5. The development of traditional Chinese medicines should have strategic awareness and overall planning
Whether there is strategic awareness and overall planning in the development of a new drug product will determine whether it can be successfully launched in the future, which is mainly reflected in the following: The following aspects:
5.1 Have business ideas
New drugs are a special product, a high-investment, high-return commodity, so the developers, whether they are enterprises or scientific researchers, , from the beginning of the development of a new drug, there should be awareness and thoughts about operating the product. What kind of product should I ultimately produce, what quality should my product achieve, and which variety on the market should my product replace? How will I market this product, what returns will I get from this new product, etc. These should all be considered when setting up the project. Only new drugs developed under the guidance of this awareness can be targeted and meet the needs of the market and patients.
5.2 The development of traditional Chinese medicines should consider the issue of drug source security
Although my country is rich in medicinal resources, the output of some medicinal materials is scarce and cannot meet the needs of industrialized production of medicines. In addition, due to the different origins of medicinal materials, the quality of medicinal materials varies greatly from place to place, making it difficult to control the quality of traditional Chinese medicine and affecting the efficacy of the medicine. Therefore, before the development of traditional Chinese medicine, prescriptions must select medicinal materials that can ensure the quality and supply of medicine sources.
5.3 Conduct comprehensive project management of research work
The development of traditional Chinese medicine is a project completed by multiple departments and multiple personnel, including prescription screening, preparation technology, Pharmacological testing, clinical research, data summary, patent design, registration and approval and other multiple processes. If there is a lack of comprehensive understanding of the entire process, technology, and market of new drug research, this will often result in disconnection in development work, reduced research efficiency, and defects in applied designs and patent applications. Therefore, the research on new traditional Chinese medicines requires professionals with comprehensive knowledge and familiarity with the technology and application process to comprehensively coordinate, manage and operate the entire new drug research project to ensure the efficiency, effectiveness and quality of development.
5.4 The strategic planning is pragmatic and the design has a sense of sustainable research
Planning for new drug development should be based on one’s actual needs, development direction and one’s own economic and technical strength , select the new drug projects that are most suitable for your own research, and adjust the research direction in a timely and far-sighted manner according to changes in relevant policies. The topic selection should not only be targeted, but also take into account the coordination and progress with other projects, and try to use limited resources to conduct sustainable research. You can adopt the strategy of using the old to support the new and small projects to support the larger project. Make the overall research proceed in a gradient manner to avoid duplication of research, so that research projects can continue to move forward one after another and continuously add value.
5.5 Make full use of network information technology to integrate advanced science and technology and development projects in various disciplines
New drug research in the 21st century is based on basic research at the genetic and molecular levels. Based on the understanding of life processes and disease mechanisms. The application of computer technology, modern synthesis technology, biotechnology, and the development and interpenetration of medicinal chemistry and molecular biology, genetics, immunology, enzymology and other disciplines have laid the foundation for the development of new drugs. In particular, the Internet enables the sharing of information and provides great convenience for scientific research in various disciplines. It can be said that the development trends and cutting-edge technologies of various disciplines can be found on the Internet. Therefore, the development of traditional Chinese medicine can be designed with full reference to the technical methods disclosed in the public literature database and patent database, integrate advanced technologies from multiple disciplines, accelerate the transformation of basic research results of traditional Chinese medicine, and conduct research on the shoulders of others. This avoids low-level duplication and improves development efficiency.
6. When developing traditional Chinese medicine, intellectual property rights must be considered in advance and the design of patents should be paid attention to.
Many traditional Chinese medicine researchers, including corporate decision-makers, do not have enough understanding of the Patent Law and do not have sufficient knowledge of the intellectual property rights of new drug research. The protection only relies on the administrative protection of new drugs and the protection of traditional Chinese medicine varieties. Only patent protection is the most fundamental intellectual property protection. Administrative protection of new drugs and protection of traditional Chinese medicine varieties only work in our country. New traditional Chinese medicines must rely on patent protection if they want to go global. Take the Compound Danshen Dropping Pills that we often mention now that the FDA has approved for clinical trials. Even if it is approved to enter the United States through clinical testing, because it does not have effective patent protection abroad, others can imitate it at will and cannot obtain the product. In the end, the exclusive right to market sales is just for marriage.
In China, with the introduction of new laws and regulations, the cancellation of administrative protection and the upcoming revision of the regulations on the protection of traditional Chinese medicine varieties, the focus of intellectual property protection for new traditional Chinese medicines will gradually shift to patent protection. Therefore, when we develop new traditional Chinese medicines, we must consider the design of new drug patents. The following topics of current traditional Chinese medicine inventions can be applied for patent protection in China: traditional Chinese medicine formulas; dosage ratios of components; traditional Chinese medicine processing technology; effective parts of traditional Chinese medicine; traditional Chinese medicine preparations; preparation methods of traditional Chinese medicine; and new medical uses. The patent system has many techniques for protecting new traditional Chinese medicines. As long as it is properly designed, almost all new traditional Chinese medicines can be effectively protected, ensuring developers’ exclusive rights to market the products they develop.
7. Pharmaceutical enterprises should become the main body in the development of traditional Chinese medicines
Enterprises should become the main body in the development of traditional Chinese medicines, and the country also has the guidance to shift the main body of new drug development to enterprises. However, many companies still do not pay enough attention to the research and development of traditional Chinese medicine. The key to achieving this goal is how to make many companies realize the importance and urgency of investing in the development of traditional Chinese medicine for their own development. Enterprise investment in R&D will not only help promote the development of traditional Chinese medicine, but more importantly, it will bring huge benefits to the enterprise itself. As the main body of the development of traditional Chinese medicine, enterprises are conducive to developing products that are most suitable for their own sales in order to obtain maximum profits and maintain the sustainable development of the enterprise; they are conducive to developing products that are most suitable for their own production to reduce production costs; they are conducive to obtaining products with their own intellectual property rights. products to ensure the exclusivity of their own sales and adapt to the needs of domestic and foreign markets after joining the WTO; to help improve their own technological level, establish their own high-tech image, increase their own brand effect, and provide technical sales for traditional Chinese medicine products. Lay a good foundation. Although some far-sighted entrepreneurs in outstanding enterprises have already realized this, such as Jiangsu Yangzijiang Pharmaceutical and Sanjiu Pharmaceutical, etc., which have invested heavily in establishing their own traditional Chinese medicine research and development teams, for the entire traditional Chinese medicine industry, the development of traditional Chinese medicine More outstanding companies are needed to join in. Only by closely integrating scientific research with enterprises can we develop products that are more suitable for market demand and of high quality.