On April 26, the CDE official website issued a notice that six anti-tumor varieties were selected after reviewing the list of varieties, which can be directly revised to increase the indications for children and the usage and dosage of the drug.
We are now seeking opinions from the industry and the society.
The 6 anti-tumor varieties are: cisplatin, ifosfamide, mesna, azathioprine, asparaginase and vindesine, involving Hengrui, Qilu, Shuanglu Pharmaceutical, Baiyunshan, Yangtze River, etc.
Table 1: The specific situation of the revised opinions on adding children's medication information to the second batch of marketed drug inserts
Source: CDE official website, compiled by Mi Nei.
Table 2: The situation of the enterprises involved in the corresponding specifications of the 6 varieties
Source: One-click search on Mi Nei.
According to data from Meinenet, the above-mentioned 6 anti-tumor drugs are all varieties of the 2020 National Medical Insurance Catalogue, and domestic giants such as Hengrui, Qilu, Shuanglu Pharmaceutical, Baiyunshan, and Yangzijiang have layouts.
In 2019, the sales scale of ifosfamide injection (including 0.
5g and 1.
0g) in China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) terminals was 190 million yuan At present, the leading company in this category is Baxter, with a market share of more than 70%.
The domestic pharmaceutical companies Hengrui and Qilu both have a market share of over 10%.
Vindesine injection (1mg) has a terminal sales of 120 million yuan in public medical institutions in China in 2019.
Currently, the three domestic giants Hangzhou Minsheng Pharmaceutical, Shandong Luoxin Pharmaceutical Group, and Yangzijiang Pharmaceutical Group dominate the market.
For a long time, my country's children's medicines have faced problems such as difficult research and development, fewer varieties of medicines, and lack of proprietary dosage forms.
It is reported that more than 90% of the medicines do not have children's dosage forms.
In recent years, with the continuous improvement of the drug review and approval system, more and more new children's drugs that have been declared for marketing or clinical have been included in the priority review.
The children's drug market in my country is developing in a positive manner.
CDE adds children's medication information to the drug inserts that are already on the market, which not only expands the number of users of the product and drives the sales of drugs, but also brings more medication options to pediatric patients so that they can have medicines available.
Source: Minet database, CDE official websiteSource: Minet database, CDE official website