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On November 14, the A-share household medical equipment sector rose, of which Kefu Medical closed up 14%, Yuyue Medical closed up and Lexin Medical closed up 8.
48%.
All this stems from the official promulgation
of the "Chinese Clinical Practice Guidelines for Hypertension" (hereinafter referred to as the "New Guidelines") jointly formulated by the National Center for Cardiovascular Diseases, the Chinese Medical Doctor Association and other academic institutions.
The New Guidelines recommend that the diagnostic threshold of hypertension in adults in China be lowered to 130/80mmHg
.
According to the new judgment standard, the number of hypertension patients in China will increase from 245 million to nearly 500 million, and more than 1/3 of the people in China will become hypertensive patients
.
The hypertension market may usher in explosive expansion
.
On the evening of November 15, Xinhua News Agency reprinted the content of the Health China public account, saying that the state has standardized procedural requirements
for the formulation and issuance of diagnostic standards for hypertension and other diseases.
Guidelines, consensus, etc.
issued by professional institutions, industry associations, individuals, etc.
, are the research results of experts and are not used as national disease diagnostic standards
.
Regarding the diagnostic criteria for hypertension, in 2005, 2010 and 2017, the national health administrative department issued publicity and education points, prevention and treatment guidelines, clinical pathways, etc.
all clarified: the diagnostic criteria for adult hypertension are blood pressure exceeding 140/90mmHg
three times a day.
At present, the diagnostic criteria for hypertension in adults have not been adjusted
.
Although the criteria for high blood pressure have not changed, the market response is real, and this track is making waves again
.
for the formulation and issuance of diagnostic standards for hypertension and other diseases.
Guidelines, consensus, etc.
issued by professional institutions, industry associations, individuals, etc.
, are the research results of experts and are not used as national disease diagnostic standards
.
At present, the diagnostic criteria for hypertension in adults have not been adjusted
.
The New Guide releases the voiceover revealed
The New Guide releases the voiceover revealedSince the country has not adjusted the diagnostic criteria for hypertension, why does the new guideline recommend lowering the standard?
At the press conference, Professor Zhao Dong of Beijing Anzhen Hospital affiliated to Capital Medical University introduced that the reason why the "New Guidelines" should be adjusted is based on sufficient international and domestic evidence-based medical evidence, and the blood pressure level is 130~139mmHg or 80~89mmHg people are mostly young and middle-aged, and the downward adjustment of diagnostic criteria reflects the concept of moving the line of defense forward and strengthening initial prevention, otherwise we will miss the key opportunity
to reduce the harm of cardiovascular disease and other diseases caused by hypertension.
At the same time, the new guidelines recommend that all patients with hypertension should undergo lifestyle interventions, including diet, exercise, stress reduction, weight loss, smoking cessation and alcohol restriction, and comprehensive lifestyle interventions
.
Based on a large amount of evidence-based medical evidence, it is recommended that most hypertensive patients should reduce their blood pressure to less than 130/80mmHg, including those without cardiovascular comorbidities, coronary heart disease, chronic heart failure, history of stroke, chronic kidney disease, diabetes, and elderly hypertensive patients
.
New diagnosis and treatment path for hypertension, source "New Guidelines"
For front-line clinicians, the more simplified the stratification criteria, the more operable and generalizable, which is conducive to judging the timing
of antihypertensive therapy for hypertensive patients as soon as possible.
Yu Jing, a professor at the Second Hospital of Lanzhou University, also said at the press conference that the "New Guidelines" recommend that patients with high-risk cardiovascular risk actively start antihypertensive drug therapy, low-risk patients can carry out lifestyle interventions for 3~6 months, and if blood pressure still does not meet the standard, antihypertensive drug treatment
can be started.
Han Yaling, an academician of the Chinese Academy of Engineering, pointed out at the press conference that although the reduction of the diagnostic value of hypertension increases the number of people included in the scope of hypertension, the cost of early treatment may increase slightly, but the high cost of treatment of serious complications such as stroke, myocardial infarction, renal insufficiency and other treatments will be greatly reduced, which can significantly improve the quality of life of
patients.
From the information announced at the launch of the New Guidelines, we can see that:
1.
The original intention of lowering the standard is to alert people at risk of hypertension;
2.
Move the threshold of hypertension treatment forward, hoping to reduce the treatment cost of subsequent complications with the increase in the upfront cost;
3.
The newly included part of the life intervention or drug treatment
according to the actual situation.
If the new standards are followed, there will be a certain impact
on patients, on related companies and on the market.
Audience multiplier, electronic blood pressure monitor
Audience multiplier, electronic blood pressure monitorThe market potential is huge
The market potential is hugeIn addition to the indicators, the new guidelines also update the classification criteria
for hypertension.
In addition to classifying hypertension into three levels, the 2018 version of the guidelines also determines that blood pressure in the range of 80~89mmHg/130~139mmHg is not judged to be hypertension, but is classified as normal high value
.
The New Guidelines classify the normal high value range as grade 1 hypertension, and the blood pressure values further up are uniformly classified as grade 2 hypertension, further simplifying the determination criteria
.
In other words, the new guidelines focus on the normal, high-value groups
of the past.
According to the data released by the "New Guidelines", among adults aged 18 and above in China, the proportion of people with normal high blood pressure values is 23.
2%, and the total number is expected to be nearly 243 million, and the blood pressure range is mainly young and middle-aged people aged
18~54.
A long-term study led by Beijing Anzhen Hospital showed that 65% of young and middle-aged people in the normal high-value group had blood pressure progression to ≥140/90 after 15 years
mmHg, the risk of cardiovascular disease increased 2.
01-fold
than those whose blood pressure remained below 130/80mmHg.
Even if the blood pressure is maintained at 130~139/80~89 for 15 years
In the mmHg range, the risk is still 1.
28-fold
.
The purpose of the adjustment of the standards is precisely to protect the health of
these nearly 243 million people.
Hypertension is a chronic disease, and patients need regular blood pressure monitoring
.
The setting of new standards has added more than 200 million target customers to related industries, and the electronic blood pressure monitor market will be further expanded, which is also the reason for
the soaring stock prices of companies such as Kefu Medical and Yuyue Medical.
Compared with the traditional mercury sphygmomanometer, the electronic sphygmomanometer has the advantages of no pollution, easy operation, data storage, etc.
, and is more suitable for patients to use
in the home environment.
Electronic sphygmomanometer is a fast-growing market, according to the data reported by the Puhua Research Institute of the Chinese Research Institute, in recent years, China's electronic sphygmomanometer production has maintained rapid growth, in the past 4 years have maintained an annual growth rate
of more than 25%.
Yuyue Medical, a well-known domestic sphygmomanometer brand, also mentioned in its 2021 annual report that electronic sphygmomanometer products increased by more than 35% year-on-year during the reporting period, and as the company's cornerstone business products, it is still in a stage of rapid growth
.
Yuyue Medical also revealed in its annual report that it is developing a number of new electronic blood pressure monitors to achieve more functions, increase product competitiveness, and iteratively upgrade
existing products.
In addition to Yuyue, Jiuan Medical, which has been in the limelight due to the epidemic, and Lexin Medical, which focuses on home medical and health electronic products, have also devoted themselves to this track
.
And Jiuan Medical's blood pressure monitor products have obtained the certification of UKCA, US FDA and EU CE, and Lexin's electronic blood pressure monitor has passed FDA review and obtained 510K certification
.
If according to the new standard, the target customer base is expanded from 245 million to 500 million, it may make electronic blood pressure monitors and thermometers become essential medical devices
for families.
Only when electronic sphygmomanometers begin to be popularized in the family can it be expected to achieve early detection, early diagnosis and early treatment
of hypertension.
Chronic disease management, digital therapeutics
Chronic disease management, digital therapeuticsUsher in the landing opportunity
Usher in the landing opportunityThe reduction of the judgment standard means that the threshold of hypertension treatment is moved forward, which is similar to the determination of normal high blood pressure in the current national standard, and the starting point of both standards is good, which is a warning and reminder
for this part of the group.
The New Guidelines have clear classification guidance for this group and add the content of non-drug treatment, rather than blindly administering drug treatment
when the standard value is reached.
Lifestyle interventions are also important treatment links, and both chronic disease management and digital therapeutics can play an important
role in it.
In the "New Guidelines", blood pressure values ≥ 140/90mmHg and in the range of 130~139/80~89mmHg, with clinical comorbidities, target organ damage or ≥ three cardiovascular risk factors are judged as high-risk patients; For groups with blood pressure values only in the range of 130~139/80~89mmHg and no remaining judgment conditions, they are classified as non-high-risk patients
.
Important factors to determine whether hypertensive patients are at high risk, source "New Guidelines"
For non-high-risk patients, the new guidelines recommend lifestyle interventions for 3~6 months, and then enter the drug treatment stage
if the blood pressure value cannot reach the standard.
Life interventions included diet interventions, exercise interventions, stress reduction interventions, weight loss interventions, smoking cessation and alcohol restriction, and comprehensive lifestyle
interventions.
From another perspective, the links that were previously overlooked by patients are highlighted
here.
This means that chronic disease management and digital therapeutics can play an important role
in this field in the future.
In the past, chronic disease management faced a big problem, they did to change a person's cognition, and then change his behavior, so that he can get lifestyle changes
.
This is not a problem for the affected group, and it is not so simple
for sub-healthy groups such as normal blood pressure values.
The general perception of such groups is that they do not feel that they are sick, so they avoid medical treatment and refuse to make changes
.
While the standard is lowered, the "New Guidelines" also gives a buffer period of 3~6 months, if it can return to normal through lifestyle intervention during this period, it is still a normal group, otherwise it will enter the drug treatment stage and officially become hypertensive patients
.
With such an official endorsement, it is easier for companies that provide relevant services to educate patients and thus implement services
.
Life intervention content of non-high-risk patients, source "New Guidelines"
In addition, just as digital therapeutics for diabetes have led to the development of CGM, chronic disease management for hypertension is likely to drive the ambulatory blood pressure monitoring market in the future
.
Ambulatory blood pressure monitoring (ABPM) is the "gold standard" for diagnosing hypertension, examiners need to wear blood pressure measurement equipment, measure blood pressure every 15~20 minutes during the day, and measure blood pressure every half hour at night, so that more comprehensive ambulatory blood pressure data can be obtained, which is convenient for doctor diagnosis
.
Because of this, some manufacturers began to introduce the concept of ambulatory blood pressure monitoring into the home electronic blood pressure monitor, through the upgrade iteration of the function and the optimization of the volume, so that patients can use the home electronic blood pressure monitor can also perform a certain degree of ambulatory blood pressure monitoring services
.
In addition to the function, the convenience of use is also the direction of
the manufacturer's efforts.
Compared with the almost insensible CGM, no matter how to optimize the integrated design of the host cuff of the home electronic blood pressure monitor, it still lacks
in wearing comfort.
Therefore, many manufacturers pin their solutions on wearable devices
.
The Guidelines for the Registration Review of Remote Monitoring Systems (Draft for Comments) issued by the State Food and Drug Administration (NMPA) at the end of August also reflect the policy attitude that wearable medical devices will play an increasingly important role
in medical treatment in the future.
With the development of technology, wearables have made tremendous progress
.
From heart rate to ECG, blood oxygen to blood pressure, wearables can already continuously monitor with medical precision the signs signals
that play a key role in the diagnosis and treatment of these diseases.
In recent years, Huawei, Samsung, Huami, Kangkang Blood Pressure, Yanhe Intelligent and other companies have successively launched smart watches with blood pressure detection functions, including technology giants and start-ups
.
Compared with the traditional arm and wrist blood pressure monitors, the products in the form of watches are more comfortable to wear and almost non-sensory applications
.
Smart watch blood pressure monitoring is a very difficult technology, in order to ensure a certain accuracy, not only need to monitor the pulse wave beating frequency, but also collect pulse wave structure information, morphological information and other information comprehensive analysis, and wearer skin color, skin condition, action, behavior and other external factors will affect the results
.
The existence of technical barriers makes the vertical field of blood pressure monitoring still in a blue ocean
in the wearable device market.
In the future, with the increase of audience groups, market demand may usher in explosive growth, and wearable devices in the field of blood pressure monitoring will be further popularized
with the landing of digital therapy.
It is difficult to expand the market of antihypertensive drugs in the 100 billion yuan
It is difficult to expand the market of antihypertensive drugs in the <> billion yuanIn addition to recommending lifestyle interventions for all hypertensive patients, the new guidelines also propose that patients with blood pressure ≥ 140/90mmHg start drug therapy immediately, which is consistent with existing diagnostic criteria
.
The above 200 million groups do not necessarily need drug treatment, and there are still many problems in the antihypertensive drug market itself that need to be solved
.
From the perspective of business model, antihypertensive drugs have a good business model - large scale and long
cycle.
According to Frost & Sullivan, there were already 326 million hypertensive patients in the country in 2020, and in recent years, the incidence of hypertension has been rising, and the scale of patients has continued to increase
.
In addition, as long as the patient takes the drug for a long time, the condition can be better controlled
.
This means that the medication cycle for hypertensive patients is extremely long
.
With the support of these two conditions, antihypertensive drugs should be a golden track
.
As early as 1996, Novartis' valsartan was approved for marketing and reached sales
of $6 billion in 2010.
Since then, the patent has expired, and although Novartis has developed a variety of valsartan compound preparations based on valsartan, it is difficult to reach the peak of the past
.
Nowadays, antihypertensive drugs mainly include calcium channel blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists, diuretics, β receptor blockers, angiotensin receptor brain coffee peptidase inhibitors and other types, but most of these "old guys" have passed the patent period, and the market is occupied
by many generic drug companies.
According to the data of China Research Network, under the diagnostic standard of 140/90mmHg, the market size of antihypertensive drugs in China in 2020 will be about 95.
6 billion yuan, a year-on-year increase of 8%, according to which it is expected that the market size of antihypertensive drugs in China will reach 111.
5 billion yuan
in 2022.
After the adjustment of diagnostic criteria, the market for antihypertensive drugs will further expand.
The price list of amlodipine besylate tablets is based on the results of centralized procurement
However, after centralized procurement, the price of antihypertensive drugs has been as low as the "cabbage price"
.
For example, the commonly used antihypertensive drug valsartan is only 0.
1 yuan per tablet after collection, and amlodipine tablets are also as low as 0.
07 yuan / tablet
.
The extremely low price of drugs makes it difficult to judge
how much performance increment this benefit can bring to many generic drug companies.
For innovative drugs, the reduction of diagnostic criteria may bring some room
for growth.
But the premise is that the drug can be truly innovative, whether in terms of efficacy or safety, it has a significant advantage
over existing drugs.
Otherwise, it is difficult to break through in the competitive environment of many generic cabbage prices
.
Although there has not been any breakthrough in the field of antihypertensive drugs in recent years, there are still many companies involved in it
.
Huahai Pharmaceutical announced earlier this year that its metoprolol succinate sustained-release tablets for the treatment of hypertension were approved by the US FDA
.
Salubris also announced that SAL0107 (alisartan amlodipine tablets) was accepted
by the National Medical Products Administration for the marketing application of new drug class 2.
3.
After the product is launched, it will form a strategic synergy with the company's already listed class 1.
1 antihypertensive drug Salubris (alisartan cilexetil tablets) to further enrich the company's innovative product pipeline in the cardiovascular field and cover a wider range of
hypertensive patients.
Write at the end
Write at the endIt can be seen that the original intention of the release of the "New Guidelines" is to target the 243 million people with normal blood pressure and high values, hoping to serve as a wake-up call to them
.
In the process of transmission, the lowering of diagnostic criteria caused great controversy, but the official announcement was timely to avoid deeper misunderstandings
.
It's just that these 243 million people are still worth paying attention to
.
Returning to the most discussed diagnostic criteria, values are not the only goal of treatment, and high blood pressure is not as simple as
"stretching your arms, measuring values, and taking drugs".
How to make these 243 million people pay more attention to their own health, how to design evaluation and management systems according to their actual conditions, and establish a three-dimensional cardiovascular health management system based on comprehensive intervention is a problem
that needs to be continuously explored in the industry.