PharmaEssentia announced on the 18th that its new drug Ropeginterferon alfa-2b (Ropeg) has received approval from Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) for the treatment of polycythemia vera (PV). Following its approval in Brazil earlier this March, this marks another milestone for PharmaEssentia’s expansion into the Latin American market, further advancing its global business footprint.

PharmaEssentia stated that Ropeg is a next-generation, long-acting interferon independently developed and manufactured by the company. To date, it has been approved and launched in approximately 40 countries worldwide for PV patients, including major pharmaceutical markets such as the European Union, the United States, and Japan, with steady growth in both patient use and sales.

Ko-Chung Lin, CEO of PharmaEssentia, said, “We are committed to addressing unmet medical needs in the myeloproliferative neoplasm (MPN) field by providing new treatment options for PV patients and continuing to expand globally. Following Ropeg’s approval in Brazil this March, receiving approval in Argentina represents another important milestone in the Latin American market, further completing our global sales layout.”

In 2023, PharmaEssentia licensed international pharmaceutical company Pint-Pharma GmbH (“Pint”) to apply for regulatory approval and commercialize Ropeg in Latin American countries including Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, and Peru. Ropeg’s launch and marketing activities in Brazil and Argentina have already been officially initiated as planned.

Additionally, in 2024, Ropeg was granted access under “Personal Importation Programs” by health authorities in Argentina, Brazil, and Colombia, allowing patients with urgent medical needs to import the drug for personal use. Through close collaboration with Pint, PharmaEssentia has efficiently shipped Ropeg to Latin America in compliance with relevant regulations. Industry analysts are optimistic about Ropeg’s potential to capture the global PV market, with promising growth prospects ahead.

Resource: 藥華藥新藥 Ropeg 獲阿根廷藥證 今年繼巴西後再下一城