Pharmaceutical companies are caught in a dilemma in developing children's drugs.

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Since the problem of less varieties of children's drugs has been concerned, the recent favorable policies in the field of children's medicine have been introduced frequently. Recently, the National Health and Family Planning Commission announced the "First List of Children's Drugs to Encourage R & D and Declaration", and released the first batch of 30 children's drugs to encourage R & D and declaration.
According to the reporter's understanding, although children's medicine is known as "one of the next gold mines" in the industry, at present, the number of enterprises producing children's medicine is small, and the varieties of children's medicine are mostly concentrated in common diseases such as colds, coughs and fevers. For pharmaceutical companies, it is a dilemma whether to deepen the existing market or respond to policy calls to develop new drugs in the field of children's medicine in the future.
policy is good
30 Children's Drugs Encouraged to Develop
According to the research report of Southwest Securities, the market size of children's drugs in China reached 68.8 billion billion last year. If we consider the part of drugs used by children by half when doctors prescribe drugs, the actual market size of children's drugs exceeds 100 billion. More than 90% of drugs in China lack children's dosage forms, so there is still a huge room for expansion in the children's drug market.
Since the liberalization of the comprehensive two-child policy this year, the industry expects that the number of children is expected to reach a 0.25 billion scale in 2020, and the children's drug market will usher in growth in the next few years. During the national "two sessions" this year, "it is difficult for children to use drugs" has aroused heated discussion among many deputies and committee members, such as "legislation on children's drugs," relaxing the policy on prescriptions for children, "and" speeding up priority examination and approval. "all put forward suggestions to relevant departments in the form of proposals.
At the beginning of this year, the National Health and Family Planning Commission issued the ''Notice on Further Strengthening the Use of Children's Drugs in Medical Instituties'', stating that children's drugs can be purchased and sold directly without bidding, thereby speeding up the rapid entry of children's drugs into the market; and the State Food and Drug Administration It provides a priority review channel for 10 children's drugs.
On June 1, the National Health and Family Planning Commission issued the "First List of Children's Drugs to Encourage R & D and Declaration" (hereinafter referred to as the "List") for children's drugs, and released the first batch of 30 children's drugs to encourage R & D and declaration. It is reported that the drugs in the list cover the treatment of common diseases of nerve, cardiovascular, endocrine, blood and other systems.
According to the explanation of the National Health and Family Planning Commission, most of these drugs have been listed abroad, but there is a lack of appropriate dosage forms and specifications for children in China. For example, clonazepam, which is used for epilepsy in children, currently has only tablets for oral preparation. The listing of oral solution will improve the compliance of children patients. Epinephrine, a commonly used emergency drug, can be used for children at a minimum of 0.01 mg/kg and is relatively safe, but there are no corresponding specifications at present. However, diazoxide for the treatment of congenital hyperinsulinemia and corticotropin for the treatment of infantile spasm are all "long term out" due to various reasons ".
In order to encourage pharmaceutical companies to focus on the research and development of the varieties in the List, the relevant departments have also formulated preferential measures, such as the establishment of special channels for application and evaluation, the establishment of major special projects, the requirement of priority use by medical institutions, and the introduction of urgently needed products can use clinical data from Hong Kong, Macao and Taiwan as reference declarations. In the view of the industry, if this series of measures are implemented, it will undoubtedly bring benefits to the development of children's medicine.
Market status of children's drugs concentrated in the field of common diseases
Although favorable policies are frequent, it may take a long time to solve the "shortage" of children's drugs on the supply side. The reporter learned from the data of the Health Industry Research Institute that among the thousands of pharmaceutical factories in China, less than 20% are involved in the production of children's drugs, of which less than 20 are specialized in the production of children's drugs, accounting for 0.1 of the total number of pharmaceutical factories, including Kangzhi Pharmaceutical, Sunflower Pharmaceutical, Dain Pharmaceutical and Wanglaoji Pharmaceutical, all of which specialize in the production or involvement of children's drugs.
In order to meet the "children's medicine" blue ocean, the relevant pharmaceutical companies have responded one after another this year. For example, on May 27 this year, Sunflower Pharmaceutical announced that it would invest 50 million yuan to set up Sunflower Pharmaceutical Group Little Sunflower Health Technology Co., Ltd. to focus on the independent operation of the children's drug market. On March 24, Kangzhi Pharmaceutical announced that it would deepen the children's drug market through its future development plan. At the beginning of March, Wang Laoji Pharmaceutical also said that it would enter children's medicine through the "three dolls" brand this year.
However, in the domestic children's drug market, the problems of single product variety and concentrated research and development fields still exist, that is, children's drugs are still concentrated in common diseases such as colds, fevers and coughs. Take sunflower pharmaceutical, which is famous for its children's drug brand "little sunflower", as an example. According to the data, the children's drugs produced by the company include cold medicine, antipyretic medicine, cough medicine and digestive medicine.
A similar situation exists in Kangzhi Pharmaceuticals, which focuses on the production of children's medicines. The company's children's medicine products are also concentrated in the fields of antipyretic, cold, diarrhea, digestion, phlegm, anti-infection and children's supplements.
For some pharmaceutical companies, children's drugs are not profitable. The reporter found from the 2015 annual report of Kangzhi Pharmaceutical that compared with 2014, its operating income last year declined to varying degrees except for children's supplement products. For example, the operating income of antipyretic products, cold products and antitussive and expectorant products, which account for a large proportion of operating income, decreased by 58.85, 27.36 and 46.07 respectively compared with last year. In terms of gross profit margin, reporters found that in addition to the cold series of products revenue increased by 4.54, antipyretic products and cough and phlegm products decreased by 0.57 and 5.46, respectively.
The reporter found in the annual report that Kangzhi Pharmaceutical's adult drug business experienced a significant increase in revenue. Although the company's adult drug gross profit margin fell by 0.80 last year compared with 2014, in terms of operating income, adult drug revenue accounted for the company's total revenue. The proportion increased from 34.73 in 2014 to 65.38 last year, an increase of 88.82 percent year-on-year. In other words, more of the company's revenue last year came from adult drugs.
Of course, there are also companies that expand in other areas of children's medicine. In the case of Dain Pharmaceuticals, the company focuses on the production, development and sales of vitamin AD supplements for infants and young children. According to the research report of Southwest Securities, the company's infant vitamin AD supplement products have occupied 60% of the market share, becoming "the most direct and biggest beneficiary after the liberalization of the two-child policy".
Experts analyze the development of new varieties of children's drugs need "disease spectrum" big data support
Although the existing policies encourage the expansion of children's medicine varieties, for enterprises, whether to continue to "deeply cultivate" existing varieties or "respond to the call" to develop new disease products into the field of children's medicine has also caused some discussion in the industry.
Those who support the "deep cultivation" of the existing market believe that colds, fever and diarrhea occur almost "100%", which is far larger than other diseases in terms of market volume. However, children's diseases such as cardiovascular and endocrine diseases are mostly caused by genetic factors, which may be found in the fetal stage with the development of genetic testing technology. In addition, rare diseases in children, due to the high difficulty coefficient and high investment cost of drug research and development, market returns may not meet expectations.
Some people believe that to open up new disease areas is actually to change the dosage form and increase the specifications on the basis of the existing listed products. Relatively speaking, the input cost is relatively low. This can not only obtain national policy support, but also enterprises are relatively more willing. A way forward.
However, some people in the industry said that whether it is to develop existing varieties or develop new varieties, the development of children's drugs is actually in a "dilemma" situation. Shi Lichen, head of Beijing Dingchen Medical Consulting Center, said that judging from the existing children's drugs, the market is actually in a saturated stage. "Although some departments have issued a document earlier this year to regulate the dosing habits of pediatricians, it has not yet worked. Under the inherent medication habits, these drugs for common diseases of children tend to face the competition from adult drugs."
Shi Lichen believes that in fact, the existing statement of "children's drug market" is a false proposition. One of the reasons is that doctors' non-standard way of "halving the habitual use of drugs for children" has not been forcibly corrected, which is equivalent to allowing the existing children's drugs to "grab the market" with adult drugs. Another reason is that the existing bidding system does not take further preferential measures for children's drugs, "If these two points are not resolved at the national level, there is no way to talk about the children's drug market".
Shi Lichen believes that it will take a long time for the policy to be implemented to encourage the development of new varieties of children's drugs, because there is no large spectrum of children's diseases in China. For manufacturers, which are the high incidence of children's diseases, which children's disease drug gap is large, need disease spectrum as a reference analysis, and comprehensive assessment of research and development costs will be invested. "Moreover, in addition to referring to the disease spectrum, the research and development cycle of new drugs for children is at least two years longer than that of ordinary drugs. This is not a simple" dose reduction "to be put into the market. It also requires clinical trials for children to evaluate and report various reactions of drugs to children before they can be put into production and sold. Therefore, it is difficult to develop new varieties of drugs for children without the support of authoritative data." Shi Lichen said.