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    Home > Active Ingredient News > Drugs Articles > Qilu, Yangzijiang...... 75 new drugs approved clinically! Zhengda Sunny into 8 billion varieties, domestic 1 class of new drugs pile declaration.

    Qilu, Yangzijiang...... 75 new drugs approved clinically! Zhengda Sunny into 8 billion varieties, domestic 1 class of new drugs pile declaration.

    • Last Update: 2020-09-25
    • Source: Internet
    • Author: User
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    Exciting content Xinda bio took $20 billion varieties; 1.5 billion anti-thrombosis drugs to welcome the new dosage form; 4 billion star anti-tumor drugs were "under siege"; the first domestic ADC drugs declared on the market; Roche 7 imported new drugs were approved clinically; Qilu, Yangzijiang 1 new drugs were approved clinically; 44 domestic 1 new drugs declared clinical.
    14 new drug listing applications made new progress, Xinda took $20 billion star drug August 22 - September 11, 14 new drugs (15 acceptance numbers) of the listing application has been reviewed and approved status updates.
    two new domestically produced drugs were approved for production, for Cymru's Adamo monoantigen injections and re-ding pharmaceutical toluene sulfonate nirapali capsules;
    (8.22-9.11) new drug listing application review and approval status update following baiotai, Haizheng Pharmaceuticals' Adamo single anti-injection fluid approved for production, Xinda Bio harvested the 3rd domestic Adamo single anti-biosypolitic drugs.
    Adamu monoantigen, the world's first TNF-alpha monoantigen developed by AbbVie, peaked at $19,936 million in global sales in 2018 and fell back to $19,169 million in 2019 as a result of biosypolytic drugs.
    Fuhong Hanxuan, Junshi Biological, Zhengda Tianqing 3 pharmaceutical companies also submitted the product's listing application, is still in the review and approval.
    toluene sulfonate nirapali capsule is an efficient, highly selective daily oral small molecule poly (ADP-UC) PARP1/2 inhibitor developed by Reedin Pharmaceuticals and was first approved for use in the maintenance of relapsed ovarian cancer in December 2019.
    this approval is a new adaptive disorder for first-line maintenance therapy in adult patients with advanced epitheliotic ovarian cancer, fallopian tube cancer, or primary peritiotic cancer who are fully or partially relieved by platinum-containing chemotherapy.
    , Nirapali has conducted seven clinical trials in China, with ovarian cancer and small cell lung cancer both in Phase III clinical trials, according to the NYMnet data.
    Grelo is AstraZeneta's new oral P2Y12-subject antagonist, primarily used in the prevention and treatment of acute coronary syndrome and cardiovascular thrombosis events, with global sales of $1.58 billion in 2019.
    general tablets were approved for listing by the FDA in July 2011, approved for entry into the domestic market in December 2012, and sold more than 1.5 billion yuan in 2019 for the terminal of China's public medical institutions.
    Adosinase beta, a recombinant human Adolfalic acid-2-Sulphate enzyme replacement therapy developed by GC, is currently available in 11 countries for enzyme replacement therapy in patients with confirmed Hunter syndrome.
    North Sea Kangcheng obtained exclusive license for the product, the company's first successful commercialization of a rare disease drug, and the country's first next-generation enzyme replacement therapy for Hunter syndrome.
    13 new drugs applied for the market, 4 billion varieties were "under siege" August 22 - September 11, 13 new drugs (17 acceptance numbers) to be listed applications to obtain CDE contractor, focusing on anti-tumor and immunomodulants (7), blood and hema production system drugs (2), cardiovascular system drugs (2) three therapeutic areas;
    from the drug type, 9 varieties (13 acceptance numbers) are chemicals and 4 varieties (4 acceptance numbers) are therapeutic biological products.
    (8.22-9.11) was the contractor of the domestic / imported new drug listing application Fuhong Hanxuan, Dongyu Pharmaceuticals have submitted the new drug 3.3 category of Beval Pearl single anti-injection application.
    Beval Pearl Is Roche's star product, with global sales of more than $7 billion in 2019 and total sales of more than 4 billion yuan in the domestic market (China's public medical institutions and urban retail pharmacy terminals).
    At present, Qilu, Xinda's Beva Zhudan anti-biological similar drugs have been approved for market, in addition to Hengrui, Green Leaf, Beida, Baiotai, Dongyu Pharmaceuticals, Fuhong Hanxuan 6 enterprises have been reported for production.
    Waterless ethanol injection is a new drug developed by Guorui Pharmaceuticals of The National Pharmaceutical Group for interventional treatment of renal cysts, is expected to fill the gap in the domestic interventional treatment drugs, belongs to the clinical urgent need for drugs, was included in the Ministry of Finance "2013 central enterprise state-owned capital operating budget expenditure plan", the state finance is to invest 100 million yuan to support Guorui Pharmaceuticals to give industrialization of the product.
    Rongchang Bio's injectable Virdixito monoanti (RC48) is the first domestic antibody-drug combination (ADC) drug to be submitted for market, used to treat local advanced or metastatic stomach cancer (including gastroesophageal binding adenocarcinoma).
    RC48 uses new, more affinity, better endo-swallowing humanized antibodies, and uses advanced connective and small molecular toxin drugs to effectively kill tumors.
    RC48 currently has 11 clinical trials registered in China, covering urethra skin cancer, non-small cell lung cancer, bile tunnel cancer and other adaptations, in addition, the product has been approved in the United States directly for Phase II clinical, and obtained fast-track approval qualification, the plan is to carry out a number of adaptation Phase II/III clinical studies in 2021.
    Vericiguat tablet is the world's first soluble bird nucleotide cyclase (SGC) astracite for patients with worsening chronic heart failure, developed and promoted by Bayer and Mercadon.
    has filed for listing in the European Union, Japan and the United States in June and July 2020, respectively, and the listing in China means it is expected to be listed simultaneously in the four major markets of China, the United States, Europe and Japan.
    Qilu, Xin Litai, Yangzijiang...... Between August 22 and September 11, 75 varieties (147 acceptance numbers) were approved for clinical trials, of which 38 varieties (69 acceptance numbers) were domestic new drugs and 37 varieties (78 acceptance numbers) were imported new drugs;
    (8.22-9.11) approved clinically approved domestic /imported new drug Roche 7 new drugs approved clinically, GDC-0077 is an oral selective PI3K alpha inhibitor, obtained two clinical implied licenses, this is the first time the product was approved in China clinical, there is no same target inhibitor on the domestic market; It is an all-human monoclonal antibody that has been applied for several clinical trials in 2014 and 2017 and has entered Phase III clinical trials worldwide, and RO7082859 is a new type of "2:1" dual resistance containing 2 Fabs combined with CD20 and 1 Fab with CD30, which were approved for the first time in China.
    Redding Pharmaceuticals introduced 2 new drugs approved clinically, REGN1979 injection is a dual-specific monoclonal antibody targeting CD20 and CD3 at the same time, first approved clinically in China, for the treatment of B-cell non-Hodgkin's lymphoma that has recurred or is difficult to treat after past systemic treatment.
    QL1806 injection is a 4-1BB humanized antibody developed by Qilu Pharmaceuticals, which is intended to be used to treat a variety of malignant tumors.
    2020, Qilu Pharmaceuticals has approved four new class 1 drugs, namely QL1806 injection, QL1711 injection, QL1706 injection, injection with recombinant human platelets to produce peptide-Fc fusion protein.
    Class 1 new drug Ennasta tablet developed by Xinlitai is an oral reactive hypooxygenated factor proline hydroxylase (HIF-PHI) inhibitor, the proposed development of the adaptation is renal anemia.
    has been listed in China with the same target drug is mainly Rosas tantal, the product was approved at the end of 2018, in 2019 in China's public medical institutions terminal sales of more than 5 million yuan.
    TQA3729 capsule is a new class 1 drug developed independently by Zhengda Tianqing, which was approved for clinical treatment of chronic hepatitis B for the first time in China.
    Zhengtianqing is the leading enterprise in the field of liver disease in China, has been listed more than 10 related products.
    in the study of liver disease class 1 new drugs, TQ-A3334 tablets (hepatitis B) for Phase II clinical, TQ-A3326 tablets (hepatitis C) completed Phase I clinical.
    CPU-118 tablets are a new class of drugs developed by China Pharmaceutical University to be used to treat advanced liver cancer.
    CPU-118 is a glutaminease (GLS1) inhibitor, preclinical studies have confirmed that GLS1 inhibitors not only have anti-tumor activity, but also significantly enhance the sensitivity of drug-resistant tumor cells to targeted drugs.
    the same target drug, Calithera Biosciences' CB-839 has entered Phase II clinical practice. the
    X4P-001 capsule is a new class 1 drug developed in collaboration with U.S. company X4, an oral CXCR4 antagonist for first-in-class, which has completed Phase II clinical studies worldwide and has been awarded FDA-granted orphan drugs and breakthrough therapies in 2018 and 2019.
    Hengrui, Zhengda Sunny, Tian Shili...... Between August 22 and September 11, 68 clinical applications for new drugs (100 receiving numbers) were accepted by CDE contractors, of which 55 varieties (82 acceptance numbers) were domestic new drugs (44 new drugs) and 13 varieties (18 acceptance numbers) were imported new drugs.
    from the drug type, chemical drugs, therapeutic biological products, Chinese medicine has 41, 25, 2 respectively.
    (8.22-9.11) to submit 7 clinical applications for new domestic/imported drugs.
    class 1 new drugs, the SHR-1314 injection is the first domestic IL-17 monoantigen, the same target drug has been listed worldwide are Novarma's Cosentyx (secukinumab), Lilly's Taltz (ixekizumab), etc.; 6 inhibitors, SHR3680 tablets is an androgen-like (AR) subject antagonist, both in the domestic research and development of the highest progress has entered Phase III clinical;
    class 2.2 new drugs, the injection of carelli pearl monoantigen resistance for PD-1, there are currently 3 adaptive disorders approved for the market.
    Zhengda Tianqing has 2 new drugs applied for clinical, TQB3720 tablets for the first time submitted clinical applications, 3.3 new drugs gate winter insulin injection is a quick-acting human insulin analoga, suitable for adults, adolescents, children and people with gestational diabetes.
    intranet data show that in 2019, China's public medical institutions terminal and China's urban retail pharmacy terminal sales close to 8 billion yuan.
    2 class 1 new drugs declared clinical, IBI323 is a LAG-3/PD-L1 dual-specific antibodies, the same target in the global research drugs, F-star FS118, Macro Genics MGD013 (Reding Pharmaceuticals licensed) are in Phase I clinical.
    there are at least 8 kinds of dual anti-drugs in the study of Xinda bio, mostly used to treat tumor diseases, of which IBI318 (PD1/PDL1), IBI322 (CD47/PDL1), IBI315 (PD1/HER2) has entered Phase I clinical.
    injection RC108 is a new class 1 drug that Rongchang Bio is working on, and is an ADC drug that targets c-MET.
    At present, most of the c-MET targeted drugs in the study are small molecule drugs, antibody drugs have 3 into the clinical stage, respectively, AbbVie's ABBV-399, Hengrui's injection SHR-A1403, upper coast organisms EMB-01 injection.
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