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Tao Jianhong talks about how to do a good job in market analysis of new drug research and development projects
The "beautiful philosophy" of Chinese-style innovation
“No one can assert that pharmaceutical innovations in opportunities, cooperation, transformation and complex global competition will eventually go where. But we know that history does not look back; no one can predict, in wealth, policy, technology Under the combined effect of culture, there are still many potentials for pharmaceutical companies to be stimulated. We only know that the future is always beyond imagination!" Tao Jianhong, deputy director of the Southern Institute of Pharmaceutical Economics and editor-in-chief of the Pharmaceutical Economics News, in an interview Ruan Dalai: "The innovative thinking in the development of new drugs, on the premise is a speculation on market demand, the market will rebut this round of conjecture. Those after a round of market defense, and constantly revised, What is finally surviving after adjustment is the truly productive innovation." So, how can we connect the test tube to the counter with the shortest time and the lowest cost? Let us share Tao Jianhong's "beautiful philosophy" about the development of new drugs.
The ability to keep thoughts happy
Reporter: What changes are taking place in the current environment of new drug research and development at home and abroad?
Tao Jianhong: At the moment, all countries in the world are looking for an industrial restructuring path that is out of the economic dilemma. Innovation is known as the vitality engine that drives sustainable development. How to keep innovative ideas and research and development practices fresh is a difficult problem. We are all familiar with the story of Don Quixote, the paranoid ideal, the personality that is not afraid of sacrifice, and somewhat similar to those who are lonely in the innovation adventure. However, innovation does not welcome sad heroes. The most important quality of scientists is optimism and tenacity. We must understand the enjoyment of drug research. The first decade of this century is the “lost decade” of global drug research and development – the pharmaceutical industry once entered a period of high investment and low output, and the value of each industry invested in research and development has shrunk by 70%. 2005~ In 2010, the number of approved NMEs fell by 40%, the number of NMEs approved by the FDA for listing each year was only 22, and the value of new drugs listed was only $430 million, down 15% from the last 10 years of the 20th century. With the expiration of patents such as Lipitor, the total value of pharmaceutical companies has shrunk by more than $50 billion. In addition, the global pharmaceutical industry is still in a relatively monopolistic situation of leading companies in a few developed countries. The weakening of innovation in large companies has lowered the overall growth rate of the pharmaceutical economy. In the next three years, the growth rate of the world pharmaceutical market will remain at 5%. about.
Fortunately, we began to recover the “lost decade”, and the global climate for drug innovation has recovered. In 2012, the top ten research and development strengths of the global pharmaceutical industry were 15.5% on average, maintaining the usual level, especially In the emerging market countries such as China, the investment in R&D has increased. According to estimates by the South, during the “Twelfth Five-Year Plan” period, China’s drug R&D investment has increased by nearly 20.8 billion yuan annually, and the R&D intensity reached 3% in 2015.
In 2013, two major policies will bring positive energy to new drug research and development. More direct is the reform of the drug review system. We noticed that the 2012 drug review report disclosed recently changed the stereotyped official document writing style. At the beginning, it used the voice of humanistic care and described the “reaction stop” incident. It reveals the powerful mission of new drug approval for defending health, and makes the seemingly mysterious drug review close to the public. At the end of 2012, Guangdong Province first tried, new drug technology transfer, drug production technology transfer and some inter-provincial drug commissioned production business have been technically reviewed and administratively approved in the provincial bureau. The National Drug Evaluation Center has established a pre-clinical pharmacy evaluation template for innovative drugs and an annual reporting system during research and development. The technical requirements for pharmacy are basically in line with international standards. Interpretation of relevant reforms, our "Pharmaceutical Economics" will be presented with thematic planning.
Another far-reaching impact is the national “12th Five-Year” bio-industry development plan. The 21st century is an era dominated by life sciences. China's life sciences industry has a large number of experienced technical talents and attracts the attention of venture capitalists. The Chinese government's support for the industry is also increasing year by year. It is likely that one day it will form a unique drug development route and compete with the Western model. In the past three years, the Chinese government has allocated 160 billion U.S. dollars for new hospitals and clinics, and has invested heavily in the construction of life science laboratories, biotechnology parks and incubator centers. All localities are also actively introducing incentive measures to increase the development of more than a dozen life industry parks nationwide. At the same time, the electronic medical record management system for clinical research is also being invested in research and development, and a clinical database with a wide range of sources will be created.
The new Chinese government will take the reform dividend, the vitality of innovation and the potential of domestic demand as the three major support for the upgrade of China's economy. Innovation itself needs to be activated. The classic "Scientific: The Endless Frontier" of the US National Science and Technology Policy requires the state to formulate policies to support science, emphasizes the need to guarantee the spirit of free exploration in scientific research, and maintains the necessary tension between government will and scientific freedom. . This concept seems to be being submerged in the Chinese pharmaceutical industry. Although the promotion is still very slow, the development of new drugs in China requires an optimism of “taking a snail walk”. The change began with the adjustment of the mindset of the developer.
Let R&D say goodbye to the regrettable experience
Reporter: You just mentioned the recovery of the innovation environment and the adjustment of the innovator's mentality. Then, in terms of actual operation, how to choose the positioning in the new drug research and development project? Tao Jianhong: Literature is a regrettable art. The price is a sense of hunger in reading experience. However, the regret of new drug research and development is the time cost of more than 5 years and the loss of funds of several hundred million yuan. Even if the new drug successfully passed the approval threshold, it will be listed. The security risks of heavy use are still tested, and some regrets in the early design will pay the price of life. Therefore, the development of new drugs must be perfect, which requires that every step must go beautiful.
Then, how to do a good job in market analysis of new drug research and development projects, we may wish to use the meaning of NICE in English to interpret, specifically N stands for novelty - innovation, I from lock-in - lock, C is complementarity - Complementary, and E means efficiency - efficiency. These keywords generally cover the key points of market analysis in the research and development of new drugs.
We are accustomed to understanding innovation as innovation, which is a relatively macroscopic meaning, including new ideas, new inventions and new facilities. The broad sense of innovation includes discovery, invention and creation. Human beings recognize the objectively existing things or laws in the natural world. This is a kind of discovery; using a discovered natural law or scientific principle, a creative technical solution is proposed. And what is creation? Creation refers to the activities of human beings using their brain power and physical strength to produce unprecedented material and spiritual products that people need. In contrast, Novelty is more specific and microscopic. On the one hand, it emphasizes the novelty of things. In the pharmaceutical industry, it refers to drugs with high technological innovation, such as a new class of drugs in China. On the other hand, it emphasizes the compactness and economy of things. This meaning is in line with the positioning of the nicheMarket in our new drug development.
The data show that in recent years, the number of 1.1 new chemical drugs in China has remained at around 70, and the number of new drugs in the three categories has increased by nearly 100 each year. The national policy of encouraging innovation has begun to appear in the drug declaration structure. Since 1986, nearly 40 self-developed Class 1 chemical drugs have been approved by China, with an average of 1 to 2 per year. Except for the special situation of the number increase in 2008 and 2009 due to the centralized review, the breakthrough of Class 1 new drug varieties in 2011 There were 5, while the modified varieties showed a downward trend, and the number of generic drugs was also greatly reduced. It can be seen that enterprises pay more attention to the development of new drugs. In the past, the low-level repetition phenomenon of simply changing the dosage form in exchange for new approvals has been reversed.
At the moment, some of the fastest-growing pharmaceutical companies are making the most of their existing assets, skills and core competencies, focusing on developing products or technologies, and working in a subdivided market to become an “invisible champion”. For example, more and more large pharmaceutical companies are involved in the market segment of the rare disease drug market with a small market size and higher pricing. In China, a well-received niche market is currently the development of pediatric-specific formulations. Regardless of the age level, the demand for medicines is a rigid demand. Children are the future of the country and the center of Chinese-style families. Their demand for drugs has drawn more attention from the society.
The prevalence of children is a basic indicator for measuring the size of the “buyer” market for children's drug market. Combined with the total population of China, it is estimated that the number of sick children in China will reach more than 30 million per year. About 86% of the patient population suffers from respiratory and digestive diseases, and there is a huge demand. However, among the more than 4,000 pharmaceutical factories in China, there are only more than 10 companies specializing in the production of children's drugs, and there are more than 30 companies that produce children's drugs. However, it cannot be said that such a large market has been abandoned by enterprises. In fact, many medicines in China are marked with instructions for children's medication reduction in the manual. Pediatricians in Chinese hospitals will give appropriate doses according to the age and weight of children. . However, pediatric special dosage forms and specifications are relatively lacking. At present, several professional pediatric drug manufacturers in China are also leading in the development of suitable dosage forms for children. However, children are a special type of drug use, and the clinical safety of drugs is very high. However, the relatively weak clinical research ability has always been a common problem in domestic enterprises. The clinical research on children's medication has difficulties in recruiting subjects and has high safety risks. Enterprises are often careful to enter this "niche" market because of the risk-benefit trade-offs.
Foreign countries are leading domestically in the development of suitable pediatric dosage forms. For example, the US FDA has paid special attention to the management of pediatric drugs in recent years, and has formulated a series of labeling regulations, requiring manufacturers to provide timely information on the safety of children's medications. The development of new pediatric drugs focuses on clinical safety evaluation, formulation development, and research on new indications. The FDA requires additional modifications to the drug instructions that can be used for the treatment of pediatric diseases. The policy support for children's medication has already had a good sign in the new medical reform phase. For example, in the case of childhood leukemia, the state has a medical insurance system for major illnesses, increasing the proportion of reimbursement; the introduction of anti-bacterial drug classification management has effectively curbed the problem of pediatric antibiotic abuse; the government has proposed to encourage the development of children's dosage forms for basic drugs, and the production of cheap drugs to ensure the production. supply. It should be said that the current policy is to ensure that children and patients have medical treatment, and emphasize the safe and rational use of drugs for children. In the national major new drug creation special project, the research and development of drug use for children's major diseases has also been included in the plan.
We believe that more companies will join the children's drug market in the future, and the future children's drug manufacturers will be polarized. One is the high-end drug field, which is mainly for children with rare diseases, genetic diseases, tumors, etc. Development of disease medication; one is a new drug release system research and development enterprise, mainly for children's antibacterial drugs (mainly cephalosporins, macrolides), childhood chronic diseases (asthma, diabetes), high incidence of children (cold, Development of pediatric special dosage forms for drugs such as cough and indigestion. There is also our traditional Chinese medicine. In the minds of most parents, it is safer than chemical drugs, such as Chinese herbal medicines that are clearing away heat, reducing inflammation and spleen appetite. However, the development of new Chinese medicines is lagging behind, and if it can be developed for children, it is suitable for development. The Chinese medicine type with simple method of taking it is believed to have a good market demand prospect.
Let the sun shine into the high walls of innovation
Reporter: So what needs to be locked in the R&D project? In the crowdsourced business environment, how can the concept of complementarity and cooperation be infiltrated?
Tao Jianhong: It is not difficult for us to feel that ensuring the safety and effectiveness of drugs has risen from the people's livelihood appeal to the national interest. The state of a country's drug safety has become an important indicator of the soft power of science and technology and the level of national health protection. This is the clinical superiority of drugs. Security puts higher demands on it. The key to new drug development is to develop safe and effective drugs, rather than an adventurous investment. Respecting common sense, respecting facts, and strictly observing the authenticity and accuracy of research and test data is a basic requirement. The development of new drugs leaving this point should be stopped as soon as possible, and each pill should be wrapped in the conscience of the industry.
The complementary thinking in R&D reflects the flexibility, and the image is “there is no one, no one, no one, no one, no one, no one.” True innovation is unpredictable, unplanned, and even unimaginable, so we should have different models and open opportunities, rather than just providing a single path, a single model.
In the past two years, because the original innovation is very difficult, and the me-too drug has the purpose of strong purpose, low investment, short cycle, high success rate, imitation in the creation, creation and creation, the characteristics of imitation and creation, in the current national conditions. And with competitive strength, me-too drugs will be the best choice for business innovation. For example, Hengrui's ericoxib is a mesto-innovative drug from celecoxib. It is a promising domestic “blockbuster” drug.
Chiral drugs have become a new direction in the pharmaceutical industry. According to statistics, sales of chiral drugs are growing at a rate of 6.6% per year, while racemic drugs are increasing at a rate of 29.5% per year, and more than 2,000 drugs are commonly used in China. There are more than 600 kinds of chiral drugs, but less than 100 single enantiomers are active, accounting for less than 20% of total chiral drugs, far below the global average. The 1.5 development of chiral mixed drug transformation has become the national strategy for drug development in China.
The huge research and development costs of new molecular entities have discouraged many manufacturers. The new drug has many advantages, such as the development process can eliminate the existing toxicology and pharmacokinetic evaluation, so it can greatly shorten the development time and research and development costs (about 40%), etc., so that many pharmaceutical manufacturers I am eager to try. The new use of old drugs is mainly reflected in the application of the new agent delivery system and the continuous expansion of product indications. It is typical to develop existing drugs into new pharmaceutical preparations. There are about 400 companies in the world engaged in the research and development of drug delivery systems. The new drug delivery system accounts for more than 10% of the entire pharmaceutical market. High-end new drug formulations such as sustained-release controlled-release preparations and targeted preparations are encouraged by China. One of the important areas. For example, in the future, on the market, microspheres, liposomes, and monoclonal antibodies will shine. By 2015, the world's seven major pharmaceutical markets will have more than 50 billion US dollars in anti-tumor targeted therapeutics. Up to 11%. In the field of hepatitis, the penetration of pegylated interferon injections in the future market will increase to 12%, while the interferon ordinary injections will drop to 1%.
In fact, innovation is interdependent. The future innovation of mankind may not be able to distinguish between the East and the West, China and the United States. All innovations must be between you and me.
The team that is doing new drug research and development is actually more willing to step on the shoulders of others, instead of stepping on the bodies of the predecessors. The open-ended innovative concept can make China’s future truly stand on the shoulders of the West, absorb its strengths, and make up for it. Short, go further.
Let efficiency stand on the shoulders of predecessors
Reporter: Benefits are the center of all economic activities of enterprises. The efficiency of R&D is based on the guarantee of efficiency. How to improve the efficiency of R&D?
Tao Jianhong: You only said half right.
Generic drug quality consistency evaluation work plan