Is margituximab an imported drug or a domestic drug?

Margetuximab (margetuximab-cmkb) is a HER2-targeted therapy drug originally developed by the American company MacroGenics. Its trade name is Margenza, and it is a typical imported original drug. The drug was first approved by the FDA in the United States in 2020 for the treatment of HER2-positive advanced or metastatic breast cancer. It is especially suitable for patients who have received at least two anti-HER2 treatment regimens but still have disease progression. As a new member of the HER2 antibody family, margetuximab is structurally optimized compared to trastuzumab. In particular, the modification of its Fc segment makes it easier to be recognized by natural immune cells, thereby improving the antibody-mediated immune killing effect (ADCC). This shows new clinical value in some patients with poor efficacy of trastuzumab.

At present, the original version of margituximab has been approved for marketing in China, with the trade name of Magituximab. However, because it is a recently introduced imported drug, domestic use is still in its early stages, so the price has not yet been fully determined, and it has not yet been included in the national medical insurance catalog. This means that if patients choose to use the drug, they need to bear the full cost and need to obtain it through a medical institution or pharmacy qualified to import drugs. As more real-world data accumulates, the drug may potentially participate in medical insurance negotiations in the future to achieve wider clinical accessibility.

As for the domestic version, there are currently no generic drugs or biosimilars of margetuximab approved for marketing in China. Considering that the drug is an improved antibody drug, its structure and mechanism have certain patent barriers and technical difficulties. If domestic pharmaceutical companies want to develop biosimilar drugs, they need to complete complex clinical equivalence verification and pass the NMPA (National Food and Drug Administration) approval process. Usually, such drugs have a long cycle from R&D to launch, and even if there are already companies making arrangements, it is still difficult to achieve commercialization in the short term.

Reference materials:https://www.margenza.com/