Hengrui again ushered in the outbreak of more than 40 domestic exclusive new drugs to disrupt the trillion market

Recently, the list of drugs that passed the preliminary form review in the 2022 national medical insurance catalogue adjustment was officially announced, and 344 drugs passed the preliminary examination, with a passing ratio of 70%.

There are a total of 199 western medicines and proprietary Chinese medicines outside the high-profile catalogue, of which 46 are domestic exclusive new drugs (that is, exclusive products that are reported and approved according to new drugs).

In terms of Western medicine, Hengrui led 3 new drugs of class 1 and 1 improved new drug to break through, Qilu's mouth-soluble membrane exclusive new drug was eye-catching, and Kangyuan, Tasly, Yiling and other Chinese medicine leaders a total of 10 new drugs participated in the battle.
.
.
The 2022 edition of the national medical insurance directory will be like a cloud, and The trillion yuan market of China's public medical institution terminals will set off a huge wave
.

 

Official! 492 drug declarations were accepted, and 344 were successfully reviewed

 

Table 1: The medical insurance catalogue has been adjusted in the past three years to adjust the drug situation that has passed the preliminary examination

Source: Official website of the National Medical Insurance Bureau

 

The situation in 2020 is more special, with 493 varieties that have been included in the provincial medical insurance catalogue of 5 or more accounting for most of the places
in the preliminary examination list.
In 2021, the Medical Insurance Bureau received 501 enterprise declarations, involving 474 drugs, and 271 drugs passed the preliminary formal examination, with a passing ratio of 57%.

In 2022, the Medical Insurance Bureau received 537 enterprise declarations, involving 490 drugs, and 344 drugs passed the preliminary formal examination, with a passing ratio of 70%.

 

Compared with 2021, the number of drugs declared or passed the preliminary examination has increased to a certain extent this year, which shows that the industry's emphasis on the adjustment of the medical insurance catalogue is also gradually increasing
.

 

46 domestic exclusive new drugs were shortlisted, and more than 70% were new faces! Anti-tumor and immunomodulatory are the hottest

 

It is reported that in 2022, there are 184 western medicines outside the directory that have passed the preliminary examination, 15 proprietary Chinese medicines, and the statistics of the intranet show that there are 36 domestic exclusive Western medicine new drugs and 10 domestic exclusive chinese proprietary medicine new drugs
.
Of these 46 products, 34 are the first to enter the national medical insurance directory to adjust the preliminary review list, and the proportion of new faces exceeds 70%.

 

Figure 1: Distribution of 46 domestic exclusive new drugs

 

Of the anti-tumor and immunomodulators, only sivotinib tablets were on the 2021 preliminary list, and the remaining 9 were new faces
.
The 9 new Class 1 drugs involve a number of blockbuster products: the first domestic third-generation BCR-ABL inhibitor orebatinib tablets, the first domestic dual antibody (PD-1/CTLA-4) cardunillimonumab injection, the first domestic PD-L1 Envolizumab injection, and the second domestic CAR-T Reggiolense injection are all within the
list.

 

The systemic anti-infective drugs have two new drugs of class 1 new drugs for injection of tomacycline tosylate and azvudine tablets (outside the catalog conditions 1, indications for anti-HIV), two improved new drugs levonidazole dispersible tablets and entecavir granules, as well as a new compound preparation for injection of cefotaxime sodium tazobactam sodium, Beijing Ruiye Pharmaceutical has 4 powder liquid double chamber bag cephalosporin injections have passed the preliminary examination
again.

 

Among the nervous system drugs, there is a new drug of phospholopophen disodium for injection of the first class of anesthetic drug leader Renfu, in addition, the exclusive new drug of the domestic oral-soluble membrane leader Qilu, the memantine hydrochloride mouth-soluble membrane, has also passed the preliminary examination
.
At present, there are 6 types of oral soluble membranes that have been listed in China, of which 5 are reported and approved according to new drugs, olanzapine oral soluble membranes passed the preliminary examination last year but finally did not "enter the insurance", and this year also appeared in the preliminary review list, but it is not an exclusive product
.

 

The 10 new Chinese medicines are distributed in the digestive system, nervous system, respiratory system, skeletal musculoskeletal system and gynecology
.
The 6.
1 class new drug Jinrong granules approved in 2018 have entered the preliminary list in 2020 and 2021
.
The wet septic particles and lung septic particles transformed into the "anti-epidemic tripartite" have successfully entered the 2021 version of the national medical insurance negotiation directory, and the lung detoxification granules have entered the preliminary review list
last year and this year.
Jianmin Pharmaceutical's Qirui Gastric Shu Capsules, Yiling Pharmaceutical's Jieyu Deborder Capsules, Yili Group's Huzhen Qingfeng Capsules, Tasly's Kunxining Granules, Shandong Phoenix Pharmaceutical's Qili Yi Kidney Capsules, Fangsheng Pharmaceutical's Xuanqi Jian Bone Tablets and Kangyuan Pharmaceutical's Yinqiao Qing Fever Tablets are all new drugs approved in 2021, and pass the audit for the first time, if they can be "fully insured", they will stimulate the research and development
of new drugs in domestic Chinese medicines.

 

With the help of medical insurance, the "brother of innovative drugs" has exploded! Blockbuster varieties of improved new drugs to break through

 

Table 2: Domestic exclusive class 1 new drugs (including 1 and 1.
1) that passed the 2022 preliminary review

Source: MED2.
0 China Drug Review Database

 

Hengrui's dalcilil isethionate tablets and proline hepagliflozin tablets were approved at the end of 2021, and reviruter tablets were approved at the end of June this year, just eligible to participate in the 2022 medical insurance catalogue adjustment work
.
Dalcililly is the first domestic CDK4/6 inhibitor, proline hepagliflozin tablets are the first domestic SGLT2 inhibitors, revirutamine tablets are the first domestic AR inhibitors, the market potential is huge, if successfully entered the medical insurance, it will usher in a large amount
.

 

Table 3: The sales of innovative drugs that Hengrui has entered the medical insurance catalogue earlier

Note: Sales below $1 million are replaced by *

 

Source: Intranet China's public medical institution terminal competition pattern

 

Hengrui has been approved to market 11 innovative drugs, the earlier 8 have entered the medical insurance directory, in 2021 in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) terminal sales of nearly 9 billion yuan, to help Hengrui firmly sit on the "innovative drug brother" throne
.

 

Erecib tablets are the earliest approved innovative drugs of Hengrui, with terminal sales of public medical institutions in China only about 80 million yuan in 2016 and the current peak sales of 930 million yuan
in 2021.

 

After apatinib mesylate tablets entered the medical insurance negotiation directory in 2017, the sales of that year directly exceeded 1.
5 billion yuan, and the sales peak in 2019 was 2.
39 billion yuan, and the sales of the product fell back to about
1.
8 billion yuan in 2021.

 

With the sales curve of thiofifiglib injection and pyrrolidinib maleate tablets, which were approved in 2018 and entered the medical insurance negotiation directory after 2019, the terminal sales of the two products in China's public medical institutions in 2018 were less than 10 million yuan, and in 2019, they broke through the 300 million yuan and 500 million yuan marks respectively, became a new 1 billion yuan single product in 2020, and created a new peak
in sales in 2021.

 

The approved carellizumab for injection in 2019 is currently hengrui's best-selling innovative drug, and after entering the medical insurance negotiation directory in 2020, sales rose to 2.
5 billion yuan in 2021; Ramazolam toluene sulfonate for injection, which was also approved in 2019, also rose to 140 million yuan
after entering the 2021 version of the medical insurance negotiation directory.

 

Table 4: Pictures of domestically exclusive improved new drugs (including 2.
2 and 2.
3) that passed the 2022 preliminary review

Note: Sales below $1 million are replaced by *

 

Source: Intranet China's public medical institution terminal competition pattern

 

Large varieties of improved new drugs have become a hot direction of new drug research and development in recent years, large varieties in the market for many years have been widely recognized by doctors and patients, improved new drugs have enhanced efficacy, reduce side effects, improve patients' medication compliance and other obvious clinical advantages, is a "more cost-effective" product
.
There are a number of improved new drugs in the domestic exclusive new drugs that have passed the preliminary examination this year, all of which are the products that have passed the preliminary examination of medical insurance for the
first time.

 

Entecavir has experienced a reduction in sales scale after national procurement, but it is still the TOP1 variety of terminal systemic antiviral drugs in Public Medical Institutions in China, and entecavir granules were approved for listing in September 2021, filling the gap
in the domestic treatment of children with chronic hepatitis B.

 

Cefotaxime is the terminal cephalosporin TOP10 variety in China's public medical institutions, and the sales of cefotaxime sulbactam, which has been listed earlier, will also exceed 1.
4 billion yuan
in 2021.
Tazobactam is a powerful β-lactamase inhibitor obtained after sulbactam transformation, and the sales of cefoperazone tazobactam that have been listed have exceeded 1.
3 billion yuan, and the potential of cefotaxime sodium for injection of tazobactam sodium can be expected
.

 

The current medical insurance catalogue adjustment work is once a year, and the PD-1 monoclonal antibody puterizumab injection approved after July 1 this year and the domestic new anti-CD20 monoclonal antibody ripperumab injection can only wait for next year's medical insurance catalogue adjustment cycle
。 Among the new products approved from July 1 last year to June 30 this year, there are still some domestic exclusive new drugs that have not entered the preliminary review list, such as the new anti-tumor drug epimedicin soft capsules of traditional Chinese medicine, the first rabies monoclonal antibody umitevir monoclonal antibody injection in China, the high-end preparation mitoxal anthraquinone hydrochloride liposome injection and the paclitaxel polymer micelle for injection, and the future development direction of these "lost pearls" has also attracted market attention
.

 

It is reported that after the end of the preliminary review list, it will enter the expert review, negotiation and bidding link, from the current progress, and the time node proposed in the earlier plan is about a month late, the expert review stage was originally carried out in August, the negotiation and bidding stage was originally in September to October, and the results
are planned to be announced in November.
This year's medical insurance catalogue adjustment is a major event in the pharmaceutical industry in the second half of the year, and Minnet will continue to pay attention to the progress, so please pay attention to the latest reports
.

 

Source: National Medical Insurance Bureau, Intranet Database, etc.
Note: Minnet "China's Public Medical Institutions Terminal Competition Pattern", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics, village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.