[latest] the "pantoprazole sodium for injection" of Puli pharmaceutical was approved by TGA; the products of Kelun pharmaceutical industry were approved for sale in Japan

Customers of Hainan Puli Pharmaceutical Co., Ltd (hereinafter referred to as "Puli pharmaceutical") recently received the drug marketing license of pantoprazole sodium for injection (specification: 40mg) issued by the Australian drug administration (TGA) Pantoprazole sodium for injection is a selective long-acting proton pump inhibitor The molecule is composed of benzimidazole linked to pyridine ring by sulfoxide group, which is relatively stable in neutral and weak acid conditions, and rapidly activated in strong acid conditions, so it has better selectivity for H +, K + - ATPase The product can specifically inhibit the secretory microtubules formed by the apical membrane of parietal cells and the H +, K + - ATPase on the tubular vesicles in the cytoplasm, causing irreversible inhibition of the enzyme, so as to effectively inhibit the secretion of gastric acid It is suitable for active peptic ulcer (gastric and duodenal ulcer), reflux esophagitis and Zhuo AI syndrome Pantoprazole sodium was developed by BYK gulden (now a subsidiary of Takeda), which was listed in Germany and Mexico in 1994 The formulation of pantoprazole sodium was slow-release tablets Pantoprazole sodium for injection in 2001, Puli Pharmaceutical Co., Ltd and all members of the board of directors guaranteed that the content of information disclosure was true, accurate and complete, without false records, misleading statements or major omissions In March, Wyeth company (authorized by Takeda) was first approved to be listed in the United States The product name is protonix, the dosage form is injection, and the specification is 40mg Pantoprazole sodium for injection has been widely sold in the world Puli pharmaceutical started the research and development of this product in 2012, and after its success, it successively submitted applications for registration in multiple markets at home and abroad In February and March 2017, the product has been approved for marketing in the Netherlands and Germany respectively The Australian market is approved for listing in the third international market after the approval of the Netherlands and Germany The marketing license of this product in the Australian market is held by the partner aftpharmaceuticals Pty Ltd, and Puli pharmaceutical is responsible for its production Sichuan Kelun Pharmaceutical Co., Ltd (hereinafter referred to as "Kelun pharmaceutical") received GMP on-site inspection of PMDA (Japan's independent administrative legal person medical device comprehensive organization) from May 21 to 24, 2018, covering quality, production, equipment and facilities, laboratory control, materials and other systems On August 3, Kelun Pharmaceutical Co., Ltd received the notice of pharmaceutical product compliance investigation results issued by PMDA, confirming that the company has passed the Japanese PMDA certification According to iqvia's rolling data for the first quarter of 2018, Japan is the third largest pharmaceutical market in the world, accounting for 7% of the global pharmaceutical market The passing of GMP certification in Japan marks that Kelun pharmaceutical products have obtained the access qualification for sales in Japan, which will have a positive impact on the company's expansion of the Japanese pharmaceutical market In the future, Kelun pharmaceutical will actively promote the application of products and prepare for the listing of products At the same time, the company has passed the GMP certification of PMDA, which can also promote the sales of large volume injection in other overseas markets Source: company announcement