Renfu Class 1 new drug, propofol disodium phosphate, approved domestically, with low side effects and good clinical experience

NMPA released information on drug approval documents to be obtained on May 24, 2021.
Among them, Yichang Renfu Pharmaceutical Co.
, Ltd.
, a new class 1 drug of propofol disodium for injection, has been approved
.

This is the company's second Class 1 new drug approved for marketing after remazolam besylate for injection

Source: NMPA

Advantages of propofol disodium phosphate

Propofol is an intravenous general anesthetic widely used in clinical practice.
Due to its fast onset, short half-life, high clearance rate, and convenient target-controlled infusion, it is widely used in clinical anesthesia and ICU sedation at home and abroad
.

However, propofol also has some adverse reactions in clinical applications, which are mainly related to the preparation of propofol with fat emulsion as the carrier, such as causing pain at the injection site, thrombophlebitis, hyperlipidemia, and potentially fatal bacteria Infections, allergic reactions, and severe and rare propofol infusion syndrome

Fospropofol Disodium, also called propofol sodium, is a water-soluble prodrug of propofol.
After intravenous injection, it is metabolized by alkaline phosphatase on the surface of endothelial cells to produce the active drug propofol.
Phenol, which quickly reaches balance in the brain tissue, exerts a dose-dependent sedative and hypnotic effect
.

Propofol disodium phosphate modifies the chemical structure of propofol and changes its dosage form to make it have good water solubility.
It does not require the currently commonly used fat emulsion carrier of propofol preparations, thus playing its pharmacological effects.
On the basis of reducing the occurrence of adverse reactions
.

It can not only reduce the pain of intravenous injection, avoid the disorder of lipid metabolism during long-term sedation in the ICU, but also reduce the chance of bacterial contamination during the infusion process

       Efficacy of propofol disodium phosphate

       Pharmacokinetic analysis showed that in the mouse model, propofol released from the prodrug has a longer elimination half-life, a larger volume of distribution and a higher plasma clearance rate than the marketed propofol.
In healthy male volunteers, the elimination half-life is relatively short
.

       Phase I clinical studies have shown that the active metabolite propofol can induce a more potent anesthetic effect than propofol in fat emulsions
.

       Phase II clinical studies have shown that the active metabolite propofol can effectively maintain the sedation of patients undergoing colonoscopy
.

       In terms of safety, common adverse reactions of propofol disodium phosphate include paresthesias and itching, and other serious adverse reactions include hypotension, hypoxemia, and respiratory depression
.

Compared with propofol, patients who use propofol disodium phosphate have more stable heart rate and blood pressure, and there is no pain after injection

       Renfu Pharmaceutical Narcotics Products

       Renfu Pharmaceutical’s holding company, Renfu Pharmaceutical, is one of the leading companies in China’s anesthetic drug market.
It has a rich pipeline of anesthetic drugs.
Among them, there are three main innovative anesthetic drugs, namely remazolam besylate and fosprofen.
Disodium phenolate and M6G injection
.

       Remazolam besylate is a Class 1 new drug that is synchronized with the original research and jointly developed globally
.

In July 2020, Renfu’s remazolam besylate was launched in China.

       Propofol disodium phosphate was reported for production in 2018 and approved for marketing in May 2021
.

       M6G injection: the full name of morphine-6-glucuronide injection, the current phase 1 clinical study has been completed
.

M6G is the active metabolite of morphine in the body.

       According to the company's financial report, Renfu Pharmaceutical's sales of narcotic drugs from 2017 to 2020 will be 2.
327 billion yuan, 2.
871 billion yuan, 3.
6 billion yuan and 4.
2 billion yuan, and the annual growth rate will remain above 10%
.

It is expected that with the approval of the new products, it will continue to grow in the future

       It is hoped that the arrival of Propofol Disodium Phosphate for Injection by Renfu Pharmaceutical will provide clinicians with better surgical options and provide patients with a more comfortable medication experience

       Reference source:

       1.

       2.
Renfu Pharmaceutical's official website

       3.
Renfu Pharmaceutical Company Annual Report