Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that it has signed a licensing and commercialization agreement with CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA., one of the leading pharmaceutical companies in Brazil, for its Denosumab Biosimilars. Under the agreement, CRISTÁLIA will spearhead the products’ registration and commercialization within Brazil.

Brazil, with a population of 215 million, is the largest pharmaceutical market in Latin America. Its National Health Surveillance Agency (ANVISA) is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and also a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), with high national standards for market access.

Mr. Huiguo Hu, Board Member, Chief Commercial Officer and Senior Vice President of Mabwell, said, “We are pleased to forge this strategic alliance with CRISTÁLIA, and work closely to register and commercialize our Denosumab Biosimilars in Brazil, which is one of the most important emerging markets. This cooperation represents a solid step forward for Mabwell in the Latin American region and signifies that our clinical data and quality system are recognized by more countries. We believe that this cooperation will further enhance the accessibility of the products to local patient community.”

About CRISTÁLIA

With more than 50 years, CRISTÁLIA is a 100% Brazilian pharmaceutical company, which has the abundant portfolio. Under the motto “Always a step ahead”, CRISTÁLIA has brought to the country technologies that now provide access to cutting-edge medicines for millions of Brazilians.