Lorcaserin

The global prevalence of obesity has continued to rise over the past 30 years, and it is often accompanied by the risk of comorbidities such as type 2 diabetes and cardiovascular diseases. There has been a long-term lack of weight loss treatment options with both efficacy and safety in clinical practice. Lorcaserin is a selective 5-hydroxytryptamine 2C receptor agonist. It reduces food intake and enhances satiety by activating 5-HT2C receptors in the hypothalamic satiety center, and has extremely low affinity for 5-HT2A and 5-HT2B receptors, effectively avoiding the cardiovascular adverse reactions commonly associated with traditional weight loss drugs. Its indications are obesity in adults with BMI ≥30kg/㎡, or overweight people with BMI ≥27kg/㎡ combined with at least one weight-related comorbidity (such as hypertension, type 2 diabetes, hyperlipidemia). It is the world's first selective weight loss API approved for long-term use.The global market size of lorcaserin once exceeded US$600 million in its peak year. Subsequently, affected by the expiration of the original research patent and regulatory adjustments in some regions, the market share of generic drugs has gradually increased to more than 80%. The compound annual growth rate of the domestic weight loss drug market in the past 3 years has reached 22.7%, among which the demand growth rate of weight loss APIs targeting central nervous system targets is particularly prominent. At present, the layout of domestic lorcaserin generic drugs is still in the early stage, and verifiable public market size data has not been disclosed yet.The original research enterprise of lorcaserin is Arena Pharmaceuticals, and the original research trade name is Belviq. The expiration date of the core compound patent in the United States is 2023. The dosage forms approved for the original research are common tablets and sustained-release tablets, with specifications of 10mg and 20mg respectively. The original research product was once included in the FDA Reference Listed Drug Catalog. At present, the original research preparation has not been approved for marketing in China. There is no approved lorcaserin API registration number (A status) in the CDE API registration database, nor is there any domestic lorcaserin preparation approved for marketing. (Data as of November 2024, please refer to the official CDE website for the latest information)In response to the full-process requirements for lorcaserin R&D and quality control, CATO can provide a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and fully meet the needs of various application scenarios such as generic drug consistency evaluation and quality research.

氯卡色林全球市场规模在峰值年曾突破6亿美元，后续受原研专利到期及部分地区监管调整影响，仿制药市场占比逐步提升至80%以上。国内减重药市场近3年复合增长率达22.7%，其中针对中枢靶点的减重原料药需求增速尤为突出，目前国内氯卡色林仿制药布局尚处于早期，可核实的公开市场规模数据暂未披露。

氯卡色林原研企业为Arena Pharmaceuticals，原研商品名为Belviq，美国核心化合物专利到期时间为2023年，原研获批剂型为普通片剂和缓释片，规格分别为10mg、20mg。原研产品曾列入FDA参比制剂目录，国内目前暂未批准原研制剂上市，CDE原料药登记数据库中暂无已获批的氯卡色林原料药登记号（A状态），也无国产氯卡色林制剂获批上市。（数据截至2024年11月，最新请以CDE官网为准）

针对氯卡色林研发及质量控制全流程需求，CATO/佳途科技可提供该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，所有标准品均符合中国药典、FDA等多法规合规要求，充分满足仿制药一致性评价、质量研究等各类应用场景的需求。