Mabwell Announces CDE Approval to Initiate Phase III Clinical Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor

SHANGHAI, Aug. 26, 2024 — Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for "a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer" has been approved. The corresponding Phase III clinical study has been initiated and is currently in the enrollment stage. As of the announcement, 9MW2821 has been approved for three pivotal clinical trials.

9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell, and it is the first of its kind in China to initiate clinical trials on the same target, with more than 400 subjects enrolled in the clinical studies for multiple indications. The results of existing clinical studies have demonstrated outstanding therapeutic efficacy and safety profile. The pivotal Phase III clinical study, "an open-label, randomized Phase 3 study to evaluate 9MW2821 vs investigator's choice of chemotherapy in subjects with locally advanced or metastatic urothelial cancer who have previously received PD-(L)1 inhibitor and platinum-containing chemotherapy", is currently in the enrollment stage.

About Urothelial Carcinoma Bladder cancer, a form of urothelial carcinoma, stands out among its various subtypes for its significant impact on public health. The American Society of Clinical Oncology reports that bladder cancer is the ninth most common malignant tumor in incidence and ranks thirteenth in mortality among all malignant tumors. According to The Global Cancer Statistics published by the International Agency for Research on Cancer (IARC) in 2022, there were approximately 614,000 new cases and 220,000 deaths from bladder cancer worldwide. The Disease Burden of Malignant Tumors in China 2022, released by the National Cancer Center in February 2024, reported 92,900 new cases and 41,400 deaths from bladder cancer in China, placing it eleventh and thirteenth globally in terms of new incidences and mortality, respectively. As a prevalent cancer in China, urothelial carcinoma is characterized by a propensity for metastasis, a high recurrence rate, and a short survival time in its advanced stages. It represents a significant disease burden and poses a serious threat to the survival and quality of life of those affected.

About 9MW2821 9MW2821 is a site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell using ADC platform, and the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. As the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data in cervical cancer (CC), esophageal cancer (EC) and breast cancer, 9MW2821 has been granted Fast Track Designation by FDA in 2024 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 also been granted Orphan Drug Designation by FDA for the treatment of EC, and Breakthrough Therapy Designation by CDE of NMPA, for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.

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.

About Mabwell

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 14 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 10 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, auto-immune diseases, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life, Benefit Health" and our vision is "Innovation, from ideas to reality". For more information, please visit www.mabwell.com/en.