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Pharmaceutical Network February 5th, recently, is day clear pharmaceutical industry happy news: Androtini's fourth adaptive disease was approved, 5 varieties to choose the fourth batch.
meters of intranet data show that in 2020, Zhengda Tianqing Pharmaceuticals won 10 heavy-duty new products (including 6 first imitations), 3 new drugs applied for market (including 1 new class 1 drug), 9 innovative drugs approved clinically (including 6 new class 1 drugs).
At present, the company has 32 varieties over-evaluation (16 first), 4 "light-footed varieties" to choose the fourth batch of collection; Take 6 heavyweight first imitation, 16 varieties of the first evaluation in terms of status start time, 2020 Zhengda Tianqing Pharmaceutical Industry has 10 generic drugs (all in the new classification of production) approved for market, as if through the consistent evaluation;
Table 1: 2020 Zhengda Tianqing Pharmaceutical Industry Approval Source: MED2.0 China Drug Review Database 6 of the 10 approved new products approved for listing are the first imitation.
DPP-4 inhibitor siggritin, anti-HIV drug entourtabinofovir, immunomodulant Pomadamine, and new oral anticoagulant Dabiga esters will have global sales of more than $3.5 billion, $2.8 billion, $2.5 billion and $1.5 billion in 2019, respectively.
Inhalation of Budinide mixed suspension is the best-selling respiratory drug in china's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) terminals in 2019, with sales of more than 7 billion yuan, with growth declining in the first half of 2020.
Two of the five varieties evaluated by consistency were exclusive reviews, Adelfowe ester was the second batch of national collection varieties, with sales peaking at more than 2 billion yuan at the terminals of public medical institutions in China, and Zhengda Tianqing Pharmaceuticals obtained approval for the production of acetic acid Garnierik injections in February 2018, which was the first of its kind in China, and was successfully evaluated in October 2020 and is still exclusive.
As of February 3, Zhengda Tianqing Pharmaceutical Industry has 32 varieties through or as if through consistency evaluation, of which 22 varieties were reported in a new classification, approved for production as the same evaluation;
Table 2: Zhengda Tianqing Pharmaceutical Industry Review Source: Minet MED2.0 China Pharmaceutical Review Database Zhengda Tianqing Pharmaceutical Industry 32 over-reviewed varieties of 16 of the first over-evaluation, including Pomadamine capsules, acetic acid Canerik injections, fluvis group injections, Adefavigate capsules, Dabiga ester capsules, methadone capsules 6 varieties of exclusive evaluation.
Table 3: The fourth batch of the collection is the day of the pharmaceutical industry to choose the situation source: Shanghai Sunshine Pharmaceutical Procurement Network in the fourth batch of national collection, is the day of the pharmaceutical industry has 5 varieties to be selected.
in addition to the injection of boron tezome, the remaining varieties are "barefoot varieties" (refers to the collection of related varieties market blank or small proportion), after successful winning the bid is expected to quickly open the market.
14 varieties to grab the first imitation, 5 varieties to grab the first evaluation in product declaration, to CDE to undertake the acceptance date, 2020 Zhengda Tianqing Pharmaceuticals has 7 generic drugs with a new classification of production, of which 5 are not approved for listing;
meters net data show that as of February 3, Zhengda Tianqing Pharmaceutical Industry is reviewing the approval of the new classification of generic drugs 21, of which 14 are not approved for listing;
Table 4: New Classification of Zhengtianqing Pharmaceuticals and No Copies Approved Source: Minet MED2.0 China Drug Review Database Ivemos Tablets, Inhaled Chlorine Vinegar Methcholine, Ume Bromide Verantro Powder Inhalants, Fluorotikasong Verantro Powders Four varieties of inhalers were exclusively reported in the new category by Zhengda Tianqing Pharmaceuticals, with Ivemos, Ume Bromide Virantero and Fluoride Cason Virantero reporting global sales of US$2,024 million, 514 million pounds and 971 million pounds respectively in 2019.
injection with polyamoxycin E sodium sulfonate, right lanso laazole intestinal capsule, taurine acid Affero atomized inhalation solution, methulphate lenphatini capsule 4 varieties by Zhengda Tianqing Pharmaceuticals first reported production.
competition for methyl sulfonate lunvatini capsules is fierce, there are currently 10 enterprises to seize the first imitation, the original research products were approved for import in September 2018. Table
: Zhengda Tianqing pharmaceutical has been submitted and in the review of the consistency evaluation of supplementary application varieties source: Minet MED2.0 China Drug Review Database injection site West tahbin, injection than apenan, hydrochloric acid Palonos Joan injection, niobium desodium injection, injection with pyrethroid acid solution 5 injections without enterprise evaluation.
Zhengda Tianqing Pharmaceuticals in June 2019 to obtain the production approval of niobium deserate injection, for the domestic first imitation, and then submitted a consistent evaluation supplement, there are currently Colum Pharmaceuticals products to imitate 4 categories of products, competing for the first evaluation.
innovation efforts, 37 class 1 new drugs directly forced "research and development of a brother" in the innovative drugs, Zhengda Tianqing Pharmaceuticals' first inhaler class 1 new drug inhalation TQC3721 mixed suspension clinical application in January 2021 was accepted by the CDE contractor.
2020, the company has applied for three new drugs, including one class 1 new drug, one biosypolisic drug, 14 new drugs applied for clinical, of which 10 are class 1 new drugs.
Table 6: 2020 to date Zhengda Tianqing Pharmaceuticals application for listing / clinical new drug Source: Minet MED2.0 China Drug Review Database application for listing of new drugs, Pian puli single anti-injection is Kangfang Biological and Zhengdatian The innovative drugs jointly developed and commercialized by Qing Pharmaceuticals are expected to become PD-1 monoantitors with better clinical benefits, with the first reported adaptation being classic Hodgkin's lymphoma, non-scale non-small cell lung cancer, squamous non-small cell lung cancer and other adaptations being carried out in Phase III clinical.
to apply for clinical new drugs, TQB2450 injection for new adaptation applications for clinical, this is an anti-PD-L1 humanized monoclonal antibody, non-small cell lung cancer, head and neck squamous cancer, triple-yin breast cancer and other adaptive disorders have entered Phase III clinical, is expected to be approved for market in 2022.
As of February 3, Zhengtianqing Pharmaceuticals is in the clinical stage or declared clinical in the research of 1 class of new drugs have 37, layout of ALK, VEGFR, PI3K, CDK4/6 and other popular targets, in the field of research and development of anti-tumor drugs (non-small cell lung cancer, breast cancer, melanoma, lymphoma, leukemia, etc.) mainly liver disease, diabetes, hematology, blood diseases and so on.
drugs with rapid clinical progress include: ALK/ROS1 inhibitor TQ-B3139 capsules, non-small cell lung cancer adaptation is in phase III clinical; -B3101 capsule, DPP-4 inhibitor TQ-F3083 capsule, TLR-7 subjector astrogen TQ-A3334 tablets, FXR astrogen TQA3526 tablets, etc. are being carried out phase II clinically.
source: Milnet database note: data statistics as of February 3, if there are omissions, welcome to point out!