Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announces that its wholly-owned subsidiary T-mab has successfully passed Brazilian Health Regulatory Agency's (“ANVISA”)  GMP on-site inspection for its denosumab biosimilars, 9MW0311 (Prolia® biosimilar) and 9MW0321 (Xgeva® biosimilar). This is Mabwell's second GMP certification from a Pharmaceutical Inspection Co-operation Scheme (PIC/S) member authority, following the one in Jordan.

As a BRICS nation and Latin America's largest economy, Brazil has the region's biggest pharmaceutical market. As a PIC/S member, ANVISA is known for its rigorous GMP standards fully aligned with ICH and WHO. Passing this inspection is a strong vote of confidence in Mabwell's quality management system and paves the way for broader access to PIC/S member markets.

Previously, Mabwell had already submitted market authorization applications for its two denosumab products in 8 countries, including Brazil, and has obtained marketing approval in Pakistan.