Mindray Bio-Medical (02493): The latest clinical data of 9MW2821 will be reported in oral and poster forms at the 2026 European Society of Medical Oncology (ESMO) Gynecologic Oncology Annual Meeting.

Maiwei Biopharma-B (02493) announced that the company will present the latest results of the Phase I/II clinical study of the innovative drug 9MW2821 (Bulumtatug Fuvedotin, BFv) targeting Nectin-4 ADC for the treatment of patients with recurrent or metastatic cervical cancer at the 2026 ESMO Gynaecological Cancers Congress in Copenhagen, Denmark from June 17 to June 19, 2026. Among the 53 evaluable patients, the median overall survival (mOS) was 19.4 months, with a 24-month overall survival rate of 49.1%. Among the patients treated with platinum-based chemotherapy and immune checkpoint inhibitors, 31 evaluable patients showed a 24-month overall survival rate of 51.1%. Preliminary results from a cohort of the Phase Ib/II clinical study of 9MW2821 in combination with Trastuzumab for treating patients with recurrent or metastatic cervical cancer were presented in a poster form: in treatment-naive patients with cervical cancer, the objective response rate (ORR) was 80.0% and disease control rate (DCR) was 100%. 9MW2821 is the first ADC drug developed by Maiwei Biopharma targeting Nectin-4, representing an innovative variety developed using the company's ADC drug development platform. The drug utilizes a proprietary conjugation technology to connect and optimize the ADC coupling process, achieving precise antibody modification. After administration, 9MW2821 can bind to Nectin-4 on the surface of tumor cells, enter the cells, and release cytotoxins through enzymatic cleavage, thereby achieving targeted tumor destruction. The company is currently conducting multiple clinical studies for various indications including urothelial carcinoma (UC), cervical cancer (CC), esophageal cancer (EC), and triple-negative breast cancer (TNBC), with over 2,000 participants enrolled. The company is conducting four pivotal Phase III registration trials, including monotherapy and combination therapy for UC (previously breakthrough therapies), monotherapy for CC (a global first-in-class drug entering Phase III clinical study targeting the same pathway), and monotherapy for TNBC (topoisomerase inhibitor ADC therapy, first in the world with the same indication). Additionally, multiple Phase I/II clinical trials are rapidly underway, including TNBC monotherapy (topoisomerase inhibitor ADC therapy), TNBC combination therapy in Phase II, perioperative UC combination therapy in Phase II, EC monotherapy in Phase II, and EC combination therapy in Phase Ib/II, CC combination therapy in Phase Ib/II. The Phase III clinical trial plan for UC monotherapy, combination therapy, and CC monotherapy is scheduled for mid-term analysis in 2026, with the potential for submission of a new drug application to the China Food and Drug Administration's Center for Drug Evaluation based on the mid-term analysis data.