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Fespixon, the new drug in treatment of diabetic foot ulcers has been approved by Indonesia BPOM and the drug license has been granted. |
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1.Date of occurrence of the event:2025/07/18
2.New drug name or code:Fespixon (ON101)
3.Indication:
A.Treatment of diabetic foot ulcers.
B.Information Website: cekbpom.pom.go.id
4.Planned development stages:None
5.Current development stage:
(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 Obatdan Makanan (BPOM). The drug license has been granted. (Registration No. POM TI247049901).
(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:NA
(3)After obtaining official approvals or the results (include interim analysis) of statistically significant sense, the future strategy: New drug launch.
(4)Accumulated investment expenditure incurred:No disclosure in consideration of future marketing strategies.
6.Upcoming development plan:
(1)Scheduled completion date:NA
(2)Estimated 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. 20.4 million DM patients in Indonesia in 2024 and will increase to 28.6 million in 2050. It is estimated that the number of DFU patients reached 2 million in Indonesia. 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)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)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. Currently, commercial negotiations with various countries are ongoing.
(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 a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/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.:
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