PharmaEssentia (TPE:6446) secured approval from China's National Medical Products Administration to proceed with the phase three clinical trial of its drug Ropeginterferon alfa-2b (P1101).
The drug is indicated for patients with pre-fibrotic/early primary myelofibrosis (PMF) or overt PMF at low or intermediate-1 risk, according to a Taiwan Exchange filing.
The trial will assess the efficacy and safety of the drug, which is already approved for Polycythemia Vera (PV) in over 40 countries.
The pharmaceutical company expects patient recruitment to be completed in 2025, it added.
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