BeiGene has successfully expanded its oncology clinical research trials into Brazil, addressing the country's significant cancer burden and disparities in treatment access. The company's strategic approach focuses on building strong local foundations, streamlining study start-up processes, and exceeding patient recruitment expectations.
Building a Foundation in Brazil
In 2021, BeiGene established a legal entity in Brazil with a dedicated team, aiming to create a fully operational company capable of conducting clinical trials and preparing for product launches. This expansion involved seamless coordination across clinical operations, regulatory affairs, and legal teams. A key step was engaging with the Brazilian Health Regulatory Agency (ANVISA) to present BeiGene's mission and pipeline.
BeiGene has also cultivated partnerships with leading healthcare institutions and physicians in hematology and oncology. These collaborations facilitate improved communication, customized solutions, and strategic planning for future studies. The company's partnership program offers mutual benefits and a tailored agenda for investigators and site staff.
Streamlined Study Start-Up
BeiGene employs a strategic feasibility process that integrates internal and external insights to develop precise study designs and streamlined approval timelines. This approach, coupled with a comprehensive understanding of local needs, enables informed selection of clinical centers, directly impacting patient recruitment and trial success.
The Brazil Study Start-Up (SSU) structure supports submissions in other Latin American countries, ensuring high-quality submissions to local ethics committees (LECs) and health authorities (HAs). SSU managers customize informed consent forms and develop regulatory strategies that accelerate approvals, particularly for rare diseases. BeiGene has consistently secured direct approvals faster than traditional timelines, benefiting from ANVISA's simplified analysis based on regulatory decisions made by trusted international health authorities.
The introduction of Law 14874 of 2024 is expected to bring more predictability to timelines and requirements, further enhancing Brazil's contribution to global studies.
Exceeding Recruitment Expectations
Brazil's high cancer incidence, diverse population, and access-related challenges necessitate precise identification of clinical sites. BeiGene's success in LATAM is driven by its team's expertise, active engagement of principal investigators, strong partnerships with clinical sites, and commitment to quality. In just two years, BeiGene initiated over 10 clinical studies, enrolling more than 200 patients.
Challenges remain, including timely importation of clinical supplies and contract negotiation timelines. However, BeiGene's agility enables it to overcome operational hurdles by adapting internal processes to meet the evolving demands of the market.
Future Directions
BeiGene plans to scale up its ClinOps operation to drive the execution of Phase 1 studies in Brazil, addressing the country's current lack of significant involvement in this type of study. With at least 10 new molecules projected to enter the clinical stage each year, BeiGene aims to help Brazil join the ranks of countries with extensive Phase 1 expertise.
Addressing Cancer Prevalence and Treatment in Brazil
Brazil faces significant cancer challenges, including disparities in care and limited access to advanced treatments. The Brazilian National Cancer Institute (INCA) projects over 704,000 new cancer cases annually from 2023 to 2025. Cancer mortality rates in Latin America are approximately double those in the United States, making cancer the second leading cause of death in the region.
Only 25% of the adult Brazilian population can afford private healthcare, leading to delays in access to medications and new cancer therapies. BeiGene's global health mission aligns with addressing these challenges by developing medicines accessible to more patients worldwide.
Brazil offers cost-effective clinical trial opportunities, with costs approximately 56% lower than in the U.S. This makes Brazil an attractive destination for clinical research and highlights its potential to contribute to global advancements in oncology and hematology.
