Kelun and Hengrui launched the seventh batch of antithrombotic class 1 new drugs, which have entered the reporting stage

In recent years, domestic pharmaceutical companies have paid more and more attention to the antithrombotic drug market, and they have gained a lot
.

The data shows that there are 27 domestic antithrombotic drugs approved for marketing in 2019 (the following are counted according to approval documents), of which 11 are deemed to have been reviewed; In 2018, 86 were approved for marketing, of which 1 was a 2.

Class 1 antithrombotic new drugs are super bright, Hengrui and Kelun make efforts, Bio-Otai sprints

Class 1 antithrombotic new drugs are super bright, Hengrui and Kelun make efforts, Bio-Otai sprints

Table 1: Some domestic class 1 new antithrombotic drugs declared and approved for clinical use in 2021

Source: CDE official website

Hengrui’s SHR2285 tablets were first declared in 2018, when the clinical indications were “prevention or treatment of arterial and venous thrombosis and reduction of thromboembolism risk caused by interventional therapy or cardiopulmonary bypass”.
Currently, Phase I clinical trials have been completed; The clinical indication that will be declared and approved in 2021 is "for the prevention of venous thromboembolism after joint replacement in adult patients", and phase II clinical trials are currently underway
.

Microtek's MT1002 for injection is a new class 1 dual anti-coagulant drug.
This product has both specific and reversible direct thrombin II inhibition and platelet glycoprotein IIb/IIIa receptor antagonism.
It effectively solves the problem of drug compatibility and dosage and reduces the risk of bleeding
.

Among the products currently on the market and under clinical research, there is no antithrombotic drug targeting the two target receptors at the same time

drug

Xinlitai's SAL0104 capsule is a coagulation factor XIa inhibitor, and the intended indication is the prevention and treatment of thrombotic diseases
.

Xin Litai said that compared with similar products, coagulation factor XIa inhibitors have the characteristics of low bleeding risk while reducing the incidence of thrombosis, and have great market potential.

disease

Shuanglu Pharmaceutical's DT678 tablet is a P2Y12 receptor antagonist, which is the world's first innovative drug in the field of anti-platelet aggregation drugs
.

It is reported that DT678 tablets do not need to be converted by hepatic cytochrome p450 enzyme (CYP), but only in the presence of endogenous glutathione.

Kelun's SKB336 injection is a new class 1 biological drug.
It is a humanized monoclonal antibody targeting FXIa/FXI factor.
It is intended to be used for the prevention and treatment of thromboembolic diseases.
At present, there is no approved drug for the same target in the world.
The drug is currently undergoing Phase I clinical trials
.

Figure 1: Bio-Thera's Batifiban Injection Application Status

Source: One-click retrieval from Minet

Bio-Thera's class 1 new drug, batifiban injection, is a synthetic platelet glycoprotein IIb/IIIa receptor antagonist, which not only has a strong affinity for the target (that is, it can inhibit platelet aggregation), but also inhibits glass-based protein (Vitronectin) receptors inhibit vascular smooth muscle growth, thereby preventing arterial re-occlusion
.

It is worth noting that Bio-Thera was approved for clinical use in 2006 and will be applied for marketing in 2020.

The pattern of 6 major varieties of national mining has been reshaped, and the seventh batch is aimed at 3 heavyweight injections

Five batches and six rounds of chemical drug national procurement have been carried out, and a total of 6 antithrombotic drugs have been included.
It is reported that the seventh batch of national procurement has entered the reporting stage.
This time, fondaparinux sodium injection, tiro A new round of fierce battle is about to start for non-ban injection and eptifibatide injection
.

Table 2: Changes in the market share of antithrombotic drugs that have been included in the national procurement earlier

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

Judging from the time of implementation, the fifth batch (dabigatran etexilate capsules, rivaroxaban tablets) will be launched in the fourth quarter of 2021.
At present, the changes in the market structure have not yet been seen, but the implementation has been implemented earlier.
Four products, Clopidogrel Hydrogen Sulfate Tablets, Apixaban Tablets, Ticagrelor Tablets, and Bivalirudin for Injection, have been reshuffled in the corporate landscape of public medical institutions in China
.

Clopidogrel Hydrogen Sulfate Tablets is a super heavyweight antithrombotic drug.
It is used in urban public hospitals , county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) terminals in China.
The sales of this product are in 2017- In 2019, the average exceeded 10 billion yuan
.

Before being included in the national procurement, the original research pharmaceutical company Sanofi has always occupied more than half of the country, with a share of 58.

Hospital

The current global sales of apixaban tablets have already exceeded 10 billion US dollars.
Since this product entered China in 2013, Bristol-Myers Squibb has been monopolizing the market
.

Since 2019, domestic high-end generic drugs have been approved for the market one after another, which has boosted the market size of this product.

medicine

Ticagrelor tablets are AstraZeneca's over 1 billion varieties.
In 2018, Xinlitai won the first domestic imitation.
Since 2019, domestic high-end generic drugs have ushered in a blowout.
The sales of this product in China's public medical institutions have risen to 1.
69 billion yuan in 2018
.

The third batch and the fourth batch of Guocai included products of different specifications respectively.

enterprise

The first antithrombotic injection that was included in the country, bivalirudin for injection was caught in a "civil war"
.
According to data from Minet.
com, before being included in the national procurement, in 2020, the product will be divided into more than 90% of the market by Xinlitai and Hansoh, and the original research pharmaceutical companies have no place to stand
.
The fourth batch of national procurement will be implemented in the second quarter of 2021.
Qilu Pharmaceutical, Hainan Shuangcheng Pharmaceutical, and Hainan Puli Pharmaceutical will start "involution" after winning the bid.
In the first half of 2021, Xinlitai's market share fell to 43.
37%, Qilu Pharmaceuticals took the lead in rising to 9.
43%.
Whether the TOP1 companies will change owners deserves follow-up attention
.

Table 3: Antithrombotic Drugs in the Seventh Batch of National Acquisition Reports

Source: MED 2.
0 National Drug Evaluation Database

According to the news, the joint procurement agency has issued the seventh batch of national procurement report volume documents to various medical institutions earlier, and the report volume work has now been started.
This time, three antithrombotic drugs are involved, all of which are injection products
.
In the first half of 2021, tirofiban, fondaparinux, and eptifibatide ranked sixth, seventh and fifteenth among the TOP20 terminal antithrombotic drug injections in Chinese public medical institutions.
In terms of sales amount , these 3 injections are all products of 100 million yuan level
.

Fondaparinux sodium injection is currently led by Jiangsu Hengrui Medicine, with a market share of more than 55% in the first half of 2021, while the original pharmaceutical company Aspen also occupies 21% of the market; tirofiban injection is currently led by Lunanfiber Pharmaceuticals, The market share in the first half of 2021 exceeds 54%, followed by Grand Pharmaceuticals (China) with 40%.
The original research pharmaceutical company Correvio has lost its competitive advantage; eptifibatide injection is currently leading the market by Shanxi Deyuantang Pharmaceutical.
The share is as high as 67.
31%.
We will wait and see whether Shenzhen Hanyu Pharmaceutical (32.
69%), which ranks second, can seize the leading position by taking the opportunity of centralized procurement
.

The exclusive variety for oral administration has skyrocketed by 180%, and the "destiny" of 9 billion injections has attracted attention

The exclusive variety for oral administration has skyrocketed by 180%, and the "destiny" of 9 billion injections has attracted attention

Table 4: Top 10 antithrombotic drugs for oral administration and injection in the first half of 2021

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

According to the data from Minet.
com, the ranking of the top 10 varieties of antithrombotic drugs for oral administration and injection in the terminal antithrombotic drug market of public medical institutions in China in the first half of 2021 has undergone great changes: clopidogrel has fallen back to the second line, and aspirin (acetyl acetylide) is the only large variety that exceeds 1 billion yuan.
Salicylic acid) has not yet been included in the national procurement, and currently only aspirin enteric-coated tablets of Chenxin Pharmaceutical have been reviewed.
In addition, it is worth noting that the exclusive variety of indobufen in East China has been included in the 2017 version of the National Medical Insurance Catalogue.
After the rapid growth of sales, it has exceeded 200 million yuan in 2020.
It is undoubtedly a group of super dark horses in the internal service market
.

Figure 2: Sales of indobufen (unit: ten thousand yuan)

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

Since the fourth batch of national procurement, antithrombotic injections have been included, and the seventh batch has also targeted 3 blockbuster injections.
The fate of low molecular weight heparin, alteplase and heparin with sales of more than 1 billion yuan in 2020 It has also attracted the attention of the market
.

Heparin drugs include unfractionated heparin and low-molecular-weight heparin.
Currently, low-molecular-weight heparin preparations are recognized by the market as having better efficacy.
The market size of terminal low-molecular-weight heparin injections in Chinese public medical institutions continues to rise.
up to 13.
55%
.

At present, there are only two products that have been reviewed/deemed to be reviewed for low molecular weight heparin injection.
The companies that have been reviewed/deemed to be reviewed for Enoxaparin Sodium Injection include Tianjin Hongri Pharmaceutical, Shenzhen Tiandao Pharmaceutical, and Changzhou Qianhong Biochemical Pharmaceutical.
Only Tianjin Biochemical Pharmaceutical Co.
, Ltd.
has reviewed Nadroparin Calcium Injection
.
At present, dalteparin sodium injection (3 companies), nadroparin calcium injection (3 companies), enoxaparin sodium injection (5 companies), nadroparin calcium injection for injection (1 Home), Enoxaparin Sodium for Injection (1 home), with more product reviews, it is only a matter of time before low molecular weight heparin injection is included in national adoption
.
In addition, Shandong, Guangxi and other provincial-level centralized procurement have also included low molecular weight heparin preparations earlier, and the results of local centralized procurement will also provide more ideas and experience for national procurement
.