"In order to encourage the development, production and use of children's drugs, the National Development and Reform Commission will study and adjust the price management methods for children's drugs." A few days ago, the three sessions of the second session of the National Chamber of Commerce and Industry for Pharmaceutical Industry sent news that the state will increase financial support. Priority will be given to the inclusion of child-specific drugs into the country's major new drug creation plan to enhance the independent innovation capability of the children's pharmaceutical industry.
Children's drug market demand big data show that China has about 300 million children, as a special group of drug consumption, with a market potential of nearly 50 billion yuan. According to the forecast of the Southern Food and Economic Research Institute of the State Food and Drug Administration, in 2015, the children's drug market reached 66.9 billion yuan. Taking fevers and fevers as an example, the average annual incidence of children aged 0 to 12 years is 3.72 times. According to the calculation of five days per illness, taking 3 packets per day, you need to have 20.48 billion bags of cold granules.
However, the current development in this area is not optimistic, and children's medicines are very scarce. There are few companies that have little local children's drug brands and produce children's drugs. In addition, in the children's drug and vaccine market, more than 90% of the market share was occupied by several multinational pharmaceutical companies such as Wyeth, Roche, Squibb, Johnson & Johnson, and Sanofi-Aventis. According to the reporter's understanding, many pharmaceutical companies currently produce adult drugs, and most children's medicines are produced by pharmaceutical companies with a small amount of production. Due to children's drug production performance as small batches, batches, the process is relatively complex, high production costs, new drug development cycle longer, lower profits, more than 6,000 pharmaceutical companies, there are few professional manufacturers of children's drug use.
What is even more worrying is that statistics show that 90% of the drugs in the domestic market have no children's dosage forms. Pediatricians rely on experience to accumulate drugs and have great safety risks. “From the perspective of the current pharmaceutical market, the Chinese children's drug market has grown rapidly and has great potential. The space for import substitution is also very large. It is worth relating to the entry and production of relevant small and medium-sized pharmaceutical companies.†Zhong Hanping, senior analyst at Hejun Group, told International Finance News The reporter said.
Promoting Development Needs Policy Support It is understood that there are currently 29 medical units in the country that are qualified to do children's drug trials, and specific to each pediatric specialty, there are very few drugs. Taking respiratory medicine as an example, only a few medical institutions in Shanghai, Shenyang, Wuxi, and Wenzhou have participated in the trial. There are a wide range of respiratory diseases among children, and the rate of drug replacement and elimination is excessively fast.
"Developers and manufacturing companies may invest huge amounts of money and energy, but may not receive corresponding returns. This is the main reason for the long-term lack of children's medicine." An unnamed drug person to the "International Finance" The reporter stated that in the research and development of children's medicines, the government must clearly specify the relevant policy subsidies. After the children's medicines independently developed by the company have been clinically tested and can be brought to market, they will be granted tax relief and development for pharmaceutical production enterprises. Innovative drug companies and companies have an extended period of intellectual property protection.
According to the reporter's understanding, in order to encourage the development, production, and use of children's drugs, the National Development and Reform Commission will consider exploring management methods that are conducive to the operators’ ability to independently determine prices according to market competition and play a role in the market competition mechanism, and improve the pricing methods for children's medications; Regarding the dosage form specifications for children who use drugs explicitly, while insisting on pricing based on cost, it will appropriately relax the restrictions on the expenses rate of the period, the profit rate of sales, and the price difference rate of circulation.
In addition, regarding the National Food and Drug Administration, it is currently stepping up its efforts to speed up the review of children's drug registration applications, studying policies for the establishment of children's drugs for the exclusive period of the drug market, and actively cooperating with departments such as drug pricing and bidding and procurement to research and formulate corresponding support and Guide policies to encourage pharmaceutical companies to research and develop drugs that are suitable for children.
Children's drug market demand big data show that China has about 300 million children, as a special group of drug consumption, with a market potential of nearly 50 billion yuan. According to the forecast of the Southern Food and Economic Research Institute of the State Food and Drug Administration, in 2015, the children's drug market reached 66.9 billion yuan. Taking fevers and fevers as an example, the average annual incidence of children aged 0 to 12 years is 3.72 times. According to the calculation of five days per illness, taking 3 packets per day, you need to have 20.48 billion bags of cold granules.
However, the current development in this area is not optimistic, and children's medicines are very scarce. There are few companies that have little local children's drug brands and produce children's drugs. In addition, in the children's drug and vaccine market, more than 90% of the market share was occupied by several multinational pharmaceutical companies such as Wyeth, Roche, Squibb, Johnson & Johnson, and Sanofi-Aventis. According to the reporter's understanding, many pharmaceutical companies currently produce adult drugs, and most children's medicines are produced by pharmaceutical companies with a small amount of production. Due to children's drug production performance as small batches, batches, the process is relatively complex, high production costs, new drug development cycle longer, lower profits, more than 6,000 pharmaceutical companies, there are few professional manufacturers of children's drug use.
What is even more worrying is that statistics show that 90% of the drugs in the domestic market have no children's dosage forms. Pediatricians rely on experience to accumulate drugs and have great safety risks. “From the perspective of the current pharmaceutical market, the Chinese children's drug market has grown rapidly and has great potential. The space for import substitution is also very large. It is worth relating to the entry and production of relevant small and medium-sized pharmaceutical companies.†Zhong Hanping, senior analyst at Hejun Group, told International Finance News The reporter said.
Promoting Development Needs Policy Support It is understood that there are currently 29 medical units in the country that are qualified to do children's drug trials, and specific to each pediatric specialty, there are very few drugs. Taking respiratory medicine as an example, only a few medical institutions in Shanghai, Shenyang, Wuxi, and Wenzhou have participated in the trial. There are a wide range of respiratory diseases among children, and the rate of drug replacement and elimination is excessively fast.
"Developers and manufacturing companies may invest huge amounts of money and energy, but may not receive corresponding returns. This is the main reason for the long-term lack of children's medicine." An unnamed drug person to the "International Finance" The reporter stated that in the research and development of children's medicines, the government must clearly specify the relevant policy subsidies. After the children's medicines independently developed by the company have been clinically tested and can be brought to market, they will be granted tax relief and development for pharmaceutical production enterprises. Innovative drug companies and companies have an extended period of intellectual property protection.
According to the reporter's understanding, in order to encourage the development, production, and use of children's drugs, the National Development and Reform Commission will consider exploring management methods that are conducive to the operators’ ability to independently determine prices according to market competition and play a role in the market competition mechanism, and improve the pricing methods for children's medications; Regarding the dosage form specifications for children who use drugs explicitly, while insisting on pricing based on cost, it will appropriately relax the restrictions on the expenses rate of the period, the profit rate of sales, and the price difference rate of circulation.
In addition, regarding the National Food and Drug Administration, it is currently stepping up its efforts to speed up the review of children's drug registration applications, studying policies for the establishment of children's drugs for the exclusive period of the drug market, and actively cooperating with departments such as drug pricing and bidding and procurement to research and formulate corresponding support and Guide policies to encourage pharmaceutical companies to research and develop drugs that are suitable for children.
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