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The new generation of high-efficiency acid-inhibiting agent injection JP-1366 by Livzon has been approved for clinical use.


Release time:

2025-02-14

Recently, Livzon Pharmaceutical announced that the clinical trial application for its injectable JP-1366 has been approved by the National Medical Products Administration, with the indication for bleeding due to peptic ulcers. JP-1366 is a new type of potassium ion competitive acid suppressant (P-CAB), expected to provide new clinical medication options for the emergency treatment of bleeding due to peptic ulcers. This is the modified new drug developed by the company targeting the same molecule after the JP-1366 tablet.Currently, there are no injectable P-CAB drugs on the market worldwide.
 
Injectable JP-1366 for treating ulcerative bleeding has a low effective dose and acts quickly.
 
Peptic ulcers commonly occur in the stomach or duodenum. According to the 2023 Gastroenterology report in The Lancet, the lifetime risk of developing the disease is 5%-10%, and ulcerative bleeding is its most severe complication. The clinical symptoms for patients include hematemesis, melena, accompanied by anemia and reduced blood volume, and in severe cases, shock, which can even be life-threatening. It is one of the common clinical emergencies in our country. Once patients exhibit these symptoms, they require urgent hospitalization for intravenous treatment, with extremely high demands for the onset time and effectiveness of the treatment drugs. Injectable JP-1366, as a new generation of highly effective acid-suppressing P-CAB drug, is expected to provide new drug options in clinical emergency treatment.
Rapid onset:No need for gastric acid activation, directly acting on the proton pump, which can significantly shorten the onset time.
Full effect of the first dose:It can simultaneously inhibit both resting and activated states of the proton pump, achieving effect without the need for multiple repeated doses, i.e., full effect of the first dose.
Not affected by CYP2C19 gene polymorphism:Currently, except for a few PPI drugs like esomeprazole and rabeprazole, most PPI drugs rely on or are partially metabolized by the CYP2C19 enzyme, making them susceptible to genetic polymorphism. Slow metabolizers are at increased risk of adverse reactions due to drug accumulation. P-CAB is not affected by this, and the differences in efficacy and safety among different individuals are small, making it easier for doctors to formulate a unified treatment plan.
 
At the same time, the injectable JP-1366 developed by Livzon Pharmaceutical adopts an innovative molecule and has obtained a patent, with patent protection lasting until 2037. Preclinical pharmacodynamic studies show that, in addition to the general advantages of P-CAB drugs, it has a lower effective dose and acts faster, which helps in rapid hemostasis during clinical emergency treatment.
 
Expected to provide candidate new options for clinical use: JP-1366 injection and sequential use of PPI.
 
The "Expert Consensus on the Emergency Diagnosis and Treatment Process for Acute Upper Gastrointestinal Bleeding" points out that for bleeding due to peptic ulcers, continuous oral administration of standard doses of PPI is required after infusion treatment until the ulcer heals. In clinical applications, injectable JP-1366 is expected to work in synergy with the company's Yilian.®(esomeprazole), and Libeile.®(rabeprazole) and other PPI drugs.
 
Livzon Pharmaceutical's JP-1366 tablet has also entered the phase III clinical research stage, with the indication for reflux esophagitis, and future indications are expected to expand to gastric ulcers, duodenal ulcers, and Helicobacter pylori infections.
 
As a leading enterprise in the domestic gastrointestinal field, Livzon Pharmaceutical continues to strengthen innovation iterations in the gastrointestinal field, based on its deep cultivation in this area, constantly exploring product combinations and medication plans that address urgent clinical needs and have high clinical value. Among them, Livzon Deler.®(potassium bismuth citrate) has become a well-known drug brand after more than 30 years on the market; Yilian.®(esomeprazole) is the first class of innovative anti-ulcer drug in China, breaking the foreign monopoly pattern and winning the National Science and Technology Progress Second Prize; Weisanlian.®is the only drug in China that uses combination packaging to treat Helicobacter pylori. The development of the JP-1366 series of drugs will further enrich the company's product pipeline in the gastrointestinal field and expand its product matrix. The company will accelerate the development process and look forward to providing new treatment drug options for patients!

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