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植入式左心室辅助系统(人工心脏)
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江苏创新药械目录凸显“苏州力量”
Su Zhou Ri Bao· 2026-01-08 00:28
Core Insights - Jiangsu Province has released its first batch of innovative drug and medical device products, including 149 products, with Suzhou contributing 60, accounting for 40% of the total [1] - Suzhou's selected products cover four key areas: Class 1 innovative drugs, Class 2 improved new drugs, Class 3 innovative medical devices, and Class 2 innovative medical devices, forming a comprehensive innovation product matrix [1] Group 1: Innovative Drugs - Suzhou has 14 Class 1 innovative drugs, addressing various treatment areas such as oncology, autoimmune diseases, metabolism, and infections [1] - Among these, Innovent Biologics' Ma Shidu Peptide Injection is the world's first dual receptor agonist for glucagon and GLP-1, targeting obesity-related metabolic issues [1] - Suzhou also includes 6 Class 2 improved new drugs, with BeiGene's Zebrutinib being the first domestically developed cancer drug approved in the U.S., projected to achieve global sales of 12.527 billion yuan in the first half of 2025, a 56.2% year-on-year increase [1] Group 2: Innovative Medical Devices - Suzhou has 25 Class 3 innovative medical devices and 15 Class 2 innovative medical devices, representing 69% and 43% of the provincial totals, respectively [1] - Peijia Medical's transcatheter aortic valve system offers a minimally invasive treatment option for heart valve disease, showcasing domestic technological advancements [2] - The implantable left ventricular assist device by Tongxin Medical is the first fully magnetic levitation artificial heart product approved in China, providing new hope for end-stage heart failure patients [2] Group 3: Industry Development and Support - Suzhou has over 4,200 biopharmaceutical companies, with an expected output value exceeding 250 billion yuan by 2025, supported by a complete industrial chain from early research to commercialization [2] - The local government is focusing on nurturing biopharmaceutical enterprises and enhancing policy support to promote the industrialization and clinical application of innovative results [2][3] - Market regulatory departments have implemented various service measures to accelerate the development and market entry of innovative products, including establishing a specialized review and approval service team [3][4]
园区海关助力苏州“人工心脏”销海外
Su Zhou Ri Bao· 2025-08-22 00:30
Core Viewpoint - Suzhou Tongxin Medical Technology Co., Ltd. successfully exported a batch of implantable left ventricular assist devices (commonly known as "artificial hearts") worth over 1 million USD to the United States, marking a significant achievement in China's medical device industry and showcasing its international competitiveness [1] Group 1: Company Achievements - The artificial heart is the first and only active implantable medical device in China to receive clinical trial approval in the United States, highlighting its unique position in the market [1] - In the past month, the product was also exported to Hong Kong, becoming the first domestically produced "artificial heart" for clinical use in Hong Kong and Macau [1] Group 2: Government Support - The Suzhou Customs has provided targeted support for the production characteristics of the "artificial heart," utilizing various platforms and services to assist the company in customs clearance and regulatory compliance [1] - The company has benefited from the optimized business environment and customs support policies, achieving nearly 50 million CNY in export value in the first seven months of this year [1] Group 3: Financial Impact - The company reported significant cost savings, with one transaction saving nearly 1 million CNY in taxes due to efficient processing of processing trade business procedures [1]