Qirui Group’s First Innovative Drug Passes Both National Key Inspections on the First Attempt

From January 20 to 23, 2026, the Center for Drug and Food Review and Inspection of the National Medical Products Administration, in collaboration with the Hubei Provincial Medical Products Administration, conducted a four-day on-site inspection for drug registration and a dynamic GMP compliance review of MY008211A Tablets, the first innovative drug product independently developed by Qirui Group. During the inspection, a panel of experts from the medical products regulatory authorities adopted a rigorous and professional approach, conducting systematic and in-depth on-site inspections and document reviews across all critical areas, including the R&D process of MY008211A Tablets, commercial manufacturing processes, the full lifecycle quality management system, facility and equipment infrastructure, the quality control laboratory, the formulation R&D and production site, the material management system, and data integrity management. Leveraging a comprehensive, multi-dimensional quality management system that spans the entire drug lifecycle and highly efficient team collaboration, Qirui Group achieved an outstanding performance—zero critical findings—and successfully passed the inspection at the highest standards on the first attempt.

MY008211A tablet is the first domestically developed innovative CFB inhibitor drug by Qirui Group, indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). A New Drug Application was submitted in October 2025, and the product has been included on the Priority Review List. This inspection represents the highest-level assessment of the product’s end-to-end capabilities across the entire pre-market value chain—research and development, manufacturing, and quality control.

This milestone achievement is rooted in Qirui Group’s long-standing commitment to the core values of “quality and responsibility.” The company consistently places pharmaceutical quality and patient safety at the forefront, regarding compliance as the fundamental principle governing all business operations. From drug molecule design to final product release, every stage adheres rigorously to the highest international and domestic standards. Through sustained and unwavering practice, a culture of quality has become deeply embedded in the very fabric of the organization, translating into conscious, collective action and highly effective execution across the entire enterprise.

The successful completion of this inspection signifies that Qirui Group’s end-to-end quality management system—spanning the entire value chain from R&D to manufacturing—has received authoritative recognition from the national drug regulatory authority. This not only lays a solid foundation for the approval and launch of MY008211A tablets, but also provides a replicable best-practice model and strong confidence to support the R&D and industrialization of the company’s subsequent pipeline of innovative drugs.

Looking ahead, Qirui Group will take this as a new starting point to continuously consolidate and deepen its “zero-defect” quality management system, further refine its dual-engine strategy of R&D innovation and quality enhancement, steadfastly uphold the core values of “quality and responsibility,” and deliver high-quality, specialized products and services that contribute to human health.