On January 22, Guichuang Tongqiao (2190.HK, hereinafter referred to as the “Company”) announced that the ZYLOX Penguin Jingji iliac stent system independently developed by Guichuang Medical has been approved for marketing by the National Drug Administration (NMPA). This marks another milestone in Guichuang Medical's overall solution for peripheral venous disease interventional treatment, and further consolidates its market position and influence in the field of peripheral vascular intervention.
The ZYLOX Penguin Iliac Stent System is an innovative medical engineering combination product developed by Guichuang Medical in cooperation with well-known domestic experts. This product has 8 invention patents and is specially designed for lower extremity and pelvic venous reflux disorders caused by compression of the iliac vein. The ZYLOX Penguin static to iliac venous stent system uses three major designs: oblique design, conical gradation, and integrated structure to reduce the risk of thrombosis while ensuring adaptation to the natural diameter of blood vessels. The ZYLOX Penguin static to iliac venous stent system has excellent adhesion and gradual chronic expansion. The proximal closed loop structure provides strong support, and the telecentric open ring structure provides excellent compliance.
The pre-marketing clinical registration trial of the ZYLOX Penguin Jing—Iliac Stent System was led by Professor Zhao Yu of the First Affiliated Hospital of Chongqing Medical University. It took 10 months to include 161 surgeries at 14 top clinical centers across the country. The patency rate of target blood vessels reached 100% 12 months after surgery. This outstanding clinical trial has fully demonstrated the safety and efficacy of this product.
Iliac Vein Compression Syndrome (IVCS) is a blood circulation disorder caused by compression of the iliac vein. Major symptoms include leg pain, swelling, and sometimes deep vein thrombosis. Treatment options for iliac vein compression syndrome mainly include medication, surgery, and vascular intervention. Currently, interventional treatment using iliac stents has become the main treatment for IVCS.
According to Frost & Sullivan, the potential number of IVCS cases in China will reach the level of one million in 2030; at the same time, the number of interventional iliac stents is expected to grow at a compound annual rate of nearly 50% from 2019 to 2030. With the launch of the ZYLOX Penguin Iliac Stent System by Guichuang Medical, it is believed that it will bring higher quality and accessible domestically produced innovative iliac venous compression treatment solutions to Chinese patients.
Up to now, Guichuang Tongqiao has 36 products approved by the NMPA, 8 products have obtained EU CE certification, and 1 product has been marketed in Brazil. Guichuang Tongqiao has gradually become one of the most comprehensive and competitive domestic vascular interventional medical device platform companies with the most comprehensive product portfolio. In the future, the company will continue to develop differentiated innovative products with significant clinical value to serve patients around the world.