Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.

The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug candidates included having demonstrated significant efficacy or safety advantages compared to existing therapies in early clinical trials.

For drug candidates included in the breakthrough therapy list, CDE will prioritize the allocation of resources to facilitate communication and provide guidance to promote drug development, which will benefit the further advancement of the clinical development progress and the speed of market review and approval. This will help to expedite the development process of 9MW2821 and meet the unmet clinical needs of Chinese patients.

About 9MW2821

9MW2821 is the first site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell using ADC platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and also the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of cervical cancer (CC), esophageal cancer (EC) and breast cancer. In 2024, 9MW2821 has been granted Fast Track Designation by FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC); 9MW2821 has been granted Orphan Drug Designation by FDA for the treatment of EC, and also Breakthrough Therapy Designation by CDE of NMPA.

9MW2821 achieves site-specific modification of antibody through proprietary conjugation technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.