(Observation by the NPC and CPPCC) When will domestic innovative drugs stop following?
China News Service, Beijing, March 10 (Li Jingze, Zhao Yejiao) Under the epidemic situation, topics related to domestically-made innovative drugs are still the hotspots of the National Two Sessions this year.
The so-called innovative drugs refer to drugs with independent intellectual property patents.
Compared with generic drugs, it emphasizes new chemical structures or new therapeutic uses.
It not only reduces dependence on foreign new drugs and facilitates domestic people, it is also of great significance to China's construction of an innovative country.
However, it is undeniable that, although the research and development of domestically-made innovative drugs in certain fields are in parallel with developed countries, they are still in a state of follow-up overall.
How to change the current situation?
May wish to find the answer from the long cycle of the birth of innovative drugs.
Targets are hard to find, strengthen basic scientific research
"Targets are the basis for the development of new drugs. To make breakthroughs in domestically-made innovative drugs, we need to start from the discovery of targets." Yuan Zhiming, member of the National Committee of the Chinese People's Political Consultative Conference and president of the Wuhan Branch of the Chinese Academy of Sciences, told reporters.
The so-called target is the binding site of the drug and the biological macromolecule in the body, and its discovery and verification is a very complicated process.
Just like a lock, to find a matching key, not only can it be inserted, but it must also be able to rotate.
"At present, most innovative drugs are developed on the basis of mechanisms and targets discovered abroad." said Hua Yawei, member of the CPPCC National Committee, full-time vice chairman of Henan Provincial Party Committee of the Peasants and Workers Party, and vice president of Henan Cancer Hospital To determine the target and the mechanism of drug action requires a large amount of literature research and bio-information analysis based on the disease to be treated. Therefore, it is necessary to strengthen basic scientific research and give full play to the advantages of the new national system.
Cai Xiujun, member of the National Committee of the Chinese People's Political Consultative Conference, chairman of the Zhejiang Provincial Committee of the Democratic Progressive Committee, and dean of Run Run Run Shaw Hospital of Zhejiang University School of Medicine, reminded that many pharmaceutical companies are keen on hot drugs, resulting in overcapacity of single drugs, which wastes resources and delays independent new drugs. Research and development.
He said that the target is the basis of new drug research and development. From the discovery of a target to the advent of an innovative drug, it is a process of high risk and high return.
This requires the state to increase support for related basic research, increase the support of personnel and funds in basic research, and increase the research and development of high-level innovative drugs and the transformation of results.
Long cycle, policy plus minus time
After discovering the target and the drug's mechanism of action, it is necessary to find compounds that are active against them, form candidate new drugs through technological transformation, and then enter in vitro, preclinical animals, clinical phase I, II, and III trials, and finally approve and market them.
According to industry sources, this process generally takes 10 to 15 years.
If domestically produced innovative drugs no longer follow suit, it is critical to compress the cycle.
The approval of clinical trials and the approval of the production and marketing of new drugs are the two main hurdles that must be passed through for the marketing of new drugs.
For those "drugs for the treatment of serious life-threatening diseases", the state has opened a "green channel", and it is clear that some drugs with obvious clinical value can obtain priority review and approval qualifications.
In addition, Ding Lieming, a representative of the National People's Congress and chairman of Betta Pharmaceuticals, pointed out to reporters that in order to improve the quality of new drug research and development and strengthen the technical guidance of drug registration applications, the Chinese Drug Administration has been committed to improving and optimizing the communication and communication of drug research and development and technical review. Mechanism, he suggested to further improve the communication efficiency between applicants (enterprises) and project review.
At present, the approval of domestically-made innovative drugs has shown an accelerated trend.
According to statistics from professional institutions, in 2020, the number of domestically-made new drugs approved will be 11, reaching double digits for the first time.
At the same time, more than 20 domestically produced innovative drugs have submitted marketing applications.
Risk is high, introduce venture capital to diversify risks
According to industry insiders, companies need up to $1 billion to develop an innovative drug.
“Due to the long R&D cycle of innovative drugs, large investment, high risks, and unstable returns, the benefits of new drugs cannot reflect the initial R&D investment, and many pharmaceutical companies are unwilling to take risks to carry out corresponding R&D.” Cai Xiujun said.
In this regard, Hua Yawei proposed to use social capital to introduce the concept of venture capital to relieve the company's worries.
He suggested establishing a diversified investment mechanism for R&D capital to encourage entrepreneurs to make venture capital investments in innovative drugs.
At the same time, further improve the financial services for small and medium-sized enterprises such as pharmaceutical research and development insurance, pharmaceutical research and development guarantees, and intellectual property pledges.
Establish a crowdfunding cooperation platform involving government agencies, financial institutions, and social capital.
In addition, Hua Yawei said that the government can also improve the incentives of enterprises to innovate through the improvement of tax reduction and exemption policies, scientific and technological project funding support policies for the research and development of independent innovative drugs, and other financial subsidies and support policies.
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