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PharmaEssentia receives regulatory approval in South Korea for BESREMi to treat polycythemia vera

Source: Press by PharmaEssentia

Next-generation interferon now approved in Taiwan, Europe and South Korea; US regulatory
decision expected in November 2021

PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that its South Korean subsidiary has received approval for BESREMi (ropeginterferon alfa-2b) for the treatment of polycythemia vera (PV) from the Ministry of Food and Drug Safety (MFDS).

“We are incredibly pleased to launch BESREMi, a next-generation interferon for people with PV in Korea,” said Ko-Chung Lin, Ph.D., Co-Founder and Chief Executive Officer for PharmaEssentia. “We will actively collaborate with key stakeholders and medical leaders to make BESREMi available for the PV community in Korea.”

BESREMi previously received regulatory approval in Taiwan and in the E.U. for the treatment of PV without symptomatic splenomegaly in adults; it received orphan drug designation from MFDS in July 2020. PharmaEssentia is also seeking approval for the PV indication in the U.S. and expects a decision by the U.S. Food and Drug Administration (FDA) in November 2021.

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