Shanghai to ramp up support for cutting-edge biomedical tech

Shanghai will strengthen efforts to develop cutting-edge biomedical technologies, such as gene and cell therapies, mRNA, synthetic biology and regenerative medicine, city government officials said in a news briefing on Tuesday.

To further encourage innovation at the source, the city will also support artificial intelligence technology to empower drug research and development, and provide more intelligent application scenarios, local government officials said after releasing a new document that supports the innovative development of the entire biomedical industry chain.

"We must make full use of new technologies, such as generative artificial intelligence and deep learning, to focus on new drug discovery and validation, drug design, screening of novel types of drugs and drug safety analysis. We must also accelerate technological breakthroughs in models, algorithms, professional software and building shared innovative platforms," according to the document unveiled recently.

Biomedicine is one of the three leading industries Shanghai is focusing on.

Since 2021, 19 first-class innovative drugs and 25 innovative medical devices from Shanghai have been approved for marketing. A number of world-level new drugs, first cell therapy drugs in the country, and global first-class medical devices have emerged in the fields of oncology, metabolism, immunity and neurology.

The scale of the city's biomedical industry has increased from 761.7 billion yuan ($105 billion) in 2021 to 933.7 billion yuan last year, and the sector's total industrial output value increased from 171.2 billion yuan in 2021 to 186 billion yuan in 2023, according to the document.

"Shanghai's biomedical industry is in a period of leveling up quality. We issued the document focusing on the requests of the industry and responding to the urgent needs of enterprises. It includes 37 measures in eight aspects and covers all the key links, such as research and development, clinical practice, new product review and approval, industrialization and marketing, investment and financing, data resources and internationalization," said Liu Duo, vice-mayor of Shanghai.

According to the document, the new measures also include further streamlining the product R&D cycle and shortening the time taken for new products to reach the market. For example, the time to kick off a clinical study shall be condensed to less than 25 weeks. Ethical review will require only one set of materials, which need to be submitted only once, and the overall review process will be compressed to three weeks.

As per the document, the time limit for reviewing supplementary applications of drugs will be shortened to 60 working days, and the time limit for the review and approval of clinical trial applications of drugs will be shortened to 30 working days.

The document also outlines support for the continuous global development of Shanghai's biomedical industry. One measure is to provide monetary support to local businesses with innovative products that have obtained registration and certification internationally.

"Enterprises in Shanghai that have obtained registration approval for innovative drugs, modern TCM (traditional Chinese medicine) therapies and high-end medical devices from regulatory agencies in the United States, Europe, Japan, the World Health Organization, as well as BRICS countries (Brazil, Russia, India, China and South Africa) and those involved in the Belt and Road Initiative — and have realized sales in the relevant foreign countries and regions — will receive support from the city government," said Zhu Qigao, deputy director of the Shanghai Municipal Science and Technology Commission.

The document also said foreign-funded enterprises will be supported to set up their regional headquarters, R&D centers, innovation platforms and proof-of-concept centers in Shanghai. About 90 percent of the world's top 20 pharmaceutical and medical devices companies have already set up their China headquarters, or R&D and production headquarters in Shanghai.

Patrick Horber, president of the international unit for Novartis, said China last year approved eight new products and indications of the Switzerland-based pharmaceutical company. So far this year, there have already been four such approvals.

"A reason for the accelerated pace is the country's evolving regulatory policies, which show a higher tilt toward innovative, high-quality products," Horber said.