鈥?HANBEITAI (bevacizumab) receives first overseas approval from Bolivia's AGEMED
鈥?The 4th self-developed product of Henlius approved overseas, continuing to expand into emerging markets
鈥?In collaboration with Eurofarma, all three partnered products have been approved for marketing in the partnered regions
Recently, HANBEITAI (bevacizumab), independently developed and produced by Henlius, has been officially approved by Agencia Estatal de Medicamentos y Tecnolog铆as en Salud (AGEMED) for marketing in Bolivia under the trade name LONGIVA. This milestone marks HANBEITAI as the fourth self-developed and -manufactured product of Henlius to be approved for overseas marketing, following HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), and HANLIKANG (rituximab). This further propels the company's globalization process.
The approval is based on the exclusive commercial cooperation between Henlius and Eurofarma, a leading pharmaceutical company in Brazil and Latin America. In 2022, Henlius entered into a license agreement with Eurofarma for the development, manufacturing and commercialization in 16 Latin American countries of Henlius' independently developed HANLIKANG, HANQUYOU, and HANBEITAI. Leveraging Henlius' leading product quality and Eurofarma's strong local capabilities, HANQUYOU and HANLIKANG have already been approved for marketing in Latin American countries including Bolivia. The approval of HANBEITAI by AGEMED signifies that all three partnered products have been successfully approved in the partnered territories, highlighting the fruitful outcomes of the聽close collaboration.
HANBEITAI鈥檚 development, manufacturing and the quality management system are in line with global standards.聽The approval of HANBEITAI by AGEMED in Bolivia is mainly based on the review of a series of data. The application dossier is mainly based on the information submitted to China鈥檚 National Medical Products Administration (NMPA) in the New Drug Application (NDA). Henlius has conducted a set of head-to-head comparisons between HANBEITAI and the reference bevacizumab, including analytical similarity studies, non-clinical studies and clinical studies. The results showed that HANBEITAI and the reference product are highly similar in terms of quality, safety and efficacy. Henlius鈥?three production sites 鈥?Xuhui Facility, Songjiang First Plant and Songjiang Second Plant 鈥?along with their quality management systems, have successfully passed approximately 100 inspections and audits conducted by NMPA, the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), and the EU qualified person, as well as multiple international business partners.
Moving forward, Henlius remains committed to its mission of "Affordable innovation, Reliable Quality", continuing to drive the global approval and marketing of more products to benefit a broader patient population.
