Trinomab Successfully Obtains EU QP Declaration
Following the marketing approval of Sintetol?, the world's first recombinant anti-tetanus toxin monoclonal antibody drug, Zhuhai Trinomab Biopharmaceutical Co., Ltd. (hereinafter referred to as "Trinomab") has achieved another major milestone. The company’s biologics manufacturing facility at Zhuhai International Health Harbor has successfully passed a rigorous compliance audit conducted by the EU Qualified Person (QP), officially obtaining the Qualified Person’s Declaration.
During the audit, the EU QP conducted a thorough evaluation in accordance with EudraLex Volume 4 (EU GMP Part I, II, III, and Annexes 1, 2, and 15). assessing:
Quality management system
Manufacturing facilities (drug substance and drug product)
Utility systems and cell bank management
Raw material, excipients, packaging, and finished product warehousing
Laboratory testing and quality control
Biosafety and data integrity practices
Having previously obtained China NMPA GMP certification, this QP Declaration signifies that Trinomab’s quality management system and production standards have met international requirements, laying a critical foundation for future EU clinical trials and global commercialization.
With the QP Declaration in hand, Trinomab will leverage this achievement to accelerate its international strategy across three key areas:
Clinical Development – Facilitating EU clinical trials and regulatory approvals.
Partnerships – Strengthening international collaborations.
Supply Chain – Ensuring global-compliant manufacturing and distribution.
This milestone represents a significant step forward in Trinomab's growth as a global biopharmaceutical innovator.
(Sintetol Trademark Registration Number: 74174546)
