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    Home > Medical News > Medical World News > In the second half of 2020, these 10 heavy generics will be approved in China.

    In the second half of 2020, these 10 heavy generics will be approved in China.

    • Last Update: 2020-08-03
    • Source: Internet
    • Author: User
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    Text . . . According to according to the incomplete statistics, Dopine approved at least 14 first imitations in the first half of 2020, of which Zhengda Qing successfully won the first imitation of Sigretin, Dabbiga group esters, Enquata bintinofuwe and The Inhalation Budinaid.
    in addition, Howson's Afatini, Theafinani of HumanFu Pharmaceuticals, the state-for-the-drug d'aurethros, Cain Technology's Sophosbuvir, MegaPharma's Quke Niel, etc. are also the first-largest approved first-class imitations in the first half of 2020.
    Insight database had predicted the next half of the year for new drugs to be approved, and today we screened 10 first generic drugs from the database and are expected to be approved in the second half of the year.
    are: 1, Jiangsu Hengrui's Azishatan tablet 2, Jiangsu Hengrui's Tovaputan tablet 3, Zhengda Qing's Pomadoamine capsule 4, Zhengda Qing's injection with polyscolicin E sodium mesosulazole 5, positive day-clear fluvis group injection saeof 6, Chongqing drug friend's methyl sulfosafini tablet 7, East Sunshine Pharmaceuticals Entamine 8 Acid Nidanibu softgel 9, Colum Pharmaceuticals Shumore sodium sodium injection 10, Jiangsu Osekang's Poshaconazi injection Jiangsu Hengrui Azishatan tablet original research manufacturers: Takeda other competition first imitation enterprises: Baio Pharmaceuticals, Zhaoke Pharmaceuticals Azishatan is Takeda original research OfiAngII receptor senile inhibitor, 2011 by the FDA approved for the treatment of hypertension, the current research has not been approved.
    August 2017, Hengrui Pharmaceuticals was the first to report three generic drugs, and then Beijing Baio Pharmaceuticals and Zhaoke Pharmaceuticals submitted applications for listing on the basis of 3 generic drugs, of which Zhaoke Pharmaceuticals received Approval from NMPA on June 24 and was not approved.
    at present, Hengrui Pharmaceuticals Azishatan tablet seisiland application has completed the clinical trial site inspection, and is about to complete the second round of information, is expected to be approved in Q3.
    Photo Source: Insight Database Jiangsu Hengrui Tovappatan Tablet Original Research Factory: Otsuka PharmaceuticalSein Other Competitive First Imitation Enterprises: Nanjing Zhengda Qing tolvaptan (tolvaptan, Samsca) is an oral selective arginine pressurized V2 found in Otsuka Receptor antagonists, through antagonistic antiuretic hormones to reduce the secretion of anti-diuretic hormones, so that the amount of water excretion in urine increased, improve the removal rate of free water, reduce urine osmosis pressure, increase the blood sodium value, but at the same time do not change the secretion of sodium and potassium in urine and affect the blood potassium value.
    May 2009, the drug was approved in the United States and approved domestically in January 2011 (commodity name Sumaka), and to date, the drug has been approved in several countries around the world for different indications, including: treatment of patients with heart failure and cirrhosis with excessive water retention, hyposodium emis, and renal swelling in patients with autosomal dominant polycystic kidney disease (ADPKD).
    at present, in China Hengrui Pharmaceuticals and Nanjing Zhengda Tianqing have submitted to the listing application of Tovaputan tablets in April and September 2019 respectively, in which Hengrui Pharmaceuticals submitted the listing application was included in the priority review, the first round of supplementary information has been completed, Q4 is expected to be approved.
    picture source: Insight database is big day qing poomadoamine capsule original research manufacturers: new base pharmaceutical industry other competitive first imitation enterprises: no pobutamine is a sarituride analog, is an immunomodulator, with anti-tumor activity, can inhibit the growth of hematopoietic tumor cells and induce apoptosis.
    January 8, 2013, the U.S. FDA approved pomadomine for patients with multiple myeloma who are still progressing after other anticancer drugs.
    multiple myeloma is a type of hematomyeloma commonly found in middle-aged and elderly people, and in many countries its incidence has exceeded acute leukemia and ranked second in the malignant tumor of the hematologic system.
    Pomadoamine capsules, although a number of declared clinical, but currently only Zhengda Qing submitted a listing application, 2 in clinical trials, 2 in the BE trial, in addition to 13 in approved clinical status.
    is expected to be approved this year q3.
    Photo Source: Insight Database is being injected with poly-scobacteria e methicillate sodium monitamate original research manufacturers: ParSterle Products other competitive first imitation enterprises: Jiangsu Oseicondo muscopic e methicillate sodium is a polypeptide class of antibiotics, is currently the treatment of drug-resistant copper-green pseudomonas and other gram-negative bacteria caused by infection son of the drug, low resistance rate (below 5 percent) and other antibiotics
    its original drug was first developed by Par Sterile Products and is a product called Coly-Mycin M, which has not yet entered the country.
    According to insight database, Zhengda Tianqing/Runzhu Pharmaceuticals and Jiangsu Osaikang submitted applications for listing of injection polysacin E monthanit e-moniturate in December 2017 and April 2019, respectively, according to class 3 generic drugs, in which the listing application of Zhengda Tianqing/Runzhu Pharmaceuticals was included in the priority review process on the grounds of major special items, and the listing application of Jiangsu Osaikang was included in the clinical shortage process on the grounds of urgent clinical shortage.
    at present, Zhengda Tianqing has entered the second round of supplementary information, Q4 is expected to be approved.
    Photo Source: Insight Database, Positive Fluovis Group Injection Research Plant: AstraZeneca's Other Competitive First Imitation Enterprise: Dr. Reddy Labs, Jiangsu Haussen Fluvis Group (Product Name: Fursted/FASLO DEX) is a new estrogen receptor antagonist developed by AstraZeneca and was approved by the FDA in April 2002 for postmenopausal breast cancer patients whose condition is still deteriorating after the treatment of anti-estrogen drugs such as tamoxifen.
    2010, the original research fluorovirgroup was approved in China and is clinically used primarily for local late-stage or metastatic breast cancer of ER-plus.
    is understood to have global sales of $1.028 billion in 2018.
    domestic, fanyave injections were negotiated to enter the national Health Care Group B list in 2017, but failed in the 2019 negotiations.
    according to Insight database, the current domestic Dr. Reddy Laboratory, Zheng Daqing and Jiangsu Hausen have submitted the listing application, in which Dr. Reddy Laboratory of India's generic application for the listing has not been approved, it is expected that the positive day-to-day fluoro-ghes group injection is expected to be approved in Q4 this year.
    Photo Source: Insight Database Chongqing Drug Maker Solafini Original Research Company: Bayer's other competitive first imitation enterprises: Yamashita Pharmaceuticals, Abao Bio, Stone PharmaceuticalGroup Sorafenib is an oral multi-target, multi-kinasse inhibitor developed by Bayer, in December 2005, Soolafini FDA approved for kidney cancer treatment, the product is later adapted to liver cancer.
    currently, Nexavar has been approved for listing in more than 120 countries around the world.
    early on, Nexavar increased year after year and peaked in sales in 2015 (EUR 892 million), with sales declining in recent years but remaining above EUR 7 million.
    sorafenib was first approved in 2006 for the treatment of kidney cancer, the drug known as Dogime, and the drug was later approved for use in liver and thyroid cancer.
    sorafenib entered the national health insurance program in 2017 through health care negotiations and successfully renewed it in 2019.
    currently, according to Insight Database, Chongqing PharmaceuticalS, Shanxiang Pharmaceuticals, Abao Bio and Stone Pharmaceutical Group have all submitted applications for listing of toluene sulfonate sorafini tablets in accordance with four generic suplunos.
    , Chongqing Pharmaceutical Friends has been to be inspected on-site production, q3 is expected to be approved.
    Photo Source: Insight Database East Sunshine Pharmaceuticals Entakapon Film Original Research: Orion Other Competitive First Imitation: General Kangli Pharmaceuticals Entakapon is a specific peripheral tea-paracetamol developed by Finnish company Orion COMTI, which reduces the function of lvodopa metabolism by inhibiting COMT enzymes, as an auxiliary drug for the standard drug levodopa/syborta or l-dopa/kabidoba, is used to treat Parkinson's disease and endotheinostic phenomena (symptom fluctuations) that the above drugs cannot control.
    the drug was first listed in the European Union in 1998 and approved in 2004 (the product is named Yandan), currently only the original research of Entakapen was approved for listing.
    but Guangdong Dongsun and Hainan General Kangli Pharmaceuticals have submitted applications for the listing of EndaKapon tablets in August 2018 and March 2020, respectively, and the listing application submitted by Dongsun is in the second round of treatment, and is expected to be approved this year.
    Photo Source: Insight Database Stone Pharmaceutical Group Ethyl Nidanib SoftCapsule Synthe: Bohringer Ingehan Other Competitive First Imitation Enterprise: Nintedanib is an oral small molecule tyrosine kinase inhibitor that is competitively inhibited into fibrocytocell growth factor receptors (F Receptor tyrosine kinases such as GFR 1-3), vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR alpha and beta) block signalconducts that play a key role in the proliferation, migration, and conversion of fibroblastcells, thereby inhibiting pulmonary fibrosis lesions.
    since october 2014, when fda-approved for the treatment of specific pulmonary fibrosis (IPF), Nidanib has been approved for a number of indications worldwide, including non-small cell lung cancer (NSCLC, the product is called Vargatef), systemic sclerosis-related interstitial pulmonary disease (SSc-ILD) and chronic interstitial fibrosis pulmonary disease (SSD).
    September 2017, Nidanib was approved for the treatment of IPF in the country and ssc-ILD in June this year.
    According to Insight database, at present, only Stone Pharmaceutical Group has submitted the application for the listing of nidanib softgels, in the first round of data replacement status, is expected to be approved this year Q4.
    Photo Source: Insight Database Collum Pharmaceuticals Shugen Sodium Injection Injection Original Research: Mercado and N.V. Organon (Oganon) Other competitive first imitation enterprises: Yangzijiang Pharmaceuticals, Nanjing Zhengda Qingqing Sodium (Sugammadex Sodium, Bridion) by Mercato Corporation and N.V. The world's first specific binding neuromuscular blockan antagonist developed by Organon reverses the pharmacological effects of rocum bromide ammonium and Viku ammonium bromine neuromuscular blockby by forming a complex of the neuromuscular blocker rocard bromoamamine or Viku bromine ammonium.
    September 2008, the drug was listed in the European Union, in the U.S. in December 2015 and in China in April 2017 (the product is named Brittin).
    , Bridion's sales for 2017 and 2018 were $704 million and $917 million, respectively.
    at present, only the original research Shu more sodium glucan approved, but there have been 10 enterprises submitted the listing application, of which Hunan Collen the earliest submitted the listing application, is now in the first round of information replacement, is expected to Be Q4 approved.
    Photo Source: Insight Database Jiangsu OssaeKangShaConazole Injection Research: Other competitive first-class enterprises in Mersadong: Yangzijiang Pharmaceuticals Poshaconazole (commodity name Noxafil) is a new generation of triazole antifungal drugs developed by Mersadong, approved by EMA on October 25, 2005, and approved by the FDA on September 15, 2006.
    is known to have sales of $742 million in 2018.
    currently only the domestic market is poisaconazole oral suspension (first approved by Schilling Pharmaceuticals in 2013) and Poshaconazole intestinal tablets (approved in 2018), the injection is in the listing application stage.
    domestic, Poshaconazole injections were included in the first batch of state-encouraged generic drugs to be released in October 2019.
    at present, Osaikang and Yangzijiang have submitted the application for listing of Poshaconazole injections, Shanghai Xuantai has submitted the listing application for Poshaconazole intestinal tablets, wherein the listing application of Osaikang Poshacona injection has completed the second round of data replacement, is expected to be approved Q4.
    picture source: Insight Database.
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