This is a randomized, open-label, controlled, multicenter Phase III clinical study designed to compare the efficacy of 9MW2821 versus investigator’s choice of chemotherapy in patients with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based therapy ± immunotherapy and antibody-drug conjugates with topoisomerase inhibitor payloads.
Currently, TOPi-ADC has become the primary treatment modality following standard therapy for TNBC. For TNBC patients who have failed prior TOPi-ADC treatment, chemotherapy remains the mainstay, representing a significant unmet clinical need.
9MW2821 is the first Nectin-4-targeted ADC globally to disclose efficacy data in TNBC, and has received Fast Track Designation (FTD) from the FDA for the treatment of locally advanced or metastatic Nectin-4-positive TNBC. TNBC is the third tumor type to enter Phase III clinical development for 9MW2821, following urothelial carcinoma (UC) and cervical cancer (CC). Currently, 9MW2821 is also undergoing clinical studies in the U.S. for ADC-pretreated TNBC, with the first patient dosed in August 2025.
About Triple-Negative Breast Cancer (TNBC)
Triple-negative breast cancer is a subtype of breast cancer in which estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) are all negative. This subtype accounts for approximately 15%-20% of global breast cancer cases and is generally considered the most aggressive form due to the lack of clear therapeutic targets. Triple-negative breast cancer is more common in younger and premenopausal women.
About Mabwell
Mabwell (688062.SH) is an innovative biopharmaceutical company with a full industry chain layout. Adhering to the vision of “Turning Innovation into Reality” and the mission of “Exploring Life, Benefiting Health,” the company is committed to providing patients with better efficacy and greater accessibility of innovative biologics through original innovation to address unmet clinical needs worldwide. Since its establishment in 2017, Mabwell has built an innovation system covering the entire drug R&D cycle, starting from antibody drug target discovery and molecular discovery, through druggability research, preclinical research, clinical research, and manufacturing translation, achieving a full industry chain layout integrating R&D, production, and marketing. The company focuses on oncology and age-related diseases, covering therapeutic areas such as oncology, autoimmune diseases, bone diseases, ophthalmology, hematology, and cardiovascular diseases. Leveraging internationally leading proprietary technology platforms and R&D innovation capabilities, Mabwell has established a rich and competitive pipeline. Currently, there are 15 key programs at preclinical, clinical, or marketing stages, including 11 innovative programs and 4 biosimilars, of which 4 programs are marketed, 1 is under marketing review, and 2 are in Phase III pivotal registration clinical trials. The company independently undertakes 1 National Major Science and Technology Project for “Major New Drug Creation,” 2 National Key R&D Programs, and multiple provincial and municipal science and technology innovation projects. Mabwell prioritizes innovation and industrial translation. Its antibody and recombinant protein drug manufacturing base, compliant with China NMPA, US FDA, and EU EMA GMP standards, has been put into operation in Taizhou, Jiangsu, and has passed the EU QP audit. Large-scale commercial production bases in Jinshan, Shanghai, and Taizhou, Jiangsu, are under construction. For more information, please visit: www.mabwell.com.
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