| In recent years, the national level has encouraged the first generic drugs, and leading pharmaceutical companies with higher R&D levels have also accelerated the work of "rushing imitations" while actively deploying innovative dru.
Note: Sources with sales exceeding 1 billion yuan in 2021 are indicated by *Source: CDE official website, Min.
com databaseMin.
com data shows that the above products will be sold in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers in 2021 ( There are 7 terminals with total sales of more than 1 billion yuan in Chinese public medical institutions) terminals, Chinese urban physical pharmacy terminals and Chinese online pharmacy termina.
Up to now, the number of BE clinical trials of tadalafil tablets is close to 90, the number of domestic approvals that have been approved exceeds 40, and the number of acceptance numbers that have been submitted for production and are under review exceeds 60; the number of BE clinical trials of rivaroxaban tablets There are also more than 80 items, more than 50 domestic approval documents have been approved, and more than 20 acceptance numbers have been submitted for production and are under revi.
It is foreseeable that there will be more and more domestic generic drugs of these two varieti.
Players should carefully consider issues such as track congesti.
In contrast, cinacalcet hydrochloride tablets and amlodipine atorvastatin calcium tablets are expected to continue to expand the market si.
In 2021, the total sales of the two major products and the three major terminals will be 500 million yuan and 900 million yuan respectively, and continue to maintain a positive growth tre.
At present, the number of BE clinical trials is about 20, and the number of domestic approvals that have been approved is less than 1 , and there are fewer than 10 acceptance numbers reported for production and under revi.
After the domestic generic drugs are approved one after another, they can provide patients with more brand choices and more favorable prices, and the increase in drug demand is bound to further increase the product market si.
The first domestic generic drugs in the five billion-dollar markets will blow out, and the top ten popular products will be expos.
With the upgrading and development of China's pharmaceutical industry, the research and development strength of domestic pharmaceutical companies is gradually improving, and innovative drugs have a long way to .
Not all pharmaceutical companies can occupy the tra.
The first generic drug has gradually become another battlegrou.
In recent years, the national level has encouraged the first generic dru.
Whether in terms of review and approval reform or market exclusivity, the first generic drugs have a great advanta.
According to the statistics of Min.
com, among the more than 800 products that have applied for imitation and marketing since 2018 and are under review, about 200 of them have not obtained domestic approval for the same product (excluding the localization of original research), digestive system and metabolic drugs, blood and dru.
Hematopoietic system drugs, anti-tumor and immune modulators, systemic anti-infective drugs, and nervous system drugs are the most popular in the five-hundred-billion-dollar market, and are expected to welcome more than 20 domestic first generic dru.
Table 2: Top 10 products that are popular for imitation listings Figure 1: Global and domestic sales of the three major products in 2021 In 2017, Novartis' sacubitril and valsartan sodium tablets were approved for import, and in 2019, they entered the national medical insurance negotiation catalog and their sales increased rapidly In 2021, the total sales of Chinese public medical institution terminals, Chinese urban physical pharmacy terminals and Chinese online pharmacy terminals will exceed 2 billion yu.
Such impressive results have naturally attracted domestic pharmaceutical companies to compe.
In November 2018, Shanghai Xuantai Haimen Pharmaceutical | Nanjing Yixinhe Pharmaceutical Technology was the first to submit 4 types of generic listing applicatio.
So far, 12 companies have participated in the first imitation competiti.
The situation of sacubitril and valsartan sodium tablets is similar to that of sugammadex sodium injecti.
Merck's sugammadex sodium injection was approved for import in 201 In the same year, Hunan Kelun Pharmaceutical was the first to apply for the listing of Class 4 generi.
In April this year, Yangzijiang overtook the first imitation, and then Hunan Kelun Pharmaceutical also won the second domestically produced pharmaceutical compa.
During this period, many pharmaceutical companies fail.
Therefore, who will lose the first imitation of sacubitril and valsartan sodium? The home has also been attracting the attention of the mark.
Another blockbuster product of Novartis, Eltrombopag ethanolamine tablets, was approved for import in 2017, and entered the national medical insurance negotiation catalog in 201 In 2021, the total sales of terminals in public medical institutions in China, physical pharmacies in Chinese cities, and online pharmacies in China will be complet.
It has exceeded 800 million yu.
With the continuous advancement of online sales of prescription drugs, the growth rate of this product in China's online pharmacies in 2021 is as high as 449
Osaikang was the first to submit 4 types of imitation listing applications in January 2020, and a total of 5 companies are currently participating in the first imitation competiti.
Bayer's regorafenib tablets are a new type of oral multikinase inhibitor, which was approved for import in 2017, entered the national medical insurance negotiation catalog in 2018, and will be available in Chinese public medical institution terminals, Chinese urban physical pharmacy terminals and Chinese online pharmacies in 202 The total terminal sales have exceeded 900 million yu.
Yangzijiang was the first to submit a 4-type imitation listing application in April 2021, and currently 8 companies have reported for production and are under revi.
Table 3: 10 Pediatric Drugs That Have Been Priority Review and Will Be Listed in the Market In addition to the first domestic imitation products of the world's largest varieties, the first imitation products of children's drugs are also the focus of the industry, especially in recent years, the country has vigorously promoted the "Children's Use special medicines for children", the market size of children's medicines is continuing to ri.
The 10 pediatric medicines that have been included in the priority review have not yet obtained domestic approval for the same product, and most of them are concentrated in the fields of blood and hematopoietic system, nervous system, e.
, and only one company has reported for production and is under review for the above 10 produc.
, winning the first domestic imitation is only a matter of ti.
Domestic giants are enthusiastic about rushing imitations, and many products from Chia Tai Pharmaceutical, Qilu, and Kelun are poised to launch.
The revenue brought by the first generic drug listing can be continuously converted into investment in the research and development of innovative dru.
In recent years, the top drugs with higher research and development levels Enterprises are adhering to the dual-drive strategy of "innovation + first imitatio.
Currently, Chia Tai Pharmaceutical, Qilu, Kelun, and Yangzijiang have more than 10 products impacting the first imitation, and many products are the first to declare, which has a time advanta.
Table 4:Data sources of the TOP10 group: CDE official website, Minet database,e.
|
