HISUN(SH:600267) Zheng Quan Shi Bao Wang·2025-10-20 12:35Core Viewpoint - The announcement from Haizheng Pharmaceutical regarding the revocation of the EU's GMP non-compliance declaration for its Taizhou factory marks a significant milestone in the company's internationalization strategy, enhancing its market position in Europe and facilitating deeper international customer relationships [1][2]. Group 1: Regulatory Compliance - The EU's GMP certification is recognized as the "gold standard" in the pharmaceutical industry, and the previous non-compliance declaration issued in July 2019 was due to deficiencies in handling hazardous substances and cross-contamination risks [2]. - Following the challenges posed by the EU ban, the company initiated a comprehensive quality improvement strategy, focusing on systematic optimization across various aspects of production [2]. Group 2: Strategic Developments - The revocation of the GMP non-compliance status is seen as a key milestone in the company's "Global Market Integration" strategy, which aims to reduce dependency on single markets and enhance strategic collaboration across multiple regions [1][3]. - The company is focusing on expanding its presence in Brazil, the Middle East and North Africa, and the CIS and Eastern Europe, while also preparing to enter the Japanese and Southeast Asian markets [1]. Group 3: Operational Improvements - The company's cGMP management system received high praise from the FDA and EDQM during inspections, indicating that the improvements made have reached international standards [3]. - The lifting of the EU ban is expected to enhance the company's image, remove market entry barriers, and promote high-value products, ultimately improving market share and profitability [3].