Company Profile
On January 28, 2016, Hubei Enoray Biopharmaceutical Co., Ltd. underwent a merger and restructuring with Tianjin Hongri Pharmaceutical Co., Ltd., a publicly listed company. Hongri Pharmaceutical increased its investment to gain a controlling stake of 51%, raising the registered capital to 136.63 million yuan. On September 9, 2020, the company’s shareholder structure was finalized, with Tianjin Hongri Pharmaceutical Co., Ltd. holding a controlling stake of 93.51%. Enoray aims to build an international heparin industry platform by integrating high-quality upstream and downstream resources, thus establishing a complete heparin industrial chain—from pig small intestine processing and mucosal heparin extraction to the production of graded low-molecular-weight heparin APIs.
The company’s main product lines include: crude sodium heparin, sodium heparin, calcium heparin, enoxaparin sodium, low-molecular-weight calcium heparin, nadroparin calcium, dalteparin sodium, heparin-like substances, and intestinal coatings. The company is equipped with active pharmaceutical ingredient (API) production lines and testing facilities that meet sFDA and cGMP standards, and has established a robust quality assurance system in strict accordance with the latest GMP requirements. All starting materials for API products are directly sourced from fresh, healthy porcine small intestinal mucosa. From the crude product stage onward, these materials are managed according to GMP specifications, ensuring source control and traceability of product quality. The company’s quality testing center, designed and constructed in compliance with sFDA and EDQM standards, is outfitted with advanced testing equipment including PCR gene amplifiers, ion chromatographs, high-performance liquid chromatographs, gas chromatographs, capillary electrophoresis instruments, atomic absorption spectrophotometers, and UV spectrophotometers. It also features dedicated cleanrooms specifically for PCR testing and microbiological analysis. Furthermore, the company has established a comprehensive system of quality control documentation, enabling it to monitor and test utility systems, raw materials, excipients, intermediates, and finished products in accordance with various standards such as CP, EP, and USP, thereby providing all-around assurance of product quality.
Yinuorui Company is a leading enterprise in China’s heparin extraction technology. It boasts core technological advantages in areas such as the controlled distribution of molecular weights in fractionated low-molecular-weight heparins, impurity control, activity testing, and structural characterization. Its product quality meets current international pharmacopoeial standards, including those set by the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP). Key technical indicators are comparable to those of originator products and surpass those of major domestic competitors. Specifically, the single-batch production capacity of its core product, enoxaparin sodium, has reached 30 kilograms, and both nadroparin calcium and dalteparin sodium have already established mature conditions for large-scale production. Yinuorui is one of only a handful of companies worldwide capable of simultaneously producing a full range of fractionated low-molecular-weight heparin active pharmaceutical ingredients.
Yinuorui Company has established extensive and in-depth collaborations with numerous domestic research institutions, including Wuhan University, Soochow University, Ocean University of China, and the China National Institute for Food and Drug Control. The company holds and has filed applications for multiple invention patents. The company’s development has attracted attention and support from governments at all levels; leading officials from the provincial Party committee and provincial government have both visited the company to inspect and provide guidance. In 2012, the Hubei Provincial Government specifically stated in a document aimed at accelerating the opening and development of Xiaochi in Huangmei: “We will support the establishment of a domestically influential biopharmaceutical base specializing in heparin products.”
Standing on the platform of Hongri Pharmaceutical, a brand-new Hubei Enoray Biopharmaceutical Co., Ltd. is being built in Xiaochi, Hubei, as a comprehensive biopharmaceutical base specializing in the heparin industry—covering the entire industrial chain from upstream resources and intermediates to active pharmaceutical ingredients and pre-filled formulations.
