Recently, Chia Tai Tianqing, the core enterprise of Sino Biopharm (1177.HK), received a formal notification from the European Medicines Agency (EMA) that the company has successfully passed the comprehensive review of EU GMP compliance inspection and has been awarded the EU GMP certificate for human medicinal products. Since first passing the EMA inspection in 2014, Chia Tai Tianqing has passed the EU GMP certification to a high standard five consecutive times, with multiple products entering the EU market to benefit patients worldwide. 

As the world's second-largest pharmaceutical market, Europe has always been a strategic high ground for the global pharmaceutical industry. According to data from the industry research firm Fortune Business Insights, the European pharmaceutical market reached a size of $437.98 billion in 2025 and is expected to continue expanding at a compound annual growth rate of 7.5%. However, for a finished drug product to enter the European market, it not only needs to obtain regulatory approval but also requires the establishment of a full lifecycle quality management and compliance system covering drug substances, drug product production, inspection and testing, and end-distribution. The EU GMP specification, recognized as one of the most stringent good manufacturing practices for medicinal products globally, imposes extreme requirements on aspects such as full-process quality management, document integrity, deviation management, and supply chain transparency. 

Since first passing the European Medicines Agency (EMA) inspection in 2014, Chia Tai Tianqing has passed the EU GMP certification to a high standard five consecutive times, further demonstrating the company's stable capabilities and leading level in quality management systems, sterile production assurance, and full-chain compliance control. 

The Chia Tai Tianqing Lianyungang production base was designed and has been operated in strict accordance with EU EMA and US FDA specifications since its inception. It has now established multiple high-standard production lines covering oral solid dosage forms, inhalation formulations, large-volume injections, small-volume injections, lyophilized powder for injection, and diagnostic reagents. The EMA inspection team conducted a comprehensive, rigorous, and professional on-site inspection of the base's GMP elements, including site facilities, equipment operation, material management, production control, quality assurance, laboratory control, documentation system, and data integrity, and gave high praise to the construction of the base's quality system. Based on continuous technological investment and strict quality control, multiple production lines at this base have been certified by the EU EMA, US FDA, and EAEU, with more than 10 products cumulatively exported to over 60 countries/regions worldwide. 

Building a brand with quality, expanding globally with strength. Chia Tai Tianqing will continue to be guided by the highest global specifications, deepen international cooperation and market layout, polish the Chinese pharmaceutical brand with hard-core quality, step onto the global stage with outstanding strength, and allow more high-quality medicines to benefit patients worldwide.