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On the ten-billion-level antidepressant track, Kanghong, Luye, Shiyao, and Dongguang Medicine took the lead in breaking through

 Last Update: 2022-10-31
 Source: Internet
 Author: User

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As we all know, diabetes, tumor, autoimmunity and other hot tracks with huge market space have always been the focus
of market attention.

However, with the approval of Johnson & Johnson's blockbuster product Spravato and Axsome's core product Auvelity in recent years, a new generation of antidepressants represented by NMDA receptor antagonists has attracted market attention
.

At the same time, domestic pharmaceutical companies are no longer limited to using generic drugs to break the dominant position of multinational pharmaceutical giants in the domestic antidepressant market, and have also rushed to deploy a new generation of antidepressants
.

There are many types of antidepressants, and the market is mainly SSRI and SNRI drugs

Depression is a common mental illness and a highly disabling disease with complex, high incidence and difficult to cure, but can be treated with medication
.

The cause is complex, high-rate, and difficult to cure, but can be treated with medication
.

The mainstream view is that the pathogenesis of depression is mainly caused by the regulation of the human neurotransmitter system, so scientists have developed various types of antidepressants
based on this mechanism (by regulating neurosynaptic mediators or synaptic receptors).

Since the introduction of monoamine oxidase inhibitors (MAOIs) in the 1950s, antidepressants have undergone several product iterations
.

Antidepressants have gone through several product iterations
.

According to the chemical structure and mechanism of action, antidepressants can be divided into:

MAOI (monoamine oxidase inhibitor): appeared in the 1950s, representative varieties are promethazine, phenelazide, but because it can cause liver toxicity, hypertensive crisis and other serious side effects, it is rarely used clinically;

TCA (tricyclic class): appeared in the 1960s, representative varieties are imipramine, doxepin, although the efficacy is significantly better than MAOI, but due to adverse reactions, it is gradually replaced by other drugs;

SSRI (5-HT reuptake inhibitor): appeared in the 1980s, representative varieties are "five golden flowers": fluoxetine (Prozac), paroxetine (Serlot), sertraline (zolov), clovoxamine (Lan release), citalopram (Ceptomyo), and later developed by Lundbeck Pharmaceuticals of Denmark escitalopram (approved by the FDA in 2002), because SSRIs have few adverse reactions and are mild, but also have the dual effects of antidepressant and anti-anxiety, widely used and become the drug of choice;

"Five golden flowers" fluoxetine (Prozac) sertraline (zolov) escitalopram

NDRI (NE and DA reuptake inhibitors): appeared in the 1980s, representing the drug bupropion, although there are fewer varieties, but it is especially effective for unipolar depression and bipolar depression with excessive sleep and overeating;

Bupropion

SNRI (5-HT and NE reuptake inhibitors): appeared in the 1990s, representative varieties are venlafaxine, duloxetine, because it can block the reuptake of 5-HT and norepinephrine (NE) at the same time, and gently inhibit the uptake of dopamine (DA), has been widely used
.

SNRI (5-HT and NE reuptake inhibitors): venlafaxine and duloxetine have been widely used
.

In addition, scientists have developed different types of antidepressants such as NARI (norepinephrine reuptake inhibitor), SARI (5-HT2A receptor antagonist and 5-HT recovery inhibitor), SSRA (5-HT reuptake activator), NaSSA (NEergic and specific 5-HT antidepressants
).

In particular, Spravato (esketamine) CIII nasal spray, an NMDA receptor antagonist developed by multinational pharmaceutical giant Johnson & Johnson, approved by the FDA in March 2019, has become the first antidepressant
with a new mechanism of action in the past 30 years because of its principle of action that is different from other antidepressants on the market.

Became the first antidepressant
with a new mechanism of action in more than 30 years.

In addition, Auvelity (Methorphan 45mg + Bupropion 105mg), the world's only oral rapid-acting NMDA receptor antagonist Auvelity (Methorphan 45mg + bupropion 105mg) compound extended-release tablet approved by the FDA in August 2022 and developed by Axsome of the United States, is a new mechanism drug
for the clinical treatment of depression in the past 60 years.

It is also a new mechanism drug
for the clinical treatment of depression in the past 60 years.

From the sales point of view, the current antidepressant market is dominated by SSRI, SNRI and NDRI drugs with few side effects, clear efficacy and safety
.

Multinational pharmaceutical giants such as Pfizer and Eli Lilly dominate, and domestic pharmaceutical companies have entered the market one after another

As mentioned above, there are many types of antidepressants on the market today (according to statistics, at least about 70 antidepressants are on the market worldwide).

Especially with the expiration of the original drug patents, generic drugs are listed in batches, and the best-selling antidepressants in China's sample hospitals have been listed with corresponding generic drugs, and the market competition can not be described as fierce.

From the perspective of the current market situation, at present, domestic antidepressants are still dominated by imported products, and multinational pharmaceutical giants such as Eli Lilly, Pfizer, and GSK occupy a dominant position in
the market.

From the current market situation, at present, domestic antidepressants are still mainly imported products

On the contrary, because domestic pharmaceutical companies mainly focus on popular tracks such as tumors, diabetes, and autoimmunity, antidepressants are mainly focused on the production of generic drugs, and at the same time are facing the pressure
of centralized procurement.

Antidepressants are mainly based on the production of generic drugs, and at the same time are facing the pressure
of centralized procurement.

According to Zhongkang CMH statistics, since the 4+7 pilot of volume procurement in 2019, antidepressants have been included in the centralized procurement varieties
.
As of the seventh batch of centralized procurement, a total of 9 antidepressant drugs have been included, and 27 local companies have won bids, all of which are domestic generic drugs, breaking the situation
that the category is dominated by foreign-funded enterprises and high-priced original drugs in the hospital market.

All are domestic generic drugs, breaking the situation
that the category is dominated by foreign-funded enterprises and high-priced original drugs in the hospital market.

From the perspective of overall sales, according to the statistics of Intranet, in the first half of 2022, the top five varieties of antidepressant sales in domestic sample hospitals were: escitalopram (22.
58%), agomelatine (13.
86%), sertraline (10.
92%), venlafaxine (10.
22%) and mirtazapine (8.
32%)
.

Take SSRIs, for example
.

The original research of sertraline is Pfizer, which was approved by the FDA in 1991 and entered the Chinese market in 1998, and the current market pattern is mainly divided by Pfizer, Jingxin Pharmaceutical, Huahai Pharmaceutical three enterprises, of which Jingxin Pharmaceutical, which occupies the advantage of sertraline dispersed film, is expanding its market share
.

Among them, Jingxin Pharmaceutical, which occupies the advantage of sertraline dispersed first imitation, is expanding its market share
.

The original research of escitalopram is Lundbeck Pharmaceutical of Denmark, is one of the "five golden flowers" of citalopram (S)-stereoisomers, the advantage is better efficacy, lower adverse reactions, in 2002 approved by the FDA for marketing, in 2006 into the Chinese market, the current domestic market pattern is mainly dominated by Lundbeck Pharmaceutical, Kelun Pharmaceutical, Jingwei Pharmaceutical, Dongting Pharmaceutical and other domestic pharmaceutical companies participate in the division
.

Escitalopram

In addition, in terms of SNRI drugs, domestic pharmaceutical companies are also struggling to catch up
.

Venlafaxine, formerly Wyeth (later acquired by Pfizer), was approved by the FDA in December 1993 to exert antidepressant effects by inhibiting the reuptake of serotonin and norepinephrine, and is suitable for those with anxiety-depressive disorder and generalized anxiety disorder
.

Venlafaxine

In terms of market sales, venlafaxine was once the world's highest-selling antidepressant, with a maximum sales of about $4 billion, but global sales have declined
since the patent expired in 2008.

However, with excellent efficacy, venlafaxine sales in the domestic market have maintained steady growth, according to PDB data, the market pattern of venlafaxine (all dosage forms) in the sample hospital is mainly divided by Pfizer and Kanghong Pharmaceutical, which is the first to launch innovative dosage forms - sustained-release tablets, and the two occupy 53.
7% and 42.
57% of the market share
in 2019, respectively.

The market structure of venlafaxine (all dosage forms) in the sample hospital is mainly divided between Pfizer and Kanghong Pharmaceutical, which is the first to launch an innovative dosage form - sustained-release tablets with its first generic status

The original research of duloxetine is Lilly, which was approved by the FDA in 2004 and entered the Chinese market
in 2007.
According to Minenet, in 2020, the domestic sample hospital of Looxetine achieved sales of 363 million yuan, a year-on-year increase of 25.
44%, and the original research Lilly has a share of more than 50% of the market, and Shanghai Medicine Pharmaceutical, Jiangsu Enhua and Chengdu Beite are 24.
84%, 16.
64% and 1.
15%
respectively.

Duloxetine Lilly has a market share of more than 50%.

However, in the fourth batch of national procurement, 5 domestic local pharmaceutical companies successfully won the bid for duloxetine hydrochloride enteric-coated capsules, and the original research Lilly was unfortunately lost, and it is expected to seize more market share
from Lilly in the future.

The original research Lilly regretted that it was lost, and it is expected to seize more market share
from Lilly in the future.

Antidepressant research and development "race", Luye Pharmaceutical, East Sunshine Medicine took the lead in breaking through

From the perspective of market prospects, compared with popular tracks such as tumors and autoimmunity, the market scale of antidepressants is relatively small, but the patient population is large and requires long-term medication, and at the same time affected by various factors, the prevalence has shown an upward trend, and there is a strong demand for
antidepressants.

On the one hand, with the rapid development of the global economy and society, the pace of life and work pressure of residents have increased, and the number of people suffering from psychological and behavioral problems and mental disorders has gradually increased
.

The number of people suffering from psychobehavioral problems and mental disorders is gradually increasing
.

According to WHO data, the cumulative number of people with depression in the world exceeded 350 million in 2021, and up to 1 million people committed suicide due to depression worldwide every year
.
At the same time, according to the "2022 National Depression Blue Book", there are currently 95 million people suffering from depression in China, and about 280,000 people commit suicide every year, of which 40% suffer from depression
.

In 2021, the cumulative number of depression patients in the world exceeded 350 million, and the number of people suffering from depression in China is 95 million

On the other hand, with the increase of prevalence and awareness, China's antidepressant industry has developed rapidly
in recent years.

In recent years, China's antidepressant industry has developed rapidly
.

According to the report of the Toubao Research Institute, the market size of antidepressants in sample hospitals in China increased from 6 billion yuan in 2013 to 10.
03 billion yuan in 2017, with a CAGR of 13.
7%; At the same time, according to Frost & Sullivan, the market size will maintain a compound annual growth rate of 12.
7% from 2018 to 2022, reaching 18.
41 billion yuan
in 2022.

From 2018 to 2022, the market size will maintain a compound annual growth rate of 12.
7%, reaching 18.
41 billion yuan
in 2022.

The good market prospects have attracted many domestic pharmaceutical companies to rush to develop antidepressants
.

At present, more than ten domestic pharmaceutical companies such as Luye Pharmaceutical, East Sunshine Pharmaceutical, Huahai Pharmaceutical, CSPC Pharmaceutical Group, Salubris, Tasly, Hengrui Pharmaceutical and other domestic pharmaceutical companies have antidepressants under development
.

▲Antidepressant R&D pipeline of domestic pharmaceutical companies Source: public information, financial reports and announcements of each company

From the perspective of R&D progress, Luye Pharmaceutical's amsufaxine hydrochloride sustained-release tablets (LY03005) have submitted marketing applications in the United States and China, of which China's marketing application has been accepted
by the China Center for Drug Evaluation in June 2021.

Among them, China's marketing application has been accepted
by the China Center for Drug Evaluation in June 2021.

According to reports, LY03005 is a new molecular entity therapeutic drug with a new mechanism of action, which is a triple reuptake inhibitor (SNDRI/TRI) of 5-HT, norepinephrine (NE) and dopamine (DA), which helps to improve the patient's anhedonia, cognitive ability and sexual function
compared with dual reuptake inhibitors.
In addition, the phase III clinical trial of LY03005 for the treatment of generalized anxiety disorder has been approved
by the China Center for Drug Evaluation in March 2022.

The phase III clinical trial of LY03005 for the treatment of generalized anxiety disorder was approved
by the China Center for Drug Evaluation in March 2022.

In addition, Pyritizodone phosphate tablets independently developed by Dongguang Pharmaceutical are a new generation, oral, highly specific small molecule serotonin (5-HT) transporter inhibitor and 5-HT1A receptor partial agonist, with dual activity, and have started phase III clinical trials
in July 2021.

Phase III clinical trials
have been initiated in July 2021.

In summary, it can be seen that the current "fierce war" in the domestic antidepressant market is not only limited to the competition between existing generic drug products and original drugs, but will also launch a new round of "fierce war"
in the next few years with the successive launch of a new generation of antidepressants under development.

【Reference】

【Reference】【Reference】

1.
Financial reports, announcements and official websites of each company

2.
"Three years of the epidemic, 70 million new depressed patients!" Where are the incremental opportunities in the tens of billions of antidepressants market? , Xinkangjie, 2022-10-08

3.
"Ten Billion Antidepressant Drug Market, 2022H1 Sales TOP5", Yao Chunqiu, 2022-09-14

4.
"The rise of domestic antidepressants? A number of pharmaceutical companies layout, 17 Class 1 new drugs under research", source: media rolling

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