Renfu Class 1 New Drug Propofol Disodium for Injection Approved for Marketing

On May 24, the official website of NMPA showed that Renfu’s Class 1 new drug, propofol disodium for injection, was approved for marketing, and the indication was general anesthesia induction
.

Since the reform of the review system, the launch of domestically produced new drugs has accelerated.

5 Class 1 new drugs take off as soon as they enter the market, and Renfu has another explosive debut

5 Class 1 new drugs take off as soon as they enter the market, and Renfu has another explosive debut

Figure 1: Approval of Propofol Disodium Phosphate for Injection

Source: NMPA official website

Propofol drugs are the largest intravenous anesthetics used in clinical practice, while Renfu’s new class 1 drug, propofol disodium phosphate, is a new short-acting intravenous general anesthetic, which is metabolized into propofol in the body to produce anesthesia Role
.

It is reported that the new drug effectively solves the problem of accumulated toxicity of propofol, is safer and has a stronger sedative effect.

Table 1: Neurological Class 1 new drugs that have been included in priority review and approved for marketing since 2016 (statistics based on the date of approval)

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

Figure 1: Hengrui's sales of remazolam tosylate for injection in 2020

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

In December 2019, Hengrui's remazolam tosylate for injection was approved for marketing, and its indication was sedation for routine gastroscopy; in June 2020, the second indication was approved for colonoscopy sedation
.

According to data from Minaiwang, the phase III clinical trials of the new drug, bronchoscopy, sedation and general anesthesia, have been completed

With the approval of new indications, the sales scale of the new drug in China’s urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) is also expanding.
From the perspective of channels, At present, urban public hospitals account for more than 80%, and county-level public hospitals account for about 16%
.

Figure 2: Sales of Renfu's remazolam besylate for injection in 2020

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

Renfu's remazolam besylate for injection was approved in July 2020, and its indication is colonoscopy sedation
.

At present, the phase III clinical trial of the induction and maintenance of anesthesia of the new drug has been completed, and the phase III clinical trial for the diagnosis and treatment of fiberoptic bronchoscopy is underway

Figure 3: Sales of Mannote Sodium Capsules of Shanghai Lugu Pharmaceutical in 2020

Source: Mi Nei Net Database

In November 2019, NMPA conditionally approved the listing application of Shanghai Lugu Pharmaceutical's Mannite Sodium Capsules for use in mild to moderate Alzheimer's disease to improve patients' cognitive function
.

The drug is a low-molecular-weight acid oligosaccharide compound prepared with marine brown algae extract as a raw material.

In 2020, at the physical pharmacy terminal in Chinese cities, the sales of mannite sodium capsules have soared, with a growth rate of 6700%, and sales of 250 million yuan
.

Figure 4: Sales of Simcere's edaravone and dextrocampine injection concentrated solution in 2020

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

Simcere's concentrated solution of edaravone and dexcamphane for injection was approved in July 2020 and entered the 2020 edition of the National Medical Insurance Negotiation Catalog.
"Only new patients with acute ischemic stroke are allowed to attack within 48 hours.
Start using it within 14 days of payment
.

” In 2020, the sales of the new drug in physical pharmacies in Chinese cities will exceed 40 million yuan.

Edaravone used to be a major neurological drug.
In 2016, the terminal sales of public medical institutions in China reached 5.
3 billion yuan.
The "First Batch of National Key Monitoring Drugs for Rational Use" was released in 2019, and then this variety Sales have plunged, leaving only about 1.
2 billion yuan in 2020
.

Simcere Pharmaceuticals mentioned in its annual report that edaravone dexcamphanol injection concentrated solution was compared with single-party edaravone injection during phase III clinical trials.

Haisco, Hengrui, Kelun, Yangtze River.
.
.
Class 1 new drugs under development are super eye-catching

Haisco, Hengrui, Kelun, Yangtze River.
.
.
Class 1 new drugs under development are super eye-catching

Table 2: Class 1 new drugs that have been clinically approved since 2016 and have entered phase II and above

Source: China Drug Clinical Trial Publicity Library of Meinenet

Statistics as of May 20

Haisco's cyclopophene injection was approved for marketing as early as December 2020.
The indication is sedation during gastrointestinal endoscopy.
The second indication for general anesthesia induction was approved in February 2021.
The third indication The application for sedation and/or anesthesia for the diagnosis and treatment of bronchoscopy is under review and approval
.

In addition, the new drug general anesthesia maintenance indication has completed phase III clinical trials, and the sedation indication during intensive care is in phase III clinical trials

Simcere’s concentrated solution of edaravone dexcamphanol for injection has entered the market and is actively developing.
The sublingual tablet of edaravone dexcamphanol (Y-2 tongue The next film) has also entered phase III clinical, the indication is acute ischemic stroke, and it is expected to be used sequentially with injections in the future
.

Hengrui's SHR8554 injection is a small molecule opioid receptor μ subtype (MOR) preferred ligand, intended for the treatment of pain
.
Currently, phase IIb/III clinical trials of the new drug for post-abdominal surgery analgesia and phase II/III clinical trials for postoperative analgesia in orthopedic surgery are underway
.

Kelun's KL280006 injection is a selective peripheral κ opioid receptor agonist, which can achieve effective analgesia while avoiding the adverse reactions of central analgesics.
It is intended for the treatment of acute pain (such as postoperative pain)
.
At present, the phase II clinical trial of the new drug for analgesia after pelvic laparoscopic surgery is underway, and the phase Ib clinical trial in patients with maintenance hemodialysis is also underway
.

The active ingredient of SPT-07A injection is a small molecule monomer compound extracted from natural medicine.
It has a certain clinical basis for safety and effectiveness.
It is used for the neuroprotective treatment of acute ischemic stroke.
It is currently suitable The Phase II clinical trial of the disease is underway
.

On May 16, Yangzijiang announced the results of a phase II clinical trial of YZJ-1139 for the treatment of primary insomnia.
The data showed that the new drug can safely and effectively improve the sleep efficiency of patients with insomnia, and has a dose-effect relationship
.
YZJ-1139 is a highly effective antagonist of orexin type 1 and type 2 dual receptors.
It improves sleep by inhibiting orexin receptors, including speeding up sleep and prolonging sleep time.
At the same time, YZJ-1139 has fast absorption and moderate half-life Advantage
.

TOP5 pharmaceutical companies reshuffle, CSPC's high-end generic drugs are about to enter the game

TOP5 pharmaceutical companies reshuffle, CSPC's high-end generic drugs are about to enter the game

Figure 5: Changes in the share of the top 5 enterprises of terminal neurochemical drugs in China's public medical institutions in 2020

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

According to data from Menet.
com, the market size of terminal neurochemical drugs in China's public medical institutions exceeded 100 billion yuan in 2019, and will decline by more than 15% due to the epidemic in 2020, while the terminal neurochemical drugs market in urban physical pharmacies in China continues to maintain positive growth Situation
.

The terminals of public medical institutions in China are the main battlefield of neurochemical drugs.
The top three of the TOP5 companies in 2020 remain the same as in 2019, while the three or four are won by Jiangsu Enhua Pharmaceutical and Lingbei
.

TOP1 pharmaceutical company Yangtze River's large variety of Dezocine injection has a slight decline in sales in 2020, but still has sales of more than 6 billion yuan, contributing more than 61% of the company's performance in this field; dexmedetomidine hydrochloride injection Due to the first batch of national procurement exclusive bids, sales have soared.
The growth rates from 2019 to 2020 are 18114.
75% and 204.
88% respectively.
In 2020, it has become the company's more than 3 billion varieties, contributing to the company in this field.
34% performance
.

In recent years, Renfu has not only been approved for Class 1 new drugs in the field of neurochemical drugs, but also a number of high-end generic drugs.
It has successfully rushed from TOP9 in 2013 to TOP2 in 2020
.
Remifentanil Hydrochloride Hydrochloride Injection and Sufentanil Citrate Injection, two large varieties with a total of over 2 billion, contributed more than 80% of the company's performance in this field.
In 2020, the exclusive new product Alfentanil Hydrochloride Injection was approved and merged Regarded as over-evaluation, the follow-up is expected to become a new driving force for the company's performance
.

Table 3: Nervous system generic drugs recently approved for marketing

Source: NMPA official website

Recently, in addition to the approval of Renfu’s Class 1 new drug, propofol disodium phosphate for injection, Xi’an Yuanda Detian Pharmaceutical also successfully won the third domestic valproate injection, while CSPC Ouyi Pharmaceutical The industry’s application for the imitation of 4 types of lacosamide tablets has also entered the “under review” status, and it is expected to win the third domestic market
.
As the domestic high-end generic drugs are successively listed, China's neurochemical drug market will usher in new challenges
.

Source: NMPA official website, Mi Nei.
com database