This kind of hypoglycemic drug outbreak! Aosaikang successfully broke through, and Hengrui 1 class 1 new drug sprint

Recently, the research and development of new oral hypoglycemic drug DPP-4 inhibitors in China has ushered in good news: HSK7653 tablets of HiSco and plumagliptin tablets of CSPC Have completed two phase III clinical trials, reaching the preset endpoint and reporting production.

In recent years, the sales of domestic DPP-4 inhibitors have grown rapidly, and the overall scale of the three terminal 6 major markets (see the end of the article for statistical scope) has exceeded 4 billion yuan in 2021, and the proportion of the terminal diabetes drug market in public hospitals in key provinces and cities in the first quarter of 2022 has reached more than
10% again.
As domestic brands continue to innovate, the pattern of such oral hypoglycemic drugs is about to change dramatically
.
The market share is more than 10%! ORSA KANG became the domestic leader, Anda Tianqing soared 53 times DPP-4 inhibitors are drugs for the treatment of type 2 diabetes, by preventing DPP-4 from decomposing GLP-1, thereby increasing the level of GLP-1, and playing a role in
controlling blood sugar.
With its significant characteristics such as no effect on body quality, low incidence of hypoglycemia, and oral administration, DPP-4 inhibitors have gradually been fully recognized in clinical guidelines at home and abroad, and their therapeutic status has been continuously improved, gradually becoming one of the main forces in the hypoglycemic drug market and occupying a large market share
。 Figure 1: Changes in the share of DPP-4 inhibitors in the terminal diabetes drug market in key provincial and municipal public hospitals Source: Intranet Key Provinces and Cities Public Hospital Terminal Competition Pattern The terminal data of key provincial and municipal public hospitals in key provinces and cities released by Intranet shows that since 2019, DPP-4 inhibitors (full text does not contain compound preparations) have accounted for more than 10% of the diabetes drug market, and have risen steadily year by year, and the third batch of national procurement in 2020 and the fifth batch of national procurement in 2021 have each been included in a variety.
Under the influence of the wave of price cuts, the proportion in the first quarter of 2022 fell back to 11.
64%.

DPP-4 inhibitors can be divided into three stages of development in the domestic market: before 2019, it is the era of monopoly of multinational pharmaceutical companies; In 2019, Aosakon's saxagliptin tablets became the first approved domestic DPP-4 inhibitor, and then domestic generic drugs entered an outbreak era; After 2022 or 2023, this type of hypoglycemic drugs will enter the era of
domestic class 1 new drugs blowout.
Table 1: Changes in THE TOP5 enterprises of the terminal diabetes drug market in key provincial and municipal public hospitals Source: Intranet Key Provincial and Municipal Public Hospital Terminal Competition Pattern In 2006, Merck's sitagliptin was successfully listed as the world's first DPP-4 inhibitor, opening a new generation of oral hypoglycemic drugs, and the original research siglitine phosphate tablets successfully entered the domestic market in 2009, opening a new chapter
for the domestic hypoglycemic drug market 。 Subsequently, AstraZeneca's saxagliptin tablets (2011), Novartis' vigliglitin tablets (2011), Boehringer Ingelheim's liglitine tablets (2013), and Takeda Pharmaceutical's alogliptin benzoate tablets (2013) have been approved for import, and multinational pharmaceutical companies have monopolized the domestic DPP-4 inhibitor market
.
In August 2021, the diglittine hydrobromide tablets developed by Mitsubishi Tanabe were approved for import, and the competition for the domestic diabetes drug market by foreign companies is still fierce
.
In 2019, Jiangsu Aosaikang Pharmaceutical's saxagliptin tablets were approved as the first imitation, becoming the first DPP-4 inhibitor generic drug in China, breaking the monopoly situation
of multinational pharmaceutical companies.
After the product was listed, the terminal sales of public hospitals in key provinces and cities soared, with growth rates of 2077% and 259% in 2020-2021, respectively, and 339% in the first quarter of 2022, helping enterprises to directly rush to the TOP4
.
Qilu Pharmaceutical won vilogtin tablets in 2019 and scaglitin tablets
in 2021.
Thanks to the rapid growth of these two products, the company's ranking rose to TOP6 in 2021, and there was also a growth rate of 255% in the first quarter of 2022, and the ranking remained unchanged
.
In July 2022, Qilu Pharmaceutical (Hainan) was approved for siglitine phosphate tablets, and the company's product matrix in the DPP-4 inhibitor market was stronger
.
Chia Tai Tianqing Pharmaceutical Group won the production approval of siglitine phosphate tablets and saxagliptin tablets in 2020
.
In the first quarter of 2022, the company's saxagliptin tablets increased by 5300% in terminal sales in public hospitals in key provinces and cities, helping the company's ranking rise to TOP7
.
Jiangsu Haosen Pharmaceutical Group was approved for vifiliptin tablets in 2019 and saxagliptin tablets
in 2020.
The two major products rose significantly, and the company's overall growth rate in the first quarter of 2022 was 511%, ranking up to TOP8
.
73 generic drugs ignite market passion, collection to promote the rise of domestic brands Data from the intranet data show that since 2019, domestic DPP-4 inhibitors have been approved, 2020 and 2021 is the approved blowout period, and the number of approved domestic DPP-4 inhibitor approvals is 73, involving 6 major products
。 Table 2: Currently approved domestic DPP-4 inhibitors Source: Mionenet MID drug index comprehensive database From the perspective of enterprises, Dongyang Medicine has sitagliptin phosphate tablets, aglitine benzoate tablets, and lifiglitine tablets; Qilu (including Hainan Company) has sitagliptin phosphate tablets, saxagliptin tablets, viglatin tablets; Lithiocemia has alogliptin benzoate tablets, sitagliptin phosphate tablets, lifittine tablets; Kelun has siglitine phosphate tablets, lifittine tablets, and triprigliptin succinate tablets, and the product matrix of 4 domestic pharmaceutical companies is currently rich
.
Figure 2: Approval of tragretine succinate tablets Source: Minnet New Edition Database Kolen's traglittine succinate tablets are currently domestic exclusive and approved in March this year, which is a long-acting DPP-4 inhibitor that can be
administered once a week.
The original research drug has not yet entered the domestic market, and the market potential of Coron can be expected
.
Table 3: DPP-4 inhibitors won by the national procurement Source: Minnet China China Public Medical Institutions Terminal Competition Pattern The third and fifth batches of national procurement included vigglitine tablets and saxagliptin tablets, respectively, the third batch of execution time is the fourth quarter of 2020, while the fifth batch of execution time is the fourth quarter
of 2021.
Before 2019, only imported drugs were approved for vifiglitin tablets, and Novartis monopolized the market
.
In March 2019, Howson won the first domestic imitation, and as of now, there are 18 domestic approvals, involving 18 domestic pharmaceutical companies
.
The third batch of national procurement has 6 domestic pharmaceutical companies winning the bid, and after Novartis lost the standard, the market share of terminals 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) was only about 34%, while the 6 winning bidders won more than 65% of the market share
in total.
As mentioned above, Aosaicon won the domestic first imitation of saxagliptin tablets in 2019, breaking the monopoly situation of AstraZeneca, and as of now there are 9 domestic approvals, involving 5 domestic pharmaceutical companies
.
From 2020 to 2021, in the terminal of Public Medical Institutions in China, Aosaicon has grown rapidly with a growth rate of 6675% and 230%, and has become the strongest opponent
of AstraZeneca.
The fifth batch of national procurement of 4 domestic pharmaceutical companies won the bid, and after the complete implementation period, the situation of domestic brands controlling the market is expected to be achieved
.
Figure 3: More than 3 enterprises that have not yet been included in the national procurement of product sales (: 10,000 yuan) Source: Intranet China China's public medical institutions terminal competition pattern As of now, the number of evaluated enterprises exceeds 3 and the DPP-4 inhibitors that have not been included in the national collection include alogliptin benzoate tablets, lifittine tablets and sitagliptin phosphate tablets
。 Recently, the State Intellectual Property Office ruled that Dongguang Pharmaceutical infringed a patent for Boehringer Ingelheim to protect the lifiglitin compound, and Dongguang was ordered to stop producing and selling the lifiliptin generic drug, the latest information shows that the patent expiration time of alogliptin benzoate tablets is 2024, and the products involving patent issues are unlikely
to be included in the eighth batch of national procurement.
Some time ago, listed pharmaceutical companies such as Gan&Lee Pharmaceutical and Huadong Pharmaceutical said in response to investors' questions that the original drug patent of sitagliptin phosphate tablets expired
in July 2022.
At present, 14 companies have won the production approval of sigueliptin phosphate tablets, and if they successfully sit on the national procurement express, it will trigger a huge change in
the market.
Hengrui leading 1 class of new drugs, CSPC, Hisco is about to report production, Yuan Dong has attracted much attention DPP-4 inhibitors have good blood sugar control, low blood sugar risk, does not affect weight and other advantages, elderly patients use is relatively safe, with the domestic aging process continues to advance, clinical demand is also increasing
.
Due to the impact of the original drug patent and other issues, the current market sales of DPP-4 inhibitors are not too much, domestic pharmaceutical companies riveting full of energy waiting for the "opening gate" at the same time, but also actively began to layout a new class of 1 drugs, turn passive into active
.
Figure 4: Currently reported and under review of PP-4 inhibitors domestic 1 new drugs Source: Minnet new version of the database Hengrui began to lay out diabetes drugs more than ten years ago, earlier the company has taken down metformin hydrochloride extended-release tablets, rosiglitazone tablets and other oral hypoglycemic drugs, but the sales situation is not prominent
.
At the end of 2021, the company's proline hengrliflozin tablets were approved, the product is the first domestic innovative SGLT2 inhibitor, and marks the opening of a new chapter in the domestic diabetes drug market of Hengrui, it is reported that the product has been officially commercially listed
in China in May this year.
Resigliptin phosphate tablets are Hengrui's second oral hypoglycemic drug class 1 new drug,According to reports, its structure is similar to siblastine, and proline hengpagliflozin tablets are also submitted for listing in September 2020, and the probability of approval before the end of this year is still large
.
If successfully approved, the new drug is expected to become the first domestic innovative DPP-4 inhibitor, helping Hengrui to show its strength
in the diabetes drug market.
Table 4: Some of the DPP-4 inhibitors that are currently undergoing clinical trials of domestically produced new drugs Source: Minnet China Drug Clinical Trial Publicity Library On August 22, CSPC Pharmaceutical Group issued an announcement that the company's two key clinical trials of class 1 new drug plumagliptin tablets (DBPR108 tablets) for the treatment of type 2 diabetes have reached preset endpoints, and the group will submit an application for pre-market communication to NMPA, and the current phase II clinical trial of DBPR108 capsules has also been completed and is progressing smoothly
。 CSPC Pharmaceutical Group continues to cultivate in diabetes medication, and before 2020, it has won a number of oral hypoglycemic drugs such as acarbose tablets, metformin hydrochloride extended-release tablets, metformin hydrochloride tablets, etc.
, of which metformin hydrochloride extended-release tablets will also exceed 100 million yuan in terminal sales in public medical institutions in China in 2021, and in 2021, it will take agliptin benzoate tablets, lifiliptin tablets, and sitagliptin phosphate tablets, adding a heavy member
to the company's diabetes drug product matrix 。 On August 25, HiSco issued an announcement that the company's Class 1 new drug HSK7653 tablets have completed two Phase III clinical trials and reached the preset end point, and the company will submit a listing application to NMPA as soon as possible in accordance with relevant regulations
.
If HSK7653 tablets are successfully approved for marketing, it will become the world's first bi-weekly preparation of hypoglycemic drugs, and hisco's currently listed products do not involve diabetes medication
.
In addition, eulogigliptin tablets and shengagliptin phosphate tablets are currently undergoing phase III clinical trials
.
Yuan Dong's eulogliptin tablets are a weekly preparation, half-life, after taking 7 days its DPP-4 inhibition rate can still reach 80%, the company has said that the product is expected to be approved
as soon as the end of 2024 。 Source: Intranet database, company announcements, 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 competition pattern database of chemical drug terminals in key provincial and municipal public hospitals in key provinces and cities of The Minenet is based on the chemical drug procurement data of 20+ provinces and cities and nearly 700 sample provincial and municipal public hospitals, and continuously monitors the whole category of chemical drugs; The above sales are calculated
based on the average retail price of the product at the terminal.
Statistics as of August 31, if there is any omission, welcome to correct! The market share is more than 10%! Ao Sai Kang into a domestic leader, Chia Tai Tianqing soared 53 times the enterprise pharmaceutical hospital 73 generic drugs ignited market passion, collection to promote the rise of domestic brands of medicine Hengrui led 1 class of new drugs, stone medicine, Haisco reported production is imminent, Yuan Dong has attracted much attention to procurement