HISUN(SH:600267) Zhong Zheng Wang·2025-10-20 14:28Core Viewpoint - Zhejiang Haizheng Pharmaceutical Co., Ltd. has achieved a significant breakthrough in its internationalization strategy with the removal of the GMP non-compliance statement for its Taizhou factory by the EU, marking a key milestone in the company's internationalization 2.0 strategy [1] Group 1: Internationalization Strategy - The removal of the GMP non-compliance statement is crucial for consolidating the company's position in the EU market and rebuilding international customer relationships [1] - The company is advancing a "global market integration" strategy, focusing on key regions such as Brazil, the Middle East and North Africa, and the Commonwealth of Independent States and Eastern Europe, while also preparing for markets in Japan and Southeast Asia [1] - The comprehensive recovery of the EU market reduces the company's reliance on a single market and fosters deep strategic collaboration with markets like the US and Brazil, creating a new pattern of multi-regional and multi-sector collaboration [1] Group 2: Quality Improvement Efforts - The EU's GMP certification is known as the "gold standard" in the pharmaceutical industry, and the non-compliance statement issued in July 2019 highlighted deficiencies in handling hazardous materials and cross-contamination risks [2] - In response, the company initiated a comprehensive quality improvement campaign, implementing a phased strategy that prioritized workshops with better foundational conditions for systematic optimization across various aspects [2] - The company's efforts were recognized by the EU, leading to a partial withdrawal of the GMP non-compliance statement in April 2021 after a remote audit [2] Group 3: Regulatory Recognition - The company's significant investments in quality management have been acknowledged by the FDA and EDQM during inspections, with the cGMP management system receiving high praise for reaching international first-class standards [3] - Following positive inspection results, the company successfully requested the withdrawal of the non-compliance statement related to the production of cytotoxic and harmful active pharmaceutical ingredients at the Taizhou factory [3]