In the first half of 2022, 12 medicines for children were approved!

On November 15, 2021, the Department of Drug Administration of the National Health Commission publicly solicited opinions on the "Selection and Adjustment of the National Essential Drug List"; the Children's Drug List was proposed for the first time (see Figure

Can children's medication find a way out for the development of pharmaceutical companies and become a heavy blow to break the cold winter of medicine?

Figure 1 Public consultation on the "Administrative Measures for the National Essential Medicines List (Revised Draft)"

Source: National Health Commission

Pediatric use refers to a class of drugs intended for use in children under the age of 1 Since the functions of the liver, kidneys, and nerves in children are not yet fully developed, there are differences in pharmacokinetics and pharmacodynamics between children and adults, and there are special requirements for the dosage, safety and taste of dru.

According to statistics from the seventh national census in 2021, the existing population of children in China is 2538 million, accounting for 195% of the country's total populati.

In order to solve this problem, the state encourages pharmaceutical companies to increase the research and development and production of children's medicines, and has successively issued a series of polici.

Table 1 In recent years, the state has issued policies related to children's drug use

Source: Collation of public information

With the strong support of the state, the research and development of children's medicines has shown a steady development trend in recent yea.

In the first half of 2022, among the new drugs approved in China, a total of 12 drugs can be used for the treatment of children's diseases, involving different fields of children's diseas.

Table 2 New medicines for children approved in China in the first half of 2022

Source: Collation of public information

       Among the 12 new drugs approved in the first half of 2022, 7 are new dosage forms/specifications; they are mainly developed for children with poor compliance and differences in dosage from adul.

       Lidocaine hydrochloride powder needle-free percutaneous injection delivery system is an improved product specially made for pediatric patients with fear of needl.

       Not only drugs for disease treatment, but also drugs for disease diagnosis are approv.

       Cyproheptadine Hydrochloride Oral Liquid and Rivaroxaban Dry Suspension are working hard to improve the taste, improve the compliance of patients, and ensure accurate dosage for childr.

       Medium and long chain fat emulsion/amino acid (16)/glucose (36%) injection is a small-scale nutritional supplement for patients aged 2 years and above with moderate to severe cataboli.

       This also provides many inspirations for the research and development of enterpris.

       If a company has advantages in the research and development of a certain formulation, such as a research and development platform for oral dissolving films, transdermal patches or sustained and controlled release formulations, it can fully utilize its own advantages to develop improved new medicines for childr.

       Of course, China's current children's drug market still has problems such as difficult research and development technology, high safety requirements, difficult clinical trials, and small profit margins, causing many companies to stay aw.

       The review and approval mechanism for children's drug use has been continuously optimized, and the priority review and approval policy is not only a paper document, but also earnestly implement.

       The research and development of children's medicines is a challenge and an opportunity, which may lead the company to the spri.