Anti-epileptic drug Kang Enbei hits the first imitation

Medical website, March 16th, March 12th, CDE official website data shows that Shanghai Okuda Biomedical Technology | Zhejiang Kangenbei Pharmaceutical applied for the application of 4 types of generic listing of lacosamide oral solution
.
Lacosamide is a third-generation new type of anti-epileptic drug.
Currently, tablets and injections on the market have been first imitated in China.
Syrups are only approved for imports, and there is no domestic approval for oral solutions
.
Figure 1: Conba’s lacosamide oral solution application.
Source: CDE’s official website Ushibi’s lacosamide was first approved by the European Union and the US FDA in September 2008 and May 2009 to be marketed for ≥ 16-year-old epilepsy patients with or without secondary general seizure treatment adjuvant therapy for partial seizures
.
According to data from Meinenet, the global sales of lacosamide in 2019 exceeded US$1.
5 billion
.
Figure 2: The sales of lacosamide in the domestic market Source: Meinenet database In November 2018, Ushibi's lacosamide tablets were first approved to enter the domestic market, and its injections were approved for import at the end of 2019 , In July 2020, lacosamide syrup also entered the Chinese market smoothly
.
In terms of domestic generic drugs, Jiangxi Qingfeng Pharmaceutical took the first domestic imitation + first review of lacosamide tablets in January 2019, and the first domestic imitation + first review of lacosamide injection in November 2020.
Currently Syrups and other types of oral solutions have not been approved for domestic imitation
.
According to data from Menet.
com, in China’s urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) terminals, currently the main sales of lacosamide are tablets, and sales will increase in the first half of 2020.
The rate is as high as 8620%, and the proportion of U-hour ratio has dropped to about 60%.
Jiangxi Qingfeng Pharmaceutical's market share has increased rapidly year by year
.
In China’s urban physical pharmacy terminals, tablet sales are currently the main product.
In 2020, the sales growth rate of this product is expected to reach 623%.

.
Table 1: The application status of the imitation listing of lacosamide syrup and oral solution currently under review.
Source: Meinenet MED2.
0 Chinese drug review database lacosamide has a huge market potential.
At the same time, domestic pharmaceutical companies are actively applying for imitation listing.
In order to get listed as soon as possible to carve up the original research market
.
At present, the domestic first imitations of tablets and injections have been taken by Jiangxi Qingfeng Pharmaceutical, and syrups and oral solutions have also become the targets of domestic pharmaceutical companies.
After Conba joined this time, the first imitation competition will become more intense
.
Data source: NMPA official website, Mi Nei.
com database Data statistics as of March 15th, if there are any omissions, please correct me!