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According to the announcement, Tigola biopics are potassium ion competitive acid blocker drugs (P-CAB), Shandong Luoxin in October 2015 and South Korea's CJ HealthCare Corporation reached an agreement to obtain the development, production and commercialization of Tigolasheng China.
in conjunction with earlier press releases and public information issued by Rohingya Pharmaceuticals, the product is codened LXI-15028.
, the mechanism of inhibition of acid secretion in Tigolasheng is the potassium ion binding site of the competitive binding wall cell of H-/K-ATP enzyme (proton pump).
unlike proton pump inhibitors (PPI), P-CAB directly inhibits the H-/K-ATP enzyme without being active in a strong acid environment, and P-CAB can be combined with it, regardless of whether the H-/K-ATP enzyme is active or not.
, Tigolasheng, used to treat digestive tract acid-related diseases, had reached the end of phase 3 clinical studies in patients with rotten esophedritis.
screenshot Source: chinadrugtrials.org This is a multi-center, randomized, double-blind, parallel grouping compared to Esomeprazole to treat patients with chinese rotting esophagitis for up to 8 weeks in phase 3 clinical studies.
The study was conducted by Dr. Li Zhaoshen, Chief Physician of Shanghai Changhai Hospital, and was conducted in more than 30 institutions in China, with the main endpoint indicator being the cumulative endoscopic healing rate of 8 weeks (research treatment for 8 weeks, the proportion of patients who were determined to heal through upper digestive tract endoscopy).
study included 261 adult Chinese patients with perishable esophoitis who were randomly assigned to the trial group (LXI-15028 once a day, 50 mg each) and the control group (Esomerazole once a day, 40 mg each).
results showed that the cumulative endoscopic healing rate of LXI-15028 treatment for 8 weeks was not inferior to that of Esomeprazole.
note that this is also the first Phase 3 clinical study of LXI-15028 to reach the main therapeutic endpoint.
China Drug Clinical Trial Registration and Information Publicity Platform shows that Luoxin Pharmaceuticals has also completed a phase 3 trial of LXI-15028 for the treatment of non-rotting reflow disease, as well as a phase 1 clinical study of gastroesoesus reflow disease (rotten esotheritis, non-rotten reflow disease), single and multiple oral LXI-15028 in tidal ulcers.
thrugable esotracheitis is one of the main types of gastroesoesoesia reflow disease, the patient manifests it as a typical heartache symptom, which may lead to Barrett's esobar, even esothra ulcers, tumors and other diseases, seriously affecting the quality of life of patients.
show that after receiving current standard treatment, about 10 to 15 percent of patients still fail to heal.
for this type of patient, one of the main objectives of treatment is to reduce reflow and reduce the stimulation and corrosion of stomach secretions.
, the clinically commonly used acid-suppressing drug PPI, such as raspzole products, is the most effective drug to inhibit the secretion of stomach acid.
P-CAB as a new generation of reversible nature subpulvert inhibitors, compared with PPI, has the advantages of fast effectiveness, long-lasting acid suppression, easy to take, etc.
congratulates Rohingya Pharmaceuticals on the acceptance of its application for the listing of a new class 1 drug for Gora, and hopes that this product will be approved as soon as possible to bring innovative treatments to more patients with gastroesoesic reflow disease.
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