Howson is working hard!

Recently, Hausen Pharmaceuticals has been continuously developing: 4 types of generic fulvestrant injections have been approved, and Class 1 new drug HS-10382 tablets have been applied for clinical application for the first time.
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In the past 10 years, Hausen has continued to increase research and development The product pipeline is welcoming the harvest period.
5 Class 1 new drugs and 18 first imitations have been approved; more than 100 drugs are under development, 27 innovative drugs (22 Class 1 new drugs) are in the clinical application and above stage, CD19 monoclonal antibody , Long-acting EPO will be launched soon, and a lot of money will be added to the new siRNA track; in terms of generic drugs, 35 varieties have been reviewed (20 are the first), and 7 new classified products have not been approved for the first imitation (4 are exclusive reports).
Production)
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In the past 10 years, 5 new class 1 drugs and 18 first generics were approved.
On November 19, the official website of the State Food and Drug Administration showed that Hausen Pharmaceuticals 4 generic drug Fulvestrant injection was approved for production and deemed to have been reviewed.
, Is the second domestically produced company
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Hausen Pharmaceuticals, founded in 1995, is a domestic leader in the development and production of anti-tumor and psychotropic drugs, and is gradually expanding into anti-infection, gastrointestinal, cardiovascular and other therapeutic areas
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In the past 10 years (2012-present), the company's product line has gradually entered the harvest period.
Nearly 40 products have been approved for listing, including 5 Class 1 new drugs, and 18 first imitations (including the first imitation of dosage forms)
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From 2012 to the present, Hausen Pharmaceuticals has been approved for listing of Class 1 new drugs and the first generic drugs.
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database.
Among 5 Class 1 new drugs, imitenofovir will participate in the 2021 national medical insurance negotiations.
The remaining 4 new drugs have been negotiated and included in the National Medical Insurance Category B list
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Judging from the terminal sales of urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions), medical insurance promotes a rapid increase in the volume of innovative drugs
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Morpholinidazole Sodium Chloride Injection, which was approved for marketing in 2014, was included in the national medical insurance in 2017.
The sales growth rate in China's public medical institutions from 2017 to 2018 exceeded 1000%, and the sales in 2020 exceeded 400 million yuan.

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In 2019, polyethylene glycol loxenatide (the first domestic long-acting GLP-1 receptor agonist), flumatinib (the first domestic second-generation BCR-ABL tyrosine kinase inhibitor) and Ametinib (the first domestic third-generation EGFR-TKI) approved for marketing in 2020 will be included in the national medical insurance in 2020
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In 2021H1 China's public medical institutions, the sales growth rates of the three innovative drugs were 622.
74%, 934.
05%, and 4514.
9% respectively
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The 18 first imitations focus on 5 treatment categories, focusing on digestive system and metabolic drugs (mainly diabetes drugs) and anti-tumor and immunomodulators (all anti-tumor drugs)
.
Many of the world’s heavyweights worth over 1 billion U.
S.
dollars, including apixaban, enzalutamide (enzalutamide), empagliflozin, paliperidone, vildagliptin, etc.
, the original research product 2020 Global sales exceeded 14 billion U.
S.
dollars, 5 billion U.
S.
dollars, 3 billion U.
S.
dollars, 3 billion U.
S.
dollars, and 1 billion U.
S.
dollars respectively
.
Spending a lot of money on the new track, data from the interim report of 22 new category 1 drugs on the road show that in 2021H1, the sales of Hausen Pharmaceutical’s innovative drugs accounted for about 28.
5% of the total revenue (about 18.
9% in the same period last year), and the R&D expenditure was about 687 million yuan.
The same period last year increased by approximately 44.
2%, accounting for approximately 15.
6% of revenue
.
In recent years, the R&D expenditure of Hausen Pharmaceuticals has increased year by year, and the R&D intensity has been increasing year by year.
At present, it has built a complete R&D system and R&D platform, and the R&D pipeline covering more than 100 drugs under research is becoming more and more perfect
.
According to data from Meinnet.
com, according to incomplete statistics, there are currently 27 new drugs in the clinical and above stages of Hausen Pharmaceuticals (excluding the new indications for new drugs that are already on the market), covering anti-tumor, nervous system, anti-infection, and digestive tract.
, Cardiovascular and other therapeutic areas, 22 of which are Class 1 new drugs
.
The source of some of the innovative drugs under development of Howson Pharmaceuticals: China Pharmaceutical Clinical Trials Public Library of Meinenet.
3 new drugs have been submitted for marketing applications
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Inebilizumab injection is the first biological drug introduced by Hausen Pharmaceuticals and the first domestic anti-CD19 monoclonal antibody; the company’s self-developed class 1 new drug Peihuaxi hippocampal peptide injection is a new long-acting peptide Erythropoietin (EPO) receptor agonists.
Currently, domestically marketed EPO drugs are mainly short-acting, and no domestic long-acting EPO drugs have been approved
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Four new Class 1 drugs have entered/will enter Phase III or Phase II/III clinical trials
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Polyethylene glycol thymosin α1 injection is a thymus immunomodulator, used for the treatment of HBeAg-positive chronic hepatitis B; HS-10342 tablets are CDK4/6 inhibitors, among similar domestic products under research, Hengrui’s SHR6390 tablets have been declared for marketing ; Ibrexafungerp tablets have been submitted for phase III clinical applications.
The product was approved by the FDA in June 2021.
It is the first fourth-generation antifungal drug with a new mechanism of action in the past 20 years
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The research and development of new drugs by Howson Pharmaceuticals focuses on small-molecule chemicals, involving multiple therapeutic targets such as PIK3, c-Met, PLK, TYK2, etc.
In recent years, it has gradually stepped into large-molecule biological drugs and entered new fields this year
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On October 12-15, Hausen Pharmaceuticals successively issued announcements and reached cooperation with Silence Therapeutics and OliX Pharmaceuticals
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The former involves over US$1.
3 billion to cooperate in the development of small interfering ribonucleic acid (siRNA) drugs for three targets, and the latter involves over US$450 million to cooperate in the development of asymmetric small interfering RNA for key targeted indications.
(AsiRNA) therapy
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The discovery of RNAi technology won the 2006 Nobel Prize in Physiology or Medicine
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In recent years, siRNA drugs have become a hot spot in the field of new drug research and development due to the advantages of precise targeting, significant curative effects, short development cycles, and relatively low drug costs.

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In August 2018, Onpattro (Patisiran) developed by Alnylam in the United States was approved by the FDA for marketing.
It is the world's first siRNA drug and represents a new turning point in the development of siRNA drugs
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At present, no drug with the same mechanism has been approved in China, and Hausen Pharmaceuticals has a major position in the siRNA field, striving to seize the opportunity on the track
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20 varieties were first reviewed, and 4 first imitations were exclusively submitted for production.
In terms of consistency evaluation, Hausen Pharmaceuticals has now won 35 reviewed varieties, covering 6 therapeutic categories, focusing on anti-tumor and immunomodulators (13 varieties) and digestive system and metabolic drugs (7 varieties)
.
Note on the review status of Hausen Pharmaceuticals: the first review with *, ** the exclusive review source: Meinenet’s MED2.
0 Chinese drug review database is the first/exclusive review of 20 varieties, of which enzalutamide soft Capsules, varenicline tartrate tablets, empagliflozin tablets, paliperidone sustained-release tablets, afatinib maleate tablets, canagliflozin tablets, fosapitant dimeglumine for injection, Vigor Liettin tablets, apixaban tablets, prucalopride succinate tablets, ambrisentan tablets and other varieties are the first imitation + first review
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Among the varieties under review for consistency evaluation, 3 varieties have submitted supplementary applications for consistency evaluation, and none of them have been reviewed by the enterprise; 14 varieties are reported for production under the new classification, and 7 of them have not been approved for the first imitation (including the first imitation of the dosage form)
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The new classification of Hausen Pharmaceuticals has been reported for production and there are no varieties approved for the first imitation.
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database 4 varieties are exclusively reported for production under the new classifications of Hausen Pharmaceuticals
.
Carfilzomib is a second-generation proteasome inhibitor developed by Amgen, with global sales exceeding 1 billion U.
S.
dollars in 2020; Selepag is an oral IP prostacyclin receptor agonist, which is a rare disease drug, 2020 Annual global sales exceed 1 billion U.
S.
dollars
.
Source: Meinnet database, announcements of listed companies, etc.
Note: The statistics are as of November 22.
If there are any omissions, please correct me!