| | SHANGHAI, Dec. 11, 2023 /PRNewswire/ --Mabwell Therapeutics, Inc. (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 for the “A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Trial of 9MW2821 versus Investigator’s Choice of Chemotherapy for Treating Unresectable Locally Advanced or Metastatic Urothelial Carcinoma in Patients Previously Treated with Platinum-Containing Chemotherapy and PD-(L)1 Inhibitors” has been approved. The company will now officially initiate the Phase III clinical study of 9MW2821 for treating locally advanced or metastatic urothelial carcinoma in patients previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors. 9MW2821 is a novel Nectin-4 targeting ADC developed independently by Mabwell, marking the first of its kind among the products developed in China with the same target to enter clinical trials. As of December 5, 2023, more than 250 subjects were enrolled. In the Phase II clinical trial of 9MW2821, at a dose of 1.25 mg/kg, the monotherapy resulted in an objective response rate (ORR) of 62.2% (95% CI: 44.8%–77.5%) and a disease control rate (DCR) of 91.9% (95% CI: 78.1%–98.3%) in patients with advanced urothelial carcinoma. The median progression-free survival (PFS) was 6.7 months (95% CI: 3.8–NR), while the median overall survival (OS) has not been reached yet. Currently, multiple clinical trials are being conducted simultaneously for this project. Clinical trials on combination therapy with other treatments, in addition to monotherapy, are also advancing. Promising antitumor activity coupled with favorable safety profiles has been observed across various cancer types. About Urothelial Carcinoma
According to the American Society of Clinical Oncology, bladder cancer is the ninth most common malignant tumor in terms of incidence and ranks thirteenth in mortality among malignant tumors. According to the 2016 Chinese national cancer statistics published by the National Cancer Center in February 2022, there were 82,300 new bladder cancer cases, with an incidence of 3.53 per 100,000 individuals. Urothelial carcinoma, ranking among the top ten most prevalent cancers in China, is characterized by its tendency toward metastasis and recurrence. Advanced urothelial carcinoma is associated with short survival, contributing to a substantial disease burden in China and seriously compromising patients’ survival and quality of life. About 9MW2821
9MW2821 is a novel Nectin-4 targeting ADC developed by world-class ADC development platform and automated high-throughput antibody discovery platform of Mabwell. It achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. 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. The company is conducting several clinical trials on a range of indications, including urothelial carcinoma and cervical cancer. Currently, the R&D progress of 9MW2821 ranks first in China and second in the world. 9MW2821 is the first to read out preliminary clinical data in cervical cancer among the products with the same target in the world. 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 R&D 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, 2 products have been approved and commercialized, 1 product has been filed for MA approval, 1 product is in the preparation of filing, 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 several 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 located in Shanghai is 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. Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company’s product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. “Forward-looking statements” are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would,” and similar expressions and the negatives of those terms. Forward-looking statements are based on the Company’s current expectations and assumptions. Forward-looking statements are subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company’s control, including, but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates, most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors, such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate, or any assumptions are incorrect, the actual results may be seriously inconsistent with the stated results. The Company cautions all the persons not to place undue reliance on any such forward-looking statements, which speaks only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions, figures and assumptions in this press release are applicable to this statement.  View original content:https://www.prnewswire.com/news-releases/mabwell-announces-the-cde-approval-of-novel-nectin-4-targeting-adc-for-phase-iii-clinical-trial-302011037.html
SOURCE Mabwell | |
