SÃO PAULO--(BUSINESS WIRE)--Mar 20, 2025--
Pint Pharma and PharmaEssentia announced today that ANVISA (Brazilian Health Regulatory Agency) has approved BESREMi® (ropeginterferon alfa-2b) for the treatment of adult patients with Polycythemia Vera (PV).
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Polycythemia Vera (PV) is a rare, chronic, debilitating, and potentially fatal myeloproliferative neoplasm, originating from a disease-initiating stem cell in the bone marrow. This results in a persistent increase in red blood cells, white blood cells, and platelets. PV can lead to cardiovascular complications such as thrombosis and embolism, and in a significant number of patients it can progress to secondary myelofibrosis or leukemia.
The global incidence of PV is estimated at approximately 2.8 cases per 100,000 people per year. In Brazil, between 2016 and 2020, DataSUS recorded 1,843 cases of Polycythemia Vera, representing an incidence of 0.16 per 100,000 inhabitants. Despite being a rare disease, these numbers suggest the possibility of underdiagnosis and underreporting, highlighting a challenge in identifying affected patients.
According to Fernanda Bertasi, General Manager of Pint Pharma in Brazil, "ANVISA’s approval of BESREMi® represents a transformative milestone for patients with Polycythemia Vera in Brazil. This new therapeutic option brings real hope, offering innovation and progress in disease treatment. This is an essential step in providing better health and well-being for these patients."
Valnei Canutti, Hematologist and Chief Scientific Officer at Pint Pharma, emphasized that "BESREMi® is an innovative, monopegylated interferon with extended action due to its unique pharmacokinetic properties. Its approval was based on robust evidence from the PEGINVERA clinical study, which demonstrated superior and more sustained hematologic and clinical responses compared to standard therapy."
For David Ricardo Muñoz Guzmán, CEO of Pint Pharma, "This therapeutic advancement reaffirms Pint Pharma’s commitment to being a community-centered company. Our mission goes beyond innovation and high technology, focusing on solutions that truly impact patients' lives by expanding access to treatments and improving healthcare quality."
Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia, added, "The approval of BESREMi® by ANVISA is a testament to the power of strong cross-border partnerships in advancing healthcare and reinforces our mission to transform care for PV patients worldwide. We deeply appreciate the collaboration with the Pint Pharma team, whose expertise and dedication have been instrumental in bringing BESREMi® to patients in Brazil."
BESREMi® is exclusively registered, marketed, and distributed by Pint Pharma in Brazil.
About BESREMi® (ropeginterferon alfa-2b) in Polycythemia Vera (PV)
BESREMi® is an innovative, monopegylated, long-acting interferon that has marketing authorization in over 40 countries, with approval from the European Medicines Agency (EMA) in 2019, the U.S. Food and Drug Administration (FDA) in 2021, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023.. With its exclusive pegylation technology, BESREMi® offers extended activity in the body and is designed for administration once every two weeks (or once every four weeks if hematologic stability is maintained for at least 1.5 years), allowing for flexible dosing tailored to individual patient needs.
About PharmaEssentia
PharmaEssentia Corporation (TWSE: 6446) headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan.
About Pint Pharma
Pint Pharma is a biopharmaceutical company that specialises in the commercialisation of innovative therapies with the potential to transform outcomes in rare disease and other patient communities across the Latin American region. By collaborating with world-class biotech and pharma companies, Pint Pharma is committed to improving the lives of Latin American patients in areas of significant unmet medical need. The company is headquartered in Europe and counts with over 250 employees across its territories in Latin America including Brazil, Mexico, Argentina, Colombia, Chile, Peru and Ecuador. Pint Pharma licensed from PharmaEssentia the rights to commercialize BESREMi® in Brazil.
Pint Pharma Announces ANVISA’s Approval of BESREMi® (ropeginterferon alfa-2b) for the Treatment of Polycythemia Vera
DUBAI, United Arab Emirates (AP) — U.S. President Donald Trump said Iran wants to negotiate with Washington after his threat to strike the Islamic Republic over its bloody crackdown on protesters, a move coming as activists said Monday the death toll in the nationwide demonstrations rose to at least 544.
Iran had no immediate reaction to the news, which came after the foreign minister of Oman — long an interlocutor between Washington and Tehran — traveled to Iran this weekend. It also remains unclear just what Iran could promise, particularly as Trump has set strict demands over its nuclear program and its ballistic missile arsenal, which Tehran insists is crucial for its national defense.
Meanwhile Monday, Iran called for pro-government demonstrators to head to the streets in support of the theocracy, a show of force after days of protests directly challenging the rule of 86-year-old Supreme Leader Ayatollah Ali Khamenei. Iranian state television aired chants from the crowd, who shouted “Death to America!” and “Death to Israel!”
Trump and his national security team have been weighing a range of potential responses against Iran including cyberattacks and direct strikes by the U.S. or Israel, according to two people familiar with internal White House discussions who were not authorized to comment publicly and spoke on condition of anonymity.
“The military is looking at it, and we’re looking at some very strong options,” Trump told reporters on Air Force One on Sunday night. Asked about Iran’s threats of retaliation, he said: “If they do that, we will hit them at levels that they’ve never been hit before.”
Trump said that his administration was in talks to set up a meeting with Tehran, but cautioned that he may have to act first as reports of the death toll in Iran mount and the government continues to arrest protesters.
“I think they’re tired of being beat up by the United States,” Trump said. “Iran wants to negotiate.”
He added: “The meeting is being set up, but we may have to act because of what’s happening before the meeting. But a meeting is being set up. Iran called, they want to negotiate.”
Iran through country's parliamentary speaker warned Sunday that the U.S. military and Israel would be “legitimate targets” if America uses force to protect demonstrators.
More than 10,600 people also have been detained over the two weeks of protests, said the U.S.-based Human Rights Activists News Agency, which has been accurate in previous unrest in recent years and gave the death toll. It relies on supporters in Iran crosschecking information. It said 496 of the dead were protesters and 48 were with security forces.
With the internet down in Iran and phone lines cut off, gauging the demonstrations from abroad has grown more difficult. The Associated Press has been unable to independently assess the toll. Iran’s government has not offered overall casualty figures.
Those abroad fear the information blackout is emboldening hard-liners within Iran’s security services to launch a bloody crackdown. Protesters flooded the streets in the country’s capital and its second-largest city on Saturday night into Sunday morning. Online videos purported to show more demonstrations Sunday night into Monday, with a Tehran official acknowledging them in state media.
In Tehran, a witness told the AP that the streets of the capital empty at the sunset call to prayers each night. By the Isha, or nighttime prayer, the streets are deserted.
Part of that stems from the fear of getting caught in the crackdown. Police sent the public a text message that warned: “Given the presence of terrorist groups and armed individuals in some gatherings last night and their plans to cause death, and the firm decision to not tolerate any appeasement and to deal decisively with the rioters, families are strongly advised to take care of their youth and teenagers.”
Another text, which claimed to come from the intelligence arm of the paramilitary Revolutionary Guard, also directly warned people not to take part in demonstrations.
“Dear parents, in view of the enemy’s plan to increase the level of naked violence and the decision to kill people, ... refrain from being on the streets and gathering in places involved in violence, and inform your children about the consequences of cooperating with terrorist mercenaries, which is an example of treason against the country,” the text warned.
The witness spoke to the AP on condition of anonymity due to the ongoing crackdown.
The demonstrations began Dec. 28 over the collapse of the Iranian rial currency, which trades at over 1.4 million to $1, as the country’s economy is squeezed by international sanctions in part levied over its nuclear program. The protests intensified and grew into calls directly challenging Iran’s theocracy.
Nikhinson reported from aboard Air Force One.
In this frame grab from video obtained by the AP outside Iran, a masked demonstrator holds a picture of Iran's Crown Prince Reza Pahlavi during a protest in Tehran, Iran, Friday, January. 9, 2026. (UGC via AP)
In this frame grab from footage circulating on social media from Iran shows protesters taking to the streets despite an intensifying crackdown as the Islamic Republic remains cut off from the rest of the world in Tehran, Iran, Friday, Jan. 9, 2026.(UGC via AP)
In this frame grab from footage circulating on social media from Iran showed protesters once again taking to the streets of Tehran despite an intensifying crackdown as the Islamic Republic remains cut off from the rest of the world in Tehran, Iran, Saturday Jan. 10, 2026. (UGC via AP)
