1.Date of occurrence of the event:2025/05/21
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® (ON101) is the world’s first macrophage-modulating drug for wound healing. By rebalancing M1/M2 macrophages and improving the local immune microenvironment, it has shown significant efficacy in accelerating diabetic foot ulcer (DFU) healing, as validated in international phase 3 trials.

This study evaluated the cost-effectiveness of Fespixon plus general wound care (GWC) versus GWC alone for DFU patients in Singapore. Results showed Fespixon offers clear pharmacoeconomic advantages: it improved patient quality of life (QALY gain of 0.15) and reduced healthcare costs by an average of USD 16,237 over 5 years. Greater savings were observed in high-risk subgroups (e.g., poor glycemic control, ulcers >5 cm², or duration >6 months), with ICERs ranging from –USD 161,963 to –USD 199,130—indicating Fespixon is a highly cost-saving therapy.

The study has been accepted and published by the prestigious SCI journal: Diabetes, Obesity and Metabolism (Impact Factor: 5.8), further supporting Fespixon’s clinical and economic value and its potential inclusion in Singapore’s national reimbursement system.
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’s wound healing efficacy is supported by robust evidence, including international Phase 3 trial results, a novel mechanism of action, and pharmacoeconomic findings—published in leading journals such as JAMA Network Open, JID Innovations, Pharmaceutics, and Advances in Wound Care. This latest publication is the first to apply a health economic model in a multi-ethnic Southeast Asian setting, demonstrating Fespixon’s clinical and financial value. It provides important reference for DFU treatment guidelines and reimbursement policies across Asia.
(2) Oneness is committed to advancing scientific research in innovative drugs   and medical devices, generating post-marketing clinical evidence, and   consistently publishing our findings in internationally renowned journals. This enhances our global recognition and the competitive advantage of our products, establishing a robust foundation for global commercialization.
(3) The article is available online on Diabetes, Obesity and Metabolism: https://dom-pubs.pericles-prod.literatumonline.com/doi/10.1111/dom.16473