Hepalink secures EMA authorization for enoxaparin sodium injection

Shenzhen Hepalink Pharmaceutical Group Co. Ltd (HKEX: 9989) announced today it has received authorization from the European Medicines Agency (EMA) to manufacture Inhixa, an enoxaparin sodium injection. The authorization covers a range of dosages, from 20mg/0.2mL to 150mg/1mL, produced at Hepalink's new pre-filled formulation production line in Pingshan Park, Shenzhen. The facility boasts a designed capacity of 330 million units per year. The company emphasizes that this approval allows for the commercialization of these injections within the European Economic Area (EEA), bolstering Hepalink's internationalization strategy and market competitiveness. Construction of the project has been completed and the Good Manufacturing Practice certificate issued by the European Union has been obtained (refer to the Company's announcement dated February 14, 2025 for further details).