罕见病药品保障先行区
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全国首款!天竺综保区引入“全球最小的心脏泵”
Bei Jing Ri Bao Ke Hu Duan· 2025-12-22 12:09
Core Insights - The introduction of the Johnson & Johnson Impella heart pump marks a significant advancement in the treatment of critical heart diseases in China, being the first clinically urgent medical device approved for importation [1][3] - The successful signing at the China International Import Expo highlights the collaboration between various governmental and healthcare entities to facilitate the import of this life-saving technology [1][3] Group 1: Product and Market Impact - The Impella heart pump is the only FDA-approved device of its kind globally, designed for patients undergoing high-risk PCI procedures or experiencing cardiogenic shock, providing effective circulatory support and improving survival rates [3] - The import of the Impella pump is seen as a model for accelerating the introduction of more innovative overseas medical devices and drugs into the Chinese market, ultimately benefiting domestic patients [3] Group 2: Policy and Future Developments - The Tianzhu Comprehensive Bonded Zone is rapidly advancing its Rare Disease Drug Guarantee Pilot Zone, aiming to facilitate the import of more urgently needed medical products [4] - The initiative is part of a broader strategy to enhance the pharmaceutical industry in Beijing, ensuring that critical medical supplies can be imported efficiently to meet public health needs [4]
北京“两区”建设五周年:打造高水平对外开放新高地
Zhong Guo Xin Wen Wang· 2025-09-07 01:48
Core Insights - The construction of Beijing's "Two Zones" (National Service Industry Expansion Pilot Zone and Free Trade Pilot Zone) has shown significant progress over the past five years, enhancing the city's capacity to attract foreign investment and support enterprises going global [1] Legal Environment Optimization - Beijing has approved the establishment of the Beijing International Law and Business Integration Demonstration Zone, covering 7.04 square kilometers in the CBD, focusing on international business cooperation and overseas service environments [2] - The region hosts over 30% of the city's legal service institutions and has established an international commercial arbitration center, enhancing legal support for businesses [2] - The initiative aims to attract global high-end resources and provide high-quality, international legal and business services to foster economic development in the capital [2] Data Facilitation - The Beijing CBD Service Station has launched a "online + offline" dual service model to assist companies with data compliance and cross-border data flow [3] - Since its operation began in 2024, the service station has supported over 50 companies across various sectors, including pharmaceuticals and banking, in meeting their cross-border data service needs [3] - Future plans include hosting specialized sessions on data security and compliance to further enhance companies' capabilities in data export [3] Rare Disease Medication Accessibility - Beijing has initiated the country's first pilot zone for rare disease medication assurance, exploring clinical application models for imported drugs not registered in China [4] - From April 2024 to July 2025, the Beijing Children's Hospital has successfully applied for temporary imports of a rare disease medication, with a total of 4,460 units approved within an average of 40 days [4] - This efficient approval process has transformed the previous situation of patients waiting for medication, ensuring continuous access to necessary drugs for rare disease patients [4] Global Innovation Drug Market - The pilot zone model in Beijing has demonstrated the convenience of the entire process from diagnosis to medication for rare disease patients, attracting attention from foreign enterprises [5] - The model has highlighted the potential of the Chinese market for global innovative drugs, providing a replicable experience for the registration and use of these drugs in China [5] - The successful promotion of this model is expected to accelerate the entry of global innovative drugs into the Chinese market [5]