Shenzhen Hepalink Pharmaceutical Group Co., Ltd.
海普瑞
002399
Shenzhen Stock Exchange
Company Profile
(1) Production technology advantage The core technology used in the production by our company is the extraction and purification of heparin sodium API, including separation of impurities and components, virus and bacterial inactivation, group integrity protection and active release technology, and directional component separation technology. The core technology is independently developed by the company and improvements had been made through the course of the company’shistory. Our core technology has the advantage of ensuring the stable quality and high yield of the product. It is one of the core competitive strength. Techdow, Wholly owned subsidiary, is a high-tech enterprise with more than 10 years of research, development, production and sales experience in the field of enoxaparin sodium API and injectable solution. Techdow has developed a set of enoxaparin sodium products production technology and key processes. (2) Advantages of quality management The company has established a quality management system and implemented it strictly according to our country's drug GMP regulations and cGMP regulations in the United States and the European Union. On the basis of verification, the company has formulated a large number of standard operating procedures, covering the production, material, equipment and facilities, inspection, packaging label, quality assurance etc., guaranteeing the stability and controllability of the whole process of production and operation of the company, ensuring the stability and safety of the product quality. (3) Customer resource advantage The company’s Enoxaparin Sodium formulation is the first originator biosimilar approved in China and the first originator biosimilar approved in the European Union. It is also the first product of its kind in China to pass the generic drug consistency evaluation. Currently, our Enoxaparin Sodium formulation, as one of the representatives of "Made in China" quality, is exported to over 50 countries worldwide. The company’s Heparin Sodium API primarily serves internationally renowned pharmaceutical companies. Due to the company’s product quality advantages and the regulatory challenges associated with customers switching suppliers, the stability of sales is relatively well maintained. (4) Increasingly diversified pipeline With the two platforms of Cytovance and SPL, the company is committed to the rapid growth of cdmo business focusing on various recombinant and naturally derived macromolecules and gene therapy products.At the same time, through independent research and investment, the company has been looking to transform into an new drug enterprise specialized in the fields of cancer, cardiovascular disease and heparin-related drugs. A diversified pipeline of new drugs in different clinical trial stages (pre-clinical to phase III) has formed, which will contribute to the Company's future business development.
Full description
Established in 1998 in Shenzhen, China, Hepalink is a leading multinational biopharmaceutical company dual-listed in Hong Kong and mainland China. Driven by patient’s unmet needs, Hepalink is striving to fulfill its mission of bringing safe and effective therapies and services to patients around the world.The company's main products and services include Enoxaparin Sodium formulations, Heparin Sodium and Enoxaparin Sodium APIs, as well as large molecule drug CDMO (Contract Development and Manufacturing Organization) services. In the heparin industry chain, the company's Enoxaparin Sodium preparations are currently sold in over 50 countries worldwide. Since obtaining approval through the Centralized Procedure (CP) from the European Medicines Agency (EMA) in 2016, the product has leveraged its exceptional quality and stable efficacy to achieve cumulative sales volumes that rank among the top in the domestic industry. In October 2020, it became the first domestically approved supplier of Enoxaparin Sodium preparations to pass the consistency evaluation for generic drug quality and efficacy by China's National Medical Products Administration (NMPA). In the CDMO (Contract Development and Manufacturing Organization) field, Hepalink operates its rapidly growing CDMO business through its two wholly-owned subsidiaries, Cytovance Biologics and SPL. With nearly half a century of expertise at Cytovance, the company focuses on the development and manufacturing of large-molecule drugs based on innovative biological therapies, while also supporting the clinical development of Hepalink's innovative pipeline drugs. Hepalink is committed to addressing unmet clinical needs by investing in, exploring, developing, and commercializing differentiated innovative drugs with a highly innovative clinical pipeline. The company is independently developing a preclinical-stage oncology candidate drug. Furthermore, it has secured exclusive development and commercialization rights for several clinical-stage innovative candidate drugs in the Greater China region.