Hengrui is fully fired!

Recently, Hengrui Pharmaceuticals, the "first brother of innovative drugs", has frequently issued news: 3 new class 1 drugs have entered the new medical insurance, SHR8554, SHR8008, SHR8058 will be reported for production soon.
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Minenet data shows that Hengrui currently has 108 innovative drugs (81 new class 1 drugs) are in the clinical application and above stage, of which 11 (9 class 1 new drugs) have been/will be submitted for production, and 13 (9 class 1 new drugs) are in phase III (including II/ Phase III) key clinical trials, in addition to the continuous acceleration of "license-in"; in terms of generic drugs, 47 varieties have been reviewed (22 are the first ones), and 16 sprints are first imitation (7 are exclusive for production)
.
The sales of 5 innovative drugs exceeded 10 billion, and 3 new class 1 drugs entered the new medical insurance.
After years of deployment, Hengrui Pharmaceuticals innovative drugs have entered the harvest period
.
Since the beginning of this year, the company has been approved for the listing of 3 new drugs, including Class 1 new drug Hytrapopapax (TPO-R agonist); in addition, a number of new Class 1 drugs have been approved for new indications, including Tosylate horse alprazolam, fluoro oxazole paclitaxel, Karui Li daclizumab, apatinib the like
.
According to data from Minai.
com, currently 8 innovative drugs of Hengrui Medicine have been approved for marketing.
5 innovative drugs approved before 2020 will be used in urban public hospitals, county-level public hospitals, urban community centers, and township health centers in China in 2020 ( The total sales scale of China's urban physical pharmacies exceeds 10 billion yuan, and it is expected to reach a new high in 2021
.
Sales of Hengrui Medicine's marketed innovative drugs Note: Less than 100 million yuan worth *Representative Source: Mi Nei.
com database Three new class 1 drugs approved after 2020 will participate in the 2021 national medical insurance negotiations, and all of them have been successfully selected
.
Up to now, the total number of drugs that Hengrui Medicine has entered into the National Medical Insurance Catalogue has reached 85, including 8 innovative drugs that have been approved for marketing
.
In the new version of the National Medical Insurance Catalogue released on December 3, Hengrui has 9 products included, of which 3 new class 1 drugs, 1 first copy are included for the first time, 1 new drug has new indications, and 2 new drugs are continued About products
.
The source of products that Hengrui Pharmaceuticals included in the new version of medical insurance: “license-in” on the official website of the National Medical Insurance Administration accelerated again, and 81 new class 1 drugs were overwhelming.
On November 21, the cooperation between Hengrui Pharmaceuticals and CStone Pharmaceuticals attracted widespread attention in the industry
.
Hengrui will introduce Cornerstone's anti-CTLA-4 monoclonal antibody CS1002 injection with a down payment of 52 million yuan and a milestone of no more than 1.
185 billion yuan.
The current domestically marketed drug with the same target is Bristol-Myers Squibb's ipilimumab
.
CTLA-4, PD-1 and PD-L1 are collectively called the "three treasures" of tumor immune drug development targets, and they are the basic components of mainstream tumor immunotherapy
.
On the one hand, this cooperation can alleviate the backward situation of Hengrui in CTLA-4 target research and development, on the other hand, it will also pave the way for the company's listed PD-1 and PD-L1 combination drugs
.
Since the beginning of this year, Hengrui Medicine has announced at least 4 cooperative projects, and the introduction of innovative drugs (mainly biological drugs) in the same category, such as Tianguangshi’s MIL62, is the first domestically produced product to enter III clinical trials.
The third-generation CD20 monoclonal antibody, the domestic drug marketed on the same target is Roche’s Otuzumab (global sales of 632 million Swiss francs in 2020); Yingli Pharmaceutical’s YY-20394 is the first domestic product to submit a marketing application PI3kδ inhibitor, no domestic drug with the same target has been approved
.
The source of the license-in announced by Hengrui Pharmaceuticals since 2019: Listed company announcements, Meinenet database, from self-developed R&D in the past to successive introduction of innovative drugs, from the full cost of R&D investment to the partial capitalization of R&D investment.
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Hengrui Pharmaceuticals is actively pursuing changes, and what remains unchanged is the original intention and determination to adhere to R&D innovation and internationalization
.
The quarterly report data shows that the company invested 4.
14 billion yuan in R&D in the first three quarters of 2021, an increase of 23.
9% over the same period last year, accounting for 20.
5% of revenue (17.
2% in the same period last year)
.
According to data from Minai.
com, including new drugs introduced through cooperation, Hengrui Medicine currently has 108 innovative drugs (excluding new drug development and indications) in the clinical application and above stage, of which 81 are Class 1 new drugs
.
Hengrui Medicine is researching innovative drugs Note: The first review with *, ** the exclusive review source: Meinenet MED2.
0 Chinese drug review database 22 varieties of the first / exclusive review, including celecoxib capsules , Glycopyrrolate injection, esketamine hydrochloride injection, abiraterone acetate tablets, temozolomide for injection, dexmedetomidine hydrochloride sodium chloride injection, tolvaptan tablets, tafluprost eye drops , Mycophenolate sodium enteric-coated tablets, Azilsartan tablets and other varieties are the first imitation + the first review
.
Among the new classifications of Hengrui Pharmaceuticals reported for the production of generic drugs, 16 have not been approved for the first imitation (including the first dosage form)
.
Many products are sold in other dosage forms in China.
It can be seen that dosage form improvement is one of the company's key research and development directions
.
Hengrui Pharmaceutical’s new classification has been reported for production and there is no product approved for the first imitation.
Source: Meinenet.
com China Drug Clinical Trial Public Library.
From the perspective of research and development progress, 11 new drugs have been/will be applied for listing (the highest research and development progress, the same below), except for others Dalafil oral dissolving film and SHR8058 eye drops, the other 9 are new class 1 drugs; 13 new drugs have entered phase III (including phase II/III) key clinical trials, of which 9 are new class 1 drugs
.
From the perspective of the treatment field, 108 innovative drugs involve more than ten treatment categories, covering all aspects, multiple diseases, and multiple organs, focusing on anti-tumor, nervous system (pain, depression, Parkinson, etc.
), digestive system (type 2) Diabetes, anti-vomiting, etc.
) and other therapeutic areas, in which anti-tumor drugs monopolize nearly half of the country, covering lung cancer, breast cancer, liver cancer, gastric cancer, gynecological tumors, urinary tumors, hematological tumors and other diseases
.
From the perspective of therapeutic targets, Hengrui Medicine has deployed global popular targets and cutting-edge therapies, such as PD-1/PD-L1, BTK, CDK4/6, JAK, etc.
; multiple drugs have not been approved for products with the same target at home and abroad.
, Including fully human OX40 monoclonal antibodies, Toll-like body immune agonists, selective FXIA inhibitors, A2aR inhibitors, ROMK inhibitors, LAG-3 antibodies, TIM-3 monoclonal antibodies, etc.
; in addition, the company is also actively embracing new technologies from pharmaceutical research ADC, force double antibody / multi-resistant, the layout of gene therapy
.
22 varieties were first reviewed and 16 varieties sprinted for the first imitation.
On November 13, Hengrui Pharmaceutical announced that the company's 4 types of generic drug tafluprost eye drops were approved for production, which was the first imitation in China
.
According to data from Minai.
com, since 2021, the company has 12 generic drugs approved for production and deemed to have been reviewed, of which 5 are the first generics, including tafluprost eye drops, dexmedetomidine hydrochloride sodium chloride injection , Tolvaptan tablets, Mycophenolate sodium enteric-coated tablets and Azilsartan tablets
.
At present, Hengrui Medicine has 47 varieties passed or deemed to have passed the consistency evaluation, covering 12 treatment categories, focusing on anti-tumor and immunomodulators (12 varieties) and neurological drugs (9 varieties); from the distribution of dosage forms See, section 21 containing injection, controlled release formulations, paragraph 4, paragraph 2 inhalant, eye drops, paragraph 1
.
Source of Hengrui Medicine's review status: Meinenet MED2.
0 Chinese drug review database is the first of two varieties/exclusive review, including celecoxib capsule, glycopyrrolate injection, esketamine hydrochloride injection, acetic acid Abiraterone tablets, temozolomide for injection, dexmedetomidine hydrochloride and sodium chloride injection, tolvaptan tablets, tafluprost eye drops, mycophenolate sodium enteric-coated tablets, azilsartan tablets, etc.
First imitation + first review
.
Among the new classifications of Hengrui Pharmaceuticals reported for the production of generic drugs, 16 have not been approved for the first imitation (including the first dosage form)
.
Many products are sold in other dosage forms in China.
It can be seen that dosage form improvement is one of the company’s key research and development directions
.
Hengrui Medicine’s new classification is reported for production and there is no first copy of the approved varieties.
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database 7 varieties are exclusively reported for production under the new classification by Hengrui Medicine, involving liposomes (Bubica Because of liposome injection), oral dissolving membrane (ondansetron oral dissolving membrane), sustained and controlled release formulations (tacrolimus sustained-release capsules) and other high-end formulations
.
Source: Meinenet database, announcements of listed companies, etc.
Note: Meinenet China's urban entity pharmacy terminal competition pattern database covers entity pharmacies in 293 prefectures and cities across the country (excluding county and rural entity pharmacies), and continuously monitors the entire category Enlarged version of the city's physical pharmacy database
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of December 6, if there are any omissions, please correct me!