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With its medical device clearance by the FDA for partial-thickness wounds, Oneness has decided to discontinue ON101CLCT04 Ph3 clinical trial in the US |
- Date of occurrence of the event:2024/06/28
- New drug name or code:ON101
- Indication:Treatment of DFUs
- Planned development stages:In compliance with U.S. FDA requirements, Oneness will conduct the required studies to support Bonvadis's 510(k) application for full thickness chronic wound indications.
- Current development stage:
- (1)File application/approved/disapproved/Each of clinical trials (include interim analysis):
i) The global strategy for chronic wound market adopted by Oneness includes two pathways, new drug and medical device, for global major markets access. The US FDA 510(k) clearance of medical device can be referenced by most of the countries globally for local approval. Oneness submitted Bonvadis first-stage application for U.S. 510(k) medical device and was cleared by FDA in 2022.08 for acute wound indications; the second-stage 510(k) clearance by FDA for chronic wound indications, including: partial thickness wounds (can be used for grade 1 diabetic foot ulcers, venous ulcers and grade 1-2 pressure ulcers), closed surgical wounds, and burns (1st degree and superficial 2nd degree). Subsequently, relevant studies will be conducted in accordance with FDA's requirements to suppor the 510(k) submission for full-thickness chronic wound indications. Once this 510(k) clearance is obtained, all chronic wound indications in U.S. will be included. Therefore, Oneneess decided to discontinue the phase III clinical trial of ON101 udner protocol number: ON101CLCT04 in U.S..
ii) According to the requirements of drug regulations, the application for each indication requires large-scale phase III clinical trial for respective indications. NDA can then be submitted in accordance with regulations after each trial's completion. It is estimated that at least more than US$300 million investment and more than 5 years will be required to get approval under drug route on all of the full-thickness indications captured by medical device route.
- (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)After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable.
- (4)Accumulated investment expenditure incurred:No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors.
- Upcoming development plan:
- (1)Scheduled completion date:Onesness will pay close attention to regulatory requirements and supplement the required study data per FDA's recommendations, before submitting a 510(k) medical device application for full thickness chronic wound indications.
- (2)Estimate responsibilities:Not applicable.
- Market situation:According to Grand Vew Research Market Analysis Report, global market of wound care in 2023 reached US$22.2 billion, at CAGR of 4.15%. It is expected to reach US$29.5 billion by 2030. To date, there are no effective drugs or medical devices for the treatment of chronic hard-to-heal wounds.
- 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)Oneness implements strategy of taking dual pathways via both new drug and medical device routes for development and marketing of our wound care products. Each type of product will comply with corresponding regulatory requirements to get earlier access to the markets. Fespixon has been approved as new drug in Taiwan, Singapore, Malaysia, and China. 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.
- (2)Bonvadis obtained FDA 510(k) in 2024.05 for chronic wound indications, including: partial thickness wounds (can be used for grade 1 diabetic foot ulcers, venous ulcers and grade 1-2 pressure ulcers), closed surgical wounds, burns (1st and superficial 2nd degree) are 510(k) cleared.
- (3)If entering U.S. market through new drug application, it will be required to conduct at least one pivotal (phase III) clinical trial for each indication, with an average cost of each pivotal (phase III) clinical trial at about US$40-60 million, and will take at least more than 5 years including NDA submission.
- (4)The Icelandic company Kerecis' 510(k) (fish skin substitute) for full thickness chronic wound indications was acquired by a Danish company Coloplast in 2023.09 for US$1.3 billion. The clinical trial efficacy of this product is mainly in DFU Texas grade 1 ( Wagner grade 1) wounds, showing that the value of a medical device in the chronic wound space is no less than that of a drug.
- (5)In summary, applying for entering U.S. market with medical device is precise, efficient and in line with the interests of shareholders.
- (6)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.
- 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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