(Shenzhen, June 9, 2026) – Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (“Hepalink” or the “Group”) recently announced that its enoxaparin sodium injection, produced by its wholly-owned subsidiary Shenzhen Techdow Pharmaceutical Co., Ltd. ("Techdow") — the core entity undertaking the Group’s global formulation business — has received marketing authorization in Kenya. The product, commercialized under the brand name Clotex, was approved by the Pharmacy and Poisons Board (PPB) of Kenya with a specification of 0.4ml:40mg. This milestone marks the fourth country in Africa where Hepalink's enoxaparin sodium injection has been approved, bringing the total number of countries and regions where the product has received regulatory approval to 80 worldwide.

Previously, the product had already gained approvals in key markets including China, the United States, the European Union, the United Kingdom, Switzerland, Poland, Brazil, Argentina, Thailand, Singapore, and South Africa. As one of the representative healthcare markets in East Africa, Kenya’s approval will further extend the Group’s service network across the African continent and demonstrate the Group’s international capabilities to address diverse regional clinical needs with high-quality anticoagulation formulations.

Against the backdrop of continuous improvement of healthcare systems across East Africa, medical service capacity in Kenya has been steadily enhanced. Demand for cardiovascular disease management, perioperative thrombus risk prevention and control, and treatment of related acute severe illnesses keeps rising, driving higher requirements for the accessibility of standardized anticoagulants within local healthcare systems.

Enoxaparin sodium is a widely used low-molecular-weight heparin anticoagulant in clinical practice. It is primarily indicated for the prevention and treatment of venous thromboembolism, as well as anticoagulation therapy for acute coronary syndrome and other clinical conditions. This approval will enrich the selection of anticoagulant medications for medical institutions in Kenya and support standardized anticoagulation treatment in a wider range of local clinical scenarios.

From expanding global market access to consolidating platform-based capabilities, Hepalink’s internationalization drive has evolved from scattered market expansion to systematic capability support. Leveraging the vertical integration of the entire heparin value chain, robust international quality systems, extensive cross-border registration expertise and proven commercial operation capabilities, the Group has built comprehensive capabilities covering raw materials, finished formulations, quality management, supply chain and market services, delivering consistent high-quality and reliable product supply for diverse healthcare systems worldwide.

Intelligent manufacturing capabilities serve as a critical foundation for this globalization process. Supported by its two formulation manufacturing sites in Nanshan and Pingshan, Shenzhen, Hepalink has established world-class annual production capacity of 550 million prefilled syringes of Enoxaparin Sodium Injection. In particular, the Pingshan formulation manufacturing facility was recognized with the ISPE Facility of the Year Award (FOYA), an internationally prestigious pharmaceutical engineering accolade, for its high-standard, automated, digitalized, and sustainable construction practices, reflecting the Group’s leading position in intelligent manufacturing, quality control and global supply assurance for pharmaceutical formulations.

Moving forward, Hepalink will continue to advance global market access, underpin business growth with high-quality manufacturing, and uphold its commitment to stable product supply. The Group remains dedicated to driving the entry of its enoxaparin sodium injection into more countries and regions with unmet clinical needs, and benefiting patients around the globe with reliable, accessible and sustainable high-quality anticoagulant formulations.

About Hepalink’s Enoxaparin Sodium Injection

The Enoxaparin Sodium Injection produced by Hepalink subsidiary Techdow was the first biosimilar to receive marketing authorization from the European Medicines Agency (EMA), and the first generic version of enoxaparin sodium injection to have all its marketed strengths pass China’s generic drug bioequivalence evaluation. The product has been approved in 80 countries and regions worldwide and exported to more than 50 countries and regions globally. It is marketed under the brand name 普洛静^® in China, Inhixa^® in the EU (excluding Poland), Neoparin^® in Poland, and Prolongin/Inhixa^® or other local brands in emerging markets.