Eribulin

For the clinical treatment of advanced breast cancer and soft tissue sarcoma, microtubule dynamics inhibitor drugs are important treatment options. As a representative innovative drug in this category, eribulin has a mechanism of action different from that of traditional taxane microtubule inhibitors. It binds to the plus end of tubulin in a non-competitive manner, inhibits microtubule growth without affecting microtubule shortening, and ultimately induces tumor cell cycle arrest and apoptosis. Currently, its approved indications include patients with locally advanced or metastatic breast cancer who have received at least two prior chemotherapy regimens, and patients with unresectable or metastatic liposarcoma, providing new possibilities for survival benefits to relevant solid tumor populations with limited post-line treatment options. Clinical studies have shown that it can significantly prolong the overall survival of patients, and its adverse reactions have better controllability.

At present, the global eribulin market size maintains steady growth, with a market size of approximately USD 420 million in 2023. With the approval of relevant indications in emerging markets and the improvement of clinical recognition, it is expected to reach USD 570 million by 2028, with a compound annual growth rate of approximately 6.3%. In terms of the domestic market, since its official import approval in 2019, its clinical utilization rate has increased year by year. The current market is still dominated by the original research drug, and 3 domestic enterprises have submitted marketing applications for generic drugs. With the subsequent launch of generic drugs and the expansion of medical insurance coverage, the market penetration rate is expected to further increase.

The original research enterprise of eribulin is Eisai Co., Ltd. of Japan, and the original brand name is Halaven. The core compound patent of the original drug expires in the United States in 2027, and the Chinese compound patent expired in 2023. The main dosage form approved for the original drug is injection, with a specification of 2ml:1mg. It has been included in the China Listed Drug Catalog as a reference preparation, and is also included in the FDA Reference Preparation Catalog. In terms of domestic API registration, there are currently 6 eribulin API registration entries including the original research drug, among which 3 are in Status A and can be used in association with preparation declaration. On the preparation side, in addition to the original imported products, generic drugs from 2 domestic enterprises have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for eribulin API, which can fully cover the needs of the whole process of R&D, declaration and quality control. Most products are in stock, and in-stock products ordered 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 can help relevant enterprises efficiently advance the R&D process of APIs and preparations.