China's NMPA Grants Breakthrough Therapy Designation to Mabwell's ADC 9MW2821

SHANGHAI, Aug. 12, 2024 -- Mabwell (688062.SH), a pioneering biopharmaceutical firm, has announced that its innovative antibody-drug conjugate (ADC) targeting Nectin-4, designated as 9MW2821, has received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). This designation is specifically for treating locally advanced or metastatic urothelial carcinoma that has not responded to previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.

Breakthrough Therapy Designation aims to speed up the development of drugs intended for serious conditions, especially those that have shown remarkable efficacy or safety benefits over current treatments in preliminary clinical trials. Drugs on the breakthrough therapy list receive prioritized resource allocation from the CDE, facilitating communication and guidance throughout the development process. This prioritization is expected to accelerate 9MW2821's clinical development and market review, addressing the unmet clinical needs of patients in China.

About 9MW2821

9MW2821 marks a significant milestone as the first site-specific conjugated ADC targeting Nectin-4 developed by a Chinese company to enter clinical trials. It is also globally the first therapeutic candidate to show clinical efficacy data in cervical cancer, esophageal cancer, and breast cancer. In 2024, this drug candidate was also granted Fast Track Designation by the FDA for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), recurrent or metastatic cervical cancer following platinum-based chemotherapy, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC). Additionally, it received Orphan Drug Designation from the FDA for esophageal cancer and Breakthrough Therapy Designation from China's NMPA.

Using proprietary conjugation technology, 9MW2821 achieves site-specific modification of antibodies through optimized linkers and ADC conjugation processes. Upon injection, it targets Nectin-4 on the cell membrane, gets internalized, releases a cytotoxic drug, and induces apoptosis in tumor cells.

About Mabwell

Mabwell (688062.SH) is an innovative biopharmaceutical company that spans the entire pharmaceutical value chain. Established in 2017, the company focuses on developing effective and accessible therapies to meet global medical needs. Mabwell has created an advanced R&D system covering target discovery, early discovery, druggability, preclinical and clinical research, and manufacturing transformation. The company has 14 pipeline products at various development stages, including 10 novel drug candidates and 4 biosimilars, concentrating on therapeutic areas such as oncology, autoimmune diseases, metabolic disorders, ophthalmologic diseases, and infectious diseases.

Among Mabwell's product pipeline, three products have been approved and commercialized, one has been filed for market authorization approval, and three are in pivotal trials. Mabwell has also undertaken key national scientific projects, including a major project for "Significant New Drugs Development" and several provincial and municipal innovation projects.

Mabwell's manufacturing capabilities are robust, with its Taizhou factory adhering to international GMP standards regulated by the NMPA, FDA, and EMA, and having passed the EU QP Audit. The company is expanding its manufacturing base in Shanghai and constructing an ADC commercialized manufacturing base in Taizhou. Mabwell's mission is "Explore Life, Benefit Health," and their vision is to transform innovative ideas into reality.

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