Genting Xinyao submits a new drug marketing authorization application for goxatuzumab in Hong Kong, China

On March 31, Genting Sunyao announced that it had submitted a New Drug Application (NDA) for sacituzumab govitecan to the Department of Health of the Hong Kong Special Administrative Region of China for the treatment of patients who have received at least two prior systemic treatments (including Adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) with at least one treatment for metastatic disease)

In addition, regulatory agencies or drug administrations in mainland China, South Korea, and Taiwan have successively accepted the marketing applications of goxatuzumab for the treatment of patients who have received at least two previous systemic therapies (at least one of which is for metastatic disease).

In November 2021, Genting Sunyao announced top-line results from the Phase 2b study of goxatuzumab, EVER-132-001, which met its primary endpoint with an objective response rate (ORR) of 38.

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