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(Shenzhen, May 13, 2026) – Shenzhen Hepalink Pharmaceutical Group Co., Ltd. ("Hepalink") today announced that enoxaparin sodium injection, manufactured by its subsidiary Shenzhen Techdow Pharmaceutical Co., Ltd. ("Techdow"), has received approval in Cambodia, further expanding the market access of the Company's high-end anticoagulation formulation in emerging markets of Southeast Asia. With this approval, Hepalink's enoxaparin sodium injection has now been approved in 79 countries and regions worldwide, covering key markets including China, the United States, the European Union, the United Kingdom, Switzerland, Poland, Brazil, Argentina, Thailand, and Singapore.
The approved product, commercialized under the brand name Prolongin, was approved by the Ministry of Health (MOH) of Cambodia in two dosages: 0.6ml:60mg and 0.4ml:40mg. The 0.6ml:60mg specification was approved on December 11, 2025, followed by the 0.4ml:40mg specification on February 12, 2026.
The approval in Cambodia represents a significant step in the deep expansion of Hepalink’s global formulations business into emerging international markets. It reflects the company’s comprehensive capabilities in integrating product quality as a foundation with coordinated progress in regulatory filing, compliance access, and international operations. As more market access is achieved, Hepalink will continue to accumulate registration and commercialization experience across diverse regulatory and market environments, laying the groundwork for further international expansion.
With nearly thirty years of expertise in the heparin field, Hepalink has vertically integrated the entire heparin value chain. The company has further enhanced its high-end global formulation supply capacity through the Shenzhen Pingshan New Pre-filled Syringe Manufacturing Facility Project. This project was awarded the 2026 ISPE Facility of the Year Award (FOYA) in the “Innovation – Novel Technology” category in April 2026, further validating the company’s systemic capabilities in innovative manufacturing, quality control, and large-scale delivery of high-end formulations. With the release of new capacity and additional market access, the company will continue to strengthen the stable supply of Enoxaparin Sodium Injection across multiple regions.
Looking ahead, Hepalink will continue to drive the entry of high-quality anticoagulation therapies into more countries and regions, steadily improving drug accessibility across diverse regulatory environments and healthcare systems, and providing stable and reliable treatment options for healthcare institutions and patients worldwide.
About Hepalink’s Enoxaparin Sodium Injection
The Enoxaparin Sodium Injection produced by Hepalink subsidiary Techdow was the first biosesimilar 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 evalsuation. The product has been approved in over 70 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.