When a malignant tumor invades the serous layer of the thoracic or abdominal cavity, it can lead to abnormal fluid accumulation, causing dyspnoea, abdominal distension, anorexia, etc., which severely affect the patient's quality of life. On May 7, Sino Biopharm (1177.HK) announced that the New Drug Application for M701, a Class 1 innovative drug co-developed by its core enterprise Chia Tai Tianqing for the treatment of malignant ascites (MA) caused by advanced epithelial malignant tumor , has been submitted to and accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. It is the first CD3/EpCAM bispecific antibody to be filed for marketing in China. 

M701 is the first domestically developed CD3/EpCAM bispecific antibody. It can simultaneously target the tumor cell target EpCAM and the immune T-cell activation target CD3. By bridging tumor cells and immune T-cells through dual-target binding, it activates T-cells to kill tumor cells. M701 is undergoing multiple clinical trials in China. Among them, a pivotal Phase III clinical trial for MA caused by epithelial solid tumors has been completed, and its marketing application has been formally accepted by the CDE. Another Phase II clinical trial for malignant pleural effusion (MPE) caused by non-small cell lung cancer has completed subject enrollment. 

Malignant effusion is a common complication of intermediate to late-stage malignant tumor , with malignant pleural effusion and malignant ascites being the most common. According to statistics, about 50% of patients with advanced malignant tumor  will develop malignant pleural and peritoneal effusion during disease progression, which directly affects their quality of life and survival ^[1]. Currently, there is a lack of effective standard treatment options. The main treatments are still paracentesis and drainage combined with local thoracoabdominal drug perfusion. The choice of local therapeutic drugs is limited, and their use lacks expert consensus guidance and support from large-scale clinical research data. Patients have a poor quality of life, short survival, and a huge unmet need. Compared with current main clinical treatment options, M701 has superior safety and efficacy and is expected to become the standard treatment for pleural and peritoneal effusion. 

This acceptance is based on a Phase III clinical trial (M70104) of M701 conducted in China. This study targets patients with malignant ascites caused by epithelial malignant tumor and aims to evaluate the efficacy and safety of M701 intraperitoneal infusion therapy in patients with advanced epithelial neoplasms who have developed moderate to large amounts of malignant ascites. Related study data is planned to be released at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. 

References:

[1] Chen, Y., Xu, X., Chen, J., Yin, M., Chen, J., Qi, Z., Shi, M., Su, W. (2026).Fluid-Derived Organoids from Pleural Effusion and Ascites: Emerging Models for Drug Resistance and Personalized Oncology.Journal of Cancer, 17(3), 614-625.

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2. The company does not recommend any drugs and/or indications. 

3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific disease diagnosis and treatment information, please follow the advice or guidance of a physician or other healthcare professional. 

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This press release contains certain forward-looking statements, including statements regarding the clinical development plan for [M701], expectations of its clinical benefits and advantages, commercialization prospects, the likelihood of clinical benefit for patients, and potential commercial opportunities. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances.