Ten billion varieties fell to the altar!

Recently, new progress has been made in the field of lipid-lowering drugs.

Long-acting lipid-lowering drugs have another victory! 3 new lipid-lowering drugs enter medical insurance

On December 22, Novartis announced that the PCSK9 siRNA drug Leqvio (Inclisiran) was approved by the US FDA for marketing

In recent years, the research and development of new drugs in the field of lipid-lowering drugs has continued to progress, and as the cornerstone of lipid-lowering therapy, statins are facing increasingly fierce competition

On July 31, 2018, Amgen's ilovolumab injection was approved for marketing in China, becoming the first PCSK9 in China for the treatment of homozygous familial hypercholesterolemia (HoFH) in adults or adolescents over 12 years old inhibitor

On December 26, 2019, Sanofi's alicizumab injection was approved for marketing in China.

On June 25, 2021, Haizheng Pharmaceutical's Class 1 new drug, Haibo Maibu Tablets, was approved for marketing in China, becoming the first domestically and the world's second oral intestinal cholesterol absorption inhibitor

It is worth noting that the newly released 2021 version of the National Medical Insurance Catalog shows that three new lipid-lowering drugs, including ilovolumab injection, alicizumab injection, and Haibo Maibu tablets, have successfully entered the national medical insurance through medical insurance negotiation.

Lipid-lowering drug market "Waterloo"! TOP10 ranking changes

Since the implementation of the national centralized procurement, the domestic blood lipid regulator market has opened the "Waterloo" mode, and the market size has continued to shrink

According to data from Minet.

Sales of terminal blood lipid regulators in public medical institutions in China (unit: 10,000 yuan)

Source: Minet.

Among the top 10 products, atorvastatin calcium tablets and rosuvastatin calcium tablets have long been the top brand products, and the cholesterol absorption inhibitor ezetimibe has risen from the tenth place in 2018 to the third place in the first half of 2021.

In the first half of 2021, the sales of atorvastatin calcium tablets and rosuvastatin calcium tablets exceeded 1 billion yuan, and the sales of the remaining 8 products exceeded 100 million yuan

2021H1 TOP10 terminal blood lipid regulator products in Chinese public medical institutions

Source: Minet.

Among the top 10 brands, foreign companies occupy six seats, with Pfizer's atorvastatin calcium tablets, AstraZeneca's rosuvastatin calcium tablets, and Merck's ezetimibe in the top three

2021H1 Top 10 brands of terminal blood lipid regulators in Chinese public medical institutions

Source: Minet.

The four major statins enter the centralized procurement, and the tens of billions of large varieties are "cut in half"

Up to now, 12 varieties (118 acceptance numbers) of blood lipid regulators have passed/deemed to pass the consistency evaluation

Atorvastatin, rosuvastatin, simvastatin, pitavastatin and other 4 statin drugs have been reviewed by leading companies in the number of reviews.
As many as 23 companies have reviewed rosuvastatin calcium tablets and atorvastatin calcium tablets.
18 companies were evaluated
.
Atorvastatin and rosuvastatin were included in the first batch of statins, and simvastatin and pitavastatin were subsequently included in the second and third batches
.

Over-evaluation of blood lipid regulators

Source: MED2.
0 China Drug Evaluation Database

As mature varieties in the blood lipid regulator market, the sales of atorvastatin and rosuvastatin declined significantly after centralized procurement
.
According to data from Minet.
com, in 2020, the sales of atorvastatin and rosuvastatin in China's public medical institutions will drop by 56.
12% and 54.
19% respectively, and the sales of atorvastatin will drop from 13.
7 billion yuan in 2018 to 56.
59 yuan in 2020.
100 million yuan, and the sales of rosuvastatin also fell from 6.
862 billion yuan in 2018 to 3 billion yuan in 2020
.

It is worth noting that although atorvastatin calcium tablets and rosuvastatin calcium tablets have been included in centralized procurement in 2018, the market size has shrunk significantly in recent years, but it still cannot reduce the enthusiasm of domestic pharmaceutical companies for imitation
.
During the three-year period from 2019 to 2021, there were 15 atorvastatin calcium tablet imitation companies and 16 approved production companies, and 17 rosuvastatin calcium tablet imitation companies and approved production companies
.

Among the 4 statins, pitavastatin was once regarded as a relay in the statin market.
When the market shares of atorvastatin and rosuvastatin declined, the market share of pitavastatin increased from 3.
95% in 2018.
It rose to 12.
45% in 2020, surpassing the third-ranked simvastatin
.
However, after the third batch of centralized procurement was included, the growth of pitavastatin was reversed.
In the first half of 2021, the sales fell by 59.
80% year-on-year, and the market share dropped to 5.
84%
.

Changes in the market share of the four major statins in China's public medical institutions

Source: Minet.
com China's public medical institutions terminal competition pattern

At present, among the 12 blood lipid regulators that have been reviewed, there are 2 varieties that have not been collected and met the conditions for centralized collection, including ezetimibe tablets, amlodipine and atorvastatin calcium tablets
.
Among them, there are 5 companies that have reviewed ezetimibe tablets, including Sandoz, Fangsheng Pharmaceutical, Chongqing Shenghuaxi, Fuyuan Pharmaceutical, and Wu Chinese Medicine; 3 companies have reviewed amlodipine and atorvastatin calcium tablets.
, including Nanjing Chia Tai Tianqing, China Resources Secco, and Jialin Pharmaceutical
.

As the seventh batch of centralized procurement approaches, whether ezetimibe tablets and amlodipine atorvastatin calcium tablets will be included in the centralized procurement is worth paying attention to
.

Data source: Minet database

Note: The statistics are as of December 27.
If there are any omissions, please correct me!