27 new varieties (deemed as the same) passed the consistency evaluation, and 10 were the first ones (list attached)

According to incomplete statistics from the Medical Cloud Studio, there are currently 2,904 product regulations that have passed the consistency evaluation, and 340 product regulations have been evaluated by more than three (including three).

According to statistics from the Medical Cloud Studio, from August 15, 2021 to August 21, 2021, 27 new varieties (deemed as equivalent) passed the consistency evaluation, of which 10 were the first in the country to have passed the evaluation

Hunan Jiudian Pharmaceutical: Ornidazole Dispersible Tablets are approved as the first in the country

Ornidazole is the third-generation nitroimidazole drug after metronidazole and tinidazole.

Ornidazole has clinical advantages such as definite curative effect, wide application population, good compliance, and small adverse reactions.

This product is a Class B drug of the 2020 National Medical Insurance Catalogue.

Hongsen Pharmaceutical: The first nationwide phenytoin sodium tablet to pass the consistency evaluation

Phenytoin sodium is suitable for the treatment of generalized rigidity-twin seizures, complex partial seizures, simple partial seizures and status epilepticus; it can be used for the treatment of trigeminal neuralgia, recessive dystrophic epidermolysis bullosa, paroxysmal chorea Chiropodactysis, paroxysmal control disorder; it can also be used for ventricular and supraventricular arrhythmias caused by digitalis poisoning

This product is the 2018 edition of the national basic medicine and the 2020 edition of the national medical insurance Class A drug

According to data from Minai.

Fresenius Kabihuarui Pharmaceuticals: Enteral Nutrition Emulsion (SP) was approved as a review, the first in the country

Enteral nutrition emulsion is a nutritional preparation with complete nutrients, which can meet the needs of patients for essential amino acids, essential fatty acids, vitamins, minerals and trace elements; it is suitable for patients with nutritional intake disorders but no severe digestion and absorption dysfunction (including cranial Face or neck trauma, high-energy nutrition stage before and after surgery, upper gastrointestinal food passage obstacles, etc.

According to Minai.

Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co.

According to Minai.

Public data shows that currently three companies in Tianjin Jinyao, Huaxia Shengsheng, and Pacific Pharmaceutical have submitted supplementary applications for consistency evaluation, and two companies, Tiansheng Pharmaceutical and Chenxin Pharmaceutical, have applied for the production of new three types of generic drugs

Hubei Shubang Pharmaceutical: Lafutidine Tablets are approved as the first in the country

Lafutidine is a new generation of long-acting and potent H2 receptor antagonist

In October 2019, Hubei Shubang Pharmaceutical took the lead in submitting a new category 3 generic drug listing application for "Lafutidine Tablets".

Public data shows that Lafutidine's domestic sample hospital sales in 2020 were 29.
61 million yuan, an increase of 5.
82% year-on-year.
Hubei Shubang Pharmaceutical occupies 48.
16% of the sales market, ranking first
.

Renfu Pharmaceuticals: Bupropion Hydrochloride Sustained-Release Tablets (Ⅱ) were approved as the first in the country

Bupropion is suitable for the treatment of moderate to severe depression and seasonal affective disorder
.
The drug was developed by VALEANT INTERNATIONAL BARBADOS SRL and was launched in the United States on August 28, 2003
.
According to relevant market sales data, the U.
S.
generic drug market sales for the 300mg dosage form of the product in 2018 were approximately US$120 million
.

According to data from Minai.
com, the sales of domestic sample hospitals in 2020 was only 9.
63 million yuan, an increase of 13.
47% year-on-year; the total sales in Q1 of 2021 was 3.
02 million yuan
.

In addition to the original research, only Renfu Pharmaceutical's bupropion hydrochloride sustained-release tablets (II) have been approved for production in China, which is the first domestic imitation product and the first deemed approved product
.
In addition, Renfu Pharmaceutical's bupropion hydrochloride sustained-release tablets have been successively marketed in the United States, China and other places
.

Yuandong Bio: Naloxone Hydrochloride Injection is the first nationally reviewed

Naloxone hydrochloride injection is an opioid receptor antagonist.
It is used after opioid combined anesthesia to antagonize the respiratory depression caused by such drugs and prompt patients to wake up; used for opioid overdose to completely or partially reverse opioids Respiratory depression caused by similar drugs; rescue acute alcohol poisoning; used in the diagnosis of acute opioid overdose
.

Naloxone hydrochloride injection was developed by the American ADAPT Pharmaceutical Company.
It was approved by the U.
S.
Food and Drug Administration in April 1971.
The product name is NARCAN, and it has not been imported into China
.

Yuandong Bio's naloxone hydrochloride injection was approved for marketing in January 2005
.
In addition, many domestic companies such as Beijing Huasu, Beijing Sihuan and other companies have been approved for production of naloxone hydrochloride injection.
Among them, Shumeiqi Chengdu Biotechnology (contracted production: Sichuan Meida Kangjiale Pharmaceutical) The State Food and Drug Administration submitted an application for the marketing authorization of naloxone hydrochloride injection, and there is no supplementary application for the consistency evaluation of the enterprise declaration
.
Yuandong Bio is the first company to pass the consistency evaluation of this species
.
cut

According to the database of Minai.
com, the terminal sales of naloxone injections (naloxone hydrochloride injection and naloxone hydrochloride for injection) in public hospitals in key provinces and cities in China in 2020 are about 104.
04 million yuan, the top three in market share.
The companies are Beijing Huasu Pharmaceutical (27.
74%), Yuandong Biological (16.
00%) and Chongqing Yaoyou Pharmaceutical (12.
20%)

Tianjin Jinyao Pharmaceutical: Isoniazid Injection is the first nationwide appraisal

Isoniazid combined with other anti-tuberculosis drugs is suitable for the treatment of various types of tuberculosis that are sensitive to isoniazid; Isoniazid can be used for the prevention of tuberculosis; according to domestic clinical experience, this product is combined with other anti-tuberculosis drugs and can also be used for other Mycobacterium infection
.

According to Minai.
com, the sales of domestic sample hospitals in 2020 is 26.
94 million yuan, a year-on-year decrease of 45.
27%
.
Southwest Pharmaceutical (42.
25%) and Tianjin Jinyao (33.
26%) together account for over 70% of the sales market for this product
.

Chenxin Pharmaceutical: The first nationwide review of aspirin enteric-coated tablets

Aspirin, originally developed by Bayer, Germany, was born in 1897.
It has as many as 14 therapeutic effects and is often sought after as a panacea
.
Up to now, aspirin is still known as the three classic drugs in the history of medicine along with penicillin and diazepam.
It is also the most widely used antipyretic and anti-inflammatory drug in the world
.

According to the inquiry, Chenxin Pharmaceutical was the first pharmaceutical company to submit a supplementary application for the consistency evaluation of this product.
It took one and a half years and finally won the first evaluation
.
Guilin Pharmaceutical and Lepu Hengjiuyuan Pharmaceutical are on the way of review and approval
.

According to data from Mi Nei.
com, the sales of aspirin in public hospitals in key domestic provinces and cities in 2020 will be 270 million yuan, and that in the first quarter of 2021 will be 66.
55 million yuan.
The original Bayer market accounted for 92.
49%
.

Changchun Leiyunshang Pharmaceutical: The first nationwide review of Azithromycin Granules

Azithromycin is suitable for the following infections caused by sensitive pathogenic strains: those caused by Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Staphylococcus aureus or Streptococcus pneumoniae need to be treated by intravenous drip first Community-acquired pneumonia
.

The original manufacturer of this product is Pfizer.
It was the first to be listed in the United States in 1991 and officially entered China in 2007.
The product name is Xishumei
.
Affected by national centralized procurement (azithromycin tablets/capsules will be included in the second batch of national procurement in January 2020; azithromycin for injection will be included in the fifth batch of national procurement in June 2021), the drug's domestic sample hospital sales in 2020 will be 203 million Yuan, down 62.
01% year-on-year; injections and solutions are the main sales formulations
.

The latest national review data bulletin:

According to incomplete statistics from the Medical Cloud Studio, there are currently 2,904 product regulations that have passed the consistency evaluation, and 340 product regulations have been reviewed by more than three (including three)
.