The market rebounded rapidly. People's welfare rose by 80%!

Medical Network, August 17 News On August 16, the NMPA official website released the latest drug approval information.
Yichang Renfu Pharmaceutical's Bupropion Hydrochloride Sustained-Release Tablets (Ⅱ) was approved for the first imitation, Nanjing Zhengda Tianqing's methanesulfonate The application for the imitation of safinamide tablets and doxylamine succinate tablets of Jiangxi Xinganjiang Pharmaceutical has also entered the "under review" status recently, and the three first generic drugs are expected to boost the neurochemical drug market
.
In Q1 of 2020, the epidemic disrupted the domestic and global economy.
The market size of terminal chemical drugs in public hospitals in key provinces and cities plummeted by 20%; in Q1 of 2021, the domestic economy recovered rapidly, and the market size of terminal chemical drugs in public hospitals in key provinces and cities rebounded by 20 %, the market for neurologic drugs in the TOP5 category has the highest increase, reaching 32.
16%
.

Domestic pharmaceutical companies are making every effort to "rescue the field," Yangtze River and People's Welfare rose by more than 50%.

Table 1: 2021Q1 Key Provinces and Municipal Public Hospitals Chemical Drugs and Neurological Drugs Top 5 Companies Source: Minenet Key Provincial and Municipal Public Hospitals Terminals in Key Provinces and Municipal Public Hospitals Chemicals In the pharmaceutical market, the top 5 neurological drug companies are all domestic pharmaceutical companies.
The rankings of 2020 and 2021Q1 have not changed.
Domestic pharmaceutical companies have quickly recovered their "combat power" in the post-epidemic era, with double-digit growth rates.
Among them, the leading company Yangzijiang The growth rate of the Pharmaceutical Group and Yichang Renfu Pharmaceutical has exceeded 50%
.
Yangtze River Pharmaceutical Group currently sells neurologic drugs in public hospitals in key provinces and cities mainly including dezocine, dexmedetomidine and dyclonine.
The growth rates of the three major varieties in 2021Q1 are 53.
28%, 56.
97% and 94.
00%, respectively.

.
With the approval of Nanjing Rook’s Dezocine injection in 2019, it broke Yangtze River’s original monopoly of the market, but Yangtze River’s leading advantage is still strong; dexmedetomidine was included in the first batch of national sources at that time.
Yangtze River’s exclusive bid to seize the market opportunity, Yangtze River’s share of this product has reached 92.
92% in 2021Q1; Dyclonine hydrochloride mortar is Yangzi River’s exclusive product and is mainly used for larynx anesthesia and lubrication during gastrointestinal endoscopy.
With the restoration of normal medical services in major hospitals, inspection items have gradually returned to their normal frequency, which has led to a rebound in product sales.

.
Table 2: New neurochemical drugs approved for listing by Yangtze River and its subsidiaries from 2021.
Source: Meinenet MID Drug Index Comprehensive Database.
In 2021, Yangtze River and its subsidiaries have three new neurochemical drugs approved for listing, among which Bippo The phenol medium/long-chain fat emulsion injection was approved in January, and the fourth batch of national procurement was successfully won in February; in addition, the two major new products of the subsidiary also attracted market attention: the approval of nalbuphine hydrochloride injection was broken With the original situation of Renfu monopolizing the market, the two leading players will compete head-on in this variety; Lurasidone hydrochloride tablets will achieve domestic imitation in 2021, and Hisun, Hausen, and Yangtze River will be approved in relatively close time after entering the market.
It remains to be seen who can come first
.
Yichang Renfu Pharmaceutical's sales soared by 80% in the first quarter, attracting attention.
At present, the company’s best-selling neurological drugs in public hospitals in key provinces and cities include Refine/Tai/Ni, Su/Fen/Tai/Ni, Hydromorph/Hydromorphone , Nabuphine, sales growth in 2021Q1 were 71.
63%, 65.
18%, 163.
86%, 120.
74%
.
Al/fen/tai/ni and remazolam, which were approved for listing in 2020, have also begun to show their strength in the market, and their contribution to the company’s performance has increased from 0.
24% and 0.
13% in 2020 to 1.
71% in 2021Q1, 1.
39%
.
Al/fen/tai/ni and remazolam once again passed the preliminary formal review of the adjustment of the National Medical Insurance Catalogue in 2021, and we look forward to the good news
.
Table 3: Yichang Renfu's new neurochemical drugs approved for marketing since 2021.
Source: Meinenet MID Drug Index Comprehensive Database.
In 2021, Renfu has been approved for a Class 1 new drug in the field of neurological drugs, phosporin for injection Disodium propofol is metabolized into propofol to produce anesthesia.
In 2020, the sales scale of propofol in public hospitals in key provinces and cities has exceeded 500 million yuan
.
The new drug effectively solves the problem of propofol accumulation and toxicity, and is safer and has a stronger sedative effect.
Compared with propofol, the heart rate and blood pressure of patients using propofol are more stable.
Propofol is a freeze-dried powder injection, water-soluble High sex
.
Renfu has been approved to market midazolam injection earlier.
Midazolam oral solution is a special dosage form for children.
It can be used for sedation/anxiety/amnesia before and during the diagnosis or therapeutic operation of children.
Sedation/anti-anxiety/amnesia before operation in children
.
With the encouragement of “children’s medicines” in recent years to reduce the occurrence of adverse reactions , child-specific dosage forms are expected to occupy a place in the market
.
Most of TOP6-TOP10 are foreign-funded companies.
Sanofi and Xi'an Janssen ranked TOP6 and TOP7 respectively, and their growth rates in 2021Q1 were 22.
05% and 33.
71% respectively; while Lingbei and Pfizer ranked TOP9 and TOP10 respectively, and their growth rates fell in 2021Q1.
More than 10%
.
Lingbei was the leader of foreign-funded companies in the neurological drug market in the past, and was ranked TOP6 in 2018 (the top five are all domestic pharmaceutical companies)
.
Three years have passed.
Guocai has conducted five batches and six rounds, and a total of 30 neurochemical drugs have been included in the catalog.
Lingbei involves escitalopram oxalate tablets (the first batch) and citalopram hydrobromide tablets ( The third batch) and memantine hydrochloride tablets (third batch) failed to win the bid.
The company's escitalopram decreased by 29.
99%, 37.
49%, and 3.
87% in 2019-2021Q1, while citalopram and memantine in 2021Q1 The drop rates of both are more than 50%
.
So far, Lingbei has been overtaken by Sanofi and Xi'an Janssen
.

　　The oral market has serious "involution", and the exclusive and first generic drug "PUBG Mobile"
Figure 1: Distribution of neurological drug routes that have been included in the national procurement/reviewed (including deemed over-reviewed) drug route Source: Mi Nei.
com MED2 .
0 China Drug Evaluation Database Note: Statistics on the number of products under review as of August 13th.
As of August 13, the 30 neurochemical drugs that have been included in the national procurement account for 26 for oral administration and 4 for injection, and those that have been reviewed/deemed as reviewed Among the products, 78 are for oral administration and 22 for injections.
It is foreseeable that more oral products will trigger the centralized procurement mechanism in the future.
Domestic generic drugs will not only grab the market of original research drugs, but also compete with each other more fiercely.

.
In July 2021, the " Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" was announced and implemented.
It mentioned that the first chemical generic drug that successfully challenged the patent and was approved for marketing was granted a 12-month market exclusivity period
.
Although the period of exclusivity is shorter than the industry's expectations, it is also a test of how pharmaceutical companies can do a good job in channel layout and quickly occupy the market high ground after they have won the first copy
.
Table 4: Sales of domestically-made generic drugs of TOP10 brands for oral administration.
Source: Public hospitals in key provinces and cities of Minai.
com.
Among the 2021Q1 neurochemical drugs for oral administration, 4 of the TOP10 brands for oral administration of neurochemical drugs are domestically produced, and Qilu’s exclusive product Citicoline Sodium ranks TOP3.
Capsules are used to treat the sequelae of the nervous system caused by brain injury or cerebrovascular accidents.
The terminal sales of this product in public hospitals in key provinces and cities will exceed 200 million yuan in 2020
.
Agomelatine is a new type of antidepressant drug developed by Servier.
It was approved to enter the domestic market in 2010.
Hausen’s agomelatine tablets were declared as a category 3.
1 new drug and approved in 2014, becoming the domestic exclusive After the listing, it quickly seized Servier’s market, and Hausen’s market share in 2021Q1 has reached 95.
85%
.
Recently, three more neurochemical drugs hit the first imitation
.
Renfu won the production approval for bupropion hydrochloride sustained-release tablets in November 2020, and the specifications involved are 0.
1g, 0.
15g, and 0.
2g.
At present, only bupropion hydrochloride sustained-release tablets (Ⅱ) in the domestic market GlaxoSmithKline has been approved for import, involving specifications of 150mg and 300mg
.
On August 16, a new message on the NMPA official website indicated that Renfu had won two new approvals for the product (National Medical Standards H20213640, National Medical Standards H20213641)
.
Nanjing Chia Tai Tianqing’s class 3 generic safinamide mesylate tablets is a Parkinson’s disease treatment drug.
Currently, there is no original import or other domestic pharmaceutical companies to declare and market, and the two acceptance numbers have entered the status of "approval"
.
It is reported that Safinamide is a highly selective and reversible third-generation monoamine oxidase B (MAO-B) inhibitor with both dopaminergic and non-dopaminergic mechanisms
.
In 2020, the terminal anti-Parkinson's disease drug market in public hospitals in key provinces and cities will reach 580 million yuan, and the growth rate will be 12.
59% in 2021Q1
.
Doxylamine succinate tablets are used to help alleviate the difficulty of falling asleep.
At present, there is no original imported or domestic imitation approved in the domestic market
.
Suzhou No.
4 Pharmaceutical Factory was the first to declare Category 3 generic listing in 2019, and was finally approved for clinical use.
Jiangxi Xinganjiang Pharmaceutical Co.
, Ltd.
declared Category 3 generic listing in October 2020.
The current acceptance number has entered the "under approval" status.
If it goes well If approved, it will overtake it successfully and win the first imitation
.

　　Inhalants momentum brave, Henry leading domestic brand development effort
Figure 2: Sales growth Source for each route of administration 2021Q1 nerve systematic drug: m key provinces and cities within the public hospital network terminal neurological inhaled drug market share, while not High, but it will be less affected by the epidemic in 2020, with a decrease of only 8.
01%; the rebound in 2021Q1 is the fastest, with a growth rate of more than 60%
.
The market for injections and oral administration is fierce, and the inhalation market will undoubtedly become the new focus of attention of enterprises
.
At present, there are few inhalation drugs involved in the nervous system in the domestic market, and the best-selling products are concentrated in sevoflurane, desflurane, butorphanol, isoflurane, and zolmitriptan
.
Hengrui's sevoflurane for inhalation, butorphanol nasal spray (exclusive) for inhalation, and desflurane for inhalation (exclusive) together took up 60% of the inhalation market in 2021Q1, and the sales growth rate of these three brands in 2021Q1 They are 57.
02%, 428.
57%, and 145.
00% respectively
.
Sevoflurane is a TOP1 product.
In addition to Hengrui's outstanding strength, domestic pharmaceutical companies have also continued to explode the market potential of Lunanbate.
The market share has increased from 1.
95% in 2014 to 8.
55% in 2021Q1.
The brand 2021Q1 sales growth rate is as high as 126.
30%
.
The competition for isoflurane is also fierce.
Hebei Yipin Pharmaceutical is the leader in this category.
Its market share has risen from 27.
51% in 2014 to 62.
41% in 2021Q1.
The brand's sales growth rate in 2021Q1 is as high as 180.
00%
.
Table 5: Blockbuster new products declared and approved for clinical use in the past three years.
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database.
Among the new neurologic drugs approved for clinical use, Zhaoke Pharmaceutical's two products have attracted attention , Fen/Tai/Ni aerosol inhalation (artificial intelligence cloud control system) and loxapine powder inhalation single-dose administration system are expected to bring new development directions to the market
.

　　This year's first Class 1 new drug is reported for production, and these blockbuster new drugs are coming.

Table 6: New drugs for the nervous system that have been declared for marketing and are under review since 2018.
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database Ansufaxine Hydrochloride The release tablet is the first neurological class 1 new drug to be marketed this year.
It is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI), used to treat depression, and is a new treatment based on Luye Pharma.
The central nervous system product developed by the entity/new molecular entity technology platform, the company also plans to register and market the product in the United States, Japan, Europe and other countries and regions
.
In terms of improved new drugs, Qilu Pharmaceutical’s aripiprazole oral film and memantine hydrochloride oral film are exclusive declarations.
After approval, two more members will be added to the company’s oral film product line
.
In 2021Q1, aripiprazole is the TOP5 variety of terminal neuroleptics in public hospitals in key provinces and cities
.
Levetiracetam is the TOP2 variety of anti-epileptic drugs.
Levetiracetam granules from Prilifa can be used for the treatment of partial seizures in adults, children, and infants with epilepsy over one month.
It is expected to be a special drug for children.
Add new products
.
3 new Class 1 drugs that have been approved for marketing are also rushing to declare new indications: Haisco's cyclopofol injection has completed phase III clinical indications, including 4 indications, including sedation and general anesthesia during gastrointestinal endoscopy.
The induction has been approved for marketing.
The sedation/anesthesia and maintenance of general anesthesia in bronchoscopy diagnosis and treatment are currently under review and approval.
In addition, sedation during intensive care and phase III clinical gynecological outpatient surgery are underway
.
Renfu’s remazolam besylate for injection has completed phase III clinical indications, among which, colonoscopy sedation has been approved.
Judging from the clinical completion time, the current marketing application under review should be anesthesia Induction and maintenance, and sedation in fiberoptic bronchoscopy diagnosis and treatment has also completed phase III clinical trials.
We are waiting for the follow-up "official announcement"
.
Hengrui's remazolam tosylate for injection has completed phase III clinical indications, of which two indications have been approved for gastroscopy sedation and colonoscopy diagnosis and treatment sedation, and 3 are currently under review.
One acceptance number is likely to involve general anesthesia, bronchoscopy, and sedation.
The phase II clinical trial of elective general anesthesia was completed in 2015.
Whether the follow-up phase III clinical trial will be carried out has also attracted the attention of the industry
.

　　Source: NMPA's official website and the database
review statistics of the Minet.
com database are as of August 13.
If there are any errors or omissions, please correct me
.
Data explanation: The chemical drug terminal competition pattern database of public hospitals in key provinces and cities is based on the chemical drug procurement data of nearly 700 sample provincial and municipal public hospitals in 20+ provinces and cities, and the sample provincial and municipal samples for continuous monitoring of the entire category of chemical drugs Hospital database
.
The data covers 14 categories, 90 subcategories, and a total of 4800+ generic name varieties, which can analyze the drug use structure of medical institutions from multiple angles and dimensions
.
This data is updated quarterly to provide timely feedback on the impact of policy changes on products, and analyze the sales, market shares, sales trends and development laws of various categories and varieties of chemical drugs in 20+ provinces and cities in all categories in an all-round and multi-dimensional manner
.