ED drugs sold 3.5 billion, and domestic brands won the championship for the first time!

Recently, Broad Pharmaceutical's tadalafil tablets have been approved and reviewed.
Up to now, 14 pharmaceutical companies have domestic approvals for the product, which is much higher than the number of sildenafil citrate tablets (10 companies)
.

Since July, 4 pharmaceutical companies have applied for the marketing application of tadalafil tablets in category 4 generics.

Rising to 3.
5 billion! Volume purchases boost domestic generic drugs to seize the market

Figure 1: The total sales of the three major ED drugs (unit: ten thousand yuan)

Source: Mi Nei Net Database

With the rapid development of society and economy, people’s life pressure is increasing.

Bad habits such as irregular work and rest, unhealthy diet, lack of exercise are more common, and the incidence of ED is not low.
The prevalence rate is as high as 40.

According to data from Minai.
com, in 2020, in China’s urban public hospitals, county-level public hospitals, urban community centers and township health centers (Chinese public medical institutions) terminals and Chinese urban physical pharmacies, sildenafil, tadalafil and The total sales of vardenafil exceeded 3.
5 billion yuan, and under the influence of the epidemic, it increased by 6.
7% against the trend
.

At present, sildenafil has grown into a large variety of more than 2 billion, and the sales of tadalafil will also enter the 900 million echelon, and its clinical value has been recognized by doctors and patients
.

The second batch of countries adopted tadalafil tablets, two domestic pharmaceutical companies won the bid, and the third batch of countries adopted sildenafil citrate tablets.

Table 1: The status of anti-ED drugs that have been included in the country

Source: Mi Nei.

com, China's public medical institutions terminal competition pattern

In 2020, the sales of tadalafil tablets in China’s public medical establishments accounted for about 11% of the total.

Eli Lilly’s post-harvest market share in countries that lost the bid fell to 52.

In 2020, the sales of sildenafil in China’s public medical establishments accounted for about 3% of the total.
The third batch of national procurement will be implemented in the fourth quarter of 2020.
At present, Pfizer’s market share is still around 90%.

.

Qilu's current market share is about 2%.

The domestic brand won the championship for the first time, and the original research pharmaceutical companies have different response strategies

Figure 2: Sales of TOP3 brands of terminal ED drugs in physical pharmacies in Chinese cities (unit: 10,000 yuan)

Source: China City Entity Pharmacy Terminal of Meinenet

Although the physical pharmacy terminal in Chinese cities is the main battlefield of ED drugs, the original research drug has been cultivated in domestic hospitals for many years, and the accumulated market size cannot be underestimated
.

In 2019, Baiyunshan’s sildenafil citrate tablets have defeated Pfizer in Chinese urban physical pharmacies and become the best-selling ED drug brand, but the overall total sales of the three terminals are still slightly lower than Pfizer; in 2020, Baiyunshan's retail market surged 15.
84%, and the total sales in the three major terminals reached 1.
3 billion yuan.

Figure 3: The growth rate of Pfizer's sildenafil citrate tablets in the past three years

Source: Mi Nei Net Database

Pfizer is not unprepared to face the impact of Guocai.

From the perspective of growth rate, although the product is directly inserted into the terminal of public medical institutions in China, due to the small proportion of the volume, it has not been "sounding the muscles and bones.
" However, the growth rate of physical pharmacy terminals in Chinese cities, the main battlefield, is slowly increasing, and the total sales of the three major terminals remain at the level of 1.

Figure 4: The growth rate of Eli Lilly’s Tadalafil tablets in the past three years

Source: Mi Nei Net Database

Eli Lilly began to meet the challenge of domestically produced generic drugs in 2019.

Up to now, the number of companies with domestic approvals for the product has risen to 14
.
In 2020, affected by the implementation of National Procurement, the sales of Eli Lilly’s tadalafil tablets plummeted by nearly 60% at the terminals of Chinese public medical institutions, while sales at the main battlefield Chinese city physical pharmacies maintained a positive growth trend.
, But in terms of volume, the gap with Pfizer Viagra is still large
.
In January 2021, there was news from Eli Lilly China that the product will no longer have a full-time retail store sales team.
The current e-commerce and retail key customer teams have also been integrated into the company's business team as a whole, and more than 100 employees have been laid off.
; In June, Eli Lilly sold the rights of Cialis (tadalafil) in the Chinese mainland market to the Italian pharmaceutical company Menarini.
.
.
In recent years, Eli Lilly has continued to promote the strategic transformation of its Chinese business, and the above move is considered by the industry It is a manifestation of the company's decision to divest Cialy's rights and interests in mainland China, concentrate resources to accelerate the listing of new products and new indications in key disease areas in China, and optimize the business promotion model
.

Figure 5: Application for the listing of tadalafil films

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

It is reported that the compound patent of Eli Lilly's tadalafil tablets expired in January 2015, and the patent for ED use also expired in April 2020.
Domestic pharmaceutical companies have made an all-out effort
.
Up to now, the number of companies that have applied for the imitation and listing of tadalafil films has exceeded 40.
There are currently 38 acceptance numbers under review and approval (22 companies involved).
It is foreseeable that Tadalafil will be listed in the next 2-3 years.
Non-tablet domestic generic drugs will usher in a blowout period for approval
.
Under such pressure, it is understandable that Eli Lilly chose to adjust its strategy
.

Qilu new drug is approaching, Kelun aims at Pfizer to grab the first imitation product

Table 2: Approval status of ED blockbuster varieties from 2021 to present (statistics based on approval date)

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

In 2021, China's ED drug market ushered in a number of new products.
Among them, Haisco won the first domestic imitation of avanafil tablets in March this year.
In May of the same year, Shanghai Huilun Jiangsu Pharmaceutical's "second imitation" was approved.
It is reported that Compared with other PDE-5 inhibitors, avanafil can take effect in the shortest time (15 minutes), which is significantly faster than tadalafil (30 minutes), sildenafil (1 hour), and valdipine Nafil (1 hour), and avanafil has higher selectivity to PDE-1 and PDE-6, less side effects, and higher safety
.
Haisco stated on the investor interaction platform on July 1 that Haichi (avanafil tablets) is expected to be listed in September this year, and the pricing strategy is currently under study.
The company stated that based on the development potential of the Chinese andrology product market, sales The prospects should be worth looking forward to
.

At the same time, we can also see that the number of domestically-made generic drugs approved for sildenafil citrate tablets and tadalafil tablets is gradually increasing, and the future market competition for the two major varieties will become more intense
.

Table 3: The status of the major varieties of ED drugs declared for marketing and under review

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

Qilu's tadalafil oral dissolving membrane was declared for marketing in 2020, and its indication is the treatment of erectile dysfunction
.
Oral instant film is a new type of oral preparation.
Compared with traditional oral preparations, it has the advantages of good taste, melts in the mouth, and does not need to be taken with water when taking it.
Qilu has started to develop oral film preparations since 2013.
Five varieties have been declared for production, among which olanzapine oral dissolving film and montelukast sodium oral dissolving film (exclusive) have been approved, and tadalafil oral dissolving film is expected to become the company's third oral instant film approved for marketing In addition, the company's memantine hydrochloride oral dissolving film and aripiprazole oral dissolving film are also under review and approval
.

Pfizer’s Sildenafil Citrate Orally Disintegrating Tablets were declared clinically in China in 2013, and they were imported into the market in 2017.
They were finally approved to enter the Chinese market at the end of 2019, giving patients with swallowing difficulties or difficulties, and erections with inconvenient water intake.
New choice of medication for patients with dysfunction
.
The news pointed out that the original research drug entered JD Health after it was listed, and at the same time it was first launched on the JD Pharmacy online.
The “renewal of old drugs” is also considered by the industry as a change after the adoption of countries that have failed the standard
.

However, the battlefield just developed by Pfizer will also usher in new changes.
In September 2020, Kelun was the first to declare the 4 types of imitation listing of Sildenafil Citrate Orally Disintegrating Tablets and is currently under review and approval
.
Kelun won the first domestic imitation of vardenafil hydrochloride tablets in 2020.
If sildenafil citrate orally disintegrating tablets can be successfully approved, it will also become the first domestic imitation, and at the same time contribute to the company's ED drug camp.

.

Figure 6: The latest situation of sildenafil citrate oral dissolution membrane declared by Kelun

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

According to data from Meinenet, Kelun declared and approved the clinical application of a new drug for sildenafil citrate oral dissolving film in 2021.
This product is Kelun’s first oral instant dissolving film and is expected to become the company’s in this field.
The first approved product
.

Conclusion In recent years, with the expiration of the patents of original research drugs, domestic generic drugs have sprung up like mushrooms.
Driven by consistency evaluation and centralized procurement by the country, domestic brands have become dazzling new stars in the market
.
Baiyunshan's Jin Ge was approved earlier, and after years of hard work, it eventually became the first brand
.
In the next period of time, old varieties will usher in a blowout period for the approval of generic drugs, and there is no doubt that market competition will become more intense
.
Leading pharmaceutical companies with strong R&D capabilities such as Qilu and Kelun have gradually set their sights on improved new drugs.
With the continuous promotion of "innovation + imitation", China's ED drug market will flourish
.

Source: Mynet database, company annual report, etc.

The review data statistics are as of July 13, if there are any errors or omissions, please correct me
.