Wuhan YZY Biopharma Co., Ltd. (2496.HK) said that the U.S. Food and Drug Administration has approved its Investigational New Drug application for M701, a recombinant anti-EpCAM and anti-CD3 human-mouse chimeric bispecific antibody.
The approval allows the company to initiate U.S. clinical trials of M701 for the treatment of malignant pleural effusion, or MPE, a serious complication commonly seen in patients with advanced lung and breast cancers.
Current treatment options for MPE are largely palliative, highlighting a significant unmet medical need.
M701 is designed to target EpCAM, which is highly expressed on malignant epithelial cells in MPE, while simultaneously engaging CD3 to activate T-cell-mediated anti-tumor immune responses, enabling a synergistic and precise therapeutic approach.
The approved study is an open-label, multicenter Phase Ib/II clinical trial. It will evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of intrapleural administration of M701 in patients with MPE caused by advanced epithelial tumors.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.