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In the past year, although Biotech has focused on hot tracks with huge market space such as tumor and autoimmunity, most of them have fallen into a trough due to serious product homogenization, fierce market competition, or stock prices or development
.
Conversely, the insomnia drug market, which has a large market space but relatively moderate competition, is "unique on this side of the landscape"
.
.
Recently, Jingxin Pharmaceutical Co.
, Ltd.
has been hyped by the market and hit a record high because a new class 1 drug for the treatment of insomnia disorder, dedacinyl capsules (EVT201 capsules), which is close to the commercialization stage, and has become the "most beautiful boy"
in the pharmaceutical industry.
.
Jingxin Pharmaceutical's stock price chart in the latest year Source: Oriental Wealth Network
Some people can't help but ask: Why is the insomnia drug market favored by capital? At present, in addition to Jingxin Pharmaceutical's dedacicil, what other potential innovative drug pipelines for sedation and hypnosis?
01 The patient population is huge, and the sedative-hypnotic drugs have changed for three generations
01 The patient population is huge, and the sedative-hypnotic drugs have changed for three generationsOne-third of life is spent in sleep, but many people are not good
sleep quality due to snoring, dreams and other factors.
According to the Datamonitor database, the number of insomnia patients worldwide in 2019 was about 1.
4 billion, including 690 million in Asia
.
In addition, according to data from the China Sleep Research Association, the incidence of insomnia among Chinese adults is as high as 38.
2%, and more than 300 million Chinese have sleep disorders, and the patient population is quite large
.
2%, and more than 300 million Chinese have sleep disorders, and the patient population is quite large
.
It should be noted that symptoms such as difficulty falling asleep and lack of sleep will affect people's cognitive performance, weaken the immune system, and increase the probability of
chronic diseases.
According to WHO, 27% of the world's population has sleep problems, and 3,000 people worldwide die
every day due to snoring.
chronic diseases.
Based on this, scientists have developed various types of sedative-hypnotic drugs, mainly by inhibiting the central nervous system to stabilize mood or promote and maintain physiological sleep
.
.
Since the introduction of barbiturates in 1911, sedative-hypnotic drugs have undergone three generations:
Sedative-hypnotic drugs have gone through three generations:The first generation of sedative-hypnotic drugs is mainly barbiturates, but due to poor efficacy and side effects, it has been eliminated;
The second generation of sedative hypnotics is mainly benzodiazepines, representative drugs include chlordiazepoxide (chlordiazepoxide), diazepam (diazepam), midazolam, esazolam, etc.
, the safety and efficacy are significantly improved than the first generation, not only the onset of action is fast, the number of awakenings after taking the drug is less, and the toxic side effects are small, but long-term use will still produce adverse reactions such as rebound insomnia, amnesia, and drug dependence;
The third generation of sedative hypnotics is mainly zolpidem, zaleplon, zopiclone, etc.
, which further improves the defects of the second generation, reduces the probability of rebound insomnia, and has no dependence on long-term use, and is expected to gradually replace traditional drugs
in the future.
At present, the widely used insomnia treatment drugs in clinical practice are mainly benzodiazepine receptor agonists (BzRAs), including benzodiazepines (BZDs) and non-benzodiazepines (NBZDs).
From the perspective of the mechanism of action, both bind to γ-aminobutyric acid (GABA)A receptor, and increase the opening frequency of GABA-mediated chloride ion channels by acting on α subunits synergistically to promote chloride ion influx
.
This enhances the inhibitory effect of GABA, producing a sedative-hypnotic effect
by inhibiting the excitatory center.
by inhibiting the excitatory center.
In March 2022, Jingxin Pharmaceutical submitted a marketing application for Andazimil (EVT201) to the State Food and Drug Administration, which has entered the marketing review stage and is expected to be launched
in 2023.
This good news caused the share price of Jingxin Pharmaceutical to be exploded and hit a record high
.
in 2023.
Andazenil is approaching the commercialization stage, and there are two main reasons for the market agitation: on the one hand, Andazenil is a partial agonist/partial forward allosteric modulator (pPAM) targeting GABAA (γ-aminobutyric acid A) receptors, selectively acting on benzodiazepine receptor α1-isotype, showing high affinity and moderate intensity agonism, which can induce rapid sleep onset and sleep maintenance
.
It is understood that EVT201 capsules are a key improvement to the traditional insomnia treatment drugs currently on the market, improving the mental state of
users during the day.
users during the day.
According to the results of phase III clinical trials, EVT201 capsules have good safety and tolerability in the efficacy evaluation indicators of insomnia disorders, sleep and wakefulness, and the main study endpoint results meet the preset efficacy standards of the program, which can significantly prolong the total sleep time
of insomnia patients.
On the other hand, due to the large market space for insomnia drugs and the relatively moderate competition, EVT201 capsules are expected to change the domestic insomnia market pattern
after they are approved for marketing.
after they are approved for marketing.
02 Status quo of insomnia medicine track: large market space and relatively moderate competition
02 Status quo of insomnia medicine track: large market space and relatively moderate competitionAs mentioned above, the current population of insomnia patients is quite large, and the resulting demand for treatment makes the insomnia drug market show good growth prospects
.
According to the report of the Toubao Research Institute, the number of people suffering from sleep problems in China currently accounts for more than 40% of the total number of people in China, and the medical treatment rate is less than 30%, and the market size of China's sedative hypnotic drug industry may reach 27 billion yuan
in 2023.
in 2023.
In addition, according to the statistics of the Medical Economic News, the sales of hypnosis/sedatives in sample hospitals in China in 2021 will be 1.
641 billion yuan, and the amount of drugs purchased by public hospitals across the country will be 5.
481 billion yuan
.
Data from the past five years shows that annual sales from 2017 to 2019 have shown double-digit growth, and the sales of sample hospitals reached the maximum in 2021, with a year-on-year increase of 8.
46%.
481 billion yuan
.
Annual sales from 2017 to 2019 showed double-digit growth
In addition, due to various factors, the current domestic insomnia drugs have been approved for marketing, and there is a large clinical unmet demand
in the market.
in the market.
At present, the treatment drugs for insomnia disorders mainly include benzodiazepines including diazepam, clonazepam, etc.
, as well as new non-benzodiazepines represented by zolpidem (listed in China in 1995) and dexzopiclone (listed in China in 2007
).
Since then, no new drugs have been approved for marketing
in China.
in China.
According to the Southwest Securities Research Report, the top 5 market shares of hypnotic drugs PDB in 2021 are zopiclone, dexzopiclone, esazolam, phenobarbital and zolpidem, of which zopiclone and dexzopiclone account for more than 60%, and the market competition pattern is relatively relaxed
.
.
It is worth mentioning that although sedative-hypnotic drugs are in a state of scarcity, researchers are still trying to improve safety
, toxic side effects and adverse reactions.
This is mainly due to: on the one hand, the causes of anxiety disorders and insomnia are quite complex, and the causes may involve genetic factors, physiological factors and psychological factors, if researchers cannot fully understand various causes of disease, it is difficult to develop targeted drugs according to specific causes;
On the one hand, the causes of anxiety disorders and insomnia are quite complexOn the other hand, the current clinical use of sedative hypnotics are directly acting on the central nervous system, and once the central nervous system is accustomed to drug stimulation, it is easy to produce dependence, once the drug is stopped or reduced, withdrawal syndrome may occur, so it is difficult to completely avoid side effects
.
.
It is understood that Jingxin Pharmaceutical's EVT201 capsule is a hypogeneous regulation of GABAa receptor caused by binding to α1-isotype, which moderately activates the receptor and leads to downstream signal transduction, thereby inhibiting the central nervous system and causing sleep effects
.
.
Compared to the full activator of the GABAa receptor, EVT201 capsules produced a lower maximum activation titer strength for the GABAa receptor
potency), this mechanism of action allows EVT201 capsules to both activate GABAa receptors and rapidly inhibit the nervous system, while avoiding deep inhibition of GABAa receptors and neurological side effects
.
.
03 Domestic and foreign players grab the beach, and the layout is rare
03 Domestic and foreign players grab the beach, and the layout is rareAt present, in addition to benzodiazepine receptor agonists, a new generation of sleeping drugs melatonin receptor agonists and orexin receptor antagonists have also attracted market attention
.
.
According to the data, melatonin is an amine hormone produced by the pineal gland of mammals and humans, which has the effect of sedation and inducing sleep, and is called a "physiological hypnotic agent"
.
In addition to biological secretion, melatonin can also be synthesized by chemical methods, and chemically synthesized melatonin can be used to improve a person's sleep or treat sleep disorders
.
.
Currently, melatonin receptor agonists are used clinically, including ramelteon, melatonin extended-release tablets (only for insomnia people over 55 years old), agomelatine (also a 5-HT receptor antagonist, with dual antidepressant and hypnotic effects).
Rameltinide, developed by Takeda Pharmaceutical of Japan, is the first and so far the only prescription drug for insomnia without abuse and dependence, mainly used for the treatment of sleep-hard-to-sleep insomnia, and also has a definite effect on chronic insomnia and short-term insomnia, which was approved by the FDA in September 2005 and is not yet available
in China.
in China.
In addition, scientists have also found that orexin receptor antagonists have therapeutic effects
on insomnia, obesity, depression, drug addiction and other diseases.
At present, orexin receptor antagonists have been approved for marketing worldwide, including suvorexant and Dayvigo (lemborexant).
Suvolexa, developed by Merck, is the world's first insomnia treatment drug with orexin receptors as the site of action for the treatment of adult insomnia (difficulty falling asleep and sleep maintenance disorders) patients, which was approved for marketing in the United States and Japan in August 2014, and is not yet available
in China.
Dayvigo, an orexin receptor antagonist developed by Eisai in Japan, for the treatment of insomnia in adults, specifically manifested as difficulty falling asleep and/or sleep maintenance disorders, was previously launched in the United States in June and July 2020 in Japan; It was approved
in Hong Kong, China in February 2021.
Domestically, because innovative pharmaceutical companies mainly focus on popular tracks with huge market space such as tumors and autoimmunity, there is less research and development of insomnia innovative drugs, and the insomnia innovative drugs that have entered the clinical stage include YZJ-1139 (phase III clinical trial) of Yangtze River Pharmaceutical and orexin of East Sunshine Pharmaceutical
receptor antagonist HEC-83518 (phase I clinical trial).
YZJ-1139 is known to be an orexin type 1 and type 2 dual receptor (OX1R and
OX2R), a highly effective antagonist that improves sleep by inhibiting orexin receptors, including faster sleep and longer sleep duration
.
At the same time, YZJ-1139 has the advantages of rapid absorption and moderate half-life, which can achieve the effect of rapid onset of action and low residual effect the next day, and is the first orexin receptor antagonist in China to complete clinical phase II.
, and the indication is insomnia
characterized by difficulty falling asleep/sleep maintenance disorder.
characterized by difficulty falling asleep/sleep maintenance disorder.
Conclusion: Overall, the current insomnia drug market is not only large in space but also relatively moderate, which allows Jingxin Pharmaceutical to obtain the favor
of capital with the adjacent commercialization of class 1 new drug desdacilib (EVT201).
However, in the future, with the successful approval of YZJ-1139 of Yangzijiang Pharmaceutical, the domestic insomnia drug market structure will change
again.
