ShanghaiMay 22, 2026 /PRNewswire/ — Mabwell (688062.SH, 02493.HK), an innovative biopharmaceutical company with a full-industry-chain layout, announced that multiple clinical research results of its Nectin-4-targeting ADC innovative drug 9MW2821 (Bulumtatug Fuvedotin, BFv) will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. These include an oral presentation of the Ib/II phase clinical study data of 9MW2821 in combination with Toripalimab for locally advanced or metastatic urothelial carcinoma (la/mUC), and a poster presentation of the Phase II clinical study data of 9MW2821 combined with Toripalimab for perioperative muscle-invasive bladder cancer (MIBC).
The Ib/II phase clinical study of 9MW2821 in combination with Toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (la/mUC) enrolled a total of 52 patients with advanced urothelial carcinoma. Follow-up results showed that as of December 1, 2025, 47 subjects were included in the efficacy analysis. The overall objective response rate (ORR) was 83.0%, the confirmed ORR was 74.5%, the complete response (CR) rate was 12.8%, and the disease control rate (DCR) was 89.4%. Among previously untreated patients, the ORR was 87.5%, the confirmed ORR was 80.0%, the CR rate was 12.5%, and the DCR was 92.5%. The median progression-free survival (PFS) was 12.9 months, while the median duration of response (DoR) and median overall survival (OS) have not yet been reached. No new safety signals for 9MW2821 or Toripalimab were observed in this study.
The Phase II clinical study of 9MW2821 in combination with Toripalimab for perioperative MIBC patients enrolled a total of 32 subjects. As of January 4, 2026, 7 subjects had completed neoadjuvant therapy (i.e., 9MW2821 combined with Toripalimab treatment), of which 6 subjects underwent radical cystectomy plus regional lymph node dissection, and 1 subject refused radical surgery due to achieving clinical complete response (CR) from neoadjuvant therapy. The pathological complete response rate (pCR) was 66.7% (4/6), and the pathological downstaging rate (pDS) was 83.3% (5/6). No new safety signals for 9MW2821 or Toripalimab were observed in this study.
About 9MW2821
9MW2821 is an innovative Nectin-4-targeting ADC drug independently developed by Mabwell based on its ADC development platform. It has been deployed in multiple ADC + immunotherapy combinations and is the world’s first Nectin-4 ADC to enter Phase III clinical trials for cervical cancer (CC) and triple-negative breast cancer (TNBC) indications. This drug has initiated 4 Phase III pivotal registration clinical trials, received FDA Fast Track designation for 3 indications, Orphan Drug designation for 1 indication, and 2 indications have been included in the CDE’s Breakthrough Therapy Designation list.
Currently, the Phase III clinical trials for 9MW2821 as monotherapy and combination therapy for urothelial carcinoma (UC), as well as monotherapy for CC, are planned for interim analysis in 2026. Based on the interim analysis data, a pre-NDA meeting with NMPA CDE is expected to be submitted. The Phase Ib/II clinical trial for CC combination therapy is planned to be completed in the second half of 2026, followed by the initiation of a Phase III clinical trial.
About Mabwell
Mabwell (688062.SH, 02493.HK) 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 more accessible innovative biologics through original innovation to meet unmet global clinical needs. 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 production transformation, achieving a full-industry-chain layout integrating R&D, production, and marketing. We focus 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, we have established a rich and competitive pipeline. Currently, there are 16 key products in preclinical, clinical, or marketing stages, including 12 innovative products and 4 biosimilars. Among them, 4 products are on the market, 1 is under marketing review, and 2 are in Phase III pivotal registration clinical trials. The company independently undertakes 1 national “Major New Drug Creation” major science and technology project, 2 national key R&D programs, and multiple provincial and municipal science and technology innovation projects. Mabwell prioritizes innovation and emphasizes industrial transformation. Its antibody and recombinant protein drug industrialization 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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