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China's NMPA Begins Review of Zai Lab's Margenza for HER2-Positive Metastatic Breast Cancer

NEW YORK – Zai Lab said on Thursday that China's National Medical Products Administration has accepted the firm's new drug application for margetuximab (Margenza) combined with chemotherapy for previously treated, metastatic HER2-positive breast cancer.

The HER2-targeting agent, which is a product of Rockville, Maryland-based MacroGenics outside of China, Hong Kong, Macau, and Taiwan, received US Food and Drug Administration approval for the same indication in late 2020 based on the results of the Phase III SOPHIA trial. In that trial, margetuximab plus chemo improved progression-free survival in breast cancer patients compared to trastuzumab (Genentech's Herceptin) plus chemo.

The agent is similar to trastuzumab in that it targets HER2 to inhibit tumor growth, but according to Zai Labs, margetuximab differs in that it is designed to "enhance the engagement of the immune system."

The new drug application in China includes data from both the SOPHIA trial as well as a subsequent bridging trial that Zai Lab conducted to confirm margetuximab's benefit. In October 2021, the firm announced that the bridging study met its primary endpoint and showed that margetuximab improved progression-free survival according to blinded independent central review and had a safety profile on track with what SOPHIA showed. The firm has plans to present the results at an upcoming medical conference.

"Both SOPHIA and Zai Lab's registrational bridging trial support the potential use of margetuximab as an important new treatment option for a very difficult-to-treat patient population," Alan Sandler, Zai Lab's president and head of global oncology development, said in a statement.