This kind of hypoglycemic drug outbreak! Aosaikang successfully broke through, Hengrui Class 1 new drug sprint, Haisco and Stone Medicine joined the fire

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.

The market share is more than 10%! Orsai Kang became a domestic leader, and the Sunshine soared 53 times

DPP-4 inhibitors are drugs used to treat type 2 diabetes and exert the effect

Figure 1: Changes in the share of DPP-4 inhibitors in the terminal diabetes drug market in public hospitals in key provinces and cities

Source: Intranet key provinces and cities public hospital terminal competition pattern

The terminal data of key provincial and municipal public hospitals in the first quarter of 2022 released by Intranet shows that since 2019, DPP-4 inhibitors (the 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 included a variety, and under the influence of the tide of price cuts, the proportion in the first quarter of 2022 has fallen back to 11.

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

Table 1: Changes in TOP5 enterprises of DPP-4 inhibitors in the terminal diabetes drug market of public hospitals in key provinces and cities

Source: Intranet key provinces and cities 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 of sitagliptin phosphate tablets successfully entered the domestic market in 2009, opening a new chapter

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

Qilu Pharmaceutical won vilogtin tablets in 2019 and scaglitin tablets

Chia Tai Tianqing Pharmaceutical Group won the production approval of siglitine phosphate tablets and saxagliptin tablets in 2020

Jiangsu Haosen Pharmaceutical Group was approved for vifiliptin tablets in 2019 and saxagliptin tablets

73 generic drugs ignited market passion and promoted the rise of domestic brands

According to the data of the intranet, since 2019, domestic DPP-4 inhibitors have been approved, and 2020 and 2021 are the approved blowout period, and the number of approved domestic DPP-4 inhibitor approvals is 73, involving 6 major products

Table 2: Domestically approved DPP-4 inhibitors

Source: Minnet MID Drug Index Comprehensive Database

From the perspective of enterprises, Dongguang Medicine has siglitine phosphate tablets, alogliptin benzoate tablets, and lifittine 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 tripridgetin succinate tablets

Source: New version of the Intranet database

Coron's trafiglitine succinate tablets, which are currently domestically exclusive and approved in March this year, are a long-acting DPP-4 inhibitor that can be

Table 3: The DPP-4 inhibitor that won the bid in the national mining

Source: Intranet China China Public Medical Institutions Terminal Competition Pattern

The third and fifth batches of national procurement included vilogliptin tablets and saxagliptin tablets respectively, and the third batch of execution time was the fourth quarter of 2020, while the fifth batch of execution time was the fourth quarter

Before 2019, only imported drugs were approved for vifiglitin tablets, and Novartis monopolized the market

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

Figure 3: Sales of products that have not yet been included in the national procurement of more than 3 enterprises (unit: 10,000 yuan)

Source: Intranet China China Public Medical Institutions Terminal Competition Pattern

Up to now, the number of rated enterprises exceeds 3 and the DPP-4 inhibitors that have not been included in the national collection include aloglistine 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 leads the 1 class of new drugs, CSPC and Haisco are about to be produced, and Yuan Dong has attracted much attention

DPP-4 inhibitors have the advantages of good blood sugar control, small risk of hypoglycemia, and do not affect weight, and it is safer for elderly patients to use, and with the continuous advancement of the domestic aging process, 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 DPP-4 inhibitors domestically produced Class 1 new drugs

Source: New version of the Intranet database

Hengrui began to lay out diabetes drugs more than ten years ago, and earlier the company has taken a number of oral hypoglycemic drugs such as metformin hydrochloride extended-release tablets and rosiglitazone tablets, but the sales situation is not outstanding
.
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.

Repaglitine phosphate tablets are Hengrui's second oral hypoglycemic drug class 1 new drug, according to reports that its structure is similar to siglidine, and proline hengliflozin tablets were also submitted in September 2020 for listing applications, 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 new domestic 1 drugs of DPP-4 inhibitors that are undergoing clinical trials

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, the group will submit an application for pre-market communication to NMPA, and the production is imminent, 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
.