Source: Pudong Release

This year marks the 30th anniversary of the development of the biopharmaceutical industry in Shanghai. As the birthplace of modern biopharmaceutical in China, Shanghai is accelerating its efforts to build a world-class biopharmaceutical industrial cluster with international influence.

At the press conference of 2023 Shanghai International Biomedical Industry Week (hereinafter referred to as "Industry Week") held by the Municipal Government Information Office on October 7, it was revealed that in the past 30 years, China's biomedical industry represented by Shanghai has grown from small to large, from weak to strong, and biomedicine "Shanghai International Express Line" quickly links inside and outside and takes the lead in connecting with the world. Jointly promote Shanghai biopharmaceutical from a total output value of less than 5 billion yuan to an emerging industry with an industrial output value of nearly 200 billion yuan and a total scale of nearly 900 billion yuan.

"Since 1993, the Municipal Party committee and the municipal government took the lead in listing the modern biological and pharmaceutical industry as a key high-tech industry, Shanghai has consistently promoted the high-quality development of the biomedical industry in the past 30 years, especially since entering the new era, and a world-class biomedical industry cluster like a 'tropical rainforest' is accelerating its formation." City economic information committee director Wu Jincheng said.

Continue to build an industrial spatial pattern led by Zhangjiang to further achieve "tropical rainforest" expansion

Since 2019, a total of 17 category 1 innovative drugs have been approved in Shanghai, accounting for about 1/4 of the country; The third type of innovative medical devices were registered and approved 23 items, accounting for about 1/6 of the country, realizing the transformation from "creation and imitation combination" to "first lead", and emerging a number of the world's first new drugs, the country's first new cell therapy drugs, and international first-class medical devices. 80% of the top 20 pharmaceutical equipment companies in the world are headquartered in Shanghai, 16 of the top 20 companies in the country are located in Shanghai, and 70% of the world's top 10 CIO and CMO companies have operations in Shanghai. In the fields of cell and gene therapy, synthetic biology, medical robots, AI+ pharmaceutical, high-end medical imaging, it has formed an advantageous track and advantageous industrial cluster.

The formation of "tropical rainforest" construction can not be separated from policy joint efforts. Since the beginning of this year, Shanghai has officially implemented version 2.0 of the "Shanghai Pilot Program for the Import of biomedical Research and Development Items", and continued to expand the "Zhangjiang Science City Entry special pilot Unit List" to improve the degree of import facilitation; Promote the establishment of the "Shanghai Biomedicine" "New excellent pharmaceutical equipment" product catalog ", and provide support for the pharmaceutical equipment products included in the catalog and their enterprises in hospital application, medical insurance catalog recommendation, commercial insurance design, etc.; Several Measures for Shanghai to Further Improve the Multi-Payment Mechanism to Support the Development of Innovative Pharmaceutical Devices, actively develop new commercial insurance, and improve the medical insurance payment mechanism.

According to Liu Ping, deputy director of the Shanghai Municipal Economic Information Commission, in order to achieve the expansion of the "tropical rain forest", promising that "good enterprises do not lack of land, good industries do not lack of space" in Shanghai, Shanghai is actively expanding the industrial space, promoting the cluster development of enterprises, continuing to build the city's "1+5+X" industrial space pattern led by Zhang Jiang, and promoting the "intelligent space construction action plan". Orderly construction of biomedical standard plant with a total size of nearly 5 million square meters. Of this, about 1.8 million square meters will be started in 2023.

"While strengthening the improvement of original innovation capabilities and breakthroughs in key core technologies, we will achieve high-quality results transformation, forward-looking leadership in emerging industries, and high-quality ecological creation." Through the superposition of municipal and district secondary policies, a spatial pattern of complementary industrial characteristics of each district is formed." Liu Ping said.

In the first eight months, 133 clinical approvals of Class 1 innovative drugs were approved in Shanghai, accelerating the development and listing of a number of cell and gene therapy drugs

Focusing on the new track of biomedicine, Shanghai adheres to the top-level design, strengthens the forward-looking layout, adheres to the innovative policy source, and strengthens the full-chain development. In the past five years, the number of listed class 1 innovative drugs and Class 3 innovative medical devices in Shanghai accounted for 1/4 and 1/6 of the country, respectively, ranking in the forefront of the country. At the same time, Shanghai is rich in clinical elements, and there are 36 first-class hospitals in the city, of which 17 hospitals set up clinical research centers independently, and 6 hospitals build "National Clinical medical research centers" as supporting units.

According to Zhao Jian, chief engineer of Shanghai Science and Technology Commission, from January to August this year, Shanghai received a total of 133 clinical approvals for class 1 innovative drugs, including 20 for cell and gene therapy clinical trials; Eight medical devices entered the national innovative medical device special approval channel.

It is worth noting that two CAR T cell drugs in Shanghai have achieved domestic debut, all from Pudong enterprises. In the next step, Shanghai will launch the implementation of cell and gene therapy in terms of enhancing the ability of innovation sources, and conduct research on new targets and mechanisms of cell and gene therapy in a forward-looking manner, and carry out key technological research including the development of new systems for DNA enzymatic synthesis, new vector targeted delivery systems, and new CAR-T technology development. We hope to form a number of key core technologies with independent intellectual property rights.

"In terms of improving clinical research capabilities, promote the construction of institutions and platforms such as research hospitals, clinical medical research centers, and research wards, support medical institutions to focus on the diagnosis and treatment of common multiple diseases and major difficult diseases to carry out high-level clinical research, and comprehensively improve the clinical research and transformation application capabilities of innovative biomedical products in the city." In terms of enhancing public service capabilities, we will establish an engineered functional platform service system for gene therapy and related fields, accelerate proof of concept, product testing and pilot scale up, shorten research and development, clinical trials and production cycles, and accelerate the development and launch of a number of cell and gene therapy drugs." Zhao Jian said.