Domestic Class 1 new drugs broke out! Cinda, Hausen... the sales of 12 innovative drugs soared, and the 21st Class 1 new drug was born this year

Recently, Microchip's original innovative drug Siglita sodium tablets was approved for marketing
.
Since 2021, the number of Class 1 new drugs approved for marketing for the first time in China has reached 21, focusing on the fields of anti-tumor and anti-infection, and 9 new drugs are expected to participate in a new round of medical insurance negotiations

Microchip is showing its power! Won China's first innovative diabetes drug

On October 19, the official website of NMPA revealed that Microchip's Class 1 innovative drug Siglita sodium tablets (trade name: Shuangluoping/Bilessglu) was approved for marketing recently
.
The drug is an innovative drug independently researched and developed by China with independent intellectual property rights.

Chiglitazar Sodium (Chiglitazar Sodium) is a peroxisome proliferator activated receptor (PPAR) full agonist that can simultaneously activate the three subtypes of PPAR receptors (α, γ, and δ), and induce downstream The expression of target genes related to functions such as insulin sensitivity, fatty acid oxidation, energy conversion and lipid transport, inhibits PPARγ receptor phosphorylation related to insulin resistance
.
The listing of this variety provides a new treatment option for adult patients with type 2 diabetes

Siglipta Sodium is China's first original diabetes drug and is known as China's indigenous new diabetes drug
.
The product entered clinical trials in 2005, and the research and development lasted more than 16 years

Chipchip Biosciences was established in March 2001, focusing on the research and development of new molecular entities and original innovative drugs with novel mechanisms of action
.
On August 12, 2019, Microchip Technology was officially listed on the Science and Technology Innovation Board, becoming the first stock of original innovative drugs on the Science and Technology Innovation Board

21 new class 1 drugs approved! Market "One Brother" Changed Ownership

Class 1 new drug approved for marketing for the first time in China since 2021

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

According to data from Mi Nei.
com, since 2021, there are 21 types of new drugs (including category 1.
5, excluding imports, new indications, and vaccines) that have been approved for marketing for the first time in China
.
Among them, the second quarter was the peak period for the approval of Class 1 new drugs.

From the perspective of drug types, there are 16 small-molecule chemical drugs in 21 new class 1 drugs, and only 5 large-molecule biological drugs, specifically Ruiji Orenza injection (the first domestically produced CAR-T), Sepali Anti-injection solution (PD-1), Pianprizumab injection solution (PD-1), Wendixituzumab for injection (the first domestically produced ADC), and Tetaxel for injection (dual target preparation)
.

It is not difficult to find that anti-PD-1 monoclonal antibodies occupy two seats
.
Although there are only a handful of Class 1 biological drugs, Rongchang Biotech has been approved for two

From the perspective of the treatment field, 21 new class 1 drugs are mainly concentrated in the fields of anti-tumor and anti-infection.
Anti-tumor drugs lead by 9 new drugs.
There are 3 types of systemic antibacterial drugs and systemic antiviral drugs
.
In addition, there are 1 types of blood lipid regulators, systemic antifungal drugs, anesthetics, immunosuppressants, hemostatic drugs, and diabetes drugs

As new products such as anti-tumor drugs continue to enter the market, the domestic pharmaceutical market has also undergone significant changes
.

According to data from Meinenet, in recent years, the scale of the terminal market of anti-tumor and immunomodulators in urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) has continued to rise in recent years.
Anti-infective drugs, digestive system and metabolic drugs, blood and hematopoietic system drugs have all been PKed off one by one
.

It is worth noting that 15 of the 21 new Class 1 drugs were approved for marketing in the first half of this year.
Among them, 9 new drugs were selected into the "List of Drugs Approved by the 2021 National Medical Insurance Drug Catalog Adjustment Passed the Preliminary Formal Review" and are expected to participate in the new one.
Round of medical insurance negotiations
.

Medical insurance "God assists"! 12 new class 1 drugs skyrocket

In the past three years (2018-2020), a total of 32 new category 1 drugs (including category 1.
5, excluding imports, new indications, and vaccines) were approved for marketing in China for the first time
.
In the past three years, the national medical insurance catalogue has also been adjusted three times
.
Currently, 18 of the 32 Class 1 new drugs have entered the 2020 National Medical Insurance Catalog, 13 of which are included for the first time
.

The 2020 National Medical Insurance Catalogue has been implemented on March 1 this year.
How about the sales of 18 Class 1 new drugs in the hospital market?

Sales of 18 Class 1 new drugs in the first half of the year (medical insurance products)

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

The latest data from Mi Nei.
com shows that in the first half of 2021, the terminal sales of 18 new category 1 drugs in public medical institutions in China have achieved positive growth, with the highest increase of 86.
6.
12% and the lowest of 8.
66%
.
It is worth noting that there are 12 new class 1 drugs with sales growth of more than 100%
.

It is true that in the early stage of market development, innovative drugs can easily achieve excellent sales growth due to their small base
.

Then, look at the sales of 18 Class 1 new drugs in the first half of the year.
There are 12 varieties of 100 million yuan, 4 of which are 1 billion yuan, including Chia Tai Tianqing’s Anlotinib Hydrochloride Capsules and Xinda Bio’s Xindili Monoclonal antibody injection, Hengrui Medicine's pyrrotinib maleate tablets and Carrelizumab for injection
.

It can be seen that these Class 1 new drugs can still achieve rapid growth after the market size exceeds 100 million yuan and 1 billion yuan
.

On the other hand, 14 of the 32 new Class 1 drugs were not included in the medical insurance, and 9 of them were approved for listing in the second half of 2020, failing to keep up with the medical insurance negotiations at the end of 2020
.
In addition, there are 2 and 3 new drugs approved for marketing in 2018 and 2019, respectively
.

Growth rate of 14 Class 1 new drugs in the first half of the year (non-medical insurance products)

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

Although the terminal sales of 14 new class 1 drugs in China’s public medical institutions increased well in the first half of the year, the market did not open up.
There were only 3 new drugs with sales of more than 10 million yuan, namely Beta Pharmaceutical’s Hydrochloride Satinib capsules, Renfu Medicine's remazolam besylate for injection and Hengrui Medicine's remazolam tosylate for injection
.

Medical insurance is an important catalyst for increasing the volume of innovative drugs, and without the assistance of medical insurance, the commercialization capabilities of pharmaceutical companies play a decisive role in the market sales of innovative drugs
.

On September 28, the National Medical Insurance Administration issued the "Announcement on the Inquiry of the Phased Results of the Expert Review of the National Medical Insurance Drug Catalogue in 2021", and stated that the end of the expert review phase, which means that the new round of medical insurance catalog adjustments has come to the negotiation stage
.
We will wait and see how domestically produced 1 new drugs will play out!