Wuhan YZY Biopharma Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has formally accepted the New Drug Application for M701, a self-developed bispecific antibody targeting malignant ascites (MA) caused by advanced epithelial tumors.

The filing is supported by data from a Phase III trial in China that evaluated intraperitoneal infusion of M701 in patients with moderate- to large-scale MA. Efficacy and safety results from this study are scheduled for presentation at the 2026 American Society of Clinical Oncology Annual Meeting.

M701 simultaneously binds EpCAM on tumor cells and CD3 on T cells, activating immune cells to eradicate tumor cells in the abdominal cavity. In addition to the pivotal MA study, patient enrollment has been completed in a Phase II trial for malignant pleural effusion related to non-small cell lung cancer.

Malignant effusion affects roughly 50% of patients with advanced cancers, yet no standard-of-care regimen is established. Current management relies on drainage procedures and locally administered agents with limited clinical guidance. Preliminary findings indicate M701 offers superior safety and efficacy compared with existing options, positioning it as a potential new treatment benchmark for MA and malignant pleural effusion.

Under an exclusive, sublicensable agreement, Chia Tai Tianqing Pharmaceutical Group Co. Ltd. holds the rights to develop, register, manufacture and commercialize M701 and its stabilizer for all human disease indications within China.

In accordance with Listing Rule 18A.05, the company cautions that successful development and commercialization of M701 are not guaranteed, and shareholders and prospective investors should exercise caution when dealing in the company’s shares.