The first-in-class novel prodrug, OBI-3424, has been granted by TFDA to proceed to Phase II clinical trial

1.Date of occurrence of the event:2023/02/16
2.New drug name or code: first-in-class novel prodrug, OBI-3424
OBI-3424 is converted into a potently cytotoxic DNA alkylating agent specifically by the AKR1C3 enzyme, which is expressed by a variety of tumors leading to selective killing of those cells. Potential study subjects will have their tumor cells tested by IHC to assess expression of AKR1C3 to decide whether they can be enrolled into this Phase II clinical trial.
4.Planned development stages: Phase I, II, III clinical trial, and NDA
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): The first-in-class novel prodrug, OBI-3424, has been granted by TFDA to proceed to Phase II clinical trial
(2)Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur:
Not applicable
(3)After obtaining official approval or the results of statistically significant sense, the future strategy: Proceed to phase II human clinical trial
(4)Accumulated investment expenditure incurred: To negotiate future licensing deals, and in the best interest of shareholders, this information is kept temporarily confidential.
6.Upcoming development plan: Phase II human clinical trial
(1)Estimated date of completion: Subject recruitment will be completed for the phase II trial in 2024
(2)Estimated responsibilities: None
7.Market situation:
According to a public research report from IQVIA, the global oncology drug market size was valued at USD $185 billion in 2021, with a 10.7% compound annual growth rate (CAGR). OBI-3424 is intended to target unmet medical needs when a meaningful clinical benefit to patients has been identified. Therefore, selection of future OBI-3424 studies will be based on data from this study and determined as part of an overall development strategy.
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.):None.
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.