Announcement on behalf of AP Biosciences that application for Phase I human clinical trial of Bispecific Antibody, AP505, has been granted by US FDA

1.Date of occurrence of the event: 2023/01/14
2.New drug name or code: Bispecific Antibody, AP505
Bispecific antibody AP505 is a novel cancer immunotherapy developed by AP Biosciences (hereinafter referred to as APBio). It suppresses tumor growth through dual-blockade of PD-L1 and VEGF signaling pathways, and therefore, avoids immune escape of tumor cells and inhibits angiogenesis at the same time for improved efficacy.
4.Planned development stages: Phase I, II, III clinical trial, and Biologics License Application (BLA)
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): Application for Phase I human clinical trial of Bispecific Antibody, AP505, has been granted by US FDA.
(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: Phase I clinical trial in progress
(4)Accumulated investment expenditure incurred: For negotiation on potential licensing deals in the future, and for the best interest of shareholders, this information is kept confidential temporarily.
6.Upcoming development plan:
Phase I human clinical trial
(1)Estimated date of completion: 2024
(2)Estimated responsibilities: None
7.Market situation:
According to public research report of IQVIA, the global oncology drug market size was valued at USD 185 billion in 2021, with 10.7% of compound annual growth rate (CAGR). While AP505 is intended to target unmet medical needs where a meaningful clinical benefit to the patients is identified, advancement of AP505 in further studies will be determined eventually as part of the development strategy for the entire product pipeline.
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.