Hausen Pharmaceuticals: 6 blockbuster new products were approved, the first with an over-review rate of over 80%, 14 new class 1 drugs attract attention

Class 1 new drugs, first imitation... So far this year, six new products have been approved for market, covering anti-tumor, type 2 diabetes, neurological diseases and other therapeutic areas, including 1 new class of drugs, 3 as the first generic drugs.
table 1:2020 to date Howson approved varieties Source: Minet MED2.0 China Drug Review Database Amethystini is the third generation of EGFR inhibitors independently developed by Haussen Pharmaceuticals, and the first domestic third generation EGFR inhibitors.
AstraZeneta's Oghitini is the first three-generation EGFR inhibitor in China, with terminal sales of more than 2 billion yuan in 2019 in urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions), up 359.17 percent year-on-year.
Malay acid afatinib is a second-generation EGFR inhibitor developed by Grigg Ingham, the original research products were approved for import in February 2017, in 2019 in China's public medical institutions terminal sales of more than 200 million yuan, an increase of 2148.36 percent year-on-year.
Howson took the first imitation, Qilu immediately followed, in addition to Colum, Yangzijiang, Zhengda Tianqing and other six domestic enterprises' products to the new classification of production, is still under review.
Palisterone is the main metabolite of liposterone, is the second generation of antipsychotic drugs developed by Johnson and Johnson, the original research products (including slow release tablets and injections) in 2019 to achieve global sales of 3.33 billion U.S. dollars, currently only Howson's products to achieve localization, stone medicine European medicine, Kangzhe biological products in a new classification, is still under review.
is a highly selective SGLT-2 inhibitor developed jointly by Lilly and Grigg Ingham, with global sales of more than $3 billion in 2019.
the first imitation, Colum Pharmaceuticals immediately followed, in addition to Zhengda Tianqing, Osaikang and other 4 enterprises to report products with a new classification, is still under review.
first over-evaluation rate of more than 80%, 5 varieties to grab the first imitation Table 2: Howson Pharmaceuticals has been evaluated varieties Source: MED2.0 China Drug Review Database Currently HOWSON Pharmaceuticals has 16 varieties through Or as if through the consistent evaluation, of which 13 were the first review, reglinai tablets, injection with fusapitan double glucosamine, palifier ketone slow release tablets, Kaglie net tablets 4 varieties for exclusive review.
in the third batch of national mining recently, Haussen Pharmaceuticals has five varieties of winning bids, namely apixaban, pruscabili, Viglitin, rinazine, cephalosporine.
addition to cephalosporine, Howson Pharmaceuticals' share of the other four varieties is low or basically zero.
table 3: Howson consistency evaluation in review (including new classification of production) Source: Minet MED2.0 China Drug Review Database Howson Pharmaceuticals in review varieties, 10 varieties submitted consistent evaluation supplementary applications, 9 of which are injections, in addition to injection of bivaldide, hydrochloric acid dornabizi tablets, injectable boratemi, injection of injections Mercuse two sodium, the remaining 6 varieties have not yet been evaluated by enterprises; 12 varieties to the new classification of production, 6 varieties have not yet been evaluated by enterprises, of which the injection with kafezome, Nzaluamine softgels, hydrochloric acid lulassin tablets, saline acid valenicum tablets, right lansoraquine intestinal capsules 5 varieties have not been approved for the market.
Kafezome is the second generation of protease inhibitors developed by Amgen, with global sales of more than $1 billion in 2019, original products are being imported, Howson Pharmaceuticals is reporting exclusively in a new classification, Nzaluamine is a androgen-transmitted signaling inhibitor developed jointly by Pfizer and Astellas, original products are approved for import at the end of 2019, and Haussen Pharmaceuticals is exclusively reporting in new classifications.
17 new drugs are in the spotlight, the fifth class 1 new drug will be born on September 18, Howson Pharmaceuticals independently developed a new class of 1 drug Amephenol amine novowe tablets (HS-10234 tablets) The listing application was accepted by the CDE contractor for the treatment of chronic hepatitis B, and on 17 September, the new drug was included in the priority review on the grounds of "clinically urgently needed shortages of medicines, innovative and improved new drugs to combat diseases such as major infectious diseases and rare diseases".
Amphenol amine tynofovir tablets are a nucleoside retrovirus inhibitor that is very stable in plasma and a new type of tynofovir pre-drug that improves efficacy and reduces toxic side effects.
2019, China's public medical institutions terminal sales of Nofove diamide more than 1.5 billion yuan.
Hausen Pharmaceuticals currently has four new Class 1 drugs approved for the market, namely, sodium chloride injection, polyglycol locena peptide injection (the first domestic long-acting GLP-1 perturbation agent), methafolfonate tablets (second-generation BCR-ABL tyrosine kinase inhibitors) and methylatonin tablets (the first domestic three-generation EGFR-TKI inhibitors), Amphenol amine nofovir tablets are expected to become the company's fifth approved innovative drug on the market.
Table 4: Howson's independent research and development of new drugs Source: Minet China Drug Clinical Trials PublicIty Library Howson Pharmaceuticals focuses on anti-tumor, central nervous system diseases, anti-infection, digestive diseases and other fields of new drug research and development, is currently in research projects more than 100, of which 1 class 1 new drugs, 1 class 2 modified new drugs on the market application, 3 class 1 and class 1.1 new drugs (including new adaptive disorders) for Phase III clinical, 1 class 1.1 new drugs for Phase II clinical, 7 class 1 and 1.1 new drugs for Phase I clinical, 2 class 1 new drugs, 2 class 2 new drugs approved for clinical.
In the field of anti-tumor, HS-10296 tablets (EGFR-TKI inhibitors) have been approved for EGFR-T790M mutation of non-small cell lung cancer adaptation has been approved for the market, EGFR mutation of non-small cell pneumonia (first-line therapy) adaptation is in phase III clinical, other adaptation The disease has also been declared clinically, HS-10241 tablets (c-Met inhibitors), HS-10342 tablets (CDK4/6 inhibitors), hydrochloric acid carpentry injections (PLK inhibitors) and other new drugs for solid tumors are in phase I clinical.
In the field of anti-infection, the new hepatitis B drug Amephenol amine nofovir tablets (nucleoside reverse transcriptase inhibitors, new pre-drugs for nofovir) have been declared on the market;
central nervous system field, 2 types of modified new drug O nitrogen flat oral instant film declared listed, the current domestic listing of O nitrogen flat dosage form has tablets and mouth collapse tablets, in 2019 China's public medical institutions terminal sales of more than 4 billion yuan;
the digestive system and metabolic field, HS-10220 capsules (H-/K-ATPase inhibitors) have completed Phase 1 clinical treatment of peptic ulcers, and HS-10356 tablets have been approved clinically for the treatment of non-alcoholic fatty hepatitis.
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