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22:21

Biomedicine is one of the three leading industries that Shanghai focuses on developing, and it is also an important field for accelerating the cultivation of new quality productivity. Recently, Shanghai has issued a new round of opinions to support the innovative development of the entire chain of the biomedicine industry. Focusing on key links such as R&D, clinical, review and approval, application promotion, industrialization, investment and financing, data resources, and internationalization, it insists on full-chain innovation, full-chain reform, and full-chain empowerment, and has launched 37 policy measures in 8 aspects. Providing full-cycle services for "one pill", how will the new regulations accelerate the biomedicine industry? Dragon TV's "Tonight" special column "Understanding Shanghai" invited Tang Jun, deputy director of the Shanghai Biomedicine Industry Promotion Center, and Qu Xia, chief industrial development planner of Lingang Life Blue Bay, to discuss together.

The new round of policies is a timely relief

The "Several Opinions on Supporting Innovation and Development of the Entire Chain of the Biomedicine Industry" issued this time focuses on supporting six aspects, including further encouraging innovation sources, further expanding the advantages of clinical resources, further shortening product research and development and market launch cycles, further accelerating the application and promotion of innovative products, further improving the full-factor support system, and further releasing the vitality of reform and innovation.

The outside world has noticed that among these key support directions, further encouraging innovation is the top priority. As a typical knowledge-intensive industry, insisting on source innovation is an inexhaustible driving force for the high-quality development of the biopharmaceutical industry. The Opinions proposes to increase support for the research and development of innovative drugs and equipment, encourage companies to carry out original innovation, and vigorously cultivate blockbuster products. Proactively layout cutting-edge tracks such as gene and cell therapy, support artificial intelligence technology to empower drug research and development, and provide more intelligent application scenarios.

This is the first time in three years that Shanghai has issued several opinions to support the development of the biopharmaceutical industry. Since 2021, 19 Class I innovative drugs and 25 Class III innovative medical devices have been approved for marketing in Shanghai. In the fields of tumors, metabolism, immunity, and neurology, a number of world-first new drugs and world-class medical devices have emerged.

Innovative achievements continue to emerge, and the industry level is also accelerating. The scale of Shanghai's biopharmaceutical industry has increased from 761.7 billion yuan to 933.7 billion yuan, especially in new frontier tracks such as cell and gene therapy, synthetic biology, and high-end medical imaging, accelerating the development of new momentum.

At the same time, Shanghai has actively promoted the international development and layout of the bio-pharmaceutical industry. Including Zhangjiang Hi-Tech Park, it has formed a "1+5+X" spatial layout. 90% of the top 20 international pharmaceutical and medical device companies have established their headquarters in Shanghai.

"At present, Shanghai's biomedicine industry has formed a relatively complete industrial chain layout, which also makes the upgrading and improvement of policies imminent." In the view of Tang Jun, deputy director of the Shanghai Biomedicine Industry Promotion Center, the "Opinions" issued this time are based on the previous round of policies released in 2021. It optimizes and improves around the demands and concerns of enterprises and the new trends and new requirements of industrial development. Therefore, it is more comprehensive and more targeted.

Qu Xia, chief industrial development planner of Lingang Life Blue Bay, also said that the targeted measures released in this "Opinion" are "timely rain". From key links such as R&D, clinical, approval, listing to application, it accurately responds to the needs of enterprises and provides important support for the innovative development of the entire chain of the biopharmaceutical industry.

Institutional innovation further shortens product development and launch cycles

Focusing on pain points and bottlenecks and responding to industry needs is the original intention of the new round of "Opinions". And using institutional innovation to accelerate the entire chain of the biopharmaceutical industry has become a top priority. Among them, Shanghai has actively promoted the pilot of the drug marketing authorization holder system for many years, accelerating the original and industrialization process of Zhangjiang biopharmaceuticals, and has attracted much attention from the outside world.

In the first half of this year, Shanghai approved three Class I innovative drugs, one of which was Tolametinib, which targets melanoma. This world's first targeted drug for NRAS gene mutation indications was approved on March 15 and shipped on May 20. It has now entered the Shanghai Huibao program, benefiting more than 80 patients across the country.

The owner of this new drug is Kezhou Pharmaceutical, which is located in Zhangjiang. The birth of new drugs involves more than a dozen disciplines such as biology, medicinal chemistry, and drug metabolism. The company relies on contract outsourcing at almost every stage. Zhangjiang's highly concentrated industrial chain has solved the worries of companies.

The final step in the development and marketing of drugs depends on the drug marketing authorization holder system established in Zhangjiang. The core of this system is to separate the production license and marketing authorization of drugs; drug research and development companies can obtain drug marketing authorization by entrusting third parties to produce, which greatly speeds up the launch of innovative drugs.

From "laboratory" to "production line", and then to hospitals and pharmacies, how to enable patients to use new and better drugs faster, this time Shanghai also proposed a new goal of "further shortening the product research and development and market launch cycle."

The latest "Opinion" clearly states that by establishing innovative measures such as a clinical preparatory queue, we will strive to shorten the clinical start-up time to within 25 weeks; establish mechanisms such as "one set of materials, one submission" for ethical review to shorten the overall process to within 3 weeks; and promote the implementation of the national registration review and approval reform pilot to achieve the review period for drug supplementary applications to be shortened to 60 working days, and the review and approval period for drug clinical trial applications to be shortened to 30 working days.

In addition, in order to further accelerate the application and promotion of innovative products, the "Opinions" proposed to promote more "new and excellent drugs and devices" to be included in hospitals and medical insurance, ensure that Shanghai medical institutions "equip as much as possible", and increase medical insurance payments for innovative products.

Tang Jun noted that the Opinion mentioned "compression" five times in total, and gave specific time limits for clinical start-up time, ethical review process, etc., to further shorten product development and launch cycles and accelerate the application and promotion of innovative products. "Innovative drugs can be launched earlier, which can reduce investment costs for companies; and for patients, new drugs are tantamount to creating opportunities for life and racing against death."

Cultivate "patient capital" to inject vitality into leading industries

Strengthening investment and financing support for the biopharmaceutical industry is also a major focus of the newly issued "Opinions". The biopharmaceutical industry has the characteristics of high risk, high investment, long cycle, etc., and has a strong dependence on industrial capital. In conjunction with the introduction of this new policy, Shanghai has made an overall deployment to improve the investment system of the biopharmaceutical industry.

According to Zhu Qigao, deputy director of the Shanghai Science and Technology Commission, there are four main measures: First, cultivate medium- and long-term investors and "patient capital", set up a biopharmaceutical industry mother fund, and set up a future industry fund, targeting early high-quality projects in the concept verification and pilot stage; second, encourage corporate venture capital. Support leading enterprises to set up corporate venture capital (CVC) alone or jointly, strengthen the incubation of innovative projects and industrial chain collaboration; third, support enterprises to become bigger and stronger through mergers and acquisitions, and promote the establishment of a biopharmaceutical industry merger and acquisition fund; fourth, broaden corporate financing channels in multiple forms.

Shanghai has also made early plans to leverage more social capital, support original innovation and achievement transformation, and strengthen key core areas such as biomedicine. Another important opinion released on July 30, "Several Opinions on Further Promoting the High-Quality Development of Venture Capital in Shanghai", mentioned that it is necessary to make good use of the three leading industry mother funds, promote the synergy between government resources and social capital, focus on supporting technology-based enterprises in the seed, start-up and growth stages, and establish a new future industry fund.

The total scale of Shanghai's three leading industry mother funds has reached 100 billion yuan. It was officially announced only four months after the first official announcement at the end of March this year. At the launch ceremony on the 26th, the three leading industry mother funds' investors signed cooperation intentions with a number of ecological partners. Among them, 10 chain-leading enterprises, including Shanghai Pharmaceuticals, which participated in the signing, are all leading enterprises in Shanghai's three leading industries and have strong driving capabilities in the industrial chain.

In order to accurately direct hundreds of billions of dollars of funds to the three leading industries, Qu Xia believes that these mother funds not only need to have accurate professional knowledge to identify projects, but also have multi-dimensional post-investment empowerment capabilities to help related companies build upstream and downstream industrial chains. "So when bringing in capital to invest, the 'capital' here is not just money, but resources."

From the support of large-scale "living water" of funds to starting from small things to save days for research and development and approval, focusing on the new track of biomedicine, Shanghai insists on top-level design, strengthens forward-looking layout, insists on innovation sources, strengthens full-chain development, insists on empowering industries, strengthens policy guarantees, and further improves the ecological system of scientific and technological innovation and industrial development, and promotes the biomedicine industry to move towards higher-quality development.

Kankan News Reporter: Song Yi, Shu Ke, Zhao Feifei

Editors: Fang Feifei, Huang Yanlin

Editor: Zhao Xin