[scene · viewpoint] he Shengjiang: Pediatrics is in the ascendant, source decision helps new development

The development of Chinese children's drug market is slow, and there are many problems such as few varieties, vague dosage and lack of specifications for a long time, which are concerned by both the industry and the state At the same time, the state has issued a series of policies to encourage and support the development of children's drug All walks of life are calling for the development of children's drug use, to ensure the safety and efficacy of children's drug use; however, there are few manufacturers focusing on research and development of children's drug use Is the appeal not enough? Insufficient support from the national government? No, why? Dr he Shengjiang, executive director of Guangzhou egger Biotechnology Co., Ltd., made a report on pediatric drug development strategies and technical points at the 2019 China Pharmaceutical Health Industry Development Conference and the fourth China Pharmaceutical R & D Innovation Summit (PDI Conference), analyzed the difficulties and coping strategies of children's drug development from the source, and answered questions and doubts What is the focus of drug development for children? Paediatrics has been established in China for a long time The classic ancient book craniofontanelle Sutra has already classified and explained it No matter in the world or in China, children are defined as anyone under the age of 18, so the problem comes The words such as "available at the age of 18", "drug for children" and "available for children" are often seen on the drug manual What stage of children can children here really use? 14-year-old children can use the medicine 2-year-old children can use it? This requires more in-depth study of enterprises, to subdivide the age stage of children's drug use, in order to better guide doctors and patients to rational drug use According to the data of National Bureau of statistics in 2019, benefiting from the influence of the two child policy, the number of children in China has now exceeded the elderly population over 65 years old In terms of pharmacoeconomics, the main users of drugs are the elderly and children at both ends According to the survey, when they are 15 to 45 years old, when they are rich, they are less likely to get sick, and the drug application market is relatively small It can be seen that the potential market of children's medication is promising In the classification of children's diseases, the main diseases are respiratory system diseases, accounting for 79%, followed by digestive system diseases, accounting for 10% Therefore, the use of drugs in respiratory system and digestive system has become the main focus of children's drug use The distribution of children's diseases is different from that of adults With two child policy in recent years, the incidence rate of new diseases, including childhood leukemia, solid tumors and other malignant tumors, has gradually increased Malignant tumors are modern diseases, and are rare diseases for new drug development There are several characteristics of children's drug market, such as few regulations, single dosage form, unable to meet the market demand According to the survey, among the more than 7000 drugs in the sample, only 7% of the drugs that children can take, more than 500 kinds, and 60% of them are Chinese patent medicines, more than 300; few chemical drugs, only 7%; in addition, there are fewer special drugs for children, only 3% It can be seen that children's drug market is calling for more drug output, but the research and development of drugs for children has stagnated Fortunately, the country has already found problems, and issued corresponding policies to support and encourage enterprises to develop children's medicine On July 30, 2011, the outline of China's children's development (2011-2020) issued by the State Council encouraged the research and development and production of children's special drugs, expanded the range of paediatric drug varieties and dosage forms in the national basic drug catalog, and improved the children's drug catalog; in 2014, the State Food and Drug Administration issued the technical guidelines for pharmacokinetic research in paediatric population, 2016 The health and Family Planning Commission released the list of the first batch of drugs for children to encourage R & D and declaration, the list of the second batch of drugs for children to encourage R & D and declaration, and other special documents on children's drug use, strengthening supervision, optimizing process and deepening support for the R & D, approval, production, procurement, pricing and use of children's special drugs, so as to ensure the effective supply and rational use of children's drugs Six departments including the family health and Family Planning Commission jointly issued several opinions on the protection of children's drug use to ease the difficulty of children's drug use; in 2018, the national basic drug catalog was adjusted to add 22 kinds of children's drug use urgently needed in clinical practice, bringing good news for children's drug use Children's medicine is a direction supported and encouraged by the state We should take active actions to study and explore At the same time, research developers need to face new challenges In many kinds of drugs, how to select the projects that meet their own needs is very important, which is directly related to the future of the enterprise How to choose a project for children's drug use? First of all, we should pay attention to the indication and applicable population in the selected varieties, and pay attention to the effective ingredients and other ingredients in the selected varieties Secondly, it is difficult for children to take medicine, most of them are bitter, too sweet, with peculiar smell and sense of sand As the second generation of R & D personnel, on the basis of ensuring safety and efficacy, we try to ensure the good taste of drugs If children are willing to take it, the Prescription Research of this kind of product is successful, not only if the technology, quality and stability are qualified At the same time, as a R & D company, it not only needs to provide a complete set of processes for enterprises, from thinking to reality to practice, but also should provide a good choice and a good direction What kind of good direction? The first is to save money, the second is to have a good market, the third is to shorten the review time limit and reduce the risk; in addition, it is necessary to increase the indications and expand the scope of application, such as: the United States of America's haloperidol to expand the scope of application for children aged 13-17 years; with this application, it is possible to go on the green channel and pass the review and approval quickly There are several directions to increase indications: first, direct revision based on no problem of safety and effectiveness; second, direct revision based on further demonstration and analysis of the real events of evidence-based medicine, providing clinical data and clinical instructions; third, appropriate supplement of clinical experiments to ensure safety and effectiveness, which can also be revised In addition, prescription concerns are also a major focus The main concerns of the prescription are whether there is peculiar smell, the limit standard of microorganism, the control of excipients, and the limit of heavy metal content Prescriptions focus on how to choose children's drugs, what dosage form to choose, what excipients to use, and what technology to use at last, which are all decided by the whole process rather than by brain tapping It needs decision-making and risk assessment to ensure that children's drug choice will not go astray from the beginning Egger biotechnology has several breakthrough key technologies, including oral salt taste technology, liquid slow release technology, taste evaluation system, bitterness evaluation and irritant evaluation technology It is committed to providing a standardized scientific platform, providing development direction for pharmaceutical enterprises, making overall development route, helping pharmaceutical enterprises to make correct decisions and reduce risks Seek the development of children's medicine Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.