MABWELL-B (02493) surged over 13% during morning trading, with shares up 11.38% to HK$25.06 as of press time, on a turnover of HK$33.0181 million.

According to an official announcement from MABWELL, its wholly-owned subsidiary Taikang Biomedical has successfully passed the Good Manufacturing Practice (GMP) on-site inspection conducted by the Brazilian National Health Surveillance Agency (ANVISA) for two denosumab injections: 9MW0311 (a Prolia® biosimilar, domestic brand name: Mailishu®) and 9MW0321 (an Xgeva® biosimilar, domestic brand name: Maiweijian®).

This marks the second time MABWELL has received a GMP certificate from a regulatory authority in a PIC/S (Pharmaceutical Inspection Co-operation Scheme) member country, following its earlier success in Jordan. As a PIC/S member, Brazil's ANVISA is known for its rigorous and stringent GMP review standards, which are fully aligned with International Council for Harmonisation (ICH) and World Health Organization (WHO) international guidelines. This certification underscores that MABWELL's quality management system has once again gained recognition from a high-standard overseas regulator, laying a stronger foundation for the company's products to enter more PIC/S member markets.