On the 18th, PharmaEssentia announced that its new drug Ropeginterferon alfa-2b (Ropeg) has been approved by Brazil’s National Health Surveillance Agency (ANVISA) for the treatment of polycythemia vera (PV). This marks Ropeg’s official entry into the Latin American market, further expanding the company’s global footprint.
Ropeg is PharmaEssentia’s independently developed next-generation, long-acting interferon. It has been approved and marketed in multiple countries for the treatment of adult patients with PV, including major markets such as the United States, Japan, mainland China, and Europe. The number of patients using Ropeg in these regions continues to grow steadily, with global sales maintaining strong momentum.
PharmaEssentia CEO Dr. Kochung Lin stated that the company is committed to addressing the urgent medical needs within the field of myeloproliferative neoplasms (MPNs), providing innovative treatment options for PV patients while continuing to expand globally. Ropeg has already received regulatory approvals for PV treatment in several countries. Its latest approval in Brazil represents the first step in entering the Latin American market. Brazil ranks among the top three countries in the world in terms of PV patient numbers (excluding Europe). It is also the second-largest commercial market in the Americas, after the United States, and the largest in Latin America. According to market research, there are an estimated 100,000 PV patients in Latin America. Current clinical treatment options in the region include phlebotomy, hydroxyurea (HU), interferons, and JAK2 inhibitors. Ropeg’s approval in Brazil not only expands the market reach into Latin America but also strengthens the company’s comprehensive global sales network.
In 2023, PharmaEssentia licensed its partner Pint-Pharma GmbH (Pint) to handle the regulatory filings and commercialization of Ropeg in several Latin American countries, including Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, and Peru. Following the strategic plan, Ropeg has officially launched in Brazil, with sales and marketing activities already underway. Industry analysts are optimistic about Ropeg’s potential to capture a significant share of the global PV market, with promising growth prospects ahead.
In 2024, Ropeg was also approved under the Named Patient Program (NPP) by the health authorities of Colombia, Argentina, and Brazil. This allows patients with urgent medical needs to import Ropeg on an individual-use basis. Through close collaboration with Pint, PharmaEssentia has rapidly delivered Ropeg to Latin America in compliance with relevant regulations, laying a solid foundation for its commercialization in the region and achieving a successful market entry.
Meanwhile, the global supply disruption of Pegasys has attracted international attention. Brazil recently announced a shortage of Pegasys, with supply not expected to resume until 2027. Patients are advised to consult their physicians for alternative treatment options. PharmaEssentia stated that it has proactively expanded production capacity to ensure supply chain stability and is well-positioned to respond quickly to market demand. With Ropeg now approved for launch in Brazil, the company is poised to offer innovative treatment options to more PV patients and continue driving global business growth.
Resource: 藥華藥新藥Ropeg再下一城 獲巴西藥證、進軍拉美市場
