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 China NMPA. Date of occurrence of the event: April 26, 2024. 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. Market situation: Primary Myelofibrosis (PMF) is myelofibrosis (MF) that occurs on its own and is a myeloproliferative neoplasm (MPN), along with Polycythemia Vera (PV) and Essential Thrombocythemia (ET). According to the Orphanet, the annual incidence of PMF is approximately 1 case per 100,000 individuals.

For low-risk MF patients with symptoms, current treatments include off-label hydroxyurea (HU) and pegylated interferon, and in some cases JAK2 inhibitors or allogeneic stem cell transplantation. JAK2 inhibitors are primarily indicated for patients with intermediate to high-risk MF. This study is a multinational, multicenter global phase III clinical trial.

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 nearly 40 countries in the world, including major new drug markets such as the European Union, the United States, and Japan.