Forever in short supply of children's medicine: high demand research and development difficult enterprises less

The two medical events in early winter opened up the long-term dilemma of children's medicine: on the one hand, the 32nd China Pharmaceutical Industry Development Summit Forum, practitioners, medical institutions warmly discuss clinical needs and broad market space, on the other hand, "78-year-old" old drug exchange venue is difficult to find children's medicine figure.
Guo Yunpei, president of the China Pharmaceutical Enterprise Management Association, said: "At present, there are more than 7,000 pharmaceutical enterprises in China, specializing in children's medicine only more than ten, the vast majority of pediatric drugs in China are adult drugs, children's drug shortage and other issues need attention." "
children in the country have been a headache. In the past, adult drugs are used to change the dose, "drug" and other ways to solve the needs of children,the final result is drug poisoning, adverse reactions and other problems frequently. To this end, the national policy to encourage research and development, clinical approval and other solutions to the shortage of drugs for children.
behind this, there are few domestic clinical trial institutions for children's medicine, higher requirements for clinical researchers, and even the vast majority of research and development institutions do not have children's drug research and development personnel, making the overall research and development capacity weak. Research and development costs are higher than ordinary drugs, but the terminal price is difficult to raise, profit margins are small, pharmaceutical manufacturers research and development of children's drugs power is insufficient.Clinical, market dual contradiction
China Pharmaceutical Enterprise Management Association children's drug professional committee chairman, Dain Pharmaceutical President Yang Jie disclosed a set of data caused a heated debate: In China's more than 170,000 registered drugs, clearly marked "children" or "children" drug information has 2,650, accounting for only 1.55% of the total proportion of registered drugs.
" the country now has a particularly small number of children's medicine is a legacy of history. Li Hanxiong, chairman of One Pinion Pharmaceuticals, told the 21st Century Economic Report, "In recent years, the country has attached great importance to the safety of children's medicines and needs to have a development process." The state is also encouraging innovative research and development, so there will be more and more companies studying children's medicines in the market and more innovative medicines introducing pediatrics. "
hospitals are most affected by the shortage of children's medicines, which also greatly increases the risk of doctors practising.
, vice president of Guangzhou Women's and Children's Medical Center, pointed out that children's gastrointestinal, liver, blood system and other physiological characteristics determine the difference between drug use and adults. In the case of the gastrointestinal tract, for example, the time of gastric emptying and pH in children, especially in newborns and infants, is different from that of adults;
" changes in the development of children at different ages have a great impact on the role of drugs and dosages, in the use of drugs can not be regarded as a reduced version of adults, children have their own unique disease type, dose range and stage of development. He said.
the reality, however, that due to the lack of specialized children's medicines, doctors can only give adult medicines to children, as appropriate, based on their age, weight, etc. Lack of dosage form specifications and dosage information, coupled with the lack of specific legal provisions for the use of medicines in children, the prevalence of paediatric "hyper-instructional drug use" has led to great medical and legal risks for paediatricians.
a huge gap, there is no such as an influx of businesses. For market practitioners, this line is called the outsider to see lively, the inside doorman.
China Investment Industry Research Center predicts that children's medicine will continue to maintain double-digit growth in the next five years, with a compound growth rate of about 10% in five years, and the size of China's children's drug market is expected to exceed 110 billion yuan by 2020. The children's drug market has also become a hot topic in investment reports, with the full liberalization of the two-child policy dividend.
" played more enthusiastically outside, we see a lot of national policies are good, but really engaged in children's medicine enterprises are not so many. Ren Wei, vice president of Yabao Pharmaceutical Group, described the market environment for children's drugs, "the same is a generic drug, if the heart and cerebrovascular can be sold to 500 million, do pediatrics can sell up to 100 million, but the cost of research and development is similar, so the market capacity is not so large."
, children's medicines are mainly concentrated in the respiratory tract, digestive tract areas, other areas include rare diseases, anti-allergy drugs. Among them, the respiratory tract refers to cold, fever, cough, the incidence rate is relatively high, the market is relatively large, but homogenization competition is very fierce, a number of manufacturers involved in a single variety.
in the whole prescription drug market, compared with diabetes, hypertension, endocrine and other drugs, children's drug market space, profit overall is relatively small. From the market point of view, in terms of tender prices, access to various provinces, cities and hospitals, the national policy does not have a specific incentive mechanism, so the advantages of children's drug manufacturers in the prescription drug market is not obvious.policy incentives, legislative vacancies,
shortage of legislation, wall-breaking research and development, accelerated approval has become the main solution. Since 2015, there have been a number of good policies in the field of children's medicines, including encouraging research and development, priority review, strengthening hospital staffing, and bidding and purchasing directly.
Even so, Li Hanxiong told reporters: "To do a common drug clinical trial project may be completed in two years, but children's medicine may take four years, many children are only children, clinical trials and promotion need more time." "
difficulty in clinical research is a problem that every children's pharmaceutical manufacturer can't get around.
, deputy secretary of the Party Committee of the Capital Paediatric Research Institute, believes that the clinical evaluation of children's drug use is lagging behind. Domestic children's drug clinical trials started late, small scale, quality control is not perfect, but also lack of children's drug clinical trial base. However, there are great differences between children's clinical drug use and evaluation and adults, and there is a lack of technical guidelines for carrying out clinical trials of children's medicine. In medical institutions, hospitals have heavy medical tasks, fewer researchers with qualifications and research experience, and low enthusiasm among doctors.
In terms of geographical distribution, Beijing and Shanghai are the regions with the largest distribution of clinical trial institutions for children's drugs, with 4 to 5 clinical trial institutions for children in Jiangsu, Guangdong, Liaoning and Zhejiang, and 2 in Hubei, Shandong, Tianjin and Yunnan. In 10 other provinces, there are no clinical trials of children's drugs.
" China's pediatric clinical drug basic research, such as pediatric clinical pharmacology research is insufficient, pediatric pharmacological research only a small number of reports, most of the clinical trial stage of new drugs often does not include children. After the listing, there is also a lack of research on pharmacology, pharmacodynamics, pharmacodynamics and so on. Yang Jian said.
of children's medicines is accelerating. According to the latest statistics of the Drug Review Center of the State Food and Drug Administration, up to now, 353 registration applications (by acceptance number) have been included in the priority review process in the list of priority review and approval of drugs, of which 40 are children's medications, and the proportion of children's drug use in priority review and approval of drugs is 11.33 percent.
, Ren Wei admitted: "The domestic drug catalog solves the problem of access, only the catalog of drugs can enter the market." But to enter the provinces will be through bidding, now according to the disease, pay by head rise, even if into the catalog, winning the bid, with the price may not be able to use or be used. "In addition, the reporter was informed that in terms of terminal pricing and procurement, provincial tenders for children's medicine landing barriers have not been broken.
policy incentives are ongoing, but children's drug legislation has not yet been implemented. In china's two most important drug laws, the Drug Administration Law of the People's Republic of China and the Measures for the Administration of Drug Registration, no special provisions are put forward for children's drug use. At the international level, however, countries such as Iceland, Norway and Austria have special provisions on the rights of children.
"We hope that incentives can be extended at the legislative level, not just at the policy level," he said. For generic drugs, some children's drug use in foreign clinical trials under the premise of effective, domestic approval needs to be further simple. Li Hanxiong said. (21st Century Economic Report)