浙江海正药业股份有限公司关于替加环素原料药获得CEP证书的公告

Group 1 - The company Zhejiang Haizheng Pharmaceutical Co., Ltd. has received the Certificate of Suitability to Monograph of European Pharmacopoeia (CEP) for the active pharmaceutical ingredient Tigecycline from the European Directorate for the Quality of Medicines & HealthCare (EDQM) [1][2] - The CEP certificate indicates that the quality of Tigecycline is recognized by European standards, allowing the product to enter the EU market and other markets that acknowledge the CEP certificate, which positively impacts the company's international market expansion [2] - The global sales volume of Tigecycline active pharmaceutical ingredient is projected to be approximately 601.30 kilograms in 2024 and around 290.22 kilograms for the first half of 2025, according to IQVIA data [1] Group 2 - The company is the first domestic enterprise to obtain the CEP certificate for Tigecycline active pharmaceutical ingredient, highlighting its competitive position in the market [1] - Tigecycline is primarily used for treating infections caused by specific bacterial strains in patients over 18 years old, including complicated intra-abdominal infections, complicated skin and soft tissue infections, and community-acquired bacterial pneumonia [1] - The international active pharmaceutical ingredient business is subject to changes in overseas market conditions and exchange rate fluctuations, which may impact the company's operations [2]