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On November 2, NMPA's official website showed that Zhengda Qing", "Sodium Esomerazole for injection", passed a consistent evaluation, becoming the first injection of the variety to be evaluated.
, more than 30 of the injections have been approved for the market without a review.
Esomerazole, also known as Esomerazole, is a single L-isomer of Omeprazole, both of which belong to proton pump inhibitors, can effectively inhibit the secretion of stomach acid, clinically used to treat gastroesophageal reflow disease, rotting reflow esophagitis and so on.
the drug is one of the most successful examples of isomer development, and is more resistant to stomach acid and has smaller adverse reactions than the first generation of omeprazole.
, three dosage forms of Esomeprazole sodium cointestinal tablets, intestinal capsules and injections have been marketed.
In which, injections have been included in the Medicare Category B directory as an alternative therapy for gastroesoesovirus when oral therapy is not applicable or as a low-risk patient for acute stomach or tidal ulcer bleeding not applicable for oral therapy (under the gastroscope Forrest Classification II.c-III.).
the drug was first developed by AstraZeneta, whose oral preparation was launched in Sweden in 2000 under the ® Nexium ®, and the injection was introduced in 2003.
AstraZeneta reported a peak of $5.2 billion in sales, but its sales have been declining in recent years and may be affected by the impact of patented generics and other acid suppressors being approved for listing.
2019, its global sales were $1,483 million.
: Insight database () and domestically, public data show that sales of Esomerazole sodium for terminal injections at public medical facilities exceeded $3 billion in 2019.
, AstraZene coutin's original research products led the way with 51.48% of the market, while among the more than 30 domestic companies that received approvals, Dayi Qing and Osaikang are now leading with 34% and 11%, respectively.
Insight database shows that as of November 2, 14 of the 33 companies approved in China, including Zhengda Tianqing, had submitted supplementary applications for consistent evaluation, and 6 had filed applications for listing in the new category 4.
23 other companies have not yet submitted additional applications.
from the Insight Database () Insight database, the first company to submit a consistent evaluation supplement application was submitted on June 13, 2018.
from: Insight Database ()