Sprint 200 billion market value! Hansen Class 2 biological new drug HS-20090 injection approved clinical

Medical Network May 18, Hansen Pharmaceuticals announced that the company's subsidiary Hansen Bio and Howson Pharmaceuticals developed a class 2 biological new drug HS-20090 injection approved clinicallyIn recent years, Howson pharmaceutical research and development efforts have been strengthened year by year, innovation inflection point has comeSince May 2018, there are 3 new drugs of class 1, 6 first imitation, 3 ANDA approved for listing, 12 varieties have been evaluated (10 for the first);Compared with Hengrui, Zhengda sunny, in 1995 was only set up in Howson pharmaceutical industry is relatively lateBut after more than 20 years of development, the company based on generic drugs, well-known in the first imitation, the successful transition of imitation combination, to achieve innovation beyond the excellentOn June 14, 2019, Howson Pharmaceuticals successfully landed in Hong Kong, with the listing of the main body named Hansen PharmaceuticalsOn the first day of listing, the company's market capitalisation exceeded HK$100 billionClosing on 15 May 2020 at HK$33.350, up 5.21%, with a market capitalisation of HK$197.398 billionthe current performance of Haussen Pharmaceuticals is mainly contributed by 13 core products, covering the central nervous system, anti-tumor, anti-infection, diabetes, digestive tract and cardiovascular system and other areas of chronic diseases and major diseases, in addition to a new class of drugs, sodium nitrate and imitation drug injection site, the remaining 11 are the first imitation drugFigure: 2016-2019 Howson Pharmaceutical Research and Development Expenditure (unit: 100 million yuan)Howson Pharmaceutical Research and Development Team is composed of about 1200 researchers, located in Shanghai, Lianyungang two development centers, currently more than 100 research projectsIn recent years, the company has increased its research and development efforts year by year, with research and development spending exceeding 1 billion yuan in 2019, reaching 1.121 billion yuan, up 27.16% year-on-year, accounting for nearly 13% of revenue's annual report on Howson Pharmaceuticals shows that in 2019-2020, the company is expected to have nearly 30 drugs in the research and development of the market, of which more than 50% of the drugs have high growth potential, including four new molecular entities 1.1 innovative drugs and 8 potential first-class genericdrugsTable 1: Products approved for listing in Haussen from May 2018 to dateNote: With the first-rate review varieties, with the "priority review- and special review varieties
in a state-based start-up time, from May 2018 to date, Howson Pharmaceuticals has 12 products approved for listing, Covers anti-tumor, type 2 diabetes, anti-infection and other therapeutic areas, of which 3 are 1 new drug, 6 are the first imitation drug, 12 varieties through or as if through consistency evaluation, 10 as the first, international aspects, 3 ANDA symbol signed by the FDApolyethyl glycol rossenatide (commodity name Fulaimei) is the first domestic long-acting GLP-1 receptor agonist, for long-acting Essena peptide me-better, the first innovative drug in the field of sugar-lowering drugs by Haussen Pharmaceuticals; Martini to the innovative drug flumartinibini, Haussen Pharmaceuticals out of the road from imitation to creation of the upgrade, the sulfonate Amatinib (commodity name Ammel) for the first domestic three-generation EGFR-TKI inhibitors, directly "to the sun" Oxitini (global sales of more than 3 billion U.S dollars in 2019), recently listed in Jiangsu Province for 19,600 yuan / box / 20 tablets (55 mg) in the past two years, Howson Pharmaceuticals has approved nine generic drugs, six as the first generic sand, and three for the second Two of the six first imitations are sugar-lowering drugs, Cagletin is net of SGLT-2 inhibitors, and Vigretin belongs to THE DPP-4 inhibitor, of which Vigretin in 2019 in China's urban public , county-level public hospitals, urban community centers and township health hospitals (referred to as China's public health institutions) terminal sales of more than 200 million yuan; 12 varieties, 10 of which were the first, cephalosporine capsules, regletine tablets, memartintablets, onitrogle flat tablets in the four major product species are the first review, in addition to the pemequer sodium, boronzomi 10 varieties (9 for injections) such as Gisi-Tabin, Dixi-Tabin and Tegarcycline have been declared for consistency evaluation, and 8 varieties have been declared for consistency evaluation with new registered classification (6 for the first imitation), and the approved production is treated as a consistency evaluation company's fist product injection with pemequer sodium, onitrogen flat tablets in 2018 in the United States obtained the ANDA code, Aitib injection has been approved clinical lying in the country, and is now approved for listing in the United States, or help to speed up the progress of domestic review Table 2: Howson Pharmaceuticals in the research of new drugs
Howson Pharmaceutical research and development pipeline, although not very strong, but has begun to take shape, can be called the essence of the concentrated version At present, 4 new drugs of class 1, 1 class 2 improved new drug reported production, 4 class 1 and 1.1 new drugs (including new indications) to Phase III clinical, 1 class 1.1 new drugs to Phase II clinical, 6 class 1 and 1.1 new drugs are being carried out in Phase I clinical, 1 class 2 biological drugs approved clinical, 3 class 1 new drugs declared clinical HS-10296 (Ametinib) EGFR-T790M mutation of non-small cell lung cancer indications has been approved for market, for EGFR mutation of non-small cell pneumonia patients (first-line therapy) phase III clinical completed all clinical trials of patients enrolled in the group; -10234 tablets, polyethyl thycopenoid alpha1 injection to Phase III clinical, where HS-10234 tablets are expected to be submitted for listing in 2020, the variety compared to the previous drug, tinofory, while significantly reducing toxic side effects clinical phase I in the study of c-Met inhibitors HS-10241 tablets and CDK4/6 inhibitors HS-10342 tablets in the domestic research and development progress is among the best, and are currently in the field of anti-tumor research and development targets in the field of biologics, the first independent lying class of biopharmaceutical HS-20090 injections has been approved for clinical use, and the development of anti-CD19 monocdizumab from VielaBio is progressing smoothly, with indications including diffuse large B-type hematomas, optic neuromyelitis spectrum disorder (NMOSD) and other autoimmune Table 3: Howsen Pharmaceuticals New Registration Classification Reported The production of generic drugs note: belt for the domestic no generic drugs listed, with the domestic market temporarily blank meters of the net data show that the company has 13 generic drugs to the new registered classification of production, 7 have not yet been approved the first imitation, Among them, the right lansolaquine intestinal capsule, luracekethydrohydronate tablets, fluorovirise group injections, tatric acid valniklan tablets, palipyrone reprieve tablets 5 varieties of competitive pattern is good, the new classification of production enterprises within 3 (including 3) Howson Pharmaceuticals has listed imitation kinds of income is more concentrated, the first batch of 4 plus 7 sets of mining and alliance collection, Howson's fist product O-nitrogen flat film significantly reduced prices, PeimeiQuse two sodium because not over-rated can not participate in the bidding, short-term impact on the company is relatively controllable, long-term still need new products listed to make up In the study of potential first imitation drugs, sulaxiketone hydrochloric acid tablets, palaeononed reprieve tablets and onotazole tablets are schizophrenia drugs, fluorovirs group injections, Malayacid actatinib tablets, etc are anti-tumor drugs sources: Mi net database, listed companies announcement note: data statistics as of May 15, if there are omissions, welcome to point the finger!