Second PIC/S GMP Certification | Mabwell Passes Brazilian GMP Inspection for Its Denosumab Injections

SHANGHAI , Aug. 9, 2026 /PRNewswire/ -- 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 denosumab products in 8 countries, including Brazil, and has obtained marketing approval in Pakistan.

About Mabwell Mabwell (688062.SH, 02493.HK) is an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain. The company is committed to providing more effective and accessible therapies to meet global medical needs, with a focus on oncology and aging-related diseases. Mabwell's mission is "Explore Life, Benefit Health" and its vision is "Innovation, from Ideas to Reality." For more information, please visit www.mabwell.com/en .