Drug companies to develop children's medicine in dilemma

July 1, 2016 source: m Intranet

Since children after attention drug varieties less problem, recent children's good policy has been introduced in the field of medicine. Recently, the national health development planning commission published to the list of the first encourage r&d to declare the children's medicine, released the first batch of 30 kinds of encourage research and development of the children's medicine to declare.

According to reporter understanding, although children drug in the industry known as "one of the next gold mine", but at present, the production of children's medicine enterprise quantity less, and the variety of children's medicine more concentrated in the cold, cough, fever and other common diseases. For drug companies, the future in the field of children's medicine is the deepening existing markets or response policy called for the development of new drugs, it is a dilemma.

The policy of good

30 children's medicine are encouraged to research and development

Last year, according to southwest securities research report, China has reached 68.8 billion children's drugs market scale, if considering the doctor prescribe medicines in half for children to use part of the actual size of the market more than billions of children's medicine. By more than 90% of drug lack children dosage forms in our country, so the children's medicine market is huge expansion space.

Since this year two child policy let go after comprehensively, the industry is expected to scale of children's number is expected to reach 250 million in 2020, children's medicine market will usher in the next few years. Medicine for children during the NPC and CPPCC this year, the "hard" has caused the number of representatives, such as "children's medicine legislation", "easing children medicine prescription policy" and "priority to speed up the approval" and so on are proposed in the form of recommendations to relevant department.

Earlier this year, the national health development planning commission issued "on further strengthening the medicine for children with medical institutions use work notice, points out that children's medicine without bidding concentrated net purchase direct sales, so as to accelerate children's medicine quickly enter the market sales; And the state administration of food drug safety is for 10 types of children's priority review.

On June 1st, the national health development planning commission for children medicine released the first batch to encourage r&d declare children drug list "(hereinafter referred to as the" listing "), released the first batch of 30 kinds of encourage research and development of the children's medicine to declare. It is understood that the list of drugs in the treatment of nervous, cardiovascular, endocrine, blood, and other system of common diseases.

Explain according to national health development planning commission aspect, most of these drugs have been listed abroad, but domestic children lack appropriate types and specifications. Used in pediatric epilepsy clonazepam, for example, at present only tablet, oral preparations of oral solution of listing will improve the compliance of patients take children; Common first-aid drug epinephrine, children dosage minimum can be up to 0.01 mg/kg and relatively safe, but so far no corresponding specifications; And treatment of congenital hyperinsulinemia diazoxide, treatment of infantile spasms corticotrophin are due to various reasons such as "out of stock for a long time.

To encourage drug companies to focus on research and development in "listing" varieties, related department has formulated the preferential measures, such as establishing declare review dedicated channels, set up the special priority of medical institutions, required to use and the introduction of urgently needed products can be used clinical data as a reference to declare Hong Kong, Macao and Taiwan regions, etc. In the industry point of view, this a series of measures, if fall to the ground, there is no doubt that drug development is good for children.

The market status of the children's medicine focus in the field of common diseases

Although good policy, but to solve the children's medicine on the supply side "shortage" may require a long period of time. The reporter understands from the institute of health industry data, thousands of pharmaceutical companies in the country, involving the production of children's medicine manufacturer is less than 20%, with less than 20 specialized manufacturer of children's drugs, 0.1% of the total number of companies, including such as Kang Zhi pharmaceutical, sunflower pharmaceutical, dyne pharmaceutical and wang ji pharmaceutical industry, etc., are specializing in the production of or involving children.

For the "children" blue ocean, related drug firms have to cope with this year. Announced on May 27, for example, sunflower pharmaceutical will invest 50 million yuan to set up small sunflower sunflower pharmaceutical group healthy technology co., LTD., focusing on children's drug market to operate independently. But on March 24th, Kang Zhi pharmaceutical announced by the future development plan, cultivates children's medicine market. In early march, wang ji pharmaceutical industry also said that this year will be sent to you by "three dolls" brand into the children's medicine in an all-round way.

But at present in domestic children's medicine market, single product variety and research focus in the field of problems still exist, namely children medicine still concentrated in the cold, fever and cough, and other areas of the common diseases. Known for their children's medicine brand "little sunflower" sunflower pharmaceutical industry as an example, according to the company production of children's medicine including cold, fever, cough, digestion, etc.

Similar situation also exists in the focus in the production of children's medicine Kang Zhi pharmaceutical industry, the company is also focused on children's drug products, cold fever, diarrhea, digestion, phlegm, anti-infection and children's supplements, etc.

For some drug companies, children's profit is not high. Reporter from Kang Zhi pharmaceutical industry's annual report in 2015 found that its operating income last year compared with 2014, in addition to the children's supplements are different degree of decline, such as business income accounted for larger antifebrile series products, series products of cold and cough phlegm series products, operating income compared with last year fell 58.85%, 58.85% and 46.07% respectively; And on the gross profit margin, reporters found that in addition to a cold series product sales increased by 4.54%, antifebrile series products and reduce phlegm series products fell 0.57% and 0.57% respectively.

Reporter in the annual report found that adult Kang Zhi pharmaceutical drug revenue is a substantial increase in business and although adult medicine gross margin last year, the company 0.80% lower than in 2014, but in terms of revenue, adult medicine company revenue proportion of the revenue from the 34.73% growth in 2014 to 65.38% last year, rose 88.82%. In other words the company's revenues last year more is from the adult medicine.

Of course, there are companies for children medicine to expand in other fields. Dyne pharmaceutical industry, for example, the company focused on infant vitamin supplements AD production, research and development and sales. According to southwest securities research report, according to the company of infant vitamin AD supplements products have occupied 60% market share, become the "two child policy direct after let go of the biggest beneficiaries".

New products children medicine expert analysis need support "disease" big data

Although existing policies to encourage children's drug varieties, but for the enterprise, into the children's medicine field is continuous "deep" existing varieties, or "calls" develop new disease to plant product, it also caused some discussion in the industry.

Support the "deep," thinks the existing market, the common cold, fever and diarrhea is almost a "one hundred percent", in terms of market size is far greater than other diseases; Such as cardiovascular, endocrine, such as children's disease is caused by genetic factors, more likely found in fetal stages with the gene detection technology development; Drugs for rare diseases like other children, because the difficulty coefficient and high input costs, market returns may not meet expectations.

It is thought that to develop new areas of disease is, in fact, on the basis of existing products change types increase specifications, relatively low cost, it can not only access to the national policy support, but also relatively willing to go into a road.

However, there is the personage inside course of study says, both development existing varieties and develop new varieties, children's medicine development actually into the "dilemma" situation. The Beijing Shi Lichen minister medical consultation center chief, said children with existing product, the market is actually a saturation stage. "Although there are departments have post earlier this year to regulate drug habit of pediatrician, but has not yet play a role. Under the inherent custom, these drugs tend to be face to face with the adult children's common diseases medicine competition."

Shi Lichen think, in fact, the existing "children's drug market" statement is a false proposition, one reason is that a doctor "habitual half of children's drugs" is not standard way has not been forced to correct, that equals to the existing product with adult children medicine go to "seize the market"; And another reason is that existing bidding system is not for children's medicine further preferential measures, "if not handled through the national level, these two children's medicine market is impossible".

Policy to encourage the development of children's medicine varieties, Shi Lichen think be born to a long time, the reason is that at present our country does not have a large ariations of children. For manufacturing enterprise, which is a high incidence of disease in children, which children disease drug gap is big, ariations needs to be used as a reference analysis, and comprehensive evaluation research and development costs to invest. "And research and development in addition to the reference disease, like children's new drug research and development cycle is longer than ordinary drugs at least two years, this is not a simple 'reduce dose can be cast out of the market, also need for clinical trials in children, to assess and report on children's various drug reaction, can be put into production and sales, so there is no authoritative data support, develop children's medicine varieties is difficult." Shi Lichen said.