104 varieties have been evaluated, and 4 varieties have been evaluated for the first time! Injection declaration accounted for 75%, Renhe Yikang, Hubei Xinghua, Tianjin Jinyao...

According to the consistency evaluation and analysis system of the enterprise version of PharmaSmart Data, 72 new consistency evaluation acceptance numbers were added in November 2022; There are 158 acceptance numbers (including 121 deemed to pass acceptance numbers) that have been evaluated (a detailed evaluation table of consistency evaluation of November declaration and evaluation is attached at the end of the article).

Figure 1 Notification/adoption trend from January 2022 to November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

Review details

In November, a total of 37 consistency evaluation acceptance numbers and 121 generic drug marketing application acceptance numbers were deemed to have passed the consistency evaluation, involving 104 varieties
of 111 enterprises.
Among them, 4 varieties were the first to be evaluated in the consistency evaluation, as detailed in Table 1

In terms of evaluated enterprises, the 6 acceptance numbers and 3 varieties jointly declared by Renhe Yikang Group Co.
, Ltd.
and Hebei Renhe Yikang Pharmaceutical Co.
, Ltd.
in November occupied the first place in the list of acceptance numbers passed in November, and Qilu Pharmaceutical ranked second
with 5 acceptance numbers.
See figure below for details

Figure 2 In November 2022, the enterprise passed the acceptance number TOP10

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

Renhe Yikang Group has 6 subsidiaries
, including Shijiazhuang Development Zone Boxin Pharmaceutical Technology Development Co.
, Ltd.
, Hebei Renhe Yikang Pharmaceutical Co.
, Ltd.
, Hebei Chuangjian Pharmaceutical Co.
, Ltd.
, Hebei Anjian Chengyi Pharmaceutical Technology Co.
, Ltd.
, Shijiazhuang Keren Pharmaceutical Technology Co.
, Ltd.
, and Hebei Fred Pharmaceutical Co.
, Ltd 。 November Renhe Yikang Group Limited; Hebei Renhe Yikang Pharmaceutical Co.
, Ltd.
jointly declared a total of 3 varieties reviewed, of which zoledronic acid injection is an inhibition of bone resorption, belongs to nitrogenous bisphosphonic acid compounds, mainly acts on human bones, can be used to treat bone pain caused by malignant tumor osteolytic bone metastasis and postmenopausal osteoporosis, deforming osteitis (Paget disease).

From the perspective of varieties, in November, 4 companies ranked first
in the evaluation of sodium valproate concentrated solution for injection.
See figure below for details

Figure 3 In November 2022, the variety passed the acceptance number TOP10

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

Sodium valproate concentrated solution for injection is currently being produced by 9 enterprises, with a total of 16 approvals of 11 specifications on the market
.
It is an injection mainly used for the treatment of simple or complicated absence seizures, myoclonic seizures, and generalized tonic-clonic seizures (large seizures) of epilepsy
.
According to the registration data, 10 enterprises have been imitated and listed, and 5 enterprises have applied for listing
as the same consistency evaluation.

48 varieties declared,

Injections account for three-quarters

In November 2022, CDE added 72 new consistency evaluation acceptance numbers, involving 48 varieties from 44 enterprises, of which injections accounted for three-quarters of the declared dosage forms, an increase
from previous months.

Figure 4 Details of dosage forms declared in November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

In terms of declared varieties, in November 2022, lidocaine hydrochloride injection became the first
with 5 acceptance numbers of Jiangsu Huayang Pharmaceutical Co.
, Ltd.
See figure below for details

Figure 5 Variety declaration acceptance number TOP10 in November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

Lidocaine hydrochloride is an amide local anesthetic and antiarrhythmic drug
.
At present, there are 85 enterprises producing this product, with a total of 161 approvals and a total of 8 specifications, 18 approvals and 12 enterprises have passed/deemed to have passed the consistency evaluation application, of which 1 company has applied for listing through generic drugs, 9 companies are applying for consistency evaluation, and 4 companies are in the process
of review and approval of generic drug marketing applications.

From the perspective of enterprises, in November, Hubei Xinghua Pharmaceutical, Tianjin Jinyao and Tianjin Jinyao Group, a subsidiary of Tianjin Pharmaceutical Group Co.
, Ltd.
, and Hubei Tianyao Pharmaceutical Co.
, Ltd.
each ranked first
with four acceptance numbers.
See figure below for details

Figure 6 Top 10 enterprise application acceptance numbers in November 2022

Data source: PharmaIntelligence Data, PharmaIntelligence Consulting

Tianjin Jinyao Pharmaceutical Co.
, Ltd.
was established on November 12, 2010, and is committed to becoming the world's leading corticosteroid preparation drug research and development and industrial base
.
At present, the company has 207 approvals for 147 varieties, of which 14 varieties have passed/deemed to have passed the consistency evaluation, 6 varieties are in the consistency evaluation review sequence, and 6 varieties are declared for marketing
as generic drugs.

Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co.
, Ltd.
was established on April 16, 2001, and its products include hormones, antibiotics, vitamins, cardiovascular and cerebrovascular products, antivirals, antipyretic and analgesic, blood and other more than 70 specifications
.
At present, the company holds 131 approvals for 82 varieties, a total of 4 varieties have passed/deemed to have passed the consistency evaluation, 4 varieties are in the consistency declaration, and 1 variety is applied for marketing
as a generic drug.

Hubei Xinghua Pharmaceutical Co.
, Ltd.
was founded in 2009, mainly engaged in: small-volume injection (including second-class essence drugs: trimadol hydrochloride injection), inhalation preparation production and sales
.
The company has 19 varieties and 23 specifications of production approval, the main products are tramadol hydrochloride injection, atropine sulfate injection, lomefloxacin hydrochloride injection, etc
.

Appendix 1: Details table of the first company to pass the consistency evaluation in November 2022

Image data source: PharmacoIntelligence Data, PharmaIntelligence Consulting

Schedule 2: Details of conformity evaluation adopted (including deemed passed) in November 2022

Image data source: PharmacoIntelligence Data, PharmaIntelligence Consulting

Appendix 3: Detailed table of consistency evaluation of the November 2022 filing

Image data source: PharmacoIntelligence Data, PharmaIntelligence Consulting

Data as of November 30, 2022