30 billion market Livzon "Fengwang" collection variety "big dive"

Recently, through the 2022 medical insurance preliminary review of the drug list released to the public, this year's medical insurance catalog adjustment work has entered a critical period, and various drug markets will usher in a new round of reshuffle
.
Peptic ulcer is a common multiple disease, with the incidence increasing year by year, the market size of drugs for the treatment of gastric acid secretion related diseases continues to rise, and after 2019, a number of heavy varieties have been included in the national collection, making room
for innovative drugs to enter medical insurance.
Lizhu Group, which has an exclusive variety of eprazole, Lizhu Pharmaceutical became a new leader in 2021, and Shandong Luoxin Pharmaceutical Group's Class 1 new drug Tigola Sheng tablets has entered the preliminary list of medical insurance in 2022, and this 10 billion market pattern is being reshaped
。 A new faucet is born! Lizhu ultra-high-speed summit, Jichuan Yipin unique treatment of gastric acid secretion-related diseases drugs mainly involve proton pump inhibitors, H2-blockers, other drugs for the treatment of gastrointestinal ulcers, antacids and anti-flatulence drugs, in 2017 in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) terminals, the market size of this subcategory has exceeded 40 billion yuan, reaching a peak of 42.
4 billion yuan
in 2019 。 In 2020, the second batch of national mining began to be included in this sub-category of products, and a number of heavy varieties ushered in a sharp price reduction, superimposed on the impact of the epidemic, and the scale of the sub-category market remained at the level of
37 billion yuan in the past two years.
The market scale has shrunk greatly, but some domestic pharmaceutical companies have seized the opportunity to usher in a new wave of outbreaks, and new leading enterprises have been born
.
Figure 1: Change in the share of drugs TOP5 companies for the treatment of diseases related to gastric acid secretion in 2021 Source: Intranet China's public medical institution terminal competition pattern Livzon Group's Livzon Pharmaceutical in China's public medical institutions from 2013 to 2014 accounted for less than 1% of the market for the terminal treatment of gastric acid secretion-related diseases in China's public medical institutions, missing the TOP20; Ranked TOP14 in 2015 with a market share of 1.
37%; In 2017, it rose to the top 10, and its market share exceeded 2%; Rush into the TOP3 in 2020, with a market share of 6.
52%; Successfully reaching the top in 2021, it is currently the only enterprise
with a share of more than 10% in this sub-market.
Table 1: Livzon Group's best-selling drugs for the treatment of gastric acid secretion-related diseases (: 100 million yuan) Picture Note: Sales of less than 100 million yuan replaced by * Source: Intranet China's public medical institutions terminal competition pattern Eprazole is an innovative drug and exclusive variety approved by Livzon Pharmaceutical in 2007, and has maintained a rapid growth trend in the terminals of public medical institutions in China in recent years, exceeding 1 billion yuan in 2019 and rising to 3.
5 billion yuan
in 2021 。 In July this year, a marketing application was submitted for the new indication of injectable eprazole sodium for the prevention of stress ulcer bleeding in critically ill patients; In August, the improved new drug eprazole pellet enteric-coated tablets were declared clinical.
.
.
With the new adaptation and new dosage forms being approved, the sales of this variety are expected to continue to rise, leading the company to climb the peak
again.
In addition, Jichuan Pharmaceutical Group has also shown a steady growth trend
.
In 2013, the company ranked TOP7 in the market for drugs for the treatment of diseases related to gastric acid secretion, with a market share of more than 3%; In 2019, it rose to TOP4 and its market share exceeded 4%; The ranking will remain unchanged in 2021, but the market share will rise to more than 5%, and the potential should not be underestimated
.
Figure 2: Jichuan Pharmaceutical Group's rabeprazole sales (: 10,000 yuan) Source: Intranet China's public medical institutions terminal competition pattern Rabeprazole is the flagship product of Jichuan Pharmaceutical Group in this sub-market, and the terminal sales of public medical institutions in China have exceeded 1 billion yuan in 2014, and reached a new high in 2021, close to 2 billion yuan
.
Rabeprazole is a reversible proton pump inhibitor, with sales of more than 6.
4 billion yuan in 2021 to become the top 1 variety of drugs for the treatment of diseases related to gastric acid secretion, Jichuan Pharmaceutical Group has always been a leader in this variety, with a market share of more than 30%.

。 From 2020, in addition to the sixth batch of insulin special collection, each batch of national collection has included drugs for the treatment of diseases related to gastric acid secretion, and the total sales of these 6 varieties of national medical institutions in China before (2019) exceeded 29 billion yuan, while the total sales in 2021 were only 17.
3 billion yuan, and the scale shrank by more than 10 billion
。 Table 2: The treatment of gastric acid secretion-related diseases that have been included in the national collection Note: Bid red for the winning enterprise Source: Intranet China's public medical institutions terminal competition pattern 6 varieties have no original research drugs won the bid, Bayer has been a leading enterprise in aluminum magnesium carbonate earlier, and in 2021, Chongqing Huasen Pharmaceutical grabbed the championship throne; AstraZeneca, which has always dominated esoprazole, has been declining in its market share after the national harvest, and half of the country cannot be defended
.
With the help of national harvesting, domestic brands have accelerated the market
for grabbing original research drugs.
At present, there are 26 products that have been evaluated / deemed to have been evaluated for the treatment of diseases related to gastric acid secretion, and the number of enterprises that have not been included in the national collection and the number of evaluated enterprises exceeds 3 are omeprazole enteric-coated tablets (Sinopharm Group, Hunan Fangsheng Pharmaceutical, Shandong New Era Pharmaceutical), omeprazole sodium bicarbonate capsules (Beijing Bio Pharmaceutical, Hangzhou Sino-American Huadong Pharmaceutical, Xiamen Encheng Pharmaceutical), Cimetidine Tablets (Shanghai Baolong Pharmaceutical, Shanghai Xinyi Tianping Pharmaceutical, Tianfang Pharmaceutical).

The products that have been included in the national procurement have not yet involved H2-blockers, and whether cimetidine will enter the eighth batch of the list has also attracted market attention
.
Guocai has entered the normalization stage, the medical insurance catalog has also implemented "annual adjustment", and the pattern of the domestic pharmaceutical market is constantly being reshaped
.
High-quality generic drugs stand out in the competition, but they have also entered the era of low profits, and innovative drugs have taken off with the help of medical insurance and gradually become the main force
in the market.
Table 3: Drugs that enter the national medical insurance catalog after 2019 for the treatment of diseases related to gastric acid secretion (: 100 million yuan) Note: Sales of less than 100 million yuan replaced by *; P-CAB is classified as PPI inhibitors in the international ATC code classification system Source: Intranet China public medical institutions terminal competition pattern Livzon Group's Lizon Pharmaceutical for injection of eprazole sodium in 2017 obtained production approval, in 2018 in China's public medical institutions terminal sales were only about 10 million yuan, in 2019 for the first time into the national medical insurance negotiation directory, the growth rate of the year was as high as 780%, 2021 has become a large single product of more than 2 billion yuan, It is the best case of
medical insurance helping innovative drugs take off.
Takeda's vonola fumarate raw tablets are a new type of acid suppressor, which became the first potassium-ion competitive acid blocker (P-CAB) in China after being approved to enter the Chinese market in 2019, and entered the national medical insurance category B catalogue through negotiations in 2020, with sales exceeding 100 million yuan
in 2021.
The potential of the product can be expected, attracting many domestic star pharmaceutical companies to grab imitation, Shandong New Era Pharmaceutical reported production in August 2020 and won the first imitation in August 2022, and the domestic pharmaceutical companies currently under review are Kelun, Renfu and so on
.
This year's medical insurance catalogue adjustment through the preliminary review of the list of drugs also involved in the treatment of gastric acid secretion-related diseases of new products (according to the off-catalog condition 1 through the review, that is, the new generic name drugs approved for listing between January 1, 2017 and June 30, 2022), Shandong Luoxin Pharmaceutical Group's class 1 new drug Tigola Sheng tablets is the first domestic P-CAB class drugs, with the brilliant results of vonola fumarate tablets after entering medical insurance.
The market potential of this domestic new drug should not be underestimated
.
In recent years, the domestic proton pump inhibitor compound preparation research and development is more and more hot, Nanjing Haina Pharmaceutical's exclusive products omeprazole sodium bicarbonate dry suspension (I) and omeprazole sodium bicarbonate dry suspension (II) in February 2021 was approved for listing, last year entered the preliminary list but did not succeed in "insurance", this year again passed the preliminary examination, if the final smooth entry into medical insurance, it can become the first proton pump inhibitor compound preparation
to enter the national medical insurance directory 。 Class 1 new drugs, improved new drugs outbreak, tens of billions of market surprises continue Intranet data show that in the past decade, the number of domestic new drugs approved for the treatment of gastric acid secretion-related diseases is only a few, with the continuous improvement of domestic pharmaceutical companies' research and development strength, this 10 billion market will continue to usher in heavy new drugs
。 Table 4: Drugs that have been declared and listed since 2018 and under review and have not yet been approved for similar products Source: MED2.
0 China Drug Review Database Class 1 new drug analprazole sodium enteric-coated tablets are a new generation of proton pump inhibitors, and the safety and symptom alleviation of the new drug are the best Best-in-class
of similar products 。 Its first indication for the treatment of duodenal ulcer has been submitted for a new drug marketing application in 2021, and the clinical application for the treatment of the new indication for adult reflux esophagitis (RE) and its related symptoms (acid reflux, heartburn, retrosternal pain or discomfort, belching reflux, etc.
) was approved
in June this year.
In terms of improving new drugs, esomeprazole magnesium sodium bicarbonate capsules and lansoprazole sodium bicarbonate capsules are compound preparations for proton pump inhibitors
.
Xiamen Encheng Pharmaceutical won the production approval of omeprazole sodium bicarbonate capsules in 2015, and the product has become the best-selling proton pump inhibitor compound preparation on the market, and the terminal sales of the product in China's public medical institutions will exceed 200 million yuan
in 2021.
The advantage of such compound preparations is that antacids (sodium bicarbonate) can directly neutralize gastric acid, so that omeprazole (esomeprazole, lansoprazole, etc.
) is not decomposed by gastric acid before absorption, so as to achieve a long-lasting inhibition of
gastric acid.
Eometaprazole magnesium enteric-dried suspension is an FDA-approved proton pump inhibitor for children, and its storage is stableFixation, accurate dosage, convenient administration, good taste, greatly improve the compliance of the child
.
Beimei Pharmaceutical and India Sipula Pharmaceutical signed an exclusive license agreement in China in October 2020 for the product, and the application for import imitation listing was undertaken by CDE in April 2021, and the product also attracted domestic star pharmaceutical companies such as Chengdu Yuandong Biologics and Aosaikang to participate in the imitation, and finally the imported generic drugs were approved first, or the domestic generic drugs won the first place, and we are waiting for the results
.
Data source: the official website of the National Medical Insurance Bureau, the intranet database, etc.
Note: Intranet "China's public medical institutions terminal competition pattern", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics, village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
Statistics as of September 15, if there are any errors and omissions, welcome to correct
.
A new faucet is born! Lizhu ultra-high-speed summit, Jichuan Yipin unique enterprise 6 varieties into the national procurement to free up tens of billions of space, new products into the medical insurance soaring continuous medical drugs 1 class of new drugs, improved new drugs broke out, tens of billions of market surprises continue to children's hospitals