PharmaEssentia Corporation announced Marketing Authorization Application Submission of Ropeginterferon alfa-2b (P1101) for PV in China. Date of occurrence of the event: December 30, 2022. New drug name or code: Ropeginterferon alfa-2b (P1101).

Indication: Polycythemia Vera (PV) patients resistant or intolerant to Hydroxyurea (HU). Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): The Company submitted the marketing authorization application of Ropeginterferon alfa-2b for PV patients resistant or intolerant to HU to the China National Medical Products Administration (NMPA). Upcoming development plan: The China NPA accepts the marketing authorization application Estimated date of completion: In accordance with the China NMPA case acceptance procedure.

Ropeginterferon alfa-2b is approved to treat adult patients with PV in the European Union, Taiwan, Switzerland, Israel, South Korea, and the United States. 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.