Shanghai, August 26, 2024 /PRNewswire/ -- Maiwei Bio (688062.SH), an innovative biopharmaceutical company with a full Industry Chain layout, announced that the "Evaluation of the Randomized, Controlled, Open, Multicenter Phase III Clinical Study of 9MW2821 Combined with Trepulimab Compared to Standard Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma" protocol submitted to the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has been approved, and the Phase III clinical study of 9MW2821 combined with PD-1 monoclonal antibody for the first-line treatment of urothelial carcinoma has been initiated and is currently in the enrollment stage. A total of 3 key registration clinical studies for 9MW2821 have been approved.

9MW2821 is an innovative drug independently developed by Maiwei Bio, targeting Nectin-4 ADC, and is the first in its class in China to conduct clinical research for the same target, with over 400 subjects enrolled in clinical studies for multiple indications. Existing clinical study results demonstrate outstanding therapeutic efficacy and safety. The Phase III key registration clinical study for this product treating locally advanced or metastatic urothelial carcinoma after platinum-based chemotherapy and PD-(L)1 inhibitors is currently in the enrollment stage.

Regarding Urothelial Carcinoma

Bladder cancer is classified as urothelial carcinoma. According to data from the American Society of Clinical Oncology, bladder cancer ranks 9th in incidence and 13th in mortality among malignant tumors. The "2022 Global Malignant Tumor Statistics Report" published by the International Agency for Research on Cancer (IARC) indicates that there were approximately 0.614 million new cases and approximately 0.22 million deaths from bladder cancer worldwide in 2022. According to the 2022 cancer burden report published by the National Cancer Center in February 2024 on JNCC, there were 0.0929 million new cases and 0.0414 million deaths from bladder cancer in China, ranking 11th and 13th in terms of new cases and deaths respectively. As one of the common cancers in China, urothelial carcinoma is prone to metastasis and recurrence, with a short survival period for advanced cases, making it a significant disease burden in China and seriously threatening patients' survival time and quality of life.

About 9MW2821

9MW2821 is a targeted ADC new drug by Maiwei Bio that targets Nectin-4. It is an innovative variety developed by the company's ADC drug development platform and is the first to conduct clinical trials among domestic drugs targeting the same site. It is also the first among Global counterpart drugs to disclose clinical efficacy data for cervical cancer, esophageal cancer, and breast cancer indications. In 2024, it received multiple review qualifications granted by the USA FDA, including "Fast Track Designation" (FTD) for the treatment of late-stage, recurrent, or metastatic esophageal squamous cell carcinoma, recurrent or metastatic cervical cancer that has failed prior platinum-based chemotherapy, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer; and "Orphan Drug Designation" (ODD) for the treatment of esophageal cancer. It has also been included in the list of breakthrough therapies by the National Medical Products Administration of China for the treatment of locally advanced or metastatic urothelial carcinoma that has failed prior platinum-based chemotherapy and PD-(L)1 inhibitor treatment.

This product uses independently owned coupling technology to connect subunits and optimize the ADC coupling process, achieving site-specific modification of the antibody. After injection into the body, 9MW2821 can bind to Nectin-4 on the surface of tumor cells and enter the cells, releasing cytotoxins in a targeted manner through enzymatic action, thereby achieving precise killing of the tumor.

About Maiwei Bio

Maiwei Biopharma (688062.SH) is an innovative biopharmaceutical company with a full Industry Chain layout, adhering to the vision of "turning innovation from dreams into reality" and practicing the mission of "exploring life, benefiting health." Through source innovation, it provides patients with biological Innovative Drugs that have better efficacy and greater accessibility, meeting the unfulfilled clinical needs globally. Since its establishment in 2017, Maiwei Biopharma has built an innovative system that starts with antibody drug target discovery and molecular discovery, covering the entire drug research and development cycle including drugability research, preclinical research, clinical research, and production transformation, achieving an integrated layout of R&D, production, and marketing. The company focuses on tumors and age-related diseases, involving treatment areas such as tumors, autoimmune diseases, metabolism, ophthalmology, and infections. Leveraging internationally leading unique technology platforms and R&D innovation capabilities, it has established a rich and competitive pipeline. Currently, there are 14 varieties at different stages, including 10 innovative varieties and 4 biosimilars, among which 3 varieties have been launched, 1 variety's drug market authorization application has been accepted, and 3 varieties are in critical registration clinical trial stages. Additionally, Maiwei Biopharma independently undertakes 1 national "Major New Drug Creation" special science and technology project, 2 national key R&D programs, and several provincial and municipal science and technology innovation projects. Focusing on innovation and emphasizing industrial transformation, the company has established an antibody and recombinant protein drug industrialization base compliant with China's NMPA, USA's FDA, and EU's EMA GMP standards in Taizhou, Jiangsu, which has already passed the EU QP audit. Large-scale commercial production bases located in Jinshan, Shanghai and Taizhou, Jiangsu are under construction. For more information, please visit: .

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