Mabwell passes Brazilian GMP inspection for denosumab

August 10, 2026 | 11:12

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Mabwell, dual-listed under 688062.SH and 02493.HK, announced its subsidiary T-mab passed the Brazilian Health Regulatory Agency's GMP inspection for its denosumab injections, marking a second PIC/S GMP certification.

SHANGHAI, Aug. 10, 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.

By PR Newswire

Mabwell

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