First-time generic drugs, that is, the first generic drugs
approved for marketing.
With market and pricing advantages, the first generic drug has always been the focus of the R&D layout of
domestic pharmaceutical companies.
According to incomplete statistics, since the beginning of this year, more than 50 first-class generic drugs have been approved in China, involving 38 enterprises
.
It is reported that in addition to a large number of pharmaceutical companies that have obtained the first imitation, since the beginning of this year, many pharmaceutical companies are about to obtain the first imitation
.
For example, on October 19, Shuanghe Pharmaceutical (Hainan) Co.
, Ltd.
, a wholly-owned subsidiary of China Resources Shuanghe, submitted an application for the marketing of linalotide capsules, which was accepted
by CDE.
Linarclotide is a guanylate cyclase-C (GC-C) agonist independently developed by Ironwood, which was approved for use in constipation and irritable bowel syndrome
in August 2012.
At present, Ironwood is continuing to develop the drug, aiming to add new indications and benefit more patient groups
.
According to statistics, in 2021, the global sales of linaclotide exceeded the $1 billion mark
.
At present, only the original research has been approved for marketing in China, so the domestic market of the drug is exclusively occupied
by AstraZeneca.
In terms of generic drugs, in addition to Shuanghe Pharmaceutical, which reported production this time, Sichuan Guowei Pharmaceutical submitted a marketing application in November 2021, which is still under
review and approval.
At the end of August, Fuyuan Pharmaceutical Co.
, Ltd.
was accepted by
CDE for the marketing application of fusidic acid cream submitted by imitation class 4.
According to the data, fusidic acid cream is an antibiotic topical drug, suitable for a variety of bacterial skin infections, such as pustules, furuncles, paronychia, trauma with infection, barbel sores, hidradenitis, erythroderma, folliculitis, acne vulgaris, eczema with infection, ulcer infection, etc
.
In 2021, the sales scale of the product in China's three major terminal markets will be close to 400 million yuan, a year-on-year increase of 21.
7%.
At present, there are fewer enterprises with the production approval of fusidic acid cream, and from the perspective of the competition pattern of manufacturers, Aomei Pharmaceutical has an exclusive market share of more than 70%.
If the generic drug of Fuyuan Pharmaceutical can be successfully approved for marketing, it may become the first company to pass the evaluation
.
In addition, Shanghai Xuantai Pharmaceutical/Jiangsu Xuantai Pharmaceutical Co.
, Ltd.
submitted a marketing application for mesalazin enteric-coated tablets in generic category 3, which was accepted by CDE, and the product has not been evaluated
by enterprises.
Data show that the total sales scale of Mesalazin enteric-coated tablets in China's three major terminal markets in 2021 will be close to 800 million yuan
.
In addition, the CDE website shows that Lepu Pharmaceutical's canagliflozin metformin sustained-release tablets have also been accepted as imitation 3 types of production, and canagliflozin metformin extended-release tablets are oral compound hypoglycemic drugs
.
At present, no domestic enterprises have been approved
.
In general, the first generic drug has always been one of the key points of the R&D layout of domestic pharmaceutical companies, with the upgrading and development of China's pharmaceutical industry, the gradual improvement of the research and development strength of domestic pharmaceutical companies, the first generic drug is gradually becoming a must for
pharmaceutical companies.
With the continuous advancement of drug review reform and the intensification of competition in the innovative drug market, such drugs are expected to become a sharp weapon for market competition, and the first imitation of large varieties will become the focus
of attention in the industry.
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