The third listing application for cyclophenol was accepted

February 6, according to the CDE official website, Hesco Pharmaceutical cyclophenol injection 2.4 new drug application was accepted, this is the third application for the listing of cyclophenol injection in China, the author guesses that the declaration of the adaptive disorder is: fiber bronchoscopy treatment sedation and/or anesthesia.
phenol (research and development code: HSK348) is a class 1.1 innovative drug developed by Hesco Pharmaceuticals after eight years of research and development, with fully independent intellectual property rights, and the first intravenous anesthetic drug in China to innovate its own compounds.
The drug is a new build-up to the classic anaesthetic sedative propofol, with multiple benefits such as rapid action and quick wake-up; less dosing, wider safety windows; less respiratory suppression; fewer cardiovascular adverse events; less injection pain; less operation and easier use.
According to the insight database, up to now, a total of 20 clinical trials of cyclophenols have been registered in China (see table below), and adaptations include sedation and anesthesia of adult endoscopic procedures, induction of general anaesthetic in adults, and sedation during intensive care.
August 2019, the first domestic listing application for cyclophenols was accepted by CDE for the diagnosis and treatment of sedative and/or anesthesia in the digestive tract endoscopy.
december 2020, the listing application was approved by the NMPA and the product is called Sisshuning.
January 2020, the second application for the listing of cyclophenol was accepted by CDE, and the allergy was induced by general anaesthetic.
To now, cyclophenol in the country submitted a third listing application, according to the drug in the domestic clinical trials and its progress, the author speculates that the declared adaptive disorder is the sedation and/or anesthesia of fiber bronchoscopy.
propofol is a widely used and indispensable general intravenous anesthetic, known as the "king" of anesthetics.
Since propofol is a high-fat soluble drug that does not meet the needs of clinical intravenous administration, there are two types of propofol injections currently in clinical use, namely propofol emulsions (with long-chain glycelin trilipid) and propofol medium/long-chain fat emulsions (containing medium/long-chain triglycerides).
, according to the insight database, a number of domestic enterprises have obtained propofol injection production batch.
it is known that domestic sales of propofol emulsions and propofol medium/long-chain fat emulsions in 2019 were RMB3,672 million and RMB 1.95 billion, respectively.
as an upgrade to propofol, Hesco estimates that its domestic market size is expected to exceed $3 billion.
In addition, in recent years, China has also approved two new class 1 anesthetic drugs, namely, Hengrui Pharmaceutical's injection of toluene sulfonate remathazolen (commodity name: Ripinen) and Yichang Renfu's injection of benzene sulfonate remazolun (commodity name: Rema), both drugs are rhemazolund salt compounds, a new type of short-acting GABAA body agonist.
of these, Ripinen was approved for sedation (2019/12) and colonoscopy sedation (2020/06), while Rei horse was approved only for colonoscopy sedation (2020/07).
, Rui Bening also submitted a third listing application in China, speculating that the declaration of adaptive disorders is general anaesthetic.