Daiichi Sankyo Initiates Phase I Clinical Trial of Subcutaneous Trastuzumab Deruxtecan (DS-8201) for Metastatic Solid Tumors

▎Armstrong

On June 11, 2025, Daiichi Sankyo registered a Phase I clinical trial on the Clinicaltrials.gov website for the subcutaneous injection of Trastuzumab Deruxtecan (DS-8201) in the treatment of metastatic solid tumors.

This Phase I clinical trial plans to enroll 76 patients with metastatic solid tumors.

In November 2024, Daiichi-Sankyo introduced Hybrozyme, a novel hyaluronidase technology from South Korean biotechnology company Alreogen, for the development of a subcutaneous injection version of DS-8201. Under the agreement, Daiichi-Sankyo will pay a $20 million upfront payment and up to $280 million in milestone payments, with the total agreement amounting to $300 million.

Hybrezyme technology adopts a novel hyaluronidase, which improves enzyme activity and thermal stability, with an expression level higher than that of the wild-type PH20.

Alteogen's hyaluronidase technology has reached collaborations with multiple MNCs, and the subcutaneous injection version of Keytruda utilizing this technology is already in the application stage for market approval.

Summary

Subcutaneous injection can significantly reduce the administration time of biologics from one or two hours to just a few minutes, greatly improving the convenience of drug delivery. Halozyme, a leading company in subcutaneous injection technology using hyaluronidase, has a market value of up to $6.6 billion. Its technology has been successfully applied to several blockbuster antibody drugs, including Johnson & Johnson's CD38 antibody, Roche's HER2 antibody, PD-L1 antibody, CD20 antibody, BMS's PD-1/LAG-3 bispecific antibody, and Argenx's Efgartigimod.