• ANVISA approval for the Spectrila® marketing authorization transfer enables SteinCares to ensure uninterrupted access to essential Acute Lymphoblastic Leukemia (ALL) treatment in Brazil.
• The milestone strengthens SteinCares’ onco-hematology portfolio and reinforces the company’s commitment to pediatric cancer care across Latin America’s largest market.

São Paulo, Brazil, March 26th 2026 – SteinCares, a leading specialty healthcare company in Latin America, today announced Brazil’s Agência Nacional de Vigilância Sanitária, ANVISA, has approved the registration transfer for Spectrila®, an essential recombinant E. coli asparaginase biologic used in the treatment of Acute Lymphoblastic Leukemia (ALL). SteinCares will now relaunch the product in the country and manage its complete commercialization, distribution, and regulatory oversight, reinforcing its commitment to expanding access to critical onco-hematology and rare disease therapies.

This transfer ensures continuous access to Spectrila® for pediatric patients across Brazil, supporting sustained treatment protocols in specialized centers that rely on asparaginase as an essential therapy for ALL. This milestone strengthens SteinCares’ onco-hematology portfolio and reinforces its strategic presence in Latin America’s largest pharmaceutical market.

Acute Lymphoblastic Leukemia (ALL) represents approximately 25% of pediatric cancer cases in Brazil¹-leading diagnosis among children. With estimated incidence reaching 135 cases per million children², according to Brazil’s National Cancer Institute (INCA), sustained access to essential therapies like asparaginase remains critical.

“The addition of Spectrila® to our portfolio is a powerful reflection of our commitment to the SteinCares project in Brazil and ensuring that pediatric patients have access to high-quality, innovative specialty care treatments they need”, said Julio Avella, General Manager Brazil and LATAM Head of Rare Diseases at SteinCares. “Driven by deep market knowledge and operational excellence, we are turning purpose into real impact, creating healthcare opportunities for patients and driving sustainable value for health systems throughout the region.”

About SteinCares

SteinCares is a leading specialty pharmaceutical company dedicated to expanding patient access to innovative and cost-effective treatments across Latin America. With more than 45 years of experience and an integrated “one-stop-shop” platform across 30 countries of Latin America and the Caribbean, SteinCares combines deep local expertise, regulatory agility, and end-to-end operational capabilities — from licensing and commercialization to market access and patient support.

For more information, please visit http://www.steincares.com/ or follow the company on LinkedIn.

1. Outcome of childhood acute lymphoblastic leukemia treatment in a single center in Brazil: A survival analysis study. National Library of Medicine. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC8789616/ Last review: March, 2026. ↩︎
2. Acute lymphoblastic leukemia: an update on treatment and Brazilian perspective. Frontiers in Oncology. Available at: https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2026.1637924/full . Last review: March, 2026. ↩︎