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

About this update from Mabwell (shanghai) Bioscience Co., Ltd. Class A

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.  Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These s...

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