Foreword
On February 16, 2023, Professor Shao Guoliang's team at Zhejiang Cancer Hospital completed the enrollment of the first patient in Yangshun Medical's multicenter clinical study on "Polyvinyl Alcohol Embolization Microspheres for Transarterial Chemoembolization of Liver Cancer." The successful completion of this first case marks a new stage in the registration clinical study of Yangshun Medical's first polyvinyl alcohol embolization microspheres, representing a significant breakthrough and a major milestone towards formal clinical market launch.
Latest data shows that liver cancer ranks 5th in incidence and 2nd in mortality among cancers in my country, seriously threatening public health. Because early-stage liver cancer lacks specific symptoms, most patients are diagnosed at an intermediate or advanced stage. Therefore, interventional therapy plays a crucial role in the overall treatment of liver cancer.
Among interventional therapies, transcatheter embolization (TACE) is a very important type. It involves injecting an embolic agent into the blood vessel supplying the target organ via an arterial or venous catheter, causing occlusion of the vessel, interrupting blood supply, and ultimately achieving the therapeutic goal. Therefore, recent improvements in TACE technology have consistently aimed to reduce systemic adverse reactions and enhance treatment efficacy. The latest guidelines for the diagnosis and treatment of primary liver cancer fully affirm the role of TACE as a mainstream treatment option for intermediate and advanced liver cancer, while further expanding its indications to include CNLC stage Ia patients, those unsuitable for surgery, or those unwilling to undergo surgical resection. The concept of "refined TACE" has been specifically proposed—TACE technology needs to be standardized, refined, and normalized to further improve TACE efficacy and play a better role in the treatment of liver cancer, especially intermediate and advanced liver cancer. In the concept of refined TACE, the application of appropriate embolic materials is particularly crucial, playing a significant role in improving patient prognosis and reducing postoperative complications. Embolizing microspheres are mainly used as embolic agents in vascular embolization interventional procedures, achieving the therapeutic effect of interrupting the blood supply to the diseased target organ by injecting the microspheres into the blood vessels supplying the target organ.
Background: This study, initiated by Professor Shao Guoliang of Zhejiang Cancer Hospital as the principal investigator (PI), aims to evaluate the safety and efficacy of Yangshun Medical's polyvinyl alcohol embolizing microspheres for transarterial chemoembolization of liver cancer. On February 16th, Professor Shao Guoliang and his team at Zhejiang Cancer Hospital successfully enrolled the first patient, who has since been discharged. This marks another significant milestone in the clinical application of this product, achieved through years of close collaboration between clinicians and the R&D team. It signifies an acceleration in the domestic production of polyvinyl alcohol (PVA) embolization microspheres for TACE treatment of liver cancer, providing more and better benefits for domestic liver cancer patients in terms of microsphere selection and application.
Dedicated Research and Development: Yangshun Medical Accelerates the Domestic Production of its Polyvinyl Alcohol Embolization Microspheres
Embossed microspheres, as a novel material, represent a potentially excellent chemoembolization material for clinical application. The PVA embolization microsphere product consists of PVA embolization microspheres and a physiological sodium chloride preservation solution. Polyvinyl alcohol (PVA) macromolecules are cross-linked with a cross-linking agent to form polymer microspheres. Yangshun Medical's polyvinyl alcohol embolization microspheres are the first domestically produced iso-size embolization microspheres to undergo clinical trials. Compared to traditional embolization microsphere products, iso-size embolization microspheres have a smooth surface, more uniform particle size, and excellent compressibility. The microspheres are more evenly distributed within the tumor, resulting in more controllable and thorough embolization. Furthermore, Yangshun Medical's embolization microspheres are simple to prepare preoperatively, improving overall embolization efficiency and effectiveness.
Expert Profile
Professor Shao Guoliang
Cancer Hospital Affiliated to University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Vice President, MD, Chief Physician, Doctoral Supervisor, University of Chinese Academy of Sciences; Leading Talent in Zhejiang Provincial Health Care, Recipient of State Council Special Allowance; Vice Chairman of the Interventional Oncology Committee of the Chinese Anti-Cancer Association; Standing Committee Member of the Oncology Imaging Committee of the Chinese Anti-Cancer Association; Chairman of the Interventional Medicine Branch of the Zhejiang Medical Association; Chairman of the Oncology Imaging Committee of the Zhejiang Anti-Cancer Association. Also serves as an editorial board member/reviewer for 9 journals including *Chinese Journal of Oncology*, *Chinese Journal of Radiology*, *Journal of Interventional Radiology*, and *Journal of Interventional Medicine*. Published over 60 academic papers in the past 5 years, including 23 SCI papers; edited or co-edited 9 academic books; and obtained 3 utility model patents. Leading or participating in the compilation of 6 guidelines and expert consensus documents, and presiding over 6 projects including National Natural Science Foundation of China projects, major projects jointly funded by the provincial and municipal governments, and key projects of the Provincial Department of Science and Technology. About Hangzhou Yangshun Medical Technology Co., Ltd.
Hangzhou Yangshun Medical Technology Co., Ltd., established in March 2021, is located in Hangzhou Binjiang High-tech Industrial Development Zone, known as the "Silicon Valley of Paradise." The company is committed to providing doctors and patients with comprehensive solutions for medical embolization products. Adhering to national GMP and ISO13485 standards, the company has built a factory of several thousand square meters, equipped with a Class 10,000 cleanroom, Class 100 cleanroom equipment, and a complete R&D and testing center. In 2021, it was recognized as a "5050" innovation and entrepreneurship plan enterprise in Hangzhou High-tech Zone. The company mainly develops innovative medical embolization materials, covering areas such as malignant tumors, benign tumors, hemoptysis, arthritis, and medical aesthetics. Currently, its key products feature precise embolization, multiple specifications, and adaptability to different target vessels. Future plans include developing multiple new products, benchmarking against the most advanced international products, providing more treatment options for clinicians and reducing patient suffering.
Website: www.china-pva.net
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