Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its wholly-owned subsidiary, T-mab, has successfully passed the on-site GMP inspection conducted by the Jordan Food and Drug Administration (JFDA).

The inspection covered two denosumab injections: 9MW0311 (Prolia® biosimilar) and 9MW0321 (Xgeva® biosimilar). The facility was granted conclusion of "Compliance" from JFDA. This marks Mabwell's inaugural recognition by a regulatory authority in a PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) member country.

As an authoritative international organization for pharmaceutical GMP inspections worldwide, PIC/S is committed to harmonizing inspection standards and strengthening international cooperation. As a PIC/S member, Jordan's GMP standards are aligned with high-level international regulatory requirements. The inspection provided a comprehensive and systematic review of Taizhou Mabwell's facilities and equipment, quality systems, production, warehousing, testing, and batch release processes, earning high praise and recognition from the auditors.

To date, Mabwell has reached strategic collaborations covering 33 countries for its denosumab injection products, submitted marketing applications in 8 countries, and obtained marketing approval in Pakistan in 2025.

Mr. Huiguo Hu, Board Member, Senior Vice President, and Board Secretary of Mabwell, said, " Successfully passing this GMP inspection by a PIC/S member country demonstrates that Mabwell's quality management system is gaining increasing recognition from high-standard overseas regulatory authorities, which will help accelerate the registration and marketing process for our products in more countries. At the same time, this represents significant progress for us in the Middle East region, further enhancing the accessibility of high-quality biologics locally and benefiting more patients."