Announcement on behalf of AP Biosciences that application for Phase I human clinical trial of Bispecific Antibody, AP203, has been granted by US FDA

1.Date of occurrence of the event:2022/09/10
2.New drug name or code:Bispecific Antibody, AP203
3.Indication:Bispecific antibody AP203 is a second-generation cancer immunotherapy developed by AP Biosciences (hereinafter referred to as APBio). It binds to PD-L1 and CD137, and induces T-cell activation, as well as cancer cell killing, in a target-dependent manner with reduced systemic cytokine release.
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, AP203, 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 Fortune Business Insights, the global oncology drug market size was valued at USD 141.3 billion in 2019, with 11.6 % of compound annual growth rate (CAGR). While AP203 is intended to target unmet medical needs where a meaningful clinical benefit to the patients is identified, advancement of AP203 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: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.