The first domestically produced intracranial aneurysm assisted embolization stent was approved for marketing Yuanda Pharmaceutical (00512) “Go Global” high-end device cluster continues to expand

The Zhitong Finance App learned that recently, Yuanda Pharmaceutical (00512) intracranial aneurysm assisted embolization stent Blue Whale TM was approved for listing by the State Drug Administration (China Machinery Note 20253131589). According to reports, Blue Whale TM is the first woven aneurysm assisted embolization stent produced in China. It not only enriches the product range of Yuanda Pharmaceutical in the field of precise cardiovascular and cerebrovascular intervention diagnosis and treatment, but also highlights the effectiveness of the company's forward-looking layout, and will also bring new treatment options for intracranial aneurysm treatment in China.

The first domestically produced braided aneurysm assisted embolization stent, with excellent performance benefiting tens of millions of patients

As an “random time bomb” in the brain, intracranial aneurysms are the most common cause of brain hemorrhage, and once the hemorrhage ruptures, the fatality rate is extremely high. According to data from the “Expert Consensus on Microsurgical Treatment of Intracranial Aneurysms (2025 Edition)”, the overall prevalence of intracranial aneurysms in China reached 1.3%-7.6%. The prevalence of unruptured intracranial aneurysms among people aged 35-75 in China was about 7%, and the fatality rate of aneurysm subarachnoid hemorrhage due to rupture was as high as 43% within 30 days. According to Frost & Sullivan data, the number of patients with unruptured intracranial aneurysms in China is expected to increase to 89.514 million in 2028.

Behind the huge number of patients is a huge medical market that needs to be satisfied. Among them, interventional surgery is increasingly becoming the main choice for treating intracranial aneurysms due to its advantages such as minimally invasive, quick recovery, and few complications. According to the Frost & Sullivan report, from 2017 to 2022, the number of interventional procedures for intracranial aneurysms in China has increased from 44,000 to 84,000, with a compound annual growth rate of 13.8%. The corresponding hemorrhagic neurointerventional medical consumables market is expected to grow at a compound annual growth rate of 39.6% to 27.04 billion yuan in 2028.

This also means that with the spread of interventional surgery and the release of clinical demand, high-end medical consumables such as Yuanda Pharmaceutical Blue Whale TM will usher in a wider market space. Also, judging from the product itself, Blue Whale TM has superior performance - this product is the first domestically produced braided aneurysm assisted embolization stent, which consists of a delivery system and a nickel-titanium wire braided self-expanding support structure. Compared with existing auxiliary stents, their innovative structure and performance design can better meet treatment needs in complex anatomy and diverse clinical scenarios.

Specifically, Blue Whale TM uses a unique woven design and imaging technology to provide a certain degree of blood flow shunt to achieve occlusion of more than 95% of angiographic aneurysms. The entire Blue Whale TM auxiliary stent series is a nickel-titanium monofilament 16-head braided design, which significantly enhances the radial support and vascular adhesion of the stent. Furthermore, 80% of the entire Blue Whale TM series can be recycled and released, enabling controlled delivery and accurate implantation. Based on various clinical advantages such as unique coil wrap imaging technology, Blue Whale TM intracranial aneurysm assisted embolization stents are expected to enable more patients to obtain more accurate interventional treatment plans for intracranial aneurysms in the future, and the future market potential is very impressive.

Forwardly lay out the 10 billion neurointerventional device market and build a high-end device product cluster

According to the Insight Consulting Report, the number of interventional neurological procedures in China was about 161,400 units in 2020, which is expected to grow to 740,500 units at a compound annual growth rate of 28.6%. With a sharp increase in the volume of surgeries, the market size of neurointerventional medical devices is also continuously expanding, and is expected to grow to 17.5 billion yuan in 2026.

In this context, the strategic advantages of Yuanda Pharmaceutical's forward-looking layout are remarkable. According to reports, Yuanda Pharmaceutical has been deeply involved in the field of precise cardiovascular interventional diagnosis and treatment for many years. Adhering to the treatment concept of “precision treatment”, the company has carried out a comprehensive layout around the three directions of pathway management, structural heart disease and heart failure, and has built a high-end medical device product cluster. Currently, the company has laid out more than 30 products, 23 of which have been approved for listing in China. Other products are also actively promoting clinical registration in China. It is expected that innovative products will be launched in stages and steps in the future, driving the steady growth of the company's business in this sector.

Since this year, the company has been approved for listing a number of innovative high-end medical devices, and the innovative layout has gradually been implemented. Among them, the BorisTM multipole renal artery radiofrequency ablation system is currently the only renal artery dessympathetic ablation (RDN) product in the world that has obtained CE certification from the EU and has a dual radial and femoral artery approach design. The product has completed the first batch of clinical applications after marketing. Compared with traditional femoral artery access, BorisTM has significant advantages such as less trauma, faster recovery time, and day surgery. The research results related to this product have been published in the top international cardiovascular journal Circulation (Impact Factor: 35.5); mitral valve After the launch of the NeoNova® clip system, the first batch of commercial implantations began in multiple centers across the country, and its ease of operation and post-operative effects were well received; the domestic coronary and peripheral shock wave systems DEEPQUAKE-CTM and DEEPQUAKETM can efficiently and safely damage superficial and deep calcified plaques on blood vessel walls, which is expected to provide more diverse treatment options for patients with coronary and peripheral vascular calcification lesions.

As an international technology-innovative pharmaceutical company, Yuanda Pharmaceutical is also actively expanding its global presence in the field of precise cardiovascular interventional diagnosis and treatment. The company has now carried out technical cooperation with clinical centers or R&D platforms in the United States, Canada, Germany, Italy, Switzerland, etc., and has achieved comprehensive construction of a “passive+active” innovative device platform. In the future, as the company's “Go Global” strategy continues to advance, Yuanda Pharmaceutical is expected to build this sector into the world's leading “accurate cardiovascular and cerebrovascular interventional diagnosis and treatment platform” to further enhance the company's value.