GRANDPHARMA aXess demonstrates globally leading revolutionary potential, accelerating global innovation layout and advancing the "Go Global" strategy

According to the Zhitong Finance APP, recently, GRANDPHARMA (00512) has continuously achieved high-quality clinical results in its innovative pipeline. In addition to the completion of patient enrollment for the registration clinical study of the innovative temperature-sensitive embolic agent GPN00289, which adds competitive advantages to the company's nuclear medicine anti-tumor diagnosis and treatment sector, GRANDPHARMA's cardiovascular precision interventional diagnosis and treatment sector has also welcomed breakthrough product results — the globally innovative artificial blood vessel product aXess has obtained successful data from key clinical trials (aXess EU), demonstrating unprecedented safety and efficacy characteristics, outperforming current standard therapies in all aspects.

This also means that as an endogenous tissue repair product, aXess is expected to provide a safer and more effective clinical treatment solution for patients with end-stage renal disease (ESRD) undergoing hemodialysis, potentially reshaping the current treatment landscape. For GRANDPHARMA, this significant progress will also become an important milestone in the construction of its cardiovascular precision interventional diagnosis and treatment sector, providing substantial data support for the future clinical development and registration of the product.

aXess sets a new standard for hemodialysis treatment, technological innovation breakthroughs benefit global patients

Chronic kidney disease (CKD) is a major health challenge worldwide. According to international epidemiological data, there are approximately 850 million CKD patients globally. Among them, end-stage renal disease (ESRD) is the final stage of CKD. According to Frost & Sullivan data, in 2022, over 10 million patients worldwide were affected, and it is expected that the global case number will grow to nearly 14.61 million by 2030, with a compound annual growth rate of about 4.5%. The number of ESRD patients in China accounts for more than 30% of the global total, and it is expected to exceed 6.2 million by 2030.

ESRD patients' kidneys are close to failure or have completely failed, requiring long-term reliance on dialysis or kidney transplantation to sustain life. Hemodialysis, as a low-risk and widely applicable treatment method, is favored by ESRD patients. The latest data from the national blood purification case information registration system shows that by the end of 2024, the number of maintenance hemodialysis (MHD) patients in China has reached 1.027 million.

This has directly driven the growth of the hemodialysis medical device market size. According to Frost & Sullivan data, from 2019 to 2022, the compound annual growth rate in the domestic market was approximately 6.5%, and it is expected to increase to nearly 48.4 billion yuan by 2030. Among them, the vascular access product market occupies an important share and is growing faster than the overall market.

Despite the huge market demand, the currently commonly used blood dialysis access—autologous arteriovenous fistula (AVF)—still faces issues such as thrombosis, infection, and unsatisfactory patency rates, which directly affect patients' quality of life and prognosis.

The excellent performance demonstrated by aXess is expected to address this clinical pain point and build a safer and more efficient "lifeline" for patients. The results of the prospective study (aXess EU) conducted at 18 centers in Europe show that aXess exhibits superior patency rates in both primary and secondary endpoints compared to other arteriovenous grafts, with fewer interventions; compared to AVF, aXess has a lower re-intervention rate and high anti-infection properties.

Notably, the safety data from the study is particularly impressive. Among the 120 patients participating in the trial, only one case of (partial) artificial vessel removal due to puncture-related infection occurred, demonstrating the product's high anti-infection performance. aXess allows for nearly instantaneous puncture operations, with a bleeding complication rate of less than 0.02% over more than 15,000 dialysis treatments.

It is also worth mentioning that most of the patients participating in the trial had a history of arteriovenous graft or dialysis fistula failure or had relied on central venous catheters (CVC). These patients originally faced severe health challenges, and the significant efficacy of the trial results further highlights the clinical application value of aXess in such cases.

It is reported that the revolutionary potential of aXess stems from its unique endogenous tissue repair (ETR) technology, which utilizes a porous microstructure to provide a structural framework for the patient's autologous tissue repair. Through the rapid filling of the porous microstructure by the patient's own tissue, a "living" vessel identical to the patient's own blood vessels is ultimately formed, accelerating the establishment of the dialysis access and reducing the occurrence of thrombosis and related complications.

The results of the aXess EU study will also provide further data support for its global research and development. Currently, the pivotal clinical study approved for aXess in the United States has completed the enrollment of its first patient in November 2024, while the pivotal clinical study conducted in Europe is expected to complete the enrollment of all patients by January 2025. Meanwhile, the registration work for this product in China is also actively progressing.

The global development of aXess not only helps the company absorb advanced international technologies but also lays the foundation for the product's smooth expansion in the global market. With the steady advancement of global clinical research, this product is expected to be promoted and applied worldwide, benefiting more patients troubled by blood dialysis vascular access issues and bringing revolutionary breakthroughs to the field of chronic kidney disease treatment. GRANDPHARMA may also further enhance its international influence in the high-end medical device sector through this product.

Collaborative products broaden dialysis access, precise interventional diagnosis and treatment sector fulfills innovative product layout expectations

The successful progress of aXess is an important achievement in the construction of GRANDPHARMA's cardiovascular precision interventional diagnosis and treatment platform. This product can also synergize with another innovative medical device from the company, APERTO® OTW, to create smooth dialysis access for patients This product portfolio represents GRANDPHARMA's vertical expansion in the field of precise intervention for cardiovascular and cerebrovascular diseases. Currently, the company adheres to the concept of "precision treatment" in this field, conducting comprehensive layouts around three directions: pathway management, structural heart disease, and heart failure. It has established a high-end medical device product cluster that includes over 30 products, with 22 products in the pathway management direction approved for market launch in China, and 1 product for structural heart disease approved for market launch in China.

Especially this year, the company's precise intervention diagnosis and treatment sector for cardiovascular and cerebrovascular diseases has entered a phase of commercial harvest, with multiple products successfully approved for market launch. The multi-polar renal artery radiofrequency ablation system Platinum Iberis™ received approval from the National Medical Products Administration in February 2025 for launch in China and has successfully completed post-market clinical applications. This product is currently the only renal denervation (RDN) product globally that has obtained EU CE certification and features a dual access design for both radial and femoral arteries. Related research results have been fully published in the top international cardiovascular academic journal Circulation (impact factor: 35.5).

In addition, the transcatheter mitral valve clip system NeoNova® and the coronary shockwave system DEEPQUAKE-C™ received approval from the National Medical Products Administration for launch in China in February and June 2025, respectively. NeoNova® has quickly initiated its first batch of commercial implants across multiple centers nationwide after its launch, and its ease of surgical operation and postoperative results have received high praise from clinical experts. Meanwhile, other products are actively advancing their clinical registration work in China, and the company aims to achieve phased and tiered market launches of innovative products in the coming years, driving stable growth in the cardiovascular and cerebrovascular precise intervention diagnosis and treatment sector.

The continuous emergence of product research and commercialization progress is backed by the company's solid technical platform construction. Currently, GRANDPHARMA has achieved comprehensive construction of an "active + passive" innovative device platform in the cardiovascular and cerebrovascular precise intervention diagnosis and treatment sector. This includes the active device R&D and production base in Wuhan Optics Valley, the passive device R&D and production base in Changzhou, and the Shanghai device R&D center focusing on structural heart disease, all of which are now in operation. At the same time, GRANDPHARMA is actively expanding international cooperation, establishing technical partnerships with clinical centers and R&D platforms in the United States, Canada, Germany, Italy, Switzerland, and other countries, steadily advancing its "Go Global" innovation strategy layout.

The fruitful results of product and technology platform development not only demonstrate GRANDPHARMA's global R&D strength in the high-end medical device field but also reflect the company's profound understanding of patients' clinical needs. With the successful development of innovative products like aXess and the advancement of the company's "Go Global" strategy, GRANDPHARMA's development prospects in the high-end medical device field are promising. The company is expected to leverage its innovative products and technological advantages to make a stronger "Chinese voice" in the global healthcare industry, providing better treatment options for patients worldwide