NEWS

1.Date of occurrence of the event:2025/08/28

2.New drug name or code:OB318

3.Indication:Treatment for liver cancer

4.Planned development stages:NA
5.    Current development stage:
(1)    File application/approved/disapproved/Each of clinical trials (include interim analysis):
i)    The OB318CLCT01 Phase I clinical trial has completed patient enrollment for six dose cohorts and received approval from the Safety Review Committee to proceed to the seventh dose cohort. Overall safety data also indicate that OB318 has shown no safety concerns within the completed dose range (25 mg to 225 mg).
ii)    However, considering the availability of existing cancer immunotherapies and targeted therapies as treatment options for liver cancer, and given the more favorable progress achieved in the development of the Company’s other drug candidates, the Company has decided to discontinue the development of OB318 to enable a more efficient allocation of internal resources.
(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 approval or the results (include interim analysis) of statistically significant sense, the future strategy:NA
(4)    Accumulated investment expenditure incurred:No disclosure in consideration of business development.
6.    Upcoming development plan:
(1)    Scheduled completion date:NA (2)Estimate responsibilities:NA
7.    Market situation:The global liver cancer drug market is highly competitive, and current treatment guidelines for advanced liver cancer have incorporated immunotherapy as a standard of care. The future development of therapies for advanced liver cancer is expected to focus on combination regimens, where mainstream immunotherapy-based combinations have already become the standard and reinforced market entry barriers through reimbursement coverage. Considering future commercial competition and the required R&D investment, the advantages of small-molecule or botanical new drugs are likely to be less significant than initially expected.
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)    Oneness will allocate R&D resources on other high-potential products and core technologies, accelerating the development of key projects to align with shareholders’ interests and long-term corporate value.
(2)    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.