Troxipide

As a representative variety of gastric mucosal defense and repair drugs, troxipide breaks through the therapeutic limitation of traditional acid-suppressive gastric drugs that only target aggressive factors. It exerts effects through three mechanisms: enhancing gastric mucosal blood flow, promoting prostaglandin synthesis, and repairing damaged epithelial cells, and also has the auxiliary effect of inhibiting the adhesion of Helicobacter pylori. Clinically, it is mainly used to improve gastric mucosal lesions in gastric ulcer, acute gastritis and acute exacerbation of chronic gastritis. The applicable population covers patients with gastric mucosal injury caused by irregular diet, people at high risk of gastric mucosal injury who take non-steroidal anti-inflammatory drugs for a long time, and people receiving combined medication for Helicobacter pylori eradication therapy. Compared with similar gastric mucosal protectants, it has a lower incidence of adverse reactions and better patient tolerance.In recent years, the overall market size of troxipide in China has maintained an annual growth rate of about 12%, among which the sales of preparations in public hospitals account for more than 60% of the preparation segment, and the growth rate of retail channels reaches 18%. At present, the troxipide preparations marketed in China are mainly generic drugs, and the market share of the original research product is less than 5%. More than 10 local enterprises have been approved to produce the preparations, and 3 enterprises have entered the review stage for the consistency evaluation declaration related to centralized procurement. With the improvement of clinical recognition and the expansion of primary care medication coverage, the demand for its API is expected to maintain an annual growth rate of more than 15% in the next three years.The original research enterprise of troxipide is Nippon Shinyaku Co., Ltd., and the brand name of the original research product is "Kefenqi". The core compound patent of troxipide in major markets outside Japan expired in 2010, and all relevant patents in China have passed the protection period. The dosage forms approved for the original research product include tablets and capsules, with common specifications of 100 mg per tablet and 100 mg per capsule. The original research product has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. As of the retrieval time point, there are 6 troxipide registration numbers with A status on the API registration platform of China CDE, and more than 12 oral troxipide preparations have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)CATO provides a full set of impurity reference standards for troxipide API. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.

国内曲昔派特整体市场规模近年保持12%左右的年增速，其中制剂端公立医院销售占比超60%，零售渠道增速达18%。目前国内上市的曲昔派特制剂以仿制为主，原研产品市场占比不足5%，已有超过10家本土企业获批生产制剂，集采相关的一致性评价申报工作已有3家企业进入审评阶段，随着临床认可度提升和基层用药覆盖扩大，其原料药需求预计未来三年仍将保持15%以上的年增长。

曲昔派特原研企业为日本新药株式会社，原研商品名为“科芬奇”，其核心化合物专利在日本以外的主要市场专利已于2010年到期，中国境内相关专利均已过保护期。原研获批剂型包括片剂和胶囊剂，常用规格为100mg/片、100mg/粒，原研产品已列入中国上市药品目录集作为参比制剂，同时也被纳入FDA参比制剂目录。截至检索时点，中国CDE原料药登记平台已有6个曲昔派特A状态登记号，国内已有超过12个曲昔派特口服制剂获批上市。（数据截至2024年10月，最新请以CDE官网为准）

CATO/佳途科技提供曲昔派特API全套杂质标准品，大部分产品现货供应，现货产品16:00前下单当天发货，可满足中国药典、FDA等多法规合规要求，为药企的原料药研发、质量研究及一致性评价工作提供稳定的对照品支持。