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The National Medical Products Administration has approved 255 medical devices!


Time:2024-11-22 17:23:50  Source:  Author:

 

At present, China's biopharmaceutical industry has entered a new stage of innovative development. The comparative advantages of the biopharmaceutical industry park in talent gathering, technology integration, fund integration, and achievement transformation are significant, and it will become the basis for promoting the high-quality development of the biopharmaceutical industry.

 
 
 
Policies are also tilting towards biopharmaceutical industrial parks. Recently, the Ministry of Commerce issued several measures to support the comprehensive experiment of deepening opening up and innovation in Suzhou Industrial Park. Among them, it is mentioned to build a strategic emerging industry cluster represented by biomedicine. Expand and strengthen the core carrier area of Suzhou Biomedical National Strategic Emerging Industry Cluster, the National Advanced Manufacturing Industry Cluster of Biomedical and High end Medical Devices, the National Innovative Industry Cluster of Biopharmaceutical Product Manufacturing, the National Advanced Manufacturing Industry Cluster of Nanomaterials, and the National Innovative Industry Cluster.
 
 
 
At the same time, support Suzhou Industrial Park to carry out pilot projects for open innovation in the entire biopharmaceutical industry chain. Allow Suzhou Industrial Park to select 1-2 enterprises to carry out pilot projects for segmented production of biological products. Establish a human genetic resource management service station in the park. Build a future industrial innovation pilot zone, proactively layout key industries such as cell and gene therapy, advanced semiconductor technology and applications, and new generation artificial intelligence.
 
 
 
Data shows that by the end of 2023, the biopharmaceutical and big health industries in Suzhou Industrial Park had gathered over 2000 enterprises, with an industrial output value of 152.3 billion yuan. In addition, the sales of PD - (L) Class 1 antibody drugs listed in the park in 2023 amounted to approximately 4.9 billion yuan, and there were 53 authorized cooperative transactions in the park's biopharmaceutical pipeline. The park has obtained approximately 25 clinical approvals in the field of cell and gene therapy. In the past three years, the biopharmaceutical and large health enterprises in the park have raised approximately 45 billion yuan in market financing. The competitiveness of the biopharmaceutical industry, talent competitiveness, and cooperation competitiveness in the park rank among the top in the country.
 
 
 
The park has achieved significant results in terms of clinical approvals for Class I new drugs, the number of new drugs on the market, the number of products entering national medical insurance, the number of approved Class II and III medical device registration certificates, and the number of medical device products on the market. Among them, there are 721 clinical approvals for a type of new drug, with a total of 29 new drugs on the market, of which 17 have entered the national medical insurance; The total number of registration certificates for Class II and III medical devices is 1650, and 16 innovative medical device products have been approved for market.
 
 
 
In 2023, focusing on the actual development of industries, the park will make efforts in laying out national level major strategic platforms, accelerating the construction of industrial clusters, and innovating service models, and continue to explore open innovation in policy systems. In 2023, the park was approved to build three State Key Laboratory, the headquarters base of the National Biomedical Technology Innovation Center was started, the nucleic acid drug technology innovation platform was officially put into use, and 89 key technology research projects of cell therapy were established. The innovative industrial cluster of biopharmaceutical product manufacturing in the park has been successfully selected as a national level innovative industrial cluster by the Torch Center of the Ministry of Science and Technology.
 
 
 
In addition, Suzhou Industrial Park has also made significant progress in policy and institutional innovation. In addition to the "Several Measures to Support the Comprehensive Trial of Deepening Opening up and Innovation in Suzhou Industrial Park", for example, the "Work Plan for Pilot Implementation of Joint Supervision Mechanism for Imported Special Goods (Trial)" has been released, the "White List" system for imported R&D products of "Yanyida 2.0" biopharmaceutical enterprises has been optimized, and the purchase scope and enterprise scope of "Yanyigou 2.0" reference drugs have been expanded. These measures further promote the development of the biopharmaceutical industry in the park.

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