Polaprezinc

Gastric mucosal injury is the core pathological feature of diseases such as peptic ulcer and chronic gastritis. Clinical conventional mucosal protective agents generally have the pain points of short action duration and incomplete repair. As a new generation of organic zinc-based mucosal protective agent, polaprezinc can simultaneously achieve mucosal injury repair and enhanced defense function through three core pathways: chelating free radicals to inhibit lipid peroxidation, promoting endogenous prostaglandin synthesis, and accelerating epithelial cell proliferation. It is mainly used clinically for the treatment of gastric ulcer, acute gastric mucosal lesion, and acute exacerbation of chronic gastritis, and can also assist in reducing the irritation of non-steroidal anti-inflammatory drugs and Helicobacter pylori eradication regimens to the gastric mucosa. The applicable population covers patients at all stages from adult patients with mild mucosal injury to those with refractory ulcers.

The prevalence of peptic ulcer in China exceeds 10%, and the prevalence of chronic gastritis is close to 50%. The overall market size of mucosal protective agents has exceeded 9 billion yuan. With its multi-target action advantage, polaprezinc has achieved a compound annual growth rate of 18.2% in the past three years, with a growth rate significantly higher than that of traditional mucosal protective agent categories. At present, the original research product still accounts for about 65% of the domestic market share, and 3 local enterprises have passed the generic drug consistency evaluation. In the 2023 provincial-level centralized drug procurement, the average price reduction of the winning bid for this variety reached 49%, further promoting the increase of penetration rate in the primary market.

The original research enterprise of polaprezinc is Nippon Shinyaku Co., Ltd., and the original research trade name is Promac. Its core compound patent expired in Japan in 2009, and the Chinese compound patent expired in 2011. The original research dosage form is granules, with the specification of 0.5g:75mg, which has been included in the Chinese Listed Drug Catalogue as the reference preparation. As of now, there are 9 polaprezinc registration records on the CDE API registration platform, 5 of which are in status A and can be legally supplied for preparation production; the original research product and 7 generic drug preparations have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of polaprezinc impurity reference standards. Most products are in stock, in-stock products ordered before 16:00 will be shipped on the same day, and they comply with multiple regulations such as Chinese Pharmacopoeia and FDA, which can fully meet the R&D and production quality control needs at different stages such as API quality research, targeted impurity control, and preparation consistency evaluation.