Deruxtecan

In response to the treatment needs of HER2-positive tumors, ADC drugs have become one of the core directions of current clinical research. As a representative variety of the new generation of anti-HER2 ADCs, deruxtecan conjugates humanized anti-HER2 monoclonal antibodies with topoisomerase I inhibitors via cleavable linkers, and has both precise targeting and potent killing effects. The drug has currently been approved for indications such as unresectable or metastatic HER2-positive breast cancer in patients who have received prior anti-HER2 therapy, HER2-mutant non-small cell lung cancer, and HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma, providing a new option that significantly prolongs survival for patients with HER2-positive tumors who have failed multi-line therapy.

The global market size of deruxtecan has exceeded USD 2.2 billion in 2023, with a compound annual growth rate of over 100%, making it one of the fastest-growing anti-tumor drugs at present. In terms of market competition landscape, the original research product occupies an absolutely dominant position. Only a small number of enterprises around the world have laid out the R&D of biosimilars, and more than 10 domestic pharmaceutical companies have submitted clinical trial applications for deruxtecan biosimilars. With the further expansion of indications, the global market size is expected to exceed USD 12 billion in 2030.

The original research enterprise of deruxtecan is Daiichi Sankyo, which jointly develops and promotes it with AstraZeneca, under the trade name Enhertu. The expiration date of its core compound patent in Europe and the United States is 2037, and the expiration date of the core compound patent in China is 2038. The main dosage form currently on the market is lyophilized powder for injection, with specifications including 100mg/vial and 160mg/vial. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA, and is also included in the FDA Reference Preparation Catalogue. Domestically, no domestic deruxtecan API has been approved for marketing at present. The original research API has been registered in the CDE, and the original research preparation was approved by the NMPA for import and marketing in 2022. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for deruxtecan API, 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 such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard needs of pharmaceutical enterprises in the stages of API R&D, quality research and declaration.