National talks varieties soared by 6000%! 27 Class 1 new drugs to challenge Hengrui and Renfu to fight again

Wonderful content

Wonderful content

2021 National Medical Insurance Drug Catalogue Adjustment Passed Initial Formal Review The list of drugs was announced recently.
After review, a total of 271 drugs have passed, of which condition 1, that is, those approved for marketing by NMPA from January 1, 2016 to June 30, 2021 There are 160 new generic drugs.
From the date of approval, 52 new products (including domestic and imported) were approved in the first half of 2021
.

In recent years, with the improvement of the R&D capabilities of domestic pharmaceutical companies and the acceleration of review and approval, more and more new drugs have entered the market.

Western medicine accounted for 96%, and anti-tumor and immunomodulators are far ahead

Western medicine accounted for 96%, and anti-tumor and immunomodulators are far ahead

According to statistics, among the 160 new products that meet Condition 1, Western medicine accounts for 96.
25%, and 6 Chinese patent medicines are distributed in gynecological medicine (2), respiratory disease medicine (3), and dermatological medicine (1)
.

The Huashibaidu Granules, Qingfei Paidu Granules, and Xuanfeibaidu Granules transformed from the "three parties" of the new crown treatment have successfully entered the preliminary review list.

Figure 1: Distribution of 154 Western medicines

154 Western medicines are distributed in 14 categories, of which anti-tumor and immunomodulators (43), systemic anti-infective drugs (30), nervous system drugs (21), digestive system and metabolic drugs (18) account for The ratio is more than 10%
.

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 (referred to as Chinese public medical institutions), the digestive system and metabolic drugs, anti-tumor and immunomodulators, and systemic anti- The market size of infectious drugs exceeds 100 billion yuan, and neurological drugs also exceed 90 billion yuan.
It can be seen that the relevant departments are closely watching the market dynamics during the review, and the matching degree is quite high
.

Figure 2: TOP5 subcategories

In terms of sub-categories, anti-tumor drugs take the lead.
11 of the 32 new products are products approved for import/production in the first half of 2021.
It can be seen that the government has increased protection in the field of major diseases, so that patients can use them as soon as possible.
These new drugs improve the quality of life
.

Systemic antiviral drugs accounted for 13, of which 4 were approved for import/production in the first half of 2021; systemic antibacterial drugs accounted for 12, and 2 were approved for production in the first half of 2021; 9 neuroleptics All of them are domestically produced, with 5 approved in the first half of 2021
.

Among the 7 immunosuppressive agents, 4 are imported monoclonal antibodies, and only 1 domestic injection was approved for production in the first half of 2021
.

Hengrui and Rongchang Class 1 new drugs will explode, and the two "nominations" of Geli and Lvgu attract attention

Hengrui and Rongchang Class 1 new drugs will explode, and the two "nominations" of Geli and Lvgu attract attention

Table 1: 27 domestic Class 1 new drugs that passed the preliminary formal review

Note: The products marked blue are products that have entered the 2020 preliminary review list.

*For products approved in the first half of 2021

Of the 160 new products that passed the preliminary formal review in 2021, 27 were domestically produced Class 1 new drugs
.

Among them, 13 new drugs were approved in the first half of 2021.

From the perspective of enterprises, Hengrui, the “innovative drug first brother”, is still a big hit.
Fluzoparib capsules, remazolam tosylate for injection, and Hetrobopar ethanolamine tablets (approved in the first half of 2021) have passed the preliminary Under review, these three Class 1 new drugs are distributed in anti-tumor and immunomodulators, nervous system drugs, and blood and hematopoietic system drugs
.

Last year, Hengrui's remazolam tosylate for injection and Renfu's remazolam tosylate for injection both passed the preliminary formal review.

The danoprevir sodium tablets and lavidavir hydrochloride tablets approved by Golly Pharmaceuticals in the field of chronic hepatitis C were also "nominated" again.
It is reported that Golly Pharmaceuticals finally competed with Gilead and Merck & Co.
Sorry to be out
.

In 2020, the sales of danoprevir sodium tablets in China's public medical institutions and China's urban physical pharmacies have plummeted, falling by 72% and 63% respectively.

Rongchang Biopharmaceuticals' R&D strength is gradually showing.
In 2021, the company won the injection of tytaxep and vedicutumab for injection in the field of anti-tumor and immunomodulators, and the two new drugs have successfully entered this preliminary stage.
We will wait for the results of the formal review to see if we can win
.

Figure 3: Sales of Ganlut Sodium Capsules in Lugu (Unit: 10,000 yuan)

Source: Mi Nei.
com, China's urban physical pharmacy terminal layout

Ganlut Sodium Capsules, which are also twice "nominated", are domestically produced Class 1 new drugs approved in 2019 for the treatment of Alzheimer's disease
.

With the increase in the aging of the social population, the incidence of Alzheimer’s disease is also gradually increasing.

Table 2: Sales of domestically-made Class 1 new drugs that were partially negotiated in 2019 in China's public medical institutions in 2020

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

If domestic new drugs want to quickly seize the market at the hospital terminal, entering medical insurance through negotiation is the best choice
.

We found that most of the domestically produced Class 1 new drugs that successfully entered the medical insurance catalogue for the first time in 2019 will have a substantial increase in sales in China’s public medical institutions in 2020, such as Hengrui’s pyrrotinib maleate tablets and Cinda’s Sintilimab injection has become a large variety of over 1 billion, and the first internationally researched drug Roxastat capsule developed and incubated in China has soared by 6278.

After the nanofloxacin malate capsule of Zhejiang Pharmaceutical Xinchang Pharmaceutical Factory entered the medical insurance in 2019, its sales in 2020 soared by 207%.
The company was approved for nanofloxacin malate sodium chloride injection in 2021, a new dosage form of the same variety We will wait and see whether we can continue this situation and reap dividends
.

Merck, Johnson & Johnson, Pfizer.
.
.
once again challenged, just give up or switch to retail?

Merck, Johnson & Johnson, Pfizer.
.
.
once again challenged, just give up or switch to retail?

Of the 160 new products that have passed the preliminary formal review, 9 products have been approved for import as well as domestically produced imitations.
Of the 66 new imported drugs, currently 26 have been sold in physical pharmacies in cities in China.
The top 7 imported new drugs with sales of over 100 million yuan in 2020 have attracted market attention
.

Figure 4: Domestic sales of 7 imported new drugs in 2020 (unit: ten thousand yuan)

Source: Mi Nei Net Database

These 7 imported new drugs have actually passed the preliminary formal review as early as 2020, but ultimately failed to enter the medical insurance.
This time the challenge is launched again.
How high is the probability of success?

Merck’s pembrolizumab injection has global sales of over 14 billion U.
S.
dollars in 2020.
The sales of this product in China’s public medical institutions and Chinese urban physical pharmacies both exceed 1 billion.
With new domestic indications, it continues to gain Approved, overall sales are expected to increase again
.

Judging from the current situation, it is estimated that the product will not enter the medical insurance to have a limited impact on it, but from the patient's point of view, being able to enter the medical insurance will greatly reduce the treatment cost, which is really a good thing

Bristol-Myers Squibb’s nivolumab injection and AstraZeneca’s duvalizumab injection have won a scale of over 800 million yuan in physical pharmacies in cities in China in 2020, and nivolumab is in China’s public healthcare industry.
The end result of the institution is good, but the dose of Duvalizumab injection has not been increased
.
Also in the terminal of public medical institutions in China that have not been increased in quantity are Amgen's iloyuumab injection, Johnson & Johnson's daratumumab injection and usnumab injection, as well as Pfizer's dacotinib Slices
.

It is widely speculated that foreign pharmaceutical companies will not offer ultra-low prices in the Chinese market due to the consideration of maintaining international pricing.
Especially, the annual treatment cost of domestic PD-1 has dropped to less than 100,000 yuan.
It is better to switch to the out-of-hospital and retail markets.
This may be one of the reasons why the negotiation of seven imported new drugs failed last year
.
However, with the implementation and improvement of new policies such as the outflow of prescriptions and online sales of prescription drugs, it is a good strategy for foreign pharmaceutical companies to increase their retail market layout.
Especially for foreign pharmaceutical companies with complete product lines, they can also use their existing channel layout to make a good move.
Battle
.

Concluding remarks

Concluding remarks

The dynamic adjustment of the medical insurance catalog will benefit the most domestically produced new drugs, and the enthusiasm of domestic pharmaceutical companies is also quite high.
In order to balance international pricing, foreign pharmaceutical companies cannot achieve "no distractions" despite the huge potential of the Chinese market.
The retail market may become a new battlefield for imported new drugs in the future
.
According to data, in 2020, 722 kinds of drugs passed the formal review, but only 162 were finally sitting at the negotiation table, and only 119 kinds were finally negotiated.
Using last year as a reference, this year's final negotiation was about 40 kinds.

.

Data source: the official website of the Medical Insurance Bureau, the database of Mi Nei.
com