浙江海正药业股份有限公司 关于替格瑞洛原料药获得CEP证书的公告

Group 1 - The company has received the Certificate of Suitability (CEP) for the active pharmaceutical ingredient Ticagrelor from the European Directorate for the Quality of Medicines & HealthCare (EDQM), indicating compliance with European pharmacopoeia standards [1][2] - Ticagrelor is used for the treatment of acute coronary syndrome (ACS) and is known to reduce the incidence of cardiovascular death, myocardial infarction, and stroke in patients with a history of myocardial infarction [1] - The global sales volume of Ticagrelor active pharmaceutical ingredient is projected to be approximately 171,705.29 kilograms for 2024, with an estimated 143,714.60 kilograms sold from January to September 2025 [1] Group 2 - The CEP certification signifies recognition of the quality of the active pharmaceutical ingredient in the European market, enhancing the company's qualifications to enter the EU and other markets that recognize the CEP certificate [2] - The international active pharmaceutical ingredient business is subject to fluctuations in overseas market conditions and exchange rates, which may impact the company's operations [2]