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The development of new drugs is a long-term, costly project with low success rate. Only investing enough time and money can produce results. Although there are 1500-2000 pharmaceutical companies in China, the vast majority of SMEs have relatively weak independent innovation and R&D capabilities. They do not have their own R&D bases, but rely on the innovation resources of scientific research institutes. At present, China has not yet been able to cooperate with international large-scale pharmaceuticals. Companies and their products compete against each other for their companies and pharmaceutical products.
Although the basic research of Chinese pharmaceutical companies is weak and the diversity of compounds is not abundant, there is a lot of room for innovation. For example, it can be used to innovate generic drugs, compound drugs, and innovations in Chinese medicine. Pharmaceutical companies need the support of the state in many aspects such as capital, land, policies, and taxation. It is also necessary to introduce and cultivate enough suitable talents.
On December 26, 2007, the executive meeting of the State Council reviewed and approved in principle the implementation of three major national science and technology projects. The major new drug creation project will focus on the prevention and control of major diseases and develop a batch of innovative drugs with independent intellectual property rights to provide safe, effective, and inexpensive pharmaceutical products for the people.
According to Ye Zuguang, general manager of Beijing Zhongyan Tongrentang Pharmaceutical Research Co., Ltd. and executive deputy director of the National Engineering Center for New Drug Development of Traditional Chinese Medicine Compound, the major new drug creation project aims to improve the innovation capability of Chinese pharmaceutical companies. Although basic research is weak and innovation is difficult in China's pharmaceutical companies, there is a lot of room for innovation and it is necessary for the State to support funds, policies, and shortening the time for approval of new drugs.
Special purpose is to cultivate corporate innovation capabilities
“The purpose of establishing a major new drug to create a major scientific and technological project is to cultivate the independent innovation capability of pharmaceutical companies and enable some companies to have their own R&D bases.†Ye Zuguang said that another important point is to promote the research and development of large varieties and to support existing medicines that hold broad market prospects. Variety stronger and bigger. At present, although there are medicines with an annual sales of 1 billion yuan, there are relatively few varieties in China. It is difficult for enterprises to achieve a scale of 2 billion yuan and 3 billion yuan from a scale of 1 billion yuan. We hope that with this special project, after five years of support and development, China will be able to produce pharmaceutical products with annual sales of 10 billion yuan, and produce several companies and products that can compete with internationally renowned large-scale pharmaceutical companies and their products.
For enterprises, the major new drug creation project is to support the strong and not weak. Ye Zuguang believes that this will promote the reshuffle of the industry. Some enterprises with strong innovation ability will develop and grow, while those without innovation ability or weak innovation ability will be merged, acquired or gradually eliminated by the large companies. Chen Yongle, chief scientist of Livzon Pharmaceutical Group Co., Ltd., said that this special program is not poverty alleviation, and it should not help the weak, but compared to the huge amount of funds required for new drug research and development, the special project can give the company a small amount of financial support to promote the industry. The effect of shuffling is limited.
A vast world of innovation
Although the implementation plan for the creation of major new drugs has passed, China's pharmaceutical companies currently rely mainly on the production of generic drugs, and there are still fewer truly innovative drugs. Do they have the ability to undertake the development of innovative drugs with independent intellectual property rights? Chen Yongle believes that “China’s basic corporate research is weak, and the diversity of compound samples is not rich enough, and the funds are limited. Innovation is indeed very difficult, but it is not without innovation ability and space. Under the premise of not infringing the patents of others, the local innovation approach is still There are many."
For example, an innovative imitation drug can be used to make compounds slightly change in the same situation as the compound backbone, and a new drug can be developed. This is common in large international pharmaceutical companies; the molecular structure of some active pharmaceutical ingredients is asymmetric and changes. Its structural direction is also innovation; if it is known that the metabolites of a certain drug in the human body can treat a certain disease, drugs based on this metabolite can be developed; some drug molecules need to remove one group in the body. The active ingredient that produces the disease for treatment can be directly synthesized by removing the molecular compound formed after removing the group from the drug molecule, or developing a drug that can automatically remove a certain group in the human body to generate an active ingredient known to treat the target disease. It is also possible to improve the drugs with poor water solubility and low availability, expand the range of known drug efficacy, and combine the active ingredients of the two drugs together as a compound drug.
Innovation in Chinese medicine is the advantage of Chinese companies. Although phytochemistry has studied the chemical composition of almost all plants for 100 years and has applied for a patent, it is not always clear which diseases these chemical components can treat, and this is exactly what Chinese companies can do. Moreover, Chinese medicine has been used for thousands of years, which is equivalent to having completed human tests. What is unclear is the chemical structure of the active ingredients that can really treat diseases in the medicine soups that are extracted from many kinds of Chinese medicines. Recently, 11 ministries and commissions including the Ministry of Health and the Ministry of Science and Technology jointly issued the "Guiding Opinions on Practically Strengthening the Development of Ethnic Medicine", and the development of Chinese medicine has been highly valued by the state. Ye Zuguang believes that the composition of Chinese medicines is complex. Unlike western medicines, the molecular structure with clear effective ingredients can serve as the basis for intellectual property protection. How to protect the intellectual property rights of Chinese medicine? Actual operation is more difficult.
Need to support in many ways
What are the benefits that the implementation of a major new drug creation project can really bring to the company? Although the special projects will give pharmaceutical companies certain financial support, the huge amount of funds required for R&D of new drugs is “just a small sum of money, and the main cost or corporate commitmentâ€. However, people in the industry said that the adoption of this special implementation plan gave great encouragement to corporate innovation and strengthened their determination to innovate. The reporter was informed that enterprises need not only financial support, but also policy support in terms of land, policies, taxes, etc., especially the approval of new drugs needs to be accelerated. Livzon Pharmaceutical Group Co., Ltd. has a new class of drugs that should receive approvals in early 2007. The results were only obtained in December 2007, and the IPO will probably wait until after June 2008.
When asked by reporters about the current talent situation of the company, Chen Yongle immediately said that "certainly not enough." Although talent is already one of the most important factors in the development of a company, it is not easy for companies to recruit high-level and suitable talents. Although there are many overseas students who have returned to China in recent years, few are suitable for business needs. Some returnees do not understand the domestic situation, and the mode of thinking is not suitable for the development of enterprises. The problem cannot be considered from the perspective of the market, and there are various types of drugs produced by enterprises. There are a lot of things that I don't understand. Chen Yongle said that Livzon Pharmaceutical actively introduces talents on the one hand and cultivates talents on the other. The company recruits doctors and masters from institutions of higher learning and scientific research institutes to allow them to fight for a few years in the company. After they understand the market, they can think from the perspective of the company and become professional talents suited to the needs of the company. However, there are also industry insiders who say that if companies are willing to provide generous treatment, they can still attract some talents.