On February 26, 2013, the State Food and Drug Administration (CFDA) issued the “Opinions on Deepening the Innovation of Drug Review, Approval, and Reform to Further Encourage Innovation,” and focused on proposing incentive measures for children's drug research and development. Encourage drug R&D companies to actively develop generic specifications and dosage forms for generic drugs. In June 2014, the six ministries and commissions announced the “Several Opinions on Safeguarding Children's Drug Use”, which brings positive benefits for children's drug use review and corporate research and development. At the same time, the CFDA Drug Review Center has issued the “Technical Guiding Principles for Pharmacokinetics in Pediatric Populations”, which will help to fully understand the characteristics of children's medications and provide a basis for clinical development of rational drug use plans. It will have children's drug development and production. The guiding significance further ensures the rationality, safety, effectiveness, and economy of children's medication.

Older people and children are vulnerable groups and are a group with a high prevalence. They must arouse the attention of the whole society. The data released by China’s sixth national census in 2010 showed that the population under 14 years of age in China was 224.46 million people, which accounted for 16.60% of the total population in China. Compared with the fifth national population census, the share of children decreased by 6.29%. However, under the promotion of the national policy of the second child and the fertility policies of the ethnic minorities, authoritative data show that in 2015, Chinese children accounted for 22.89% of the total population of the country. However, children's drugs accounted for only 3% of the country's total pharmaceutical market. %, only 4.1% of children in special metropolitan metropolitan areas use drugs.

According to the data from the CFDA, of the 3,500 kinds of chemical preparations in China, less than 60 are for children, and 90% of medicines do not have children's dosage forms. According to data from a joint survey conducted by the State Administration of Food and Drug Administration and relevant departments on child safety drug use, the proportion of unreasonable drug use in children in China is as high as 12% to 32%, and the incidence of adverse drug reactions in children is approximately 12.9%, which is approximately twice that of adults. . Multi-channel information shows that the current public is not satisfied with the safety of children's drug use, and there is still room for improvement. The children's drug market has a huge potential, but due to factors such as children's drug production and high research and development costs, the healthy development of children's drug use in China still needs more supporting support.

In the past 10 years, with the Chinese government’s full attention to children's health care work, the structure of drug products for adolescents and children has developed rapidly, and sales in the children's drug market have moved forward. This is inseparable from the appeals of experts and scholars and the development of pharmaceutical products for children. It objectively promotes the steady development of the children's drug market.

Demand market innovation

In the pharmaceutical market, drugs for teenagers and children have a special status. Children are in the period of growth and development, and their ability to resist diseases is weak. It is one of the most vulnerable groups. Data show that among the most common diseases in children are the respiratory system, digestive system and infectious diseases. The proportion of drugs used accounts for 88% of the total market for children's medication. The data shows that in the past two years, the sales of children's medicines in China will continue to grow at an average annual rate of more than double digits. In 2014, the sales volume of medicines that indicated that the use of drugs for children in restricted medicines reached 56 billion yuan. It will reach more than 670 billion yuan, a year-on-year growth rate of about 19.64%.

In children's medication in our country, the systemic use of anti-infective drugs is high. Over the years, it accounts for about 80% of the overall market for children's drug use; after the “Administrative Measures for the Clinical Application of Antibacterial Drugs” is fully implemented, the phenomenon of indiscriminate use of antibiotics will be regulated. With the awareness of rational use of antibiotics by doctors and children’s parents, the children’s drug market will increase. The proportion of antibiotics has been declining year by year. With the overall recovery of the antibiotic market, children's antibiotic use has also increased from the previous year.

In recent years, with the demand of the market, dosage forms suitable for special requirements such as children's taste, odor, and shape have been further developed. Children antibiotic granules, dry suspensions, suspensions, effervescent tablets, dispersible tablets The introduction of chewable tablets has improved the safety, reliability and compliance of children's medications.

The main manufacturer of antibiotics for children

With the changes in the structure of drug use in hospitals in China, it has gradually been brought into line with international standards. The structure of the main varieties of antibiotics for children has also taken place and is undergoing changes. This is mainly in the treatment of children's respiratory diseases and clinical infectious diseases. Antibiotics still occupy an important position.

At present, special antibiotics for children's clinical use are mainly oral preparations, in which granules, dry suspensions, suspensions, effervescent tablets, dispersible tablets, chewable tablets occupy a larger proportion. The main categories are semi-synthetic penicillin and compound preparations, first-generation, second-generation and third-generation cephalosporin preparations, macrolide antibiotics and erythromycin derivatives. According to statistics, there are 20 varieties of children's formulations of the three types of drugs approved by the CFDA, and a total of 600 production approvals. Granules accounted for 46%, dispersible tablets occupied 29%, dry suspensions accounted for 17%, while children's antibiotics accounted for a smaller proportion of other forms.

Although specialized children's drug manufacturers are still rare among more than 4,000 pharmaceutical manufacturers in China. However, there are more than 320 special antibiotics for children alone. The main domestic pharmaceutical drug manufacturers for children are mainly North China Pharmaceuticals, Shijiazhuang Four Drugs, Shenzhen Zhijun Pharmaceutical, Jiangsu Jichuan Pharmaceutical, Guangzhou Baiyunshan, Shandong Zibo Xinda, Xiansheng Pharmaceutical, Hainan Kangzhi Pharmaceutical Co., Ltd., Sun Stone (Tangshan ) Pharmaceuticals, Beijing First Children's Pharmaceutical Factory, Harbin Pharmaceutical Group Sanjing Children's Pharmacy, Modified Pharmaceutical Group Children's Pharmaceuticals, Harbin Children's Pharmaceutical Factory, Tianjin Children's Pharmaceutical Factory, Shiyao Group Ouyi Pharmaceutical, Shandong Lukang Pharmaceutical , Shenwei Pharmaceutical, Wuhan Jianmin, Yangzijiang Pharmaceutical Group Nanjing Soong Ching Ling Fund Children's Pharmaceuticals, etc. In addition there are foreign-funded/joint ventures Sino-US Shanghai Shiguibao, Shanghai Johnson & Johnson Pharmaceuticals, Lilly, Pfizer, Beijing Hanmei Pharmaceuticals, and Guangzhou Nanxin Pharmaceuticals.

Oral cephalosporins for children

At present, there are more anti-infective drugs used clinically, of which cephalosporins occupy an important position. Statistics show that there are nearly 40 varieties of cephalosporins used in clinical practice in China from the first to the fourth generation, and there are 8 compound preparations. Children's drugs are mainly oral preparations, commonly used drugs such as cefaclor, cefixime, cefdinir, cefprozil, cefpodoxime, ceftazidime, cephalexin, cefadroxil, cefadroxil Pyridine and so on.

For the cephalosporin and compound cephalosporin medicine market, the data showed that the amount of cephalosporin drugs used in public hospitals in major cities in China was 7.164 billion yuan in 2014, an increase of 7.26% over the previous year, of which injection drugs accounted for 84.55%, orally. The preparation accounted for 15.45%. The top five oral cephalosporin preparations were cefuroxime, cefoperazone sulbactam, cefoperazone tazobactam, cefotiam, and cefathiamidine. 2014 China's chemical and pharmaceutical industry, children's antibiotics outstanding product brand is Shenzhen Zhijun Pharmaceutical's cefixime granules (trade name duolifen), Shijiazhuang four drugs cefaclor dry suspension (brand name Shimen).

Analysis of data from public hospitals shows that oral cephalosporin preparations that are suitable for children account for about 30% of oral cephalosporin preparations, which is about 500 million yuan, and after amplification, they will reach a market size of several billion yuan. The use of cephalosporin drugs suitable for children, the drug use instructions are more cautious, the majority of anti-infective drugs for premature infants with low birth weight, the safety of newborns has not been established, especially in infants less than 6 months related safety Few data on sexuality and efficacy.

Semi-synthetic penicillin drugs for children

Semi-synthetic penicillin and compound drugs used in children also occupy an important position. Mainly amoxicillin dry suspension (granule), amoxicillin clavulanic acid, piperacillin sodium tazobactam sodium, ampicillin, amoxycillin, carbenicillin, mezlocillin and so on.

Penicillin drugs have minimal toxicity, and generally have no toxicity except for minor gastrointestinal symptoms. In particular, piperacillin sodium and tazobactam sodium for injection is a commonly used β-lactam compound preparation for clinical use. Piperacillin is a semi-synthetic broad-spectrum penicillin and has the advantages of wide antibacterial spectrum, good tissue permeability, and strong effects. The β-lactamase inhibitor tazobactam is a derivative of triazole ring added to the structure of sulbactam, and its inhibitory enzyme strength, zymogram, and enzyme stability are stronger than that of clavulanic acid and Shu. Bataan.

Among penicillin antibiotics, piperacillin and tazobactam are the most suitable combinations, which can maximize the advantages of both, and are used clinically for moderate and severe infections, especially for enzyme-producing gram-negative bacilli, including The efficacy of Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae is outstanding.

In 2010, the strong Lintan of North China Pharmaceutical Co., Ltd. obtained an approval number of 0.625g. The small-size dose is more suitable for children's applications. In the instructions, there is a clear usage and dosage of children. The use of children is also safe and effective, providing more choices for children in clinical medicine.

The data shows that the amount of semi-synthetic penicillin and compound drug used in public hospitals in major cities in China in 2014 was 2.073 billion yuan, an increase of 11.84% over the previous year. It has already bottomed out from the decline in 2013, and its growth is mainly driven by compound half. Synthetic penicillin drugs.

So far, the gap between the domestic market for children's specialty drugs and rigid demand is still relatively large, and child-specific drug formulations still show deficiencies. On the one hand, children's drug dosage is relatively small, prescription design, production process is relatively complex, the production cycle is long, the requirements for the dosage form are higher, the need to develop oral tablets, chewable tablets and other dosage forms, the requirements for accessories are also high, there are some accessories It cannot be used at all for children. However, children’s taste needs are adjusted in particular. The cost of pharmaceutical production is high, and the low efficiency of operators is still the main source. On the other hand, the progress rate of children’s drug clinical trials is sluggish. According to the current GCP requirements in China, children are used as drug research subjects. The person must obtain the informed consent of his legal guardian and sign the informed consent form. When the child can make a decision, he must also obtain his/her own consent. At the present stage, the ethical requirements for children in clinical trials are getting higher and higher, and the standardized test requirements are becoming stricter, which has led to an increase in the difficulty of children's drug clinical trials.