Another Milestone in Global Expansion: IX Passes Türkiye’s GMP Inspection

Recently, the production line for the 9-valent human papillomavirus (HPV) vaccine (Escherichia coli) of Xiamen Innovax Biotech Co., Ltd. (“IX”) passed a Good Manufacturing Practice (GMP) compliance inspection conducted by the Turkish Medicines and Medical Devices Agency (TITCK). TITCK issued GMP Certificate No. 2026-423/1.

Türkiye is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an important international regulatory cooperation framework dedicated to promoting the harmonization of GMP standards and cooperation in inspections among regulatory authorities. The successful completion of the PIC/S GMP compliance inspection marks the first time that IX’s manufacturing and quality management systems have successfully passed a GMP compliance inspection conducted by a PIC/S member country’s regulatory authority. This milestone also provides strong support for the company’s continued efforts to strengthen its global quality management system and advance international regulatory registrations.

A robust quality system is an important foundation for the international development of vaccines. IX continues to strengthen its global quality management system and enhance its manufacturing, quality control, and regulatory compliance capabilities. IX has previously submitted its 9-valent HPV vaccine for WHO prequalification (PQ) and obtained regulatory approval in Thailand. Passing the GMP compliance inspection by TITCK may strengthen confidence among regulatory authorities in target markets and help reduce preparation efforts for repeated GMP inspections in certain markets, supporting the vaccine’s international expansion.

Looking ahead, IX will continue to embrace international standards while strengthening innovation and quality systems, further advancing the global development of its vaccine portfolio. Through high-quality and accessible vaccines, IX aims to contribute to disease prevention and public health worldwide.