Bromopride

For symptoms such as nausea, vomiting, abdominal distension and abdominal pain in patients with chronic functional gastrointestinal diseases, prokinetic drugs are commonly used in clinical practice to relieve discomfort, and bromopride is a representative variety of such drugs with dual effects of promoting motility and antiemesis. As a benzamide derivative, its mechanism of action is different from that of traditional prokinetic drugs. It can antagonize dopamine D2 receptors, synergistically enhance gastrointestinal peristalsis, and inhibit the central chemoreceptor trigger zone for emesis. It can not only rapidly improve symptoms related to upper gastrointestinal motility disorders, but also has a definite relieving effect on vomiting caused by chemotherapy, surgery and other inducing factors. Its clinically applicable population covers patients with functional dyspepsia, people with postoperative gastrointestinal reactions and some patients undergoing tumor chemotherapy.At present, the global market size of prokinetic drugs has exceeded 13 billion US dollars, among which the annual compound growth rate of segmented varieties with multiple effects remains at about 4.2%. In the domestic market, due to its early launch time and clear clinical positioning, bromopride has been included in the local medical insurance reimbursement catalogs of some regions. Currently, the marketed preparations are mainly generic drugs, with the original research product accounting for less than 15% of the market share. Domestic enterprises account for more than 80% of the production capacity on the API supply side, and there is no competitive pattern of a single dominant enterprise for the time being.The original research enterprise of bromopride is Yamanouchi Pharmaceutical Co., Ltd. of Japan (now Astellas Pharma), and the original trade name is "Weihuoling". Its core compound patent expired globally in 2001. The main dosage form approved by the original research is tablet, with the specification of 10 mg per tablet. The original research tablet has been included in the Japanese Orange Book reference preparation catalog, but has not been included in the Chinese marketed chemical drug reference preparation catalog for the time being. Up to now, there are no approved marketed bromopride preparations in China, and there is no publicized API registration (status A) information in the database of the Center for Drug Evaluation of the National Medical Products Administration, and relevant research and development are all in the pre-clinical stage. (Data as of October 2024, please refer to the official website of CDE for the latest information)CATO can provide a full set of bromopride impurity reference standards. Most products support spot supply. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmaceutical regulatory regulations of various countries such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API research and development, quality research and generic drug consistency evaluation.

当前全球促胃动力药市场规模已超130亿美元，其中兼具多重作用的细分品种年复合增长率保持在4.2%左右。国内市场中，溴必利由于上市时间较早、临床定位清晰，已被纳入部分地方医保报销目录，目前上市制剂以仿制药为主，原研产品市场占比不足15%，原料药供应端国内企业产能占比超过80%，暂未出现一家独大的竞争格局。

溴必利原研企业为日本山之内制药（现安斯泰来制药），原研商品名为“胃活灵”，其核心化合物专利已于2001年全球到期。原研获批主要剂型为片剂，规格为10mg/片，原研片剂已被列入日本橙皮书参比制剂目录，暂未纳入中国上市化学药品参比制剂目录。截至目前，中国境内暂无获批的溴必利制剂上市品种，国家药监局药品审评中心数据库中也无已公示的原料药登记（A状态）信息，相关研发均处于临床前阶段。（数据截至2024年10月，最新请以CDE官网为准）

CATO/佳途科技可提供溴必利全套杂质标准品，大部分产品支持现货供应，现货订单16:00前下单即可当日发出，所有产品均符合中国药典、FDA等多国药监法规要求，能够为原料药研发、质量研究及仿制药一致性评价提供稳定的对照品支撑。