HISUN(SH:600267) Shang Hai Zheng Quan Bao·2025-10-19 19:36Core Viewpoint - The European Medicines Agency (EMA) has officially revoked the GMP non-compliance statement for Zhejiang Haizheng Pharmaceutical Co., Ltd.'s Taizhou factory, which positively impacts the company's ability to sell products in the EU market [2][3][5]. Group 1: Background Information - The EMA issued a GMP non-compliance statement for the Taizhou factory on September 20, 2016, following inspections in March 2019 and July 2019 [2]. - A remote audit was conducted from April 19 to April 30, 2021, and a final inspection report was issued in February 2022, partially lifting the non-compliance status for certain products [2]. Group 2: Recent Developments - In March 2025, the company underwent a joint audit by the European Directorate for the Quality of Medicines (EDQM) and German authorities for two anti-tumor products [3]. - On July 9, 2025, the company received a confirmation letter from EDQM stating that the anti-tumor products produced at the Taizhou facility comply with EU GMP regulations [3]. Group 3: Impact on the Company - The revocation of the GMP non-compliance statement means that the Taizhou factory is no longer under non-compliance status, which is expected to have a positive effect on the company's product sales in the EU and other markets [5]. - The company has committed not to sell products related to the second-phase project in the EU market for three years [3].