Securities code: Luoxin Pharmaceuticals Group Stock Co.Ltd(002793) securities abbreviation: Luoxin Pharmaceuticals Group Stock Co.Ltd(002793) Announcement No.: 2022020 Luoxin Pharmaceuticals Group Stock Co.Ltd(002793)
Announcement on the approval of tigolasheng tablets to carry out clinical trials for new indications
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Recently, Shandong Luoxin Pharmaceuticals Group Stock Co.Ltd(002793) (hereinafter referred to as "Shandong Luoxin"), a subsidiary of Luoxin Pharmaceuticals Group Stock Co.Ltd(002793) (hereinafter referred to as "the company"), received the notice of approval for clinical trials of tigolasheng tablets for Helicobacter pylori infection issued by the State Drug Administration. The relevant information is hereby announced as follows:
1、 Basic information
Applicant: Shandong Luoxin Pharmaceuticals Group Stock Co.Ltd(002793)
Drug name: tigolasheng tablets
Dosage form: tablet
Indications: combined with appropriate antimicrobial therapy to eradicate adult Helicobacter pylori infection
Registration category: chemical 2.4
Approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, tigolasheng tablets meet the relevant requirements of drug registration and agree to carry out clinical trials.
2、 Product introduction
Tigolasheng tablets are potassium competitive acid blockers (p-cab). Its mechanism of inhibiting acid secretion is competitive binding to the potassium binding site of H + / K + - ATPase (proton pump) in parietal cells. Unlike proton pump inhibitor (PPI), p-cab can directly inhibit H + / K + - ATPase without activation in strong acid environment. Moreover, p-cab can bind to H + / K + - ATPase whether activated or not. The combination of p-cab and antibiotics provides the best pH environment for the eradication of Helicobacter pylori by antibiotics through its acid inhibition effect.
Tigolasheng tablet has the potential to develop the indications of acid related diseases such as gastroesophageal reflux and peptic ulcer. It has the characteristics of fast onset, long action time, stable under acidic conditions, and can inhibit the proton pump in activated and resting states at the same time.
Tigolasheng tablets were officially listed in South Korea in 2019. At present, it is only listed and sold in South Korea. According to iqvia data, the sales amount of tigolasheng tablets in Korea in 2020 was US $50171652, an increase of 106.3% over 2019; The sales amount in 2021 was $72517358, an increase of 44.5% over 2020. There are no products on the market in China.
Helicobacter pylori is a world-class carcinogen. Epidemiological studies show that more than half of the world's population is infected with Helicobacter pylori, and at least 700 million people in China are infected with Helicobacter pylori, with an infection rate of more than 50%. The combination of p-cab and appropriate antibacterial therapy to eradicate adult Helicobacter pylori infection has a broad market prospect.
3、 Impact on the company
The company has always had strong market competitiveness in the field of digestion. In October 2015, Shandong Luoxin and HK inno N Corporation reached an agreement and obtained the exclusive rights and interests in the development, production and commercialization of tegorsen tablets in China. At present, the application for the listing of class 1 new drugs for the indications of reflux esophagitis of tegorsen tablets has been accepted; Phase III clinical trial of indications for duodenal ulcer is in progress. The indication for this clinical trial is to eradicate adult Helicobacter pylori infection in combination with appropriate antimicrobial therapy. In addition, on June 23, 2021, Shandong Luoxin and HK inno N Corporation reached an agreement on the introduction of tegolasheng injection products and obtained the exclusive development, production and commercialization rights of the products in China, which reflects the determination and advantages of the company's continuous deep cultivation and layout in this field.
The company will carry out clinical trials of new indications of tigolasheng tablets in accordance with the requirements of the State Drug Administration. The product will not have a significant impact on the company's short-term financial status and operating performance before listing. According to the requirements of laws and regulations related to drug registration in China, tigolasheng tablets can be put on the market only after being reviewed and approved by the State Drug Administration.
4、 Risk tips
Drug R & D has the characteristics of long cycle and large investment, and is affected by uncertain factors such as industrial policies, so there is a risk that the promotion and R & D effect will not meet the expectations. Whether the drug can pass the review and approval, the time of passing, the production and sales after passing, and the impact on the company's performance are uncertain. Please make careful decisions and pay attention to investment risks.
It is hereby announced.
Luoxin Pharmaceuticals Group Stock Co.Ltd(002793) board of directors March 6, 2022
