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    Home > Medical News > Latest Medical 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: 2020-07-29
    • Source: Internet
    • Author: User
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    According to incomplete statistics, at least 14 first imitations were approved in the first half of 2020, of which Zhengda Qing successfully won the first imitation sigletin, Dabbiga group esters, Enquata Binti nofovir and the inhaled BudinaidIn addition, Haussen's Afatini, Theafinib of Manfu Pharmaceuticals, the State-for-The-Pharmaceuticals' Dofades, Cain Technology's Sophosbuvir, And MegaPharma's Qude-Neil are also the first-largest imitations approved in the first half of 2020The Insight database had predicted the upcoming approval of new drugs in the second half of the year, and today we screened 10 first generic drugs from the database and are expected to be approved in the second half of the yearAre: 1, Jiangsu Hengrui's Azishatan tablet 2, Jiangsu Hengrui's Tovalupan tablet 3, Zhengda qing's Pomadoamine capsule 4, Zhengda Qing's injection with polyscoccal bacteria E sodium mesosulfoate 5, positive day-light fluvist ffoe group injection 6, Chongqing drug friends' methyl sulfosse solafi ni tablets 7, Dongsun Pharmaceuticals Enthakama tablets 8, Nidanibu softgel 9, Koren Pharmaceuticals Shumore glucose sodium injection 10, Jiangsu Oseikang's Poshacona injection Jiangsu Hengrui Azishatan tablet syharax original research manufacturers: Takeda other competition first imitation enterprises: BaiO Pharmaceuticals, Zhaoke Pharmaceuticals Azishatan is Takeda original research of AngII receptor antagonist, 2011 was approved by the FDA for the treatment of hypertension, the current research has not been approved in ChinaIn August 2017, Hengrui Pharmaceuticals was the first to report three generic drugs, and then Beijing Baiao Pharmaceuticals and Zhaoke Pharmaceuticals submitted a listing application for 3 generic drugs, of which Zhaoke Pharmaceuticals received approval from NMPA on June 24 and was not approvedAt present, Hengrui Pharmaceutical Azishatan tablet sashimi's application has completed a clinical trial on-site inspection, and the second round of information is about to be completed, is expected to be approved in Q3Photo Source: Insight Database Jiangsu Hengrui Tooptan Tablet Original Research Factory: Otsuka PharmaceuticalSenic Other Competitive First Imitation Enterprise: Nanjing Zhengda Qing Tolvaptan (tolvaptan, Samsca) is an oral selective arginin ewhophthine added in 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 valueThe drug was approved in the United States in May 2009 and domestically in January 2011 (commodity name Sumaka), and has been approved by several countries around the world for different indications, including: treatment of excessive water retention in heart failure patients and patients with cirrhosis, hyposodium emis, and renal swelling in patients with permanent chromosome dominant polycystic 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, of 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 approvedpicture source: Insight database Isdaqing Pomadoamine capsule original research manufacturers: new base pharmaceutical industry other competitive first imitation enterprises: no Pomadoamine is a sarituin analogue analog, is an immunomodulator, with anti-tumor activity, can inhibit the growth of hematopoietic tumor cells and induce apoptosisOn January 8, 2013, the U.SFDA approved pomadomine for patients with multiple myeloma who are still progressing after other anticancer drugsMultiple myeloma is a type of hematologic malignancies commonly found in middle-aged and elderly people, and in many countries its incidence has surpassed acute leukemia and ranked second in the malignant tumor of the hematologic systemPomadomine capsules, although a number of declared clinical, but currently only Zhengda Tianqing submitted a listing application, 2 in clinical trials, 2 in the BE trial, in addition to 13 in approved clinical statusThis year Q3 is expected to be approvedPhoto Source: Insight Database Positive Day Qing Injection with Polyscopic Bacteria E MONATIn Sodium Original Research Factory: ParSterle Products Other Competitive First Imitation Enterprise: Jiangsu Oseicon Sodium Medprosulate is a polypeptide class of antibiotics, is currently the preferred drug for the treatment of multiple-resistant copper-green pseudomonas and other gram-negative bacteria, and the drug resistance rate is low (below 5%)Originally developed by Par Sterile Products, the product is Coly-Mycin M and has not yet entered the countryAccording to insight database, Zhengda Tianqing/Runzhu Pharmaceuticals and Jiangsu Oseikang submitted applications for the listing of sodium injection polysacin E monthane 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 projects, and the listing application of Jiangsu Osaikang was included in the priority review process on the grounds of clinical shortage At present, Zhengda Tianqing has entered the second round of supplementary information, Q4 is expected to be approved Photo Source: Insight Database Zhengda Qing Fluvis Group Injection Original Research Factory: AstraZeneca Other Competitive First Imitation Enterprises: Dr Reddy Labs, Jiangsu Haussen Flovis Group (Fulvestrant, Product Name: Fusd/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 In 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 Global sales of fluorovics are understood to be $1.028 billion in 2018 Domestically, fluorovir injections were negotiated into the National Health Insurance Category B list in 2017, but failed in the 2019 negotiations According to Insight database, the current domestic Dr Reddy Laboratory, Zheng Daqing and Jiangsu Haussen have submitted the listing application, in which Dr Reddy Laboratory of India's generic drug listing application has not been approved, it is expected that the positive day-to-day fluoro-stus group injections are expected to be approved in Q4 this year Photo Source: Insight Database Chongqing Drug Maker Salafini Tablets Original Research Manufacturers: Bayer Other Competitive First Imitation Enterprises: Yamashita Pharmaceuticals, Abao Bio, Sorafenib Group Sorafenib is an oral multi-target, multi-kinasse inhibitor developed by Bayer, in December 2005, Soofini FDA approved for kidney cancer treatment, the product is later adapted to cancer Nexavar is currently listed in more than 120 countries around the world In the early days of the listing, Nexavar increased year by 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, known as Dogime, and the drug was later approved for use in liver and thyroid cancer In 2017, Solafeni entered the national health insurance program through health insurance negotiations and successfully renewed it in 2019 At present, according to Insight database, Chongqing Pharmaceutical Suyou, Shanxiang Pharmaceuticals, Yabao Bio and Stone Pharmaceutical Group have all submitted applications for listing of toluene sulfonate solafini tablets in accordance with 4 generic sass Among them, Chongqing Pharmaceutical Friends has been to be inspected on-site production, Q3 is expected to be approved Photo Source: Insight Database East Sunshine Pharmaceuticals Entakapun Films Original Research: Orion Company Other Competitive First Imitation Enterprise: General Kangli Pharmaceuticals Ntakapon 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 was approved in China in 2004 (the product is named Yandan), and only Entakapen, the original research institute, has been approved for the market However, Guangdong Dongsun and Hainan General Kangli Pharmaceuticals have submitted applications for the listing of Ntakapon 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 SoftCapsules Original Research: Bollinger Ingehan Other Competitive First Imitation Enterprises: Nintedanib is an oral small molecule tyrosine kinase inhibitor that is competitively inhibited into fibrocytocell growth factor (FF) 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 being approved by the FDA in October 2014 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 called Vargatef), systemic sclerosis-related interstitial pulmonary disease (SSc-ILD) and chronic interstitial fibrosis pulmonary disease (DSDs) In 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 an application for the listing of nidanib softgels, which is in the first round of data distribution, and is expected to be approved this year Q4 Photo Source: Insight Database Collum Pharmaceuticals Shugen Sodium Injection Original Research Manufacturers: Mercado and N.V Organon (Oganon) Other competitive first-model enterprises: Yangzijiang Pharmaceuticals, Nanjing Zhengda Qingqing Sodium Sodium (Sugammadex Sodium, Bridion) by Mercato 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 The drug was listed in the European Union in September 2008, in the United States 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, according to the company's financial results At present, only the original study Shu more sodium glucan was 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 Osekang PoshaconA injection Original Research: Mercadong Other Competitive First Imitation Enterprises: Yangzijiang Pharmaceuticals Poshaconzi (commodity name Noxafil) is a new generation of triazole antifungal drugs developed by Mercadine, approved by THE EMA on October 25, 2005 and approved by the FDA on September 15, 2006 It is reported that in 2018, poshaconazole sales reached 742 million U.S dollars At present, the domestic market only pochaconazole oral suspension (first approved by Schilling Pharmaceuticals in 2013) and Poshaconazole intestinal tablets (approved in 2018), the injection is in the listing application stage Domestically, Poshaconazole injections were included in the first batch of state-encouraged generic drugs released in October 2019 At present, Osaikang and Yangzijiang have submitted the application for listing of Poshakangazi 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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