PharmaEssentia Corporation submitted phase III clinical study protocol of P1101 for Pre-fibrotic/Early PMF or Overt PMF at Low to Intermediate-1 Risk to U.S. FDA. New drug name or code: Ropeginterferon alfa-2b (P1101); Indication: Pre-fibrotic/Early Primary Myelofibrosis or Overt Primary Myelofibrosis at low to intermediate-1 risk according to DIPSS Plus. Planned development stages: Phase III clinical trial, and later to apply for the marketing authorization.

Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): The Company submitted the phase III clinical study protocol of Ropeginterferon alfa-2b (P1101) for adult patients with pre-fibrotic/early primary myelofibrosis or overt primary myelofibrosis at low to intermediate-1 risk according to DIPSS Plus to U.S. Food and Drug Administration (FDA). Upcoming development plan: Phase III clinical trial: Estimated date of completion: The timeline will be in accordance with U.S. FDA review procedure, and disclosure will be made according to the regulations. Ropeginterferon alfa-2b is approved to treat adult patients with Polycythemia Vera (PV) in the European Union, Taiwan, Switzerland, Israel, South Korea, Macao, United States, Japan, Bahrain, Qatar, and the United Arab Emirates.