Over 1 billion anesthesia blockbuster "Sugeng Sodium Gluconate", Qilu and Huilun two generic drugs were approved on the same day

Shugeng Sodium Gluconate, known as a major drug discovery in the field of anesthesia in the past 20 years, has ushered in a new trend today
.

On October 26, according to the latest announcement on the official website of the National Medical Products Administration (NMPA), Qilu Pharmaceutical and Huilun Jiangsu Pharmaceutical's two sugammadex sodium injections were rejected at the same time
.

Screenshot from NMPA

1 Over 1 billion blockbuster products

Over 1 billion blockbuster products

It is reported that Bridion was discovered by OrganonBiosciences and then acquired by Merck for development.
In 2008, Bridion was first approved for marketing in the EU, becoming the first selective relaxation used to reverse neuromuscular blockers.
Antagonist
.

Among them, neuromuscular blockade refers to the patient's use of muscle relaxants during surgery.
After the operation, the neuromuscular function has not returned to the normal level, which causes functional limitations such as breathing, vision, and swallowing, which can cause severe postoperative complications.
Respiratory dysfunction directly threatens the lives of patients
.

In clinical surgical anesthesia, Sodium Gluconate can help patients under general anesthesia accurately and quickly reverse the deep and moderate muscle relaxation state, promote the patient's recovery of spontaneous breathing and limb mobility, and help improve the patient's postoperative outcome.

Public information shows that Sodium Gluconate is a γ-cyclodextrin derivative that antagonizes aminosteroids and non-depolarizing muscle relaxants.
It is a ring structure composed of 8 glucose molecules, which can form affinity in plasma.
Lipid core and hydrophilic outer end
.

Its lipophilic core can just wrap rocuronium, vecuronium and other aminosteroid non-depolarizing muscle relaxants to form stable water-soluble compounds, which are excreted in the urine through the kidneys, thereby reversing The pharmacological effects of rocuronium and vecuronium in neuromuscular blockade

It is worth mentioning that a large number of clinical trials have confirmed that sugammadex sodium can be used for the antagonism of aminosteroid non-depolarizing muscle relaxants quickly, effectively and safely, and is superior to acetylcholinesterase inhibitors.
Neostigmine is of great clinical significance, especially for antagonizing muscle relaxation in patients with special conditions
.

Based on this, Shugeng Sodium Gluconate has been approved for listing in more than 70 countries around the world, including the European Union, the United States, China, and Japan
.

According to Merck’s financial report, the global sales of Sodium Gluconate has increased from US$261 million in 2012 to US$1.

As Qilu Pharmaceutical and Huilun Jiangsu Pharmaceutical's Shugeng Sodium Gluconate Injection were officially rejected, it has not broken Merck’s Bridion's unique domestic market structure
.

2 over 40 models under development

Over 40 models under development

In 2017, Sugan Gluconate Sodium (Buritin) was officially approved for marketing in China for antagonizing rocuronium or vecuronium-induced neuromuscular blockade in adults and in children and adolescents (2-17 Years old), this product is only recommended for routine antagonism of rocuronium-induced blockade
.

Among them, rocuronium and vecuronium are common non-depolarizing muscle relaxants in clinical practice and are auxiliary drugs for general anesthesia
.

In recent years, about 20 million patients in China receive general anesthesia operations each year, but 30%-60% of patients use muscle relaxants and cause neuromuscular blockade, resulting in severe hypoxia, upper respiratory tract obstruction and other complications, affecting their operations Rehabilitation and increase postoperative mortality

As an antagonist of non-depolarizing steroid muscle relaxants, Shugeng Sodium Gluconate can quickly combine with free rocuronium in the blood after intravenous injection to rebuild the neuromuscular transmission function, thereby quickly restoring the patient's autonomy The ability of breathing and limb movement can provide better anesthesia management for surgery
.

According to data from Minai.
com, Buriting’s sales in urban public medical institutions in China in 2019 and 2020 will be 70.
79 million yuan and 166 million yuan, respectively
.

It is worth mentioning that the domestic compound patent of Sodium Gluconate has expired in November 2020, and according to the official website of CDE, as of now, there are over 40 generic Sodium Gluconate drugs in the R&D stage.
Including nearly 20 pharmaceutical companies such as Hengrui, Kelun Pharmaceutical, Yangtze River, and Chia Tai Tianqing
.

Sodium gluconate generic drugs are being developed in China (Collected by Shell Club)

In addition, 16 companies such as Kelun Pharmaceutical, Yangtze River, Chia Tai Tianqing and other 16 companies' Shugeng Sodium Gluconate Injection have been declared for the market, and the generic drug war is about to start
.

summary

With the continuous growth of the domestic aging population and the increase in the incidence of major diseases caused by various reasons, the rigid demand for surgical treatment has also shown a strong growth trend
.

Sedation, analgesia, and muscle relaxation drugs are currently clinically recognized as the "general anesthesia balance triangle", and neuromuscular blockade drugs are one of the important factors for the smooth implementation of general anesthesia

As a widely used and safe muscle relaxant antagonist, Sodium Gluconate, no matter which generic drug is approved for marketing, will benefit the development of the domestic anesthesia field