Koren, East Sunshine Medicine, It's Sunny... The 12 heavyweights will be approved

The first generic drug has market and pricing advantages, and is the focus area of the layout of domestic pharmaceutical companies.
with the reform of the new drug review and approval system, the approval speed of the first generic drug is accelerating day by day.
meters net data show that at the beginning of the new year, more than 10 first generic drugs (containing dosage form first imitation) have been approved for the market, including Hengrui's hydrochloric acid right metformin sodium chloride injection, Qilu's quefluluoruricoside tablets and diazepam viglitin tablets, Shanghai Xuantai Haimen's Posacon intestinal solution tablets, Tiansli's minoic acid tablets, Nanjing Sea melting saccharides.
so what other heavyweight generics are expected to be approved for sale by the end of 2021? Table 1: First imitation of heavy-weight varieties expected to be born by the end of 2021 Note: No sales or less than 10 million yuan for representative; forecast data, for reference only; first production not necessarily the first approved Azisha tablets Azisha Tan, an angiotensin II (AngII) patient antagonist developed by Takeda, was first approved by the FDA in 2011 for the treatment of hypertension and has global sales of 76.7 billion yen in 2019.
Table 2: New Classification of Azishatan Tablets Reported Production Source: MED2.0 China Drug Review Database At present, there are 4 enterprises in China to copy 3 categories to submit applications for listing of Azishatan tablets.
Hengrui Pharmaceuticals submitted its application for listing in August 2017 and was accepted by CDE contractor, the first in China, and was included in the priority review in December of the same year on the grounds of "application for pharmaceutical production one year before the expiration of the patent", and is currently in the second round of data replenishment.
addition, Baiao Pharmaceuticals' products are in the first round of data supplements.
Ivemos tablet Ivemos, a mammalian repamycin target protein (mTOR) inhibitor developed by Novartis, was approved in the U.S. in 2009 as the fda's first mTOR inhibitor, and in February 2013, a new adaptation to rejection after liver transplantation was approved, the first approved liver transplant immunosuppressant by the FDA in more than a decade.
2019 global sales of $2,024 million.
was approved to enter the domestic market in January 2013, negotiated for inclusion in the National Health Insurance Directory in 2017, successfully renewed in 2019 and added reimbursements for adaptations.
2019, total sales of public medical institutions and physical pharmacy terminals in Chinese cities exceeded 100 million yuan, up 29.5% year-on-year, according to the company's internal network data.
table 3: Evimos film new classification reporting situation Source: Minet MED2.0 China Drug Review Database At present, only the domestic day-clearing pharmaceutical industry Evimos tablet production, its listing application in November 2018 by the CDE contractor acceptance, has now left the new reporting task, in the first round of information supplement.
Shakuba quercin sodium tablet Shakuba quartzan is a compound of shakubaquo (brain morphine enzyme inhibitor) and salutan (angiotensin-stressor antagonist) that was approved by the FDA in July 2015 and is the world's first breakthrough and innovative drug for heart failure therapy, with global sales of $1.726 billion in 2019.
In July 2017, Novarma's Shakuba Qulu shatan sodium tablets were approved for entry into the domestic market and have now been negotiated into National Health Insurance, with sales of more than 400 million yuan in Public Medical Institutions and physical pharmacy terminals in Chinese cities in 2019, up 440.1% YoY. Table
4: New classification of sodium tablets in Shakuba Qulushatan Source: MED2.0 China Drug Review Database At present, there are 7 domestic enterprises to copy 4 categories of Shakuba Qusaltan sodium tablets to submit the listing application, of which Shanghai Xuantai Haimen Pharmaceuticals first reported production, its listing application in November 2018 by the CDE contractor acceptance, is currently in the second round of information replacement.
addition, stone medicine European, Zhengda Tianqing and other enterprises' products in the first round of information to supplement.
Tovaputan tablets Tovaputan is an oral selective arginine pressurized V2 subject antagonist developed by Otsuka Pharmaceuticals of Japan for the treatment of heart failure, cirrhosis, anti-diuretic hormone secretion abnormalities, etc.
, the product was approved by the FDA in May 2009 and is the world's first antagonist for angiopressin, with global sales of 149.05 billion yen in 2019.
,000-year-old Otsuka Pharmaceuticals was approved for entry into the domestic market in 2011 and negotiated for inclusion in the national health-care list in 2017, but contract renewal talks failed in 2019.
total sales of this product in China's public medical institutions and physical pharmacy terminals in Chinese cities in 2019 were 270 million yuan, an increase of 46.95 percent year-on-year.
Table 5: New Classification of Tovaputan Tablets ReportIng Production Source: MED2.0 China Drug Review Database At present, there are 3 enterprises in China to copy 4 categories of tovaptan tablets to submit the listing application, of which Hengrui Pharmaceuticals is the first to report production, its listing application was accepted by CDE contractor in April 2019, and in September of the same year into the priority review.
, Nanjing Zhengtianqing products are currently in the first round of information supplement.
Shu more glucosodium injection sodium sulphate is the world's first specific binding neuromuscular block antagonist drug developed by Mercadon and Oganon for antagonist nerve muscle blocking induced by roku bromide or vicobrominum.
the product was first approved for sale in the European Union in September 2008, in the U.S. in December 2015 and with global sales of $1.131 billion in 2019.
May 2017, Shu's sodium glucosin injection was approved for entry into the domestic market, with sales of more than 70 million yuan in 2019 at the terminals of public medical institutions in China, up 804.21% YoY, and sales of more than 50 million yuan in the first half of 2020, up 117.5% YoY.
Table 6: Shu more glucosin sodium injection new classification reported the production source: MED2.0 China drug review database Shu more glucosal sodium injection first imitation competition is more intense, there are currently 15 enterprises to copy 4 categories to submit the product listing application, of which Hunan Colum first reported production, its listing application in November 2018 by the CDE contractor acceptance, has entered the second round of information.
addition, Yangzijiang's products are in the first round of information supplement.
Mirabelon slow release tablet Mirabelon is an selective beta-3-epinephrine-induced excitation agent developed by Astellas, which is mainly used to treat urinary emergencies, urinary frequency and urinary incontinence caused by bladder hyperactive activity.
the product was first approved for sale in Japan in September 2011, in the U.S. in June 2012 and with global sales of 161.6 billion yen in 2019.
In October 2017, Astellas' Mirabelon slow-release tablets were approved for sale in the domestic market, and were officially put on the market at the end of May 2018, and are currently the only beta-3-acting excitants in China to treat bladder overactive disorders.
Table 7: Mirabelon slow release tablets new classification reported production Source: MED2.0 China Drug Review Database Currently, there are 3 domestic enterprises to copy 4 categories submitted to Mirabelon slow release tablets on the market application, including East China Pharmaceutical products The first filing, its listing application was accepted by CDE contractor in October 2019 and included in the priority review in March 2020 on the grounds of "application for pharmaceutical production one year before the expiration of the patent", and is currently in the first round of data replacement.
Sodium E methyl sulfonate, which is a peptide antibiotic, is currently the drug of choice for treating infection caused by multi-drug-resistant copper-green prosthetic monocytobacteria and other Glollaton-negative bacteria.
the product resistance rate is low and with other antibiotics will not produce cross-resistance, is the domestic acute patients urgently needed super antibiotics, the original product has not yet entered the domestic market.
table 8: New classification of sodium E methulphate for injection Source: Midnet MED2.0 China Drug Review Database Zhengda Tianqing Pharmaceuticals, Osaikang December 2017 and 20, respectively In April 19, 3 categories of imitation submitted applications for the listing of sodium E meth sulfonate for injection, and were included in the priority review process, of which Zhengda Tianqing Pharmaceutical products in the second round of supplementary information, Osaikang products in the first round of information supplement.
Entakapen tablets Entakapen is a specific exocelisamine-o-methyl transferase inhibitor developed by Orion Finland, first introduced in the European Union in 1998 for the treatment of lyso-doba/pyridine or L-Doba/Carbidoba can not control Parkinson's disease and end-of-dose phenomenon (symptom fluctuations).
original research products in 2004 was approved to enter the domestic market, for the national health insurance Category B products, limited to second-line drugs.
total sales of Entakapen tablets in China's public medical institutions and physical pharmacies terminals in Chinese cities in 2019 were 170 million yuan, up 20.27 percent year-on-year.
Table 9: New Classification of Entakapen Tablets Source: MED2.0 China Drug Review Database East Sunshine Pharmaceuticals, Hainan General Kangli, August 2018 and March 2020, respectively, in imitation 4 Class submitted to the Enda Carpente tablets to market applications, its Middle East Sunshine products in November 2018 on the grounds of "the same production line, has been listed in the United States in 2018, apply for domestic listing of generic drugs" as a priority review, is currently in the second round of additional information.
Acetic acid Aitbonte injection Aitbonte is a rare disease drug developed by Takeda's Shire company, which is a powerful selective anti-peptide B2 subject antagonist, mainly used to treat acute episodes of hereditary angioedema (HAE).
was approved for sale in the European Union in July 2008 and in the United States in August 2011, it is the third FDA-approved drug to treat HAE seizures, with global sales of 32.7 billion yen in 2019.
In China, acetic acid Aitbonte injections have been included in the list of clinically urgent need for new drugs abroad, Takeda in June 2020 to import 5.1 categories of the product to submit the listing application, is still in the "in the review and approval (in the drug review center)" state.
Table 10: New Classification of Acetic Acid Aitetam injections Reported Production Source: MED2.0 China Drug Review Database Chengdu Sanno and Howson submitted applications for the listing of Acetic Acid Aitide Injections in May 2018 and November 2020, respectively, with Chengdu Sanno's products completing the first round of supplementary information.
sulfonate lenphatini capsule lenphatinib is an oral multi-target kinase inhibitor developed by Aegean to inhibit VEGFR-1, 2,3, FGFR-1, 2, 3, 4, PDGFR, RET, KIT and many other targets.
was first awarded orphan drugs to treat thyroid cancer in Japan in August 2012 and was officially approved for listing in the United States and the European Union in 2015, with global sales of about $1.4 billion in 2019.
In September 2018, the capsule was approved into the domestic market, becoming the first domestic drug approved for first-line treatment of advanced liver cancer in nearly 10 years.
Table 11: New classification of methyl sulfonate lunphatini capsules reported production Source: Minet MED2.0 China Drug Review Database At present, there are 10 domestic enterprises to copy 4 categories of submitted methulphate lunphatini capsule listing applications, Zhengda Tianqing Pharmaceuticals, Nanjing Synong Dongyuan, Nanjing Zhengda Tianqing Pharmaceutical 3 enterprises are in the first round of information supplement.
hydrochloric acid rulassin ketone tablets Lulacetonone is an atypical (second generation) antipsychotic drug developed by Japan's Family Friend Pharmaceuticals, an antagonists for dopamine D2, 5-HT2A, and 5-HT7 subjects.
product was first approved for listing by the FDA in October 2010 and entered the domestic market in January 2019, with global sales of 189.5 billion yen in 2019 and 194.2 billion yen in 2020.
Table 12: New classification of hydrochloric acid lulassin tablets reported production Source: Minet MED2.0 China Drug Review Database At present, there are 4 domestic enterprises to copy 4 categories of submitted hydrochloric acid lulassin tablets to market applications, of which Haizheng Pharmaceuticals first reported production, its listing application in October 2019 by CDE contractor acceptance, is currently in the first round of information supplement.
entourtain propofol tynofovir tablet entourtabin propofol is a compound preparation consisting of entourtabin and propofol tynofovir, in association with other antiretroviral drugs, to treat HIV-1 infection in adults and adolescents (12 years of age and older and weighing ≥35 kg).
the product was approved by the FDA in 2016 and has global sales of $1.5 billion in 2019.
Table 13: Entourtabin propofol for Novowe tablets new classification of production Source: Minet MED2.0 China Drug Review Database Currently only Chengdu Bett Pharmaceuticals Enturtabin propofol for Nofowe tablets, its listing application in November 2019 was accepted by cdE contractor, has now left the new reporting task, in the first round of information replacement.
source: MiNet database Note: data statistics as of February 16, if there are omissions, welcome to point out!