Etoposide

In chemotherapy regimens for malignant tumors, topoisomerase inhibitors are an important class of active agents, and etoposide is a classic representative of this category of drugs. It exerts anti-tumor effects by inhibiting the activity of topoisomerase Ⅱ, blocking the replication and transcription of DNA in tumor cells, and inducing cell cycle arrest in the G2 phase. As a cell cycle-specific chemotherapeutic drug, etoposide has a very wide range of clinical applications. It is a first-line therapeutic agent for small cell lung cancer, malignant lymphoma, testicular cancer and acute myeloid leukemia, and can also be used in combination chemotherapy regimens for malignant tumors such as ovarian cancer and neuroblastoma, covering both adult and pediatric tumor patient populations.The global etoposide preparation market size is stable at around USD 800 million, of which the Chinese market accounts for approximately 22%, with an annual compound growth rate maintained at 3.2%. Due to its long time on the market, the generic drug competition for this variety is relatively sufficient. More than 30 domestic enterprises have obtained approval to produce etoposide-related preparations. After the implementation of centralized procurement, the terminal price has dropped by 68%, further improving clinical accessibility. In terms of API supply, China is the world's major producer and exporter of etoposide in the world, with production capacity accounting for more than 75% of the total global supply, and product supply covers multiple mainstream pharmaceutical markets such as Europe, America, Southeast Asia, etc.The original developer of etoposide is Bristol-Myers Squibb, with the original brand name VePesid. The core compound patent of etoposide expired globally in 1999. The dosage forms approved for the original product include injection and soft capsule, among which the specification of the injection is 100mg/5ml, and the specifications of the soft capsule are 50mg/100mg. The original product has been included in the FDA Reference Listed Drug Catalog, and is also included in the Chinese Catalog of Reference Listed Drugs for Chemical Drugs. At present, there are more than 20 domestic etoposide API registration numbers in China, 15 of which are in status A and can be supplied for associated preparation declaration. The domestically approved preparation varieties cover two major dosage forms: etoposide for injection and etoposide soft capsule. (Data as of June 2025, please refer to the official CDE website for the latest information.In the process of anti-tumor generic drug R&D and consistency evaluation, impurity research is the core link to ensure the quality and safety of drugs. CATO provides a full set of etoposide impurity reference standards. Most products are in stock, in-stock products ordered before 16:00 are shipped on the same day, and they comply with multiple regulations including Chinese Pharmacopoeia and FDA regulations, which can fully meet the needs of pharmaceutical enterprises in registration and declaration, quality research and daily quality control, and provide stable material basis support for R&D and production links.

全球依托泊苷制剂市场规模稳定在8亿美元左右，其中中国市场占比约22%，年复合增长率维持在3.2%的水平。由于上市时间较长，该品种的仿制药竞争较为充分，国内已有超过30家企业获批生产依托泊苷相关制剂，集采落地后终端价格降幅达68%，进一步提升了临床可及性。原料药供应方面，中国是全球依托泊苷主要的生产和出口国，产能占全球总供应量的75%以上，产品供应覆盖欧美、东南亚等多个主流医药市场。

依托泊苷原研企业为百时美施贵宝，原研商品名为VePesid，其核心化合物专利已于1999年全球到期。原研获批的剂型包括注射剂与软胶囊剂，其中注射剂规格为100mg/5ml，软胶囊规格为50mg/100mg。原研产品已列入FDA参比制剂目录，同时被纳入中国《化学药品参比制剂目录》。目前国内已有超过20条依托泊苷原料药登记号，其中15条状态为A，可供应关联制剂申报，国内获批的制剂品种涵盖注射用依托泊苷、依托泊苷软胶囊两大剂型。（数据截至2025年6月，最新请以CDE官网为准）

肿瘤仿制药研发与一致性评价过程中，杂质研究是保障药品质量与安全性的核心环节。CATO/佳途科技提供依托泊苷全套杂质标准品，大部分产品现货供应、现货产品16:00前下单当天发货、中国药典/FDA多法规合规，可全面满足药企的注册申报、质量研究与日常质控需求，为研发及生产环节提供稳定的物质基础支持。