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19 varieties of more than $1 billion are on the road and other strikes

 Last Update: 2022-10-25
 Source: Internet
 Author: User

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A few days ago, Simcere Pharmaceutical won the first imitation of ibrutinib, and the global sales of the original product reached 9.
78 billion US dollars
in 2021.
With market and pricing advantages, the first generic drug has always been the focus of the R&D layout of
domestic pharmaceutical companies.
According to incomplete statistics, among the star drugs with global sales of more than US$1 billion in 2021 and no first generic approval in China, 19 varieties have been deployed by pharmaceutical companies, of which 5 varieties will have sales of more than 1 billion yuan
in the three major terminal markets in 2021 (see the end of this article for detailed statistical scope).

From the perspective of enterprise declaration, China Biopharmaceutical has laid out 8 varieties, of which ruxolitinib, everolimus and fluticasone veranterol are the exclusive declarations; Qilu Pharmaceutical has laid out 7 varieties, of which dolutegravir, riociguat and olaparib are exclusive/first declarations; In addition, Kelun Pharmaceutical, Beite Pharmaceutical, Xuantai Pharmaceutical, etc.
have laid out 3 varieties
.

In 2021, the global sales exceeded 1 billion US dollars and there are no first imitation approved varieties in China

Note: No sales or sales below 100 million yuan are represented by *

Source: Intranet database

Oimertinib

Osimertinib is a third-generation oral, irreversible selective EGFR mutation inhibitor developed by AstraZeneca, which was first approved by the FDA in November 2015, and its global sales reached $5.
015 billion in 2021, a year-on-year increase of about 16%.

In March 2017, AstraZeneca's osimertinib was approved to enter the domestic market for the first time, and was included in the national medical insurance category B catalogue through negotiation in 2018, and was successfully renewed in 2020, with all first-line and second-line indications included, which is expected to achieve further expansion
.
According to data from Intranet, the sales scale of osimertinib in China's three major terminal markets will exceed 4.
8 billion yuan in 2021, a year-on-year increase of 6.
06%.

In recent years, the sales of osimertinib in China's three major terminal markets (10,000 yuan)

Source: Intranet database

The domestic compound patent CN103702990 of osimertinib will expire in July 2032, and at present, only Jiangsu Wanbang Biochemical layout generic drugs, its products completed the BE trial in August 2020, and submitted a marketing application
in May 2021 as generic class 4.

New classification of osimertinib mesylate tablets reported production

Source: New version of the Intranet database

Sacuba triva valsartan

Sacubitril valsartan, a combination formulation composed of sacubatril (enrylysin inhibitor) and valsartan (angiotensin receptor antagonist), was first approved by the FDA in July 2015 and is the world's first breakthrough innovative drug in the field of heart failure treatment, with global sales of US$3.
548 billion in 2021, a year-on-year increase of about 42%.

In July 2017, Novartis' sacubitril valsartan was approved to enter the domestic market for the first time, and in 2019, it was included in the national medical insurance category B catalogue through negotiation, and it was successfully renewed in 2021, and the indication for
essential hypertension was added.
According to data from Intranet, the sales growth rate of sacubatril valsartan in China's three major terminal markets in recent years has reached triple-digit figures, exceeding 2 billion yuan for the first time in 2021, a year-on-year increase of 127.
62%.

In recent years, the sales of sacubitril valsartan in the six major markets of the three terminals (10,000 yuan)

Source: Intranet database

Although the patent of sacubitril valsartan has not yet expired, more than 10 domestic pharmaceutical companies have submitted marketing applications for the product in generic 4 categories, of which Shanghai Xuantai Haimen Pharmaceutical was the first to report production, and its marketing application was accepted by CDE in November 2018, and is currently in the second round of data supplementation
.
In addition, the products of CSPC Ouyi, Chia Tai Tianqing and other enterprises are in the first round of data supplementation
.

Sacubitril valsartan sodium tablets new classification and production status

Source: New version of the Intranet database

Olapalib

Olaparib is a PARP inhibitor that kills cancer cells by inhibiting PARP and reducing or even preventing cancer cells carrying damaged BRCA genes from performing DNA repair
.
Jointly developed by AstraZeneca/Merck, the product was first approved by the FDA in December 2014 and is the world's first PARP inhibitor, with global sales of US$3.
337 billion
in 2021.

In August 2018, AstraZeneca's olaparib was approved to enter the domestic market for the first time, and in 2019 it was included in the national medical insurance category B catalogue through negotiation, and it was successfully renewed and added indications
in 2020.
According to data from Intranet, the sales scale of olapalib in China's three major terminal markets has increased year by year in recent years, exceeding 1 billion yuan for the first time in 2021, a year-on-year increase of 23.
08%.

In recent years, the sales of olaparib in China's three major terminals and 6 major markets (10,000 yuan)

Source: Intranet database

It is reported that olaparib's compound patent will expire in 2024, and there are currently 3 domestic pharmaceutical companies submitting marketing applications for the product in the new registration classification, including Qilu Pharmaceutical, Xuantai Pharmaceutical and Hunan Kelun Pharmaceutical, of which Qilu Pharmaceutical is the first to report production and is currently in the first round of data distribution
.

Olaparib tablets new classification reported production

Source: New version of the Intranet database

Budesonide formoterol

Budesonide formoterol is a combination inhaler composed of budesonide (glucocorticoid) and formoterol (long-acting beta2-agonist) for the treatment of asthma, chronic obstructive pulmonary disease, etc
.
Although budesonide formoterol patent has expired, its global sales have not fallen off a cliff, and it still achieved sales revenue
of $2.
728 billion in 2021.

AstraZeneca's budesonide formoterol entered the domestic market earlier, and its sales in China's three major terminal markets have increased year by year in recent years, exceeding 2 billion yuan for the first time in 2018 and exceeding 2.
8 billion yuan in 2021, a year-on-year increase of 10.
35%.

In recent years, the sales of budesonide formoterol in China's three major terminals and 6 major markets (10,000 yuan)

Source: Intranet database

At present, there are not many companies that layout the generic drug of budesonide formoterol, as one of the main tracks of inhalants in China Pririet (a subsidiary of Beite Pharmaceutical), the earliest layout of budesonide formoterol generic drugs
.
The company submitted a marketing application for budesonide formoterol inhalation aerosol in generic class 3 in December 2017, and is currently undergoing phase III clinical trials
.

Declaration of new classification of budesonide formoterol inhalers

Source: New version of the Intranet database

Salmeterol ticasone

Salmeterol ticasone is a combination inhaler composed of salmeterol (long-acting beta2-agonist) and fluticasone (glucocorticoid), which can treat asthma, chronic obstructive pneumonia, etc
.
As one of GSK's blockbuster varieties, salmeterol ticasone exceeded $5 billion in global sales in 2013 and then began to decline as patents expired, but still exceeded $1 billion
in 2021.

GlaxoSmithKline's salmeterol ticasone also entered the domestic market earlier, and its sales in China's three major terminal markets have fluctuated in recent years, approaching 2 billion yuan in 2021, a year-on-year increase of 6.
23%.

Sales of salmeterol ticasone in China's three major terminals in recent years (10,000 yuan)

Source: Intranet database

At present, there are more than 10 pharmaceutical companies deploying generic drugs for salmeterol ticasone, including well-known pharmaceutical companies such as Chia Tai Tianqing, Hengrui, and Healthyuan, but due to high generic barriers, no generic drugs have been approved
in China so far.

Declaration of new classification of salmeterol ticasone inhaler

Source: New version of the Intranet database

epilogue

Driven by policies such as the continuous promotion of consistency evaluation, the normalization of centralized procurement, and the normalization of medical insurance, the comprehensive advancement of superimposed drug review reform, the "patent linkage system" and the introduction of the "first generic exclusive period", as well as the deepening of domestic pharmaceutical companies' understanding of drug patents, in addition to accelerating the layout of innovative drugs, domestic pharmaceutical companies will also increasingly compete for first generic drugs with market and pricing advantages, especially blockbuster varieties
with global sales of more than 1 billion US dollars.

Source: Intranet database Note: Intranet "China's three major terminals and six major market competition pattern", the statistical scope is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of October 17, if there are any omissions, welcome to correct!

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