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Sihuan Pharmaceutical announced on December 21 that the anticoagulant drug Fondaparinux Sodium Injection (specification: 0.
5 ml: 2.
5 mg) developed by the group was approved for drug registration issued by the China National Food and Drug Administration, and was approved for production.
It is deemed to have passed the consistency evaluation of the quality and efficacy of generic drugs
.
Fondaparinux is a new type of synthetic anticoagulant for coagulation factor X.
It has the advantages of high bioavailability, fast onset, and long half-life
.
Compared with traditional anticoagulant drugs, Fondaparinux can not only reduce cardiovascular events, but also reduce the risk of bleeding, showing good clinical effectiveness and safety
.
Fondaparinux sodium injection is suitable for patients undergoing major orthopedic surgery of the lower limbs, such as hip fracture, major knee surgery or hip replacement, to prevent the occurrence of venous thromboembolism; for emergency without indication (<120 minutes ) Treatment of patients with unstable angina pectoris or non-ST-segment elevation myocardial infarction (UA/NSTEMI) with invasive treatment (PCI); for ST-segment elevation myocardial infarction who are treated with thrombolysis or not initially receiving other forms of reperfusion therapy Treatment of patients
.
It is understood that Fondaparinux was originally researched by Sanofi-Sundraberg Group and Organon, and then transferred to GlaxoSmithKline (GSK).
It was approved for listing in the United States in 2001, and was subsequently released in 2002.
It was launched in Europe and Japan in 2007
.
In 2008, Fondaparinux entered the Chinese market.
In 2015, it was changed to the product of Irish Aspen Company.
In 2017, it entered the National Medical Insurance Category B catalog
.
.
IMS data shows that the global sales of Fondaparinux Sodium Injection in 2019 are approximately US$210 million
.
In the domestic market, Fondaparinux Sodium Injection is in a stage of rapid growth
.
Data show that since 2017, the sales of Fondaparinux sodium injection in hospitals across the country have increased year by year.
In 2020, it has exceeded 204 million yuan, a year-on-year increase of 116.
3%.
Entering 2021, sales of this product from January to September 2021 The amount increased by more than 320.
0% year-on-year.
The industry predicts that in 2021, my country's Fondaparinux sodium injection sales will reach 502 million yuan
.
Regarding the development prospect of Fondaparinux Sodium Injection, some analysts pointed out that Fondaparinux Sodium Injection is a new generation of anticoagulant drugs, applicable to a wide range of people, and the approved indications are increasing, and the future market prospects are promising
.
At present, China’s Fondaparinux sodium injection market is in a stage of rapid growth.
However, due to the high production technology threshold, there are fewer domestic companies in the market.
Therefore, the market competition is relatively slow.
In the future, as the number of relevant filing companies increases, Fondaparinux Competition in the sodium injection market will gradually intensify
.
According to the inquiry, there are 7 domestic manufacturers approved to produce Fondaparinux sodium injection.
In addition to Sihuan Pharmaceutical, there are Aspen, Hengrui Pharmaceutical, Borui Pharmaceutical, Hisco, Zhaoke Pharmaceutical, and Nanjing Jianyou
.
Among them, Hengrui Medicine won the first imitation of this product in 2018
.
At present, in addition to Sihuan Pharmaceutical, four companies that have passed the consistency evaluation of Fondaparinux Sodium Injection include Hengrui Pharmaceutical, Nanjing Jianyou, Zhaoke Pharmaceutical, and Yangzijiang Pharmaceutical.
In addition, many companies are under review and approval.
.
It is foreseeable that in the future, competition in the anticoagulant drug market of over 500 million yuan will become fierce
.
Sihuan Pharmaceutical stated that as the product obtains the approval for drug registration, it is expected to benefit the future market sales and market competition of the product, and will further benefit the majority of patients, which will have a positive impact on the group's operating results
.
5 ml: 2.
5 mg) developed by the group was approved for drug registration issued by the China National Food and Drug Administration, and was approved for production.
It is deemed to have passed the consistency evaluation of the quality and efficacy of generic drugs
.
Fondaparinux is a new type of synthetic anticoagulant for coagulation factor X.
It has the advantages of high bioavailability, fast onset, and long half-life
.
Compared with traditional anticoagulant drugs, Fondaparinux can not only reduce cardiovascular events, but also reduce the risk of bleeding, showing good clinical effectiveness and safety
.
Fondaparinux sodium injection is suitable for patients undergoing major orthopedic surgery of the lower limbs, such as hip fracture, major knee surgery or hip replacement, to prevent the occurrence of venous thromboembolism; for emergency without indication (<120 minutes ) Treatment of patients with unstable angina pectoris or non-ST-segment elevation myocardial infarction (UA/NSTEMI) with invasive treatment (PCI); for ST-segment elevation myocardial infarction who are treated with thrombolysis or not initially receiving other forms of reperfusion therapy Treatment of patients
.
It is understood that Fondaparinux was originally researched by Sanofi-Sundraberg Group and Organon, and then transferred to GlaxoSmithKline (GSK).
It was approved for listing in the United States in 2001, and was subsequently released in 2002.
It was launched in Europe and Japan in 2007
.
In 2008, Fondaparinux entered the Chinese market.
In 2015, it was changed to the product of Irish Aspen Company.
In 2017, it entered the National Medical Insurance Category B catalog
.
.
IMS data shows that the global sales of Fondaparinux Sodium Injection in 2019 are approximately US$210 million
.
In the domestic market, Fondaparinux Sodium Injection is in a stage of rapid growth
.
Data show that since 2017, the sales of Fondaparinux sodium injection in hospitals across the country have increased year by year.
In 2020, it has exceeded 204 million yuan, a year-on-year increase of 116.
3%.
Entering 2021, sales of this product from January to September 2021 The amount increased by more than 320.
0% year-on-year.
The industry predicts that in 2021, my country's Fondaparinux sodium injection sales will reach 502 million yuan
.
Regarding the development prospect of Fondaparinux Sodium Injection, some analysts pointed out that Fondaparinux Sodium Injection is a new generation of anticoagulant drugs, applicable to a wide range of people, and the approved indications are increasing, and the future market prospects are promising
.
At present, China’s Fondaparinux sodium injection market is in a stage of rapid growth.
However, due to the high production technology threshold, there are fewer domestic companies in the market.
Therefore, the market competition is relatively slow.
In the future, as the number of relevant filing companies increases, Fondaparinux Competition in the sodium injection market will gradually intensify
.
According to the inquiry, there are 7 domestic manufacturers approved to produce Fondaparinux sodium injection.
In addition to Sihuan Pharmaceutical, there are Aspen, Hengrui Pharmaceutical, Borui Pharmaceutical, Hisco, Zhaoke Pharmaceutical, and Nanjing Jianyou
.
Among them, Hengrui Medicine won the first imitation of this product in 2018
.
At present, in addition to Sihuan Pharmaceutical, four companies that have passed the consistency evaluation of Fondaparinux Sodium Injection include Hengrui Pharmaceutical, Nanjing Jianyou, Zhaoke Pharmaceutical, and Yangzijiang Pharmaceutical.
In addition, many companies are under review and approval.
.
It is foreseeable that in the future, competition in the anticoagulant drug market of over 500 million yuan will become fierce
.
Sihuan Pharmaceutical stated that as the product obtains the approval for drug registration, it is expected to benefit the future market sales and market competition of the product, and will further benefit the majority of patients, which will have a positive impact on the group's operating results
.
