Maiwei Biotech voluntarily disclosed the latest clinical data of 9MW2821 in the form of oral reports and posters at the 2026 European Society for Medical Oncology Gynecological Oncology Annual Meeting (ESMO Gynae).
Securities code: 688062 Securities abbreviation: Maiwei Biotechnology Announcement number: 2026-047
Maiwei (Shanghai) Biotechnology Co., Ltd.
Voluntary Disclosure Regarding European Society for Medical Oncology
9MW2821 2026
Annual meeting of gynecological oncology ( ) with oral and poster presentations
ESMO Gynae
Announcement of the latest clinical data
The board of directors and all directors of the company guarantee that the contents of this announcement do not contain any false records or misleading statements.
or major omissions, and shall bear legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.
Important content reminder:
Maiwe (Shanghai) Biotechnology Co., Ltd. (hereinafter referred to as "Maiwe Bio" or the "Company") will announce the innovative drug 9MW2821 (Bulumtatug) targeting Nectin-4 ADC in the form of an oral report at the 2026 European Society of Medical Oncology Gynecological Cancers Congress (ESMO Gynaecological Cancers Congress) to be held in Copenhagen, Denmark from June 17 to June 19, 2026. The latest results of the phase I/II clinical study of Fuvedotin (BFv) for the treatment of patients with recurrent or metastatic cervical cancer: 53 patients were evaluable for efficacy, the median overall survival (mOS) was 19.4 months, and the 24-month OS rate was 49.1%. Among patients treated with platinum-containing doublet chemotherapy and immune checkpoint inhibitors, 31 patients were evaluable for efficacy, and the mOS was not reached, and the 24-month OS was 49.1%. The rate was 51.1%; the preliminary results of a cohort in the Phase Ib/II clinical study of 9MW2821 combined with toripalimab in the treatment of patients with recurrent or metastatic cervical cancer were announced in the form of a poster: in patients with previously treated cervical cancer, the ORR reached 80.0% and the DCR was 100%.
There is still uncertainty as to whether the clinical trial results can support the drug's submission for marketing application, whether it can ultimately obtain marketing approval, and when it will be obtained. Investors are kindly requested to pay attention to potential investment risks. The company will promptly perform information disclosure obligations on subsequent progress in accordance with relevant regulations.
1. Basic information on drugs
9MW2821 is Maiwei Biotech’s first new site-specific conjugation ADC drug targeting Nectin-4. It is an innovative variety developed by the company using its ADC drug development platform. It achieves site-specific modification of antibodies through coupling technology linkers with independent intellectual property rights and optimized ADC coupling processes. After administration, 9MW2821 can bind to Nectin-4 on the surface of tumor cells and enter the cells. Through enzymatic hydrolysis, it will release cytotoxins in a targeted manner, thereby achieving precise killing of tumors. The company is currently conducting multiple clinical studies for multiple indications such as urothelial cancer (UC), cervical cancer (CC), esophageal cancer (EC), and breast cancer (TNBC), enrolling more than 2,000 subjects, including: 1) Four phase III key registration clinical trials are ongoing, including UC monotherapy and combination therapy (successfully included in the list of breakthrough therapies), CC monotherapy (the world's first drug with the same target to enter phase III clinical research), TNBC Monotherapy (topoisomerase inhibitor ADC has been treated) (the first in the world for the same indication); 2) Multiple phase I/II clinical trials are being carried out rapidly, including TNBC monotherapy (topoisomerase inhibitor ADC has been treated) in the clinical phase Ib in the United States, TNBC combination therapy is in clinical phase II; UC perioperative combination therapy is in clinical phase II; EC monotherapy is in clinical phase II, combination therapy is in clinical phase Ib/II; CC combination therapy is in clinical phase Ib/II period. The project's Phase III clinical trials of UC monotherapy, combination therapy and CC monotherapy are planned to conduct an interim analysis in 2026, and are expected to submit a pre-new drug marketing application meeting to the Drug Evaluation Center of the National Medical Products Administration based on the interim analysis data.
- Clinical study data of 9MW2821 reported at the 2026 ESMO Gynae Conference
(1) Latest results of the Phase I/II clinical study of 9MW2821 for the treatment of patients with recurrent or metastatic cervical cancer
As of March 20, 2025, the confirmed ORR (cORR) and disease control rate (DCR) of 53 patients who were evaluable for efficacy were 32.08% and 81.13%, respectively. The median progression-free survival (mPFS) and median duration of response (mDOR) were 3.9 months and 5.98 months. The median overall survival (mOS) was 19.4 months, the 12-month OS rate was 72.7%, and the 24-month OS rate was 49.1%. Among patients treated with platinum-based doublet chemotherapy and immune checkpoint inhibitors, the cORR and DCR of 31 patients with evaluable efficacy were 29.00% and 77.40%. mPFS and mDOR were 4.0 months and 9.1 months respectively, mOS has not yet been reached, the 12-month OS rate was 76.6%, and the 24-month OS rate was 51.1%. No new safety signals were observed during this follow-up period.
(2) Preliminary results of a cohort in the phase Ib/II clinical study of 9MW2821 combined with toripalimab in the treatment of patients with recurrent or metastatic cervical cancer
As of March 19, 2026, a total of 19 patients were enrolled in this study cohort to receive BFv combined with toripalimab treatment, of which 3 patients were previously treated and 16 were treatment-naive patients. Among them, 13 patients completed at least 1 tumor assessment, the ORR was 76.9% (1 case of CR, 9 cases of PR), and the DCR was 100%. Among treatment-naïve patients, the ORR reached 80.0% (8/10), showing a trend toward better efficacy. Treatment-related adverse events (TRAE) were mainly grade 1-2, and no new safety signals were found overall. The research results initially demonstrate the synergistic effect of nectin-4 targeting ADC combined with PD-1 inhibitors in the treatment of cervical cancer, and are also expected to open up a new first-line treatment path for patients with recurrent or metastatic cervical cancer.
3. Risk warning
Because pharmaceutical products are high-tech, high-risk, and high-value-added, the cycle from clinical trials to approval to production is long and involves many steps, making them susceptible to uncertainties. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
The company will actively promote the above-mentioned research and development projects and perform its information disclosure obligations in a timely manner in strict accordance with relevant regulations. For relevant company information, please refer to the company's designated disclosure media and the announcement published on the website of the Shanghai Stock Exchange.
Announcement is hereby made.
Board of Directors of Maiwei (Shanghai) Biotechnology Co., Ltd.
June 19, 2026