HISUN(SH:600267) Xin Lang Zheng Quan·2025-10-21 02:50Core 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][2] Group 1: Internationalization Strategy - The removal of the EU ban is crucial for Haizheng Pharmaceutical to consolidate its market position in the EU and rebuild 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 CIS and Eastern Europe, while preparing for markets in Japan and Southeast Asia [1][2] - The comprehensive recovery of the EU market reduces the company's reliance on a single market and fosters deep strategic collaboration with markets in the US and Brazil, creating a new pattern of multi-regional and multi-sector collaboration [1][2] Group 2: Quality Management and Compliance - The EU's GMP certification is known as the "gold standard" in the pharmaceutical industry, and the initial non-compliance was due to deficiencies in handling hazardous materials and cross-contamination risks [2] - The company undertook a comprehensive quality improvement initiative, implementing a phased strategy to optimize various aspects of production, which led to the EU's partial withdrawal of the non-compliance statement [2][3] - The company's cGMP management system received high praise from the FDA and EDQM, indicating that it has reached an international first-class level [3] Group 3: Future Prospects and Competitive Edge - The lifting of the ban is expected to enhance the company's image, facilitate market access, and improve customer recognition, which will aid in promoting products internationally [3] - The company aims to optimize its product structure, focus on high-value and high-quality products, and expand market share, thereby enhancing profitability and core competitiveness in the global pharmaceutical supply chain [3][4] - The internationalization development reflects a broader transformation of the Chinese pharmaceutical industry from "manufacturing" to "intelligent manufacturing" and "quality manufacturing," showcasing the company's resilience in maintaining high-quality standards [5]