Tonghua Dongbao stormed the 50 billion market!

Medical Network News on September 6 A few days ago, Tonghua Dongbao won the first oral hypoglycemic drug and officially entered the 25 billion oral hypoglycemic drug market
.
As the leader in domestic insulin, 2021H1 Tonghua Dongbao second-generation insulin preparations and APIs have revenue of 1.
280 billion yuan, an increase of 5.
92% year-on-year, and third-generation insulin APIs and preparations have revenue of 159 million yuan, an increase of 291.
87%
.
The company is actively deploying a full product line and innovative drugs in the field of diabetes.
Insulin aspart and compound hypoglycemic preparations are expected to be approved this year
.
The start of centralized insulin procurement is imminent, and a wave of price cuts will be set off.
How will Tonghua Dongbao respond?
Won the first oral hypoglycemic drug! Entering the 25 billion market
On August 30, the official website of NMPA showed that Tonghua Dongbao's sitagliptin phosphate tablets were approved for listing, becoming the company's first oral hypoglycemic drug
.
It is understood that the product is China's first use of biological synthesis of sitagliptin generics, CDE is the first use of a non-hydrolytic enzymes biosynthesis of doctors in recent years approved drugs species
.
Sitagliptin is a potent and highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor developed by Merck In patients, blood sugar control can be improved by increasing the level of active incretin hormone
.
In 2020, Merck’s Sitagliptin's global sales were 3.
306 billion U.
S.
dollars
.
In recent years, DPP-4 inhibitors have become the fastest-growing new oral hypoglycemic drugs in China
.
As the first DPP-4 inhibitor to be marketed in China, sitagliptin's sales are far ahead of similar products
.
According to Meinenet data, in 2020, the sales of terminal sitagliptin in China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) will exceed 1.
4 billion yuan, a year-on-year increase of 45.
55%.

.
The sales of sitagliptin in public medical institutions in China (unit: 10,000 yuan).
Source: Meinenet.
com.
The competitive landscape of terminal sitagliptin in public medical institutions in China.
, Including Chia Tai Tianqing Pharmaceutical Group, Dongyang Sun Pharmaceutical, Zhejiang Pharmaceutical , CSPC, Yangtze River Pharmaceutical Group and Tonghua Dongbao
.
According to data from Menet.
com, the sales of terminal oral hypoglycemic drugs in China's public medical institutions will be close to 25 billion yuan in 2020
.
The approval of sitagliptin phosphate tablets marked Tonghua Dongbao's official entry into the oral hypoglycemic drug market
.

Insulin, GLP-1, oral hypoglycemic drugs, full layout of diabetes product line
As a leading domestic second-generation insulin company , Tonghua Dongbao has focused on the development and production of diabetes drugs for more than 20 years
.
In recent years, the company has continued to increase its R&D investment in the field of oral hypoglycemic drugs while improving its insulin product pipeline to expand the market in the field of diabetes treatment
.
At present, Tonghua Dongbao produces and sells multiple dosage forms of second-generation insulin and insulin glargine in third-generation insulin.
At the same time, the pipeline is developed for other types of third-generation insulin, fourth-generation insulin, GLP-1 receptor agonist, and chemical oral administration.
Companies in the field of antidiabetic drugs, diabetes and other innovative drugs for the treatment of endocrine diseases have layouts
.

　　Among the three generations of insulins under development in Tonghua Dongbao’s diabetes field, the application for the listing of insulin aspart was accepted by the CDE in April 2019 and is expected to be approved before the end of 2021; insulin aspart 30 and insulin aspart 50 The listing application was accepted in July 2021
.
Among the fourth-generation insulins, the super fast-acting insulin lispro injection is undergoing phase I clinical trials, and the company is striving for parallel phase III clinical trials.

.
Among GLP-1 products, liraglutide will complete the phase III clinical database lock-in in June 2021, and the clinical trial summary is planned to be completed in December
.
According to data from Menet.
com, the sales of terminal liraglutide in China's public medical institutions will exceed 1 billion yuan in 2020, a year-on-year increase of 43.
55%
.
Currently, no domestic liraglutide injection has been approved, and Huadong Medicine first submitted a listing application in August 2021
.
Among oral hypoglycemic drugs, Tonghua Dongbao has a layout for SGLT-2 inhibitors, DPP-4 inhibitors and compound hypoglycemic drugs
.
Among them, the listing application for repaglinide tablets has been accepted in June 2021, and sitagliptin and metformin tablets are expected to be approved for marketing this year
.
According to data from Meinenet, in 2020, the sales of terminal repaglinide in public medical institutions in China will exceed 2 billion yuan, and the sales of sitagliptin and metformin will be close to 200 million yuan, a year-on-year increase of 78.
47%
.
Currently there Stockhausen medicine and other four companies approved generic repaglinide, metformin has sitagliptin East Sunshine Pharmaceutical, Merck and Hangzhou in east China and the US, three companies granted production
.
Class 1 new drug WXSHC071 capsule is a three-target inhibitor (SGLT1/SGLT2/DPP4), and it is the world's first product to treat type 2 diabetes that combines these three targets
.
Under the synergy of multiple target mechanisms, the product is expected to further strengthen the hypoglycemic effect, and at the same time achieve protection in cardiovascular, kidney, liver, etc.
, play the role of multiple mechanisms to play a superimposed effect, and establish in addition to hypoglycemic effect The basis of clinical benefit
.
At present, WXSHC071 capsule has been approved for clinical use, and its indication is blood glucose control for patients with type 2 diabetes
.

　　The second-generation insulin sold 1.
2 billion in half a year ! According to the
semi-annual report of the price cut of centralized procurement, Tonghua Dongbao achieved operating income of 1.
662 billion yuan in 2021H1, a year-on-year increase of 12.
71%, and net profit of 674 million yuan, a year-on-year increase of 24.
47%.

.
Among them, the main product human insulin raw materials and injection products achieved revenue of 1.
280 billion yuan, an increase of 5.
92% year-on-year, and the revenue of insulin analog raw materials and injection products was 159 million yuan, an increase of 291.
87% year-on-year
.
In 2021H1, Tonghua Dongbao's research and development expenses were 74.
538 million yuan, a year-on-year increase of 44.
33%
.
In addition to the independent research and development of a series of products in the field of diabetes treatment, Tonghua Dongbao is also actively introducing or cooperating with Class 1 innovative drugs, and is committed to becoming an explorer and leader in the research and development of innovative drugs in the endocrine field
.
In March 2021, Tonghua Dongbao and WuXi AppTec signed three project contracts for Class 1 new drugs for the treatment of diabetes, officially entering the field of innovative drug research and development
.
In June 2021, Tonghua Dongbao introduced two new class 1 drugs for the treatment of gout (hyperuricemia) through technology transfer, officially entering the field of hyperuricemia and gout, and is a further expansion of the company's endocrine field
.
The upcoming national centralized procurement of insulin is both a challenge and an opportunity for Tonghua Dongbao
.
On August 18, the National Medical Insurance Administration issued the "National Organization of Insulin Centralized Procurement Plan (Draft for Solicitation of Comments)", which mentioned that the centralized insulin procurement will start related work in September and will be implemented in early 2022.
The procurement cycle is two years
.
The document clarifies that the second and third generation insulins are included in the collection, and each generation is divided into three groups: quick-acting, basic and pre-mixed
.
The reporting volume adopts the principle of "basic volume + incremental", which is conducive to companies with good market reputation, strong after-sales service system and large production capacity
.
Regarding production capacity, Tonghua Dongbao has established a production base that has been put into use.
The designed production capacity of APIs is 3,000 kilograms per year, and the designed production capacity of preparations exceeds 150 million units per year
.
Taking into account the production capacity of the production bases under construction and planned, the total design production capacity of APIs is over 5,000 kilograms per year, and the total design production capacity of preparations is about 300 million units per year, and the production capacity is sufficient.

.
According to data from Meinenet, the sales of terminal insulin and similar drugs in China's public medical institutions will be close to 27 billion yuan in 2020, a year-on-year increase of 7.
91%
.
Entering September, the central procurement of insulin will be officially announced, and price cuts are inevitable, and production capacity and APIs have become the key to corporate bidding
.

　　Data source: Mi Nei.
com database, company announcement