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On September 2, Kelun submitted an application for the imitation of pregabalin capsules in four categories, which is currently under review and approval; on September 9, the NMPA official website released the latest batch of drug approval information, Shijiazhuang Longze Pharmaceutical’s pregabalin The capsule was approved for listing and deemed to have been reviewed
.
In recent years, the sales of pregabalin capsules have grown rapidly in physical pharmacies in Chinese cities, and it has become the TOP1 product of oral painkillers in 2020.
The considerable market potential has attracted a large number of domestic pharmaceutical companies to declare
.
Figure 1: Kelun’s application source: CDE official website Figure 2: Shijiazhuang Longze Pharmaceutical’s approval source: NMPA official website It is reported that pregabalin is a structural derivative of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) , But does not affect the absorption and degradation of GABA.
The product has high affinity with the α2-δ sites in the central nervous system tissue, thereby reducing the release of neurotransmitters such as glutamate and norepinephrine.
It is used for the treatment of bands.
Post-herpetic neuralgia and fibromyalgia
.
Pregabalin capsules were included in the fourth batch of national centralized procurement catalogs.
Qilu Pharmaceutical (Hainan), China Resources Double-Crane Pharmaceuticals, Ningbo Minova Tiankang Pharmaceuticals, and Chongqing Saiwei Pharmaceuticals won the bids.
It is expected to be implemented after implementation.
, Pfizer can hardly keep half of the country
.
Figure 3: Sales of Pregabalin Capsules in the Retail Market (Unit: 10,000 Yuan) Source: Mynet.
com China City Entity Pharmacy Database.
Data from Mynet.
com shows that Pregabalin Capsules successfully surpassed in 2020 in physical pharmacies in cities in China .
The compound paracetamol tablets (Ⅱ) became the TOP1 product for oral administration
.
From the perspective of growth rate, it has been rising faster and faster in the past three years, and it has successfully exceeded 100 million yuan in 2020
.
Table 1: Pregabalin currently declared for marketing and under review.
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database.
Pregabalin currently approved in the domestic market involves capsules (1 imported + 7 domestically produced) and oral liquids (1 Domestically produced), the marketing application under review involves sustained-release tablets, capsules, and oral liquids.
With subsequent new products approved for marketing, the market competition for this product will become more intense
.
As of now, Kelun has declared and reviewed 20 products for the market in 2021, involving sensory system drugs (1), respiratory system drugs (2), musculoskeletal system (2), anti- tumor and immunomodulation Drugs (3), systemic anti-infective drugs (3), nervous system drugs (3), cardiovascular system drugs (1), blood and hematopoietic system drugs (5)
.
Source: CDE official website, NMPA official website, and Minet.
com database.
The review data statistics are as of September 8.
If there are any errors or omissions, please correct me
.
.
In recent years, the sales of pregabalin capsules have grown rapidly in physical pharmacies in Chinese cities, and it has become the TOP1 product of oral painkillers in 2020.
The considerable market potential has attracted a large number of domestic pharmaceutical companies to declare
.
Figure 1: Kelun’s application source: CDE official website Figure 2: Shijiazhuang Longze Pharmaceutical’s approval source: NMPA official website It is reported that pregabalin is a structural derivative of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) , But does not affect the absorption and degradation of GABA.
The product has high affinity with the α2-δ sites in the central nervous system tissue, thereby reducing the release of neurotransmitters such as glutamate and norepinephrine.
It is used for the treatment of bands.
Post-herpetic neuralgia and fibromyalgia
.
Pregabalin capsules were included in the fourth batch of national centralized procurement catalogs.
Qilu Pharmaceutical (Hainan), China Resources Double-Crane Pharmaceuticals, Ningbo Minova Tiankang Pharmaceuticals, and Chongqing Saiwei Pharmaceuticals won the bids.
It is expected to be implemented after implementation.
, Pfizer can hardly keep half of the country
.
Figure 3: Sales of Pregabalin Capsules in the Retail Market (Unit: 10,000 Yuan) Source: Mynet.
com China City Entity Pharmacy Database.
Data from Mynet.
com shows that Pregabalin Capsules successfully surpassed in 2020 in physical pharmacies in cities in China .
The compound paracetamol tablets (Ⅱ) became the TOP1 product for oral administration
.
From the perspective of growth rate, it has been rising faster and faster in the past three years, and it has successfully exceeded 100 million yuan in 2020
.
Table 1: Pregabalin currently declared for marketing and under review.
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database.
Pregabalin currently approved in the domestic market involves capsules (1 imported + 7 domestically produced) and oral liquids (1 Domestically produced), the marketing application under review involves sustained-release tablets, capsules, and oral liquids.
With subsequent new products approved for marketing, the market competition for this product will become more intense
.
As of now, Kelun has declared and reviewed 20 products for the market in 2021, involving sensory system drugs (1), respiratory system drugs (2), musculoskeletal system (2), anti- tumor and immunomodulation Drugs (3), systemic anti-infective drugs (3), nervous system drugs (3), cardiovascular system drugs (1), blood and hematopoietic system drugs (5)
.
Source: CDE official website, NMPA official website, and Minet.
com database.
The review data statistics are as of September 8.
If there are any errors or omissions, please correct me
.