. A.Treatment of diabetic foot ulcers.
    2. B.Information Website: cekbpom.pom.go.id
  4. Planned development stages: None
  5. Current development stage:
    1. (1)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 Badan Pengawas Obat dan Makanan (BPOM). The drug license can be collected upon the completion and acceptance of the revised package insert.
    2. (2)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: Not applicable
    3. (3)After obtaining official approval or the results(include interim analysis) of statistically significant sense, the future strategy: New drug launch.
    4. (4)Accumulated investment expenditure incurred: No disclosure in consideration of future marketing strategies.
  6. Upcoming development plan:
    1. (1)Scheduled completion date: Not applicable.
    2. (2)Estimate responsibilities: Oneness shall pay the licensor a certain percentage of sales royalties according to the licensing contract once the product is marketed.
  7. Market situation: 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. It is estimated that the number of DFU patients reached 2 million in Indonesia which is 100 times more than that in Taiwan. The associated complications, including foot ulcers, amputation, etc. are also on an increasing trend imposing a huge medical burden.
  8. 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. (1)Fespixon is the global first and only new drug targeting the DFU etiology. The phase 3 clinical trial and post-market study have demonstrated that Fespixon has accelerated healing in DFUs, in hard-to-heal DFUs and health economics analysis supports its cost-effectiveness.
    2. (2)Oneness implements dual strategies of both medicinal product and medical device for development and marketing of our wound care products to support the market access to the target countries with high DM prevalence by 2025. Each type of product will comply with corresponding regulatory requirements to get earlier access to the markets. Fespixon Cream has been approved as new drug in Taiwan, Singapore, Malaysia, and China. Indonesia has become the 5th market with the approval. Bonvadis as a medical device has been cleared for acute wound management in the US, India, New Zealand, South Africa and Thailand. It is cleared for scar management in European Union.
    3. (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.
  9. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.: