Sinopex is showing strong performance. The news of their success in the national project ‘Localization of Continuous Renal Replacement Therapy (CRRT) devices and hemodialysis filters for critically ill patients and securing related core technologies,’ conducted in collaboration with Seoul National University Hospital’s Nephrology Department and Seoul National University’s Biomedical Engineering Department, appears to be influencing the stock price.
As of 10:19 AM on the 27th, Sinopex is trading at 6,880 KRW, up 12.79% from the previous day.
According to Sinopex, with this national project success, South Korea has become the sixth country in the world, following the United States, Germany, Italy, and Japan, to possess technology related to CRRT devices and hemodialysis filters for critically ill patients. It is expected that exports of hemodialysis-related products will be possible not only domestically but also in overseas markets.
At the ‘Infectious Disease Prevention Technology Development Project Achievement Exhibition and Key Achievements Presentation’ hosted by the ‘Pan-Ministerial Medical Device Research and Development Project Group’ on the 26th, the CRRT devices and hemodialysis filters developed by the Seoul National University team and Sinopex were introduced as one of the three outstanding success cases.
The Pan-Ministerial Medical Device Research and Development Project Group is a government initiative jointly supported by four ministries (Ministry of Science and ICT, Ministry of Trade, Industry and Energy, Ministry of Health and Welfare, and Ministry of Food and Drug Safety) that supports the entire process of medical device development to realize medical welfare through the development of globally competitive products and localization of technology.
Sinopex was selected along with the Seoul National University team for the ‘2020 Infectious Disease Prevention Technology Development Project New Support Target’ led by the Pan-Ministerial Medical Device Research and Development Project Group and has been conducting technology development and investment.
The detailed content of the target project is a project aimed at the localization of CRRT devices and hemodialysis filters for critically ill patients and securing related core technologies as part of infectious disease prevention technology development. Based on the academic and clinical support from the Seoul National University team, Sinopex is responsible for technology development and commercialization.
The Pan-Ministerial Medical Device Research and Development Project Group announced that following the first phase of the project started in 2020, successful projects and new technologies will be linked to follow-up projects, with plans to support up to 1.5 trillion KRW by 2035 to help the domestic medical device industry gain global competitiveness.
Dr. Jin-Tae Lee, Head of Sinopex Biomedical Business Division, stated, “We have already obtained domestic GMP certification and the international medical device quality management system (ISO13485). After receiving product approval from the Korean Ministry of Food and Drug Safety, we will proceed with clinical trials involving patients at major university hospitals alongside full-scale marketing.” He added, “Once the ongoing European CE certification (MDR) is completed, we plan to actively pursue overseas market expansion.”
Sinopex has an automated production system at its Hwaseong Banggyo-dong facility capable of producing 2 million hemodialysis filters annually. The facility obtained GMP certification from the Ministry of Food and Drug Safety in August this year and the international ISO13485 certification in November. Preparations for full-scale marketing and sales are underway following expected product approval in early 2024.
Hwang Ji-ho, Vice Chairman of Sinopex, explained in a previous interview with the media, “The market for hemodialysis-related filters and consumables is approximately 1.8 trillion KRW,” adding, “Sinopex is the only company in Korea conducting localization under a national project.” Sinopex has the only automated manufacturing process in Asia. After receiving product approval from the Ministry of Food and Drug Safety early next year, Sinopex plans to start supplying hemodialysis filters. Based on clinical trial results, the company aims to increase its domestic market share to 20% by 2027.
Researcher Seong-Man Yoo from Leading Investment Securities analyzed, “Sinopex will begin supplying hemodialysis filters from next year,” and “They are also preparing CRRT devices.” He added, “The products developed by Sinopex are the first of their kind domestically. They apply an AI system in a small-sized device that analyzes blood from a single drop (about 2-3cc) and delivers results to the user’s mobile phone within 10 minutes.” He forecasted, “Domestic sales are expected to begin next year, and the company will rapidly capture market share from existing imported products.”
According to the recently published Hemodialysis Global Market Report 2023, the global hemodialysis market is valued at 116 trillion KRW this year and is expected to grow rapidly to 143 trillion KRW by 2027.
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