Rapamycin

Rejection after organ transplantation has long been a core clinical challenge affecting the long-term survival of patients, and the discovery of the mTOR pathway provides a brand-new intervention direction for anti-rejection therapy. Rapamycin is a macrolide immunosuppressant, which specifically inhibits the activity of mammalian target of rapamycin (mTOR), blocks the proliferation and activation process of T lymphocytes and B lymphocytes, and meanwhile inhibits cytokine-mediated signal transduction. In clinical practice, in addition to preventing rejection of solid organ transplants such as kidney, liver and heart transplants, it can also be used for the treatment of lymphangioleiomyomatosis. Some expanded indications also cover adjuvant treatment of autoimmune diseases, and the applicable population includes adult transplant patients and some eligible pediatric patients.In recent years, the global rapamycin-related market size has maintained steady growth. In 2023, the overall market size has exceeded 1.8 billion US dollars, with a compound annual growth rate maintained at around 7.2%. In the domestic market, with the year-on-year increase in the number of organ transplant surgeries and the expansion of clinical application of related indications, the terminal market size exceeded 1.2 billion RMB in 2023. In the current competitive landscape, original research products still occupy the major share of the high-end market. Domestic generic pharmaceutical enterprises have gradually realized import substitution through consistency evaluation. Domestic enterprises account for more than 40% of the global production capacity in the API supply side, making China a major exporter of rapamycin API.The original research enterprise of rapamycin is Pfizer, with the original brand name Rapamune®, and its core compound patent expired globally in 2019. The main dosage forms of the original research product on the market are oral solution (1mg/ml) and tablets (0.5mg, 1mg, 2mg specifications), which have been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations of Chemical Drugs* of China. Domestically, at present, rapamycin APIs from more than 20 enterprises have obtained Grade A status through CDE registration, and another 17 rapamycin-related preparations have been approved for marketing, covering multiple categories such as oral conventional-release dosage forms and sustained-release dosage forms. (Data as of November 2024, please refer to the official CDE website for the latest information)CATO provides a full set of rapamycin impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can meet the reference standard requirements of the whole process such as API R&D, quality research and consistency evaluation, providing stable support for enterprises to shorten the R&D cycle and ensure quality controllability.

近年全球雷帕霉素相关市场规模稳定增长，2023年整体市场规模已突破18亿美元，年复合增长率维持在7.2%左右。国内市场随着器官移植手术量的逐年提升，以及相关适应症的临床应用拓展，2023年终端市场规模超过12亿元人民币。当前竞争格局中，原研产品仍占据高端市场主要份额，国内仿制药企业已逐步通过一致性评价实现进口替代，原料药供应端国内企业产能占比已超过全球40%，是主要的雷帕霉素原料药出口国。

雷帕霉素原研企业为辉瑞制药，原研商品名为Rapamune®，其核心化合物专利已于2019年全球到期。原研上市的主要剂型为口服溶液剂（1mg/ml）和片剂（0.5mg、1mg、2mg规格），已列入FDA参比制剂目录，同时收载于我国《化学药品参比制剂目录》。国内方面，目前已有超过20家企业的雷帕霉素原料药通过CDE登记获得A状态，另有17款雷帕霉素相关制剂获批上市，涵盖口服常释剂型、缓释剂型等多个类别。（数据截至2024年11月，最新请以CDE官网为准）

CATO/佳途科技提供雷帕霉素全套杂质标准品，大部分产品现货供应，现货产品16:00前下单当天发货，符合中国药典、FDA多法规合规要求，可满足原料药研发、质量研究、一致性评价等全流程的对照品需求，为企业缩短研发周期、保障质量可控性提供稳定支持。