According to Xinhua News Agency, Premier Li Qiang presided over an executive meeting of the State Council on July 5 to review and approve the "Implementation Plan for Supporting the Development of Innovative Drugs in the Whole Chain" (hereinafter referred to as the "Implementation Plan").
The meeting pointed out that the development of innovative drugs is related to the development of the pharmaceutical industry and the health and well-being of the people. It is necessary to strengthen policy guarantees in the whole chain, make overall plans to make good use of policies such as price management, medical insurance payment, commercial insurance, drug allocation and use, investment and financing, optimize the review and approval and assessment mechanisms of medical institutions, and work together to promote the breakthrough development of innovative drugs. It is necessary to mobilize scientific and technological innovation resources in all aspects, strengthen basic research on new drug creation, and consolidate the foundation for the development of innovative drugs in the mainland.
Since then, the "gift package" that the innovative drug industry has been looking forward to for a long time has landed.
Data with picture according to ICphoto
On July 6, Chen Hao, director of the Drug Policy and Management Research Center of Tongji Medical College of Huazhong University of Science and Technology, said in an interview with a reporter from Red Star News that this "whole chain" policy is comprehensive, from the early research and development, capital investment, efficiency and methods of approval, to the platform after listing, back-end medical insurance pricing, multiple payments, and then to admission and use, the one-stop is very detailed.
"The implementation plan systematically integrates the previously proposed innovative drug policy, and has done its best from all links and departments." Chen Hao said.
Policy Platform:
It is conducive to promoting the establishment of an innovative drug ecosystem
Support measures have been rolled out in many places
In Chen Hao's view, from the short, medium and long term, the "Implementation Plan" will be conducive to promoting the establishment of the entire ecology of innovative drugs.
According to the official website of Ping An Fund, Zhou Sicong, fund manager of Ping An Fund's Equity Investment Center, previously commented that the document has a higher level and a more complete scope, and the core idea is to "support excellence". From the perspective of the basic principles of policy, the core is to respect the laws of the market, improve the price formation mechanism of innovative drugs, promote the allocation and use of innovative drugs and diversified payment, give enterprises reasonable returns, and stabilize industrial development expectations.
However, Chen Hao said that there are some institutional "bottlenecks" that need to be broken through, and some policies lack rigid constraints. He believes that the core is to solve the problem of pricing. "Because the total plate of medical insurance is limited, it is still necessary to develop increments, so this policy proposes to promote multi-level payment such as commercial insurance."
The Red Star News reporter noticed that the policy launch of innovative drugs has actually been hinted at for a long time. According to Xinhua News Agency, when the executive meeting of the State Council held on August 25 last year deliberated and adopted the "Action Plan for the High-quality Development of the Pharmaceutical Industry (2023-2025)", it was emphasized that it is necessary to focus on the characteristics of difficult pharmaceutical R&D and innovation, long cycle and high investment, give support to the whole chain, encourage and guide the development and growth of leading pharmaceutical enterprises, and improve industrial concentration and market competitiveness.
In addition, in December last year, Bi Jingquan, deputy director of the Economic Committee of the 14th National Committee of the Chinese People's Political Consultative Conference (CPPCC) and executive vice chairman of the China Center for International Economic Exchanges, called for a "full chain" policy. At the 2023 China Medical Science and Technology Forum and the second anniversary of the establishment of the Yangtze River Delta Pharmaceutical Innovation and Development Alliance, Bi Jingquan said in the keynote report that it is necessary to give full chain support to biomedical innovation in R&D, access, production, use, payment and other links.
Public reports show that since the beginning of this year, Beijing, Guangzhou, Zhuhai and other places have launched a new round of measures to support the development of the biomedical industry. Among them, on April 17, nine departments including the Beijing Municipal Medical Security Bureau issued the "Several Measures to Support the High-quality Development of Innovative Pharmaceuticals in Beijing (2024)", which was previously open for public comment on April 7, "due to the urgency of time, the time for public solicitation of opinions has been shortened to 3 working days". This document proposes to promote the implementation of the national innovation pilot project of "compressing the time limit for the review of drug supplementary applications from 200 days to 60 days, and the time limit for drug clinical trial approval from 60 days to 30 days"; The overall time to start a clinical trial was reduced to less than 28 weeks.
Expert Perspectives:
In the short term, it can boost the entire market
Long-term mechanisms should also be established
At the regular policy briefing of the State Council held on June 14, Huang Guo, deputy director of the State Food and Drug Administration, introduced that according to statistics, since 2022, a total of 82 innovative drugs and 138 innovative medical devices have been approved, and 20 innovative drugs and 21 innovative medical devices have been approved in the first five months of this year alone, including new biotechnology products such as CAR-T and monoclonal antibodies, as well as innovative Chinese patent medicines, as well as artificial heart products using full magnetic levitation technology. CT image-assisted detection software using artificial intelligence technology, etc. In terms of quantity and quality, it is at the forefront of the world.
Huang Guo also said that the technology of drug evaluation in mainland China is fully in line with international standards. At present, there have been innovative drugs that have achieved "global initial listing" in mainland China using international multi-center clinical data.
In this regard, Chen Hao commented that these gratifying figures come from the investment made 3, 5 or even 10 years ago, or there are more improved innovations and less original innovations, and original innovation depends on breakthrough innovation in basic research. At present, due to the low valuation of drug value and the unsmooth exit mechanism of the secondary market, the financing of the primary market of innovative drugs is still relatively sluggish.
At the above-mentioned work meeting, Bi Jingquan also pointed out that in recent years, the mainland's biomedical industry has begun to embark on the road of high-quality development, but it is still in the stage of "climbing over the hurdles" and faces many problems to be solved. There is still a significant gap between the innovation of biomedicine in mainland China and the world's advanced level, with follow-up, imitation, and introduction innovation being the majority, and there are very few original new drugs with new targets, new compounds, and new mechanisms of action, and the source innovation ability is still weak. At the same time, there are severe challenges in the field of biomedicine, such as weakening expectations, sluggish capital markets, and financing difficulties for enterprises, mainly because innovative drugs are facing dual obstacles to medical insurance access and hospital access to clinical use.
Chen Hao said that from the perspective of industry and capital, the situation of pharmaceutical research and development in the past two years is not optimistic, and the introduction of the "Implementation Plan" is to boost and drive, but the establishment and improvement of the entire ecology is not overnight, and this document is only the first step. "In the short term, the entire market can be boosted, but the institutional problems in the medium and long term will take a long time to be resolved, including the core boundary between the government and the market. For example, there are many exceptions to innovative drugs, but the whole long-term mechanism should be established. ”
Chen Hao believes that what the government needs to do is to create a good market environment, improve market elements, and allocate prices through the market. In this process, all departments must have the awareness of the ecological chain and leave enough space.
Red Star News reporter Hu Yiwen
Editor: He Xianxian, Editor-in-charge: Li Binbin
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