China's First Clinical-Emergency Impella Heart Pump Imported via Tianzhu Comprehensive Bonded Zone

Source: Beijing Daily Client

Recently, the Lin-Gong Economic Development Zone Management Committee of the Capital Airport, in collaboration with the Beijing Drug Administration, Health Commission, Medical Insurance Bureau, Customs, Anzhen Hospital, Fuwai Hospital, and SPH KDL HEALTH (Beijing) Pharmaceutical Co., Ltd., successfully facilitated the clinical urgent import project of Johnson & Johnson's Impella interventional left ventricular assist device under the support of relevant national departments. The project was successfully signed at the China International Import Expo held in early November. This is not only the first approved urgently needed medical device for emergency treatment in China, but also marks a new "life-saving tool" in the field of critical cardiac care.

Johnson & Johnson's Impella Interventional Left Ventricular Assist Pump is the world's only interventional ventricular assist device approved by the U.S. FDA, known as the "world's smallest heart pump." The product is mainly used to treat patients with severe coronary artery disease who require high-risk PCI surgery or are in cardiogenic shock, providing effective circulatory support, significantly improving rescue success rates and patient survival chances.

SPH KDL HEALTH (Beijing) Pharmaceutical Co., Ltd. undertook the import task of this product as a pilot enterprise for the import of rare disease medicines in the Tianzhu Comprehensive Bonded Area’s Rare Disease Medicine Security Pioneer Zone. "With the precise and efficient one-on-one services and customs clearance support from the Management Committee and other departments, we have successfully opened up this 'lifeline'," said a company representative. "This is not only a successful introduction of a product, but also a replicable model that paves the way for the accelerated introduction of more innovative overseas drugs and medical devices in the future, ultimately benefiting patients in China."

Since the approval of the construction of the Rare Disease Drug Security Pilot Zone at the end of 2023, innovative achievements in Tianzhu Comprehensive Bonded Area have been accelerating: the introduction of the first targeted drug for achondroplasia, vosoritide; the establishment of Beijing's first specialized rare disease treatment institution; the issuance of China’s first prescription for a new drug treating Wilson’s disease; and the inclusion of the first five overseas special drugs into the coverage of Beijing Inclusive Health Insurance… This introduction of the Impella heart pump represents another breakthrough by Tianzhu Comprehensive Bonded Area in the field of importing clinically urgently needed pharmaceuticals and medical devices. It enriches the categories of such products with "Beijing speed," showcasing the pilot zone's strong capacity to implement and support policies.

Next, the Capital Airport Lin Kong Economic Zone will accelerate the construction of a pilot zone for the provision of rare disease medicines. It aims to expedite the availability and accessibility of clinically urgent drugs and medical devices so that they can "enter the market quickly, be distributed efficiently, and become usable promptly." The goal is to fully meet the public's health needs and inject strong momentum into establishing Beijing as a highland for pharmaceutical industry innovation.

Source: Beijing Daily Client