PharmaEssentia Corp. announced significant news on the 28th, submitting an application for market approval of its new drug BESREMi (Ropeginterferon alfa-2b, also known as Ropeg or P1101) in Brazil. The indication for this drug is polycythemia vera (PV), marking the first step into the Latin American market.
According to regulations from the Brazilian Health Regulatory Agency (ANVISA), the standard review time for market approval applications is 365 days, with the possibility of expedited review within 120 days.
CEO Ko-chung Lin stated that Ropeg has already obtained approvals for PV treatment in multiple countries. This application for PV treatment approval in Brazil represents the first move towards expanding into the Latin American market.
Ropeg is a new generation of long-acting interferon independently developed and produced by PharmaEssentia. It has been approved for adult PV patients and launched in nearly 40 countries worldwide, including major markets such as the European Union, the United States, and Japan. It has also received PV treatment approvals in Taiwan and South Korea. Currently, applications for PV treatment approvals in China, Hong Kong, Malaysia, and Singapore are under review. The global sales of Ropeg continue to grow strongly, and its expansion into Latin America will further enhance its global sales layout.
Last year, PharmaEssentia licensed international pharmaceutical company Pint-Pharma GmbH to handle the application and commercialization of Ropeg in Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, and Peru in the Latin American region. Brazil, where the current application for drug approval is made, is the largest country in Latin America. According to market research estimates, there are over 100,000 PV patients in Latin America, with current clinical treatments including phlebotomy, hydroxyurea (HU), interferon, and JAK2 inhibitors.
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