Medical network on July 20 - July 11, total bureau of national food and drug supervision and administration of drug approval center (CDE) issued 21 group of quasi priority list of drugs for examination and approval procedures for drug registration, nearly half of them were children. The reporter noted that in recent years, various ministries and commissions have introduced a number of major policies to encourage the development and production of children's medicines, including priority approval, health care directory, and encouraging research and development lists... A fire has been added to the "cold kitchen" for children's medicine, but most drug companies remain on the sidelines. The analysis indicates that "high r&d investment and low gross margin" is the main cause of drug companies' reluctance to invest in children's medicines.
A, the policy frequency of children's medicine opens A new round of space
According to the data, there are more than 60 kinds of conventional medicines in China, accounting for 1.7 percent of the total number of children, and the lack of children's medicines can be seen. To speed up the development of new drugs and urgently needed generic drugs, CDE has decided to give priority to drugs with obvious clinical advantages, and children's medicines are one of them.
According to the statistics, 14 children have been given priority approval since 2017, accounting for about 13 percent. In addition to preferential treatment, the state has introduced policies to support the development of children's medicines. In 2017, the new edition of the health care catalog added 91 children's medicines, opening a new round of development for children's medicines. In may this year, the health development planning commission issued a "the second batch of encourage research and development for the children's medicine suggested list", after last year's first 32 drugs, and there are 40 children were encouraged to research and development of production. Policy has given a fire to the "cold kitchen" of children's medicine.
B. The market's huge children's medicine is expected to be blue
The children's drug industry is expected to be blue. According to statistics, there are about 220 million children in the country, and one million to two million new babies will be born every year under the "two children". The market for children's medicines is huge.
Cinda securities, medical researchers cherish li huan, points out that in 2015, domestic children's drugs (limited instructions indicate the children use the usage and dosage of the drug) the size of the market has reached 68.8 billion yuan, is expected to future sales scale will also maintain double-digit growth. Ministries issued a number of major policy in recent years to encourage children's medicine research and development and production, as rising demand and policy implementation, professional children's medicine production enterprises will usher in the golden period of development.
Under the good policy, a number of enterprises have begun to dabble in or increase the distribution of children's drug market. In 2015, the company announced its entry into the field of children's health. Wang laoji has announced a comprehensive expansion into the children's drug market in 2016. In June 2016, sunflower pharmaceutical co., LTD., which is the main business, established a subsidiary to focus on the independent operation of children's drug market.
C, the Maori low drug companies are still waiting to see
Policy positive, with broad market prospect, children's medicine production can get blowout?
Yangcheng evening news reporter found, who the first batch of development planning commission to encourage research and development of 32 height in medicine, in addition to sodium bicarbonate injection in 2016 after manufacturer to apply for the supplement, the rest of the 31 were no new application for registration of products since 2016. In the second list of drugs, some of the hot chemicals are declared by the manufacturers, but they are not the cold ones that are encouraged on the list.
Industry insiders point out that only 25 per cent of those who are expected to be in the industrialization process are expected to be encouraged to make a list of children's medicines. This reflects on the side that, while pediatric products are supported by policy, few are actually willing to invest.
"Big r&d investment and low gross margin" are the main reasons why many drug companies are reluctant to invest. Kang Zhi pharmaceutical industry, for example, medicine Kang Zhi pharmaceutical is A shares listed companies only A main children's medicine production and sales of enterprises, in recent years, the level of the r&d is in ten million yuan every year, but many children medicine decline in gross margin. According to its 2016 annual report, the gross profit of children's diarrhoea and digestive system was just 16%, down 41.96%. The overall gross profit rate for children's medicines is only 30%, and the overall rate is down 20%, while adult drugs, while not half as much as children's drugs, have a gross margin of 60%.
In its annual report, the company noted that "the development and development of new drugs for children or special technology development investment is large, long and risky."
The market for children's medicine, how to solve the problem
Policy is positive, why is the drug enterprise still insufficient? In an interview with reporters, shi lichen, head of dingchen medical management consulting center, pointed out that it is important for parents to change their medication habits to fundamentally stimulate the outbreak of children's drugs.
"Half the pill and half the dose" has long been the norm for the lack of specialized medicines for children to reduce the amount of adult medicine to their children. For many drug companies, it is not advantageous to compete with adult drugs when they invest a lot of resources to build specialized children's medicines and put them into the market. Despite the great gap in children's medicine market, the future looks very good, but most of the drug companies, the market demand for son dose of postpartum "in the mind is not at the end of", plus the gross profit margin is not high, we can't easily.
"The adverse reactions and adverse effects caused by misuse of adult drugs cannot be ignored for children who have not developed well." Shi pointed out that it is necessary to develop children's medicines from a security perspective. "You can start from the hospital and ask your doctor to prescribe special medicines for children under the precondition of being able to choose. In addition, you should strengthen the promotion of education to the family and strengthen the awareness of drug safety." "Said shi.
Another hurdle for research is clinical trials. Wang ji pharmaceutical rong-bo zheng, deputy general manager in an interview with the yangcheng evening news reporter said: "some infant drug clinical trials, to start from the pregnant women, 67 for a long time, most parents are not willing to let the child to do." According to the disclosure, since the clinical data could not be collected, wang laoji gave up the drug development of the children's medicine.
Unless a child is rare or critically ill in need of new drugs, it is difficult to obtain informed consent from a parent or guardian in order to participate in clinical trials.
The cost is big, the clinical is difficult to push forward, the development of children's new drug is difficult. Many drug companies remain on the sidelines, and there is little prospect of a major outbreak of children in the short term. |
