PharmaEssentia Corporation announced update on the company?s IND Application of Phase I Clinical Trial of Sequential Treatment of P1801 following P1101 in Patients with Advanced Solid Tumors. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): Regarding the IND application of the phase I clinical trial of sequential treatment of anti-PD-1 monoclonal antibody new drug P1801 following P1101 in patients with advanced solid tumors, the Company has completed submission of the supplementary information as Taiwan Ministry of Health and Welfare (MOHW) advised to Taiwan Food and Drug Administration (TFDA). Accumulated investment expenditure incurred: In consideration of the future marketing strategy and to protect the rights of the company and investors, no public disclosure will be made for the time being.

Upcoming development plan: Phase I clinical trial: Estimated date of completion: Subject recruitment for this trial consists of the following phases: Dose Escalation Phase and Dose Expansion Phase. The enrollment for all groups is expected to be completed in 2027 following the Dose Escalation Phase completed in 2025. The timeline will be adjusted according to the actual progress of the clinical trial, and disclosure will be made upon the progress of the study according to the regulations.

Ropeginterferon alfa-2b is an innovative monopegylated, long-acting interferon invented and manufactured by PharmaEssentia. Ropeginterferon alfa-2b is approved to treat adult patients with Polycythemia Vera (PV) in around 40 countries worldwide, including major markets such as the European Union, the United States, and Japan.