Mabwell T-mab Unit Passes Brazil GMP Inspection

Mabwell (688062.SH, 02493.HK) announced Sunday that its wholly-owned subsidiary, T-mab, has received GMP certification from Brazil's Health Regulatory Agency (ANVISA) for its denosumab biosimilar products, 9MW0311 and 9MW0321. This is the company's second GMP certification from a Pharmaceutical Inspection Co-operation Scheme (PIC/S) member country, following an earlier certification in Jordan.

The inspection by ANVISA, which adheres to rigorous standards aligned with ICH and WHO, is viewed as a significant endorsement of Mabwell's quality management system. Brazil, as a key BRICS nation and the largest economy in Latin America, represents a substantial pharmaceutical market. Passing this inspection is anticipated to facilitate broader market access within other PIC/S member nations.

Mabwell has previously submitted market authorization applications for its denosumab products in eight countries, including Brazil, and has already secured marketing approval in Pakistan.

### Catalyst Analysis: Brazilian GMP Certification

Mabwell's subsidiary T-mab successfully passed a GMP inspection by Brazil's ANVISA for its denosumab biosimilars. This certification from a PIC/S member authority is a regulatory milestone that could bolster the company's market access in Brazil and potentially other PIC/S member countries.

### Technical Analysis & Key Risk Watch

03.66 · R1 ## Technical Analysis & Key Risk Watch 01.74 · last ## Technical Analysis & Key Risk Watch 01.65 · S1 ## Technical Analysis & Key Risk Watch 01.48 · S2 $99.20.

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### Impact on Pharmaceuticals Sector

Biopharmaceutical companies seeking international market expansion often prioritize obtaining GMP certifications from regulatory bodies in key regions. This enables the companies to demonstrate adherence to high-quality manufacturing standards, which is crucial for gaining market approval and building investor confidence in pipeline assets and commercialized products.