China has become a non-negligible part of the international biomedical market, more and more foreign pharmaceutical companies want to enter the Chinese market; with the increasingly fierce competition in the domestic market, more and more Chinese innovative pharmaceutical companies have begun to turn their attention overseas. Internationalization has also become an important criterion for measuring the core competitiveness of a pharmaceutical company. Going out has become the goal and demand of more and more local pharmaceutical companies.
"It is certain that more and more Chinese pharmaceutical companies are considering internationalization. At present, the internationalization advantages of Chinese Biotech companies are still unclear, but the trend of more and more innovative drug projects in China biotech going international is gradually taking shape. Jiayue Pharmaceutical founder Li Yongguo said.
Founder of Jiayue Pharmaceutical Li Yongguo
The following is an excerpt from the wonderful dialogue between the E-drug manager and Li Yongguo, a member of the "Chuang Parkway" council
Q: E Drug Manager
A: Li Yongguo, founder of Jiayue Pharmaceutical
Q: THE CDE's guidelines on the clinical value of tumors have sparked a discussion about innovation at the source, do you think it will improve the problem of "inner volume" and "homogenization" of the track today?
A: The CDE's guiding principles on the clinical value of tumors have indeed attracted widespread attention and consideration in the industry. This guiding principle should have a guiding effect on the problem of "internal volume" and "homogenization" of pharmaceutical research and development, so that innovative drug companies and capital parties will consider the future competitive landscape and their own product positioning earlier.
Q: McKinsey & Company believes that the mainland has entered the "second echelon" of new drug research and development, what do you think are the opportunities for domestic pharmaceutical innovation to become the leader of the second echelon? In what ways is there still a gap from the first echelon?
A: China's biomedical basic research has gradually entered the position of the leader of the second echelon, and the gap with the first echelon is narrowing: first, China's economic growth is still higher than other major economies, the health industry has a huge domestic demand market, and secondly, the mainland biomedical industry is in a period of rapid development, especially the new treatment technology closely follows the first echelon.
From entering the first echelon, we still lack to produce several large-scale pharmaceutical companies that are mainly innovative drugs and rank in the top ten international rankings, and we need to continue to maintain a leading or synchronized with the original innovative innovative drug projects listed on the market, and at the same time need to build a scientific and reasonable ecosystem for the entire value chain of innovative drugs from the source to the market, in addition, the construction of the talent echelon from academia to industry also needs to be improved.
Q: What are the core influencing factors that your company will consider when setting up a new drug research and development project?
A: The first thing in the establishment of new drug research and development projects is the satisfaction of clinical needs, and the core influencing factors are also the analysis of drug ownership and market competition.
Q: When conducting clinical trial research, choose a clinical trial institution? What is the standard?
A: The main considerations for selecting clinical trial institutions are the researcher, potential subjects and institutional management, etc. First of all, the ability and enthusiasm of the researchers are the main, there are potential subjects to ensure enrollment, and institutional management is also very important, try to avoid some hospitals that are uncertain about the ethical time and contract signing time.
Q: In recent years, the number of innovative drugs entering clinical trials has increased significantly, and clinical resources have gradually become scarce, resulting in a significant increase in drug development costs. What do you think is the current breakthrough in the competition for clinical resources?
A: From the perspective of clinical research and clinical trials, there are several aspects of the breakthrough in the competition for clinical resources, one is to further encourage more hospitals and doctors to engage in clinical trials and clinical research, the second is to further expand hospitals and doctors in third- and fourth-tier cities to carry out clinical trials, and the third is to further liberalize CRO companies to engage in clinical phase I to III clinical trial services.
Q: In your opinion, pharmaceutical companies, especially Biotech companies, need to lay out commercialization at what stage of product promotion?
A: For the commercialization of the layout, it is usually 24 months before the product is launched to prepare, and the marketing department begins to participate when the clinical phase III plan is discussed.
Q: Does your company have a product that has been commercialized or is about to be commercialized? How to describe the clinical value and benefits of this product?
A: Jiayue Pharmaceutical has completed a clinical phase II product and is preparing for phase III clinical trials. The indication of this product is the treatment of drug-resistant tuberculosis, which is currently a major public health need. WHO annual reports in recent years show that the number of new patients in the world is about 10 million per year, and India, China, Indonesia, Russia and other high-burden countries are in the top few. Jiayue's researched Sudapyridine (WX-081) has advantages in terms of potential safety and subject compliance.
Q: From the perspective of clinical value and commercial value, what dimensions do you think can be used to evaluate the value of a drug?
A: The clinical value of evaluating drugs mainly includes safety, efficacy and convenience of use. Evaluating the commercial value of a drug is first of all to address the needs of patients and doctors in the clinic, first assess its use value, and then reflect its commercial value through potential commercial success.
Q: Some industry insiders believe that 2022 will be the first year of the internationalization of China's innovative pharmaceutical companies. According to your observation, what are the advantages and shortcomings of Biotech in the current process of drug internationalization?
A: Whether 2022 will be the first year of the internationalization of China's innovative pharmaceutical companies may not be certain at this time, but it is certain that more and more Chinese pharmaceutical companies are considering internationalization. At present, the internationalization advantages of Chinese Biotech companies are still unclear, but the trend of more and more innovative drug projects in China biotech going international is gradually taking shape.
The shortcomings of Biotech's internationalization are insufficient talent, difficulty in controlling the international regulatory environment and clinical research and development, and the difficulty of risk management. It is expected that the government can have specific policy encouragement and guidance to form an ecosystem for the internationalization of Chinese pharmaceutical companies, or the formation of alliances between biotech enterprises, which will reduce the cost and risk of biotech internationalization.
Q: What are the indicators that a company achieves that means that internationalization is successful?
A: The first step to international success is for the product to be listed in other countries NDA and approved, the second step is the sales situation after the market, and the share of similar products, and the third step is to continue to have new products on the market and have ideal sales.
Q: The problem caused by the shortage of talent resources is that the salary of a certain type of position is much higher than the industry's cognition, according to relevant media reports, the annual salary of the chief medical officer exceeds 10 million yuan, do you think this situation is in line with the law of talent?
A: The shortage of talent resources leads to a significant increase in the salary of some positions, which is a reaction to the law of the market, and in the long run, it will return to its value itself.
Q: As far as you know, what are the most sought-after positions in the pharmaceutical industry at present? What kind of industry reality does this reflect?
A: At present, the high-end talents with experience in the research and development of innovative drugs in the pharmaceutical industry are all in short supply, and the most sought-after positions such as high-end clinical medicine and clinical operations are in short supply. Behind this is that a large number of domestic innovative drug projects have begun to enter clinical research and development, and it is impossible to quickly cultivate a large number of experienced clinical talents in the short term.
Q: Whether it is domestic collection, national talks, or internationalization, for pharmaceutical manufacturers, reducing costs is an eternal proposition. Do you think that the "domestic substitution" of research and development reagents, equipment, production consumables, and equipment is an effective way to achieve cost reduction?
A: Whether it is equipment, or research and development reagents, instruments and production consumables, of course, is an effective way to reduce the cost of drug production, production equipment and analytical testing instruments are more and more automated and intelligent, can greatly improve production efficiency and reduce the cost of employment, etc., "domestic substitution" can undoubtedly reduce the cost from procurement to installation and operation and daily maintenance, and ultimately reduce the production cost and market price of drugs.
Q: In your opinion, in R&D and production, which key reagents, consumables and equipment cannot achieve "domestic substitution", stuck in the "neck" of cost reduction and efficiency?
A: The main card neck that cannot achieve "domestic substitution" is "know how", as far as the analytical instruments I am familiar with are some of the parts and components that require "high, fine, and sharp" requirements to the whole machine can not meet the requirements. It requires the joint efforts of all links in the industrial chain.