The 70 billion children's medicine market was ignited, and Hengrui and Kangyuan kept rising!

Recently, the "Administrative Measures for the National Essential Drug List (Revised Draft)" is open for comments.
Compared with the current 2018 edition of the Essential Medicine List, pediatric medicines are presented as a sub-category of the catalog of chemical drugs and biological products and the list of Chinese medicines.
The catalog adjustment is the first time that a children's drug catalog is proposed, and the children's drug market will usher in major benefits
.

22 children's medicines have been included in the basic medicine catalog: Kangyuan breaks through 500 million, Hengrui grows against the trend, and the market is sinking.

Table 1: The situation of children's medicines in the list of essential medicines of the 2018 edition

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

Note: * is a newly-added product, and the sales volume is less than 100 million yuan, replaced by #

Figure 1: The subcategories involved in 22 children's medicines

The 2018 edition of the basic medicine catalog involves 22 children’s medicines, and 5 chemical medicines are distributed in 4 sub-categories.
Except for children’s compound amino acid injection (18AA-I), 4 new products are distributed in psychostimulants, other respiratory preparations, Anti-tumor drugs, blood substitutes and perfusion fluids in 4 areas
.

The 17 proprietary Chinese medicines are distributed in 4 subcategories.
The new products are mainly concentrated in pediatric cold medicines accounting for 6 (3 new ones), pediatric antitussive and expectorant drugs accounting for 6 (4 new ones), and pediatric antitussive and antiseptic drugs.
The 4 products of sputum medicine and 1 pediatric antidiarrheal medicine are all varieties of the original 2012 edition of the basic medicine catalog
.

From the perspective of the treatment field, the newly added pediatric drugs in the 2018 edition of the basic drug list have expanded to popular subcategories such as psychostimulants and anti-tumor drugs.
In recent years, the incidence of these diseases has become younger Demand is also surging
.

Driven by policies, these children's medicines have achieved remarkable performance in the hospital terminal market
.

Figure 2: Channel structure of three exclusive Chinese patent medicines in 2020

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

The 2020 epidemic has affected the frequency of patients' visits to hospitals.
The overall drug sales of public medical institutions in China have fallen by 12%.
Only three of these 22 children's drugs have a positive growth, and two of them are new products
.

Figure 3: Sales of Hengrui's Peaspartase Injection (Unit: Ten Thousand Yuan)

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

On the whole, there are 9 of the 11 new products that have a positive growth rate in 2019, 2 have a positive growth rate in 2020, and only 6 of the 11 original catalog products have a positive growth rate in 2019.
There is only one with a positive growth rate in 2020; 8 of the 12 exclusive products have a positive growth rate in 2019, 2 with a positive growth rate in 2020, and 10 non-exclusive products have a growth rate of 2019 Seven are positive, and one has a positive growth rate in 2020
.

In addition, from the perspective of channels, under the influence of the 986 policy, proprietary Chinese medicines are gradually sinking into the grassroots market, while chemical medicines are actively developing the county-level public hospital market
.

Prioritize reviews and encourage R&D to yield fruitful results.
Will these new products become a big hit?

The World Health Organization (WHO) published the first International Children’s Essential Drug List in 2008.
The list not only includes 206 pediatric drug products that have been evaluated for safety, but also helps WHO judge major deficiencies in children’s drug research, reminding the industry and independence Research institutions must carry out work to fill the gaps
.

In order to be in line with international standards, and to solve the dilemma of “rely on drug use and dose guessing” for children in China, the state has formulated a series of policies in recent years, such as strengthening the provision of children’s drugs in hospitals, bidding and purchasing directly on the Internet, encouraging research and development, and giving priority.
Review, etc.
, to encourage manufacturers to increase the R&D and production of children's drugs.
The adjustment of the basic drug list to increase the children's drug list will lay the foundation for alleviating the current situation of children's drug shortages and also point out the direction for domestic enterprises
.

Table 2: Status of children's drugs that have been declared for marketing since 2018 and have been included in the priority review and approved for production

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

Since the priority review system was launched in 2015, China's drug market has undergone tremendous changes.
A large number of innovative drugs with obvious clinical value and drugs for the prevention and treatment of major diseases have accelerated the listing process and changed the situation of low-level research and development in the past
.

Among the 15 children's medicines, 1 is Chinese patent medicine, 4 are vaccines, and 10 are chemical medicines
.

Figure 4: Sales of the three heavyweight varieties in 2020 (unit: 100 million yuan)

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

Shaomazhijing Granules is the latest pediatric Chinese patent medicine approved in recent years, and its indication is Tourette's syndrome in children
.
The subcategories of children's medicines in the 2018 edition of the basic medicine catalog are mainly colds, coughs and expectorants, diarrhea, and anorexia.
If Shao Ma Zhijing Granules are successfully included, it is expected to bring new breakthroughs to the new catalog
.

In order to promote the development, creation, and application review of suitable varieties, dosage forms and specifications for children, and to meet the needs of pediatric clinical use, the National Health and Family Planning Commission, the Ministry of Industry and Information Technology, and the Food and Drug Administration organized pediatric clinical and pharmaceutical experts in 2016.
Domestically, there are no suitable children's drug formulations and specifications that have been registered and marketed.
The first batch of children's drugs to encourage research and development has been formulated and released.
Up to now, three batches of catalogs have been published, covering more than 100 varieties, and products that have been approved for marketing.
There are midazolam buccal mucosal solution from Jilin Jinsheng Pharmaceutical (5mg/ml), Tefeng Pharmaceutical's chloral hydrate/syrup combination packaging and chloral hydrate enema, and levetiracetam injection concentrated solution (500mg/ml).
5ml) 13 companies have been approved, and 2 companies have been approved for recombinant teriparatide for injection
.

Figure 5: The dosage forms involved in the three batches of encouraged R&D and application of children's drugs

In terms of dosage form, traditional oral regular-release dosage forms accounted for less than 15%, injections accounted for 28%, and oral liquids accounted for the most, accounting for more than 40%.
In addition, eye drops, nasal preparations, gels, and ointments , Suppositories, inhaled gas, etc.
are also involved
.
These hundreds of varieties that encourage research and development have pointed out the direction for research and development companies, allowing children's medicine to return to a clinical value-oriented development model
.

Concluding remarks

In recent years, the enthusiasm of the children’s drug market in China has been high.
On the one hand, the benefits of national policies have been spurred, and on the other hand, parents’ attention to the safety of children’s drugs has continued to increase.
The "Children’s Drug Catalog" has been launched.
It is the general trend
.
Judging from the sales of children’s medicines that have been included in the current basic medicine catalog in recent years, the development of exclusive and newly-added varieties has been rapid, which is good for manufacturers, but at the same time, we must continue to pay attention to the sinking of product channels.
Adjust the strategic layout in due course
.
At the same time, the country encourages the advancement of more therapeutic areas in R&D.
Manufacturers can use their own characteristics and establish differentiated advantages when laying out product lines.
They can also form product synergies from the perspective of enriching product portfolios, which can not only reduce academic research Promotion cost, you can also sort out the brand image
.