FDA Grants Fast Track Designation to 9MW2821 for the Treatment of Patients with Locally Advanced or Metastatic Nectin-4 Positive TNBC

SHANGHAI, July 12, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel Nectin-4-targeting ADC (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic Nectin-4 positive triple negative breast cancer (TNBC).

The FDA's FTD is intended to expedite the development and review of pharmaceuticals used to treat critical conditions, therefore speeding up the process of bringing these drugs to market. Therapeutics with Fast Track Designation are likely to obtain priority evaluation and speedy approval if they meet the appropriate criteria.

9MW2821 has received multiple regulatory designations from the FDA within just 6 months. Prior to this, 9MW2821 has been granted FTD for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) and recurrent or metastatic cervical cancer (CC) progressed on or following prior treatment with a platinum-based chemotherapy regimen, and also granted Orphan Drug Designation (ODD) for the treatment of esophageal cancer (EC), highlighting its potential and innovation in treating multiple tumors. These designations not only accelerate the development process of 9MW2821 but also lay the groundwork for its potential future priority review.

About 9MW2821

9MW2821 is the first site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of CC, EC and breast cancer. 9MW2821 has been granted FTD by FDA for the treatment of advanced, recurrent, or metastatic ESCC in Feb. 2024, and also respectively granted ODD and FTD for the treatment of esophageal cancer and recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen in May 2024. Then, it has been granted FTD for the treatment of locally advanced or metastatic Nectin-4 positive TNBC in July, 2024.

9MW2821 achieves site-specific modification of antibody through proprietary conjugate 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.

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/fda-grants-fast-track-designation-to-9mw2821-for-the-treatment-of-patients-with-locally-advanced-or-metastatic-nectin-4-positive-tnbc-302195745.html

SOURCE Mabwell