Jiangsu Hainekon Biotechnology Co., Ltd. (hereinafter referred to as "Hainekon" or the "Company") was established in September 2020 and is located in Qiandeng Town, Kunshan, Suzhou, only 45 kilometers away from Shanghai Hongqiao International Airport, with convenient transportation. Hainekon focuses on the R&D, production and sales of a full range of Omega-3 acid ethyl ester 90 and EPA/DHA products. It is guided by the R&D and production of EPA/DHA innovative drugs, and its sacred mission is to improve human health and well-being with innovative EPA/DHA drugs. The total investment of the project is about 100 million yuan, and the annual production capacity of high-purity EPA/DHA series products is about 3,000 tons. Before the establishment of Hainekon, its core members had been deeply involved in the industry for more than ten years. The company's predecessor was Renpu (Suzhou) Pharmaceutical Co., Ltd., which was established in September 2011. Initially, it focused on research and development, and formed a research and development team with postdoctor of Imperial College London as the core. Through the team's dedicated research and unremitting efforts, significant breakthroughs were made in EPA/DHA separation methods, purification technologies, and other aspects, with monomer purity reaching over 99%, and gradually expanding to the fields of EPA/DHA full substance analysis and EPA/DHA pharmaceutical applicability research and development, filling the gap at home and abroad. Later, it was commissioned for production in Zibo, Shandong. Starting in early 2020, it was planned to build, and the Hainekon Kunshan production base was built in 2021.
Hainekon implements the quality concept of "quality first, striving for excellence". We strictly follow the requirements of Chinese GMP, US FDA, and EU GMP for construction, management, and operation, and have a complete production system, EHS system, and quality assurance system. The internal quality control department of the company follows the ICH guidelines and specifications, and the quality system revolves around quality management. 6 Sigma internal control release standards are established for product release, and CPK evaluations are regularly conducted on the process. At the same time, we have applied for intellectual property protection and granted multiple authorizations for innovative technologies related to EPA/DHA drugs.
To ensure the foresight of research and development achievements, Hainekon has established an EPA/DHA product research and development center, with R&D personnel accounting for more than 45% of the total number of employees. The core members include several well-known domestic and foreign experts in the development and application of Omega-3 ethyl acetate 90 and EPA/DHA drug research. The company has maintained international cooperation for a long time, established variety and technology strategic cooperation with global leading enterprises in the field of fish oil, promoted the continuous research and development of EPA/DHA related drugs, and laid a solid foundation for future high-speed development.
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