(Shenzhen, August 13, 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 enoxaparin sodium API and formulation businesses — has received approval from the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria. The approved product is commercialized under the brand name PREVINOX, with a specification of 0.4ml:40mg. With this approval, Nigeria becomes the fifth African country where Hepalink’s enoxaparin sodium injection has obtained market access, further expanding the international market coverage of the Group’s core formulation product.

Nigeria is one of the most populous countries in Africa and an important pharmaceutical market in West Africa. The approval will not only further enrich the local availability of high-quality anticoagulant therapies, but also provide a new foothold for Hepalink’s enoxaparin sodium formulations to expand across the African market. Previously, the product had obtained market access in markets including South Africa and Ethiopia. Hepalink is gradually establishing a product presence across representative markets in different regions of Africa, laying a foundation for further improving the accessibility and commercialization capabilities of its formulations in the African market.

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.

As a low-molecular-weight heparin anticoagulant widely used in clinical practice, enoxaparin sodium offers stable and predictable anticoagulant effects, relatively high bioavailability, and convenient subcutaneous administration. It can be used for the prevention and treatment of venous thromboembolic disease, as well as anticoagulation in clinical settings including acute coronary syndrome and hemodialysis. As demand for healthcare services in Nigeria continues to grow, stable and reliable access to anticoagulant therapies is of positive significance in meeting relevant clinical needs.

With nearly thirty years of expertise in the heparin field, Hepalink has continuously strengthened its R&D, manufacturing, and quality management capabilities across heparin sodium API, enoxaparin sodium API, and formulations, establishing a vertically integrated value chain spanning from APIs to finished formulations. Currently, Hepalink’s enoxaparin sodium injection has gained market access in key markets including China, the United States, the European Union, the United Kingdom, Switzerland, Brazil, Argentina, Thailand, Singapore, and South Africa, and is sold in more than 50 countries and regions worldwide.

Alongside its global market expansion, Hepalink continues to enhance the large-scale manufacturing, sterile assurance, and intelligent manufacturing capabilities of its enoxaparin sodium formulations. In 2026, the Hepalink Pingshan New Pre-filled Syringe Manufacturing Facility Project received the ISPE Facility of the Year Award (FOYA) in the “Innovation – Novel Technology” category, further strengthening the Group’s capabilities in large-scale production and stable supply for global markets.

Looking ahead, Hepalink will continue to advance the market access and commercialization of its enoxaparin sodium formulations in international markets, enabling high-quality anticoagulant products that have been validated through long-term clinical use and international markets to reach more patients worldwide with needs more efficiently.

About Hepalink’s Enoxaparin Sodium Injection

The Enoxaparin Sodium Injection produced by Hepalink’s wholly-owned subsidiary Techdow was the first enoxaparin sodium injection 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 consistency evaluation. The product has now been approved in 81 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.