The first imitation of large varieties was approved intensively, and who is the first among Chia Tai Tianqing, Hengrui, Qilu and Yangzijiang

According to incomplete statistics, since 2022, more than 20 first generic drugs have been approved for marketing
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For a long time, the first imitation has been the focus of the R&D layout of domestic pharmaceutical companies, and has entered an intensive approval period in recent years
.
With the shift of business focus to innovative drugs, leading companies such as Chia Tai Tianqing, Hengrui, and Qilu are still in the forefront in the number of first copy approvals
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More than 20 first generic drugs have been approved for marketing this year.
Among the first generic drugs approved for marketing this year, Hengrui has gained a lot and won three: nimodipine oral solution, ondansetron oral dissolving film, gadobutrol injection
.
Yangzijiang and Chia Tai Tianqing each harvested 2 first copies, namely: Sodium Potassium Magnesium Sulfate Oral Solution of Yangzijiang, Tedizolid Phosphate for Injection; Sitagliptin Metformin Sustained Release Tablets of Chia Tai Tianqing, Metformin for Inhalation alkali
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There are many clinical varieties and potential varieties among these drugs
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The three varieties approved by Hengrui have their own highlights.
According to the data of Minet.
com, in the public hospital terminals in key cities in 2021, the domestic sales of nimodipine have risen steadily in recent years, reaching 128 million yuan; Ondansetron 2020 The annual sales are 243 million yuan, and the sales in 2021 are 333 million yuan; the sales of gadobutrol injection in 2021 will exceed 40 million yuan, a year-on-year increase of 56.
01%
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Tedizolid phosphate for injection, the first company in Yangtze River to declare and successfully win the first generic drug, was approved for production on April 6 and was deemed to have been reviewed
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Tedizolid phosphate, a derivative of linezolid, is a new second-generation oxazolidinone antibiotic
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At present, 10 domestic companies including Chia Tai Tianqing and Jiangxi Qingfeng have submitted listing applications
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Chia Tai Tianqing’s first approved imitation of sitagliptin and metformin is a blockbuster compound hypoglycemic drug with global sales of nearly 2 billion US dollars by Merck
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In addition, methacholine for inhalation was approved for production at the end of March as a generic type 3 product, and the original product has not yet been marketed in China.
This drug is the first domestically produced and currently the only domestically approved provocative agent for bronchial provocation tests.

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In recent years, the terminal inhalation market of public hospitals in key cities has grown steadily, with sales exceeding 3.
5 billion yuan in 2021
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In addition to methacholine for inhalation, Chia Tai Tianqing's umeclidinium bromide vilanterol inhalation, arformoterol tartrate aerosol inhalation solution and fluticasone furoate vilanterol powder aerosol, health yuan's Fuma Acid formoterol inhalation solutions have sprinted towards the first imitation
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Who is the first imitation king? According to data from Minet.
com, from 2019 to 2021, more than 150 first imitations (including first imitations in dosage forms) were approved for marketing
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Sino Biopharmaceutical (the parent company of Chia Tai Tianqing) and Hengrui have both obtained more than 10 first-simulation numbers, and Qilu and Haosen tied for third place with 9 first-simulation numbers
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Under the normalization of centralized procurement, the number of generic drug applications in 2021 will soar, reaching a new high in the past five years
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In 2021, CDE will undertake a total of 1,860 imitation applications (including import 5.
2 categories), a year-on-year increase of 63.
30%, involving 587 varieties
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Among them, the top enterprises are very active in imitation applications, and the number of imitation varieties submitted by the four medicines of Yangtze River, Kelun, Qilu, Fosun and Shijiazhuang ranks in the forefront, and has achieved different degrees of growth
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In 2021, a total of 52 first imitation varieties have been approved, involving 46 companies
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Hengrui has won 3 first imitation varieties, Huarui Pharmaceutical, Osaikang, Hansoh, Nanjing Haina Pharmaceutical and Nanjing Hairong Pharmaceutical have 2
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In 2021, 134 varieties of imitation applications have not yet been approved for domestic imitation, involving 126 enterprises, and the number of varieties (including market and clinical) declared by Yangzijiang and Qilu is 11
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From 2019 to 2021, more than 50 generic drugs of Sino Biopharmaceuticals have been approved for marketing, 16 are the first imitations, and 14 are won by Chia Tai Tianqing, leading domestic enterprises
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Most of Chia Tai Tianqing’s first imitation varieties are aimed at the original research products.
The global sales of rivaroxaban’s original research products in 2020 will exceed 7 billion US dollars, and sitagliptin and pomalidomide will exceed 3 billion US dollars respectively.

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Sino Biopharm emphasized in its 2021 performance report that generic drugs are still an indispensable business for the stable development of the group.
While promoting innovative drugs in an all-round way, it will maintain the basic market of generic drugs and continue to export new drugs with quantity, quality and efficiency.
We will continue to improve the advantages of first imitation, rush imitation and difficult imitation, and promote the research and development of generic drugs with high quality and efficiency
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It is worth noting that although Hengrui has shifted its focus to innovative drugs and international business, the number of first imitations is still in the forefront, and 5 of the 10 first imitations are injections
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In the field of generic drugs, high-end generic drugs and first generic varieties have already become the focus of Qilu's layout
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After winning the first domestic tadalafil oral dissolving film in January, in March, its second-generation atypical long-acting anti-schizophrenia drug Paliperidone Palmitate Injection was accepted by the CDE, which is the first domestic drug in China.
The first report
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Is the first imitation the way out during the transition period? It is worth noting that, as the competition in the domestic generic drug market becomes increasingly fierce, the market impact brought by centralized procurement has gradually emerged.
Many companies have chosen to cut off some generic drug projects and transform to innovative drugs and high-end generic drugs
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At the end of 2019, Hengrui announced that it would stop most generic drug projects and focus on the research and development of innovative drugs.
Qilu, Huadong Medicine and other companies have also stated that they will focus on the deployment of high-end generic drugs and innovative drugs, and clean up and eliminate low-barrier and low-commercial value drugs.
Generic drugs
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From the perspective of the industry, cutting off some generic drug projects can only be done by powerful companies that do both innovative drugs and generic drugs.
Most companies still have to think of ways on existing products or generic drugs
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Not all companies can make innovative drugs, and generic drugs need to pass the consistency evaluation, and the number of generic drugs is limited
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In the past, the industry was based on quantity to win.
In the future, there will be more competition for quality and speed.
Only by running ahead will there be market opportunities
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Some business leaders believe that the generic drug project is not impossible, but how to do it
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While intensifying the deployment of innovative drugs, it is possible to deploy innovative products in imitation and new high-barrier imitation products.
This transformation will be painful and require a certain period of time.

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Head companies have accumulated R&D experience in innovative drugs because they have been deploying first generic and innovative drugs in the past
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Due to the increasingly fierce competition in the generic drug market, it is a wise choice to make strategic adjustments to generic drug projects.
It is recommended to focus on some large varieties, or varieties with technical barriers, in line with product line positioning, and available customer resources
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