PharmaEssentia Corporation announced Taiwan MOHW Approved the IND Application of Phase I Clinical Trial of P2203 in Principle. New drug name or code: Pegylated Methionine Human Granulocyte-Colony Stimulating Factor (PEG-MetHuG-CSF, also known as P2203). Indication: Chemotherapy-induced neutropenia, Multiple Myeloma (MM), Chronic Myelogenous Leukemia (CML), Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS).

Planned development stages: Phase I clinical trial and sequential clinical trials. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): Taiwan Ministry of Health and Welfare (MOHW) has approved the IND Application for the Phase I Clinical Trial of P2203 in principle. The study will commence recruitment upon MOHW's approval of the supplemental explanation of the technical documents.

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 (1)Estimated date of completion: Subject recruitment is expected to be 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.

Neutrophil is a type of white blood cell, and G-CSF agents have been the standard of care for neutropenia, a condition where patients have a low number of neutrophils in their blood. G-CSF agents can shorten the period of neutropenia and reduce the risk of infection. Sales of currently marketed long-acting G-CSF agent, Neulasta (pegfilgrastim), reached USD 710 million in the U.S. in 2023, and the global biosimilar drugs market of Neulasta reached USD 1.41-1.59 billion in 2023 according to market research.

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 out a significant impact on shareholders rights or the price of the securities on public companies.): P2203 is a PEG-MetHuG-CSF developed by PharmaEssentia, and the Company has filed a provisional patent application for P2203 to the United States Patent and Trademark Office (USPTO) to protect the Company's patent rights on P2203 itself and its indications.