62 varieties have been evaluated, and 12 varieties have been evaluated for the first time! Hainan General Sanyo, Yangtze River, Huahai...

According to the consistency evaluation and analysis system of the enterprise version of Yaozhi Data, 84 new consistency evaluation acceptance numbers were added in August 2022; There were 85 approvals (including 62 deemed approved) that had been evaluated

Figure 1 Filing/Approval Trends from January 2022 to August 1

Data source: Yaozhi data, Yaozhi consulting collation

Review details

In August, a total of 85 approvals passed/treated as consistency evaluations, involving 62 varieties of 58 enterprises, of which 12 varieties were evaluated for the first time

From the perspective of evaluated enterprises, in August, Huaxia Shengsheng Pharmaceutical (Beijing) Co.

Figure 2 In August 2022, enterprises passed the number of varieties TOP8

Data source: Yaozhi data, Yaozhi consulting collation

Huaxia Shengsheng Pharmaceutical (Beijing) Co.

Founded in 1971, Sichuan Meida Kang Huakang Pharmaceutical Co.
, Ltd.
is a national high-tech enterprise
mainly engaged in the production, research and development and sales of chemicals controlled by Beijing Jinyuan Yaoye Pharmaceutical Technology Co.
, Ltd.
The company's dosage forms include lyophilized powder injections, sterile powder injections, large-volume injections, small-volume injections, eye drops, solutions (including nebulized inhalation), tablets, capsules, external liniments and chemical APIs
.
At present, there are more than 120 drug approval numbers, more than 70 national basic drug varieties, 12 new drug certificates (including three first-class new drug certificates), the main varieties are the production and sale of antibacterial drugs (antibacterial, fungal, anaerobic), antiviral drugs, vitamins, antipyretic and analgesic and other treatment categories, especially the latest anti-deep fungal infection drugs - voriconazole, anti-hepatitis B virus drugs - adefovir dipivoxil.

At present, the company has 15 varieties declared or deemed to be consistent, of which 3 varieties pass the consistency evaluation and 5 varieties pass the consistency evaluation
.

From the perspective of varieties, rifampicin capsules in August had 5 companies evaluated, ranking first
.
See the figure below for details

Figure 3 In August 2022, the number of varieties passed the acceptance number TOP8

Data source: Yaozhi data, Yaozhi consulting collation

Rifampicin capsules are medical insurance class A prescription drugs, belonging to the rifamycin semi-synthetic broad-spectrum antibacterial drugs, have antibacterial activity against a variety of pathogenic microorganisms, must be prescribed by the doctor after taking the drug, and strictly follow the doctor's instructions
.
This product has been applied for consistency evaluation by 8 companies, and 6 companies have been evaluated
.

57 varieties declared, and injections accounted for half of the country

In August 2022, cde added 84 new consistency evaluation acceptance numbers, involving 57 varieties of 59 enterprises, of which injection applications accounted for more than
70% of the total number of applications.

Figure 4 Details of the dosage form declared in August 2022

Data source: Yaozhi data, Yaozhi consulting collation

In terms of declared varieties, in August 2022, seven acceptance numbers of piperacillin sodium for injection were undertaken, far surpassing lorazepam tablets, cefoperazone sodium sulbactam sodium for injection or cefotaxime sodium for injection
.
See the figure below for details

Figure 5 Top 2022 number of variety declaration acceptance numbers in August 8

Data source: Yaozhi data, Yaozhi consulting collation

Piperacillin sodium for injection tazobactam sodium is a lactam antibacterial drug that can be used to relieve uncomfortable symptoms caused by bacterial infections
.
Contraindicated in patients who are allergic to any lactam antibiotics (including penicillins and cephalosporins) or lactamase inhibitors
.
Piperacillin sodium for injection tazobactam sodium has been declared by 15 companies for consistency evaluation, of which 5 companies have been evaluated and 1 enterprise has approved clinical
practice.

From the perspective of the enterprise, from the perspective of the enterprise, Hainan General Sanyo Pharmaceutical Co.
, Ltd.
is the well-deserved boss in the acceptance of the consistency evaluation application in August, not only and Hainan General Kangli Pharmaceutical Co.
, Ltd.
jointly declared 4 acceptance numbers, there are 3 separate consistency evaluation application acceptance numbers, while Atlantic Pharmaceutical Factory Co.
, Ltd.
and Hunan Kelun Pharmaceutical Co.
, Ltd.
each have 3 acceptance numbers The declaration consistency evaluation was accepted, temporarily ranked second
.
See the figure below for details
.

Figure 6 Top 2022 in august 8 for the number of enterprise declaration acceptance numbers

Data source: Yaozhi data, Yaozhi consulting collation

Hainan General Sanyo Pharmaceutical Co.
, Ltd.
is a high-tech enterprise
integrating pharmaceutical research and development and production.
The shareholder of the company is China Pharmaceutical and Health Industry Co.
, Ltd.
, which belongs to China General Technology (Group) Holdings Co.
, Ltd
.
The products cover antibiotics, lipid-modulating drugs, drugs to improve brain function, digestive system drugs and other categories, of which enzyme-resistant compound antibiotic preparations are in a position
in the industry.
At present, the company has submitted consistency evaluation applications or marketing applications for consistency for 13 products such as ceftazidime for injection and ceftriaxone sodium for injection, and 4 products have passed the consistency evaluation and 1 product has passed
the same.

Schedule 1: Detailed table of consistency evaluations adopted (including deemed) in August 2022

Data as of August 2022, 08

Schedule 2: Detailed Table for The Consistency Evaluation of the Declaration for August 2022

Data as of August 2022, 08

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