FDA Fast Tracks 9MW2821 for Advanced Nectin-4 Positive TNBC Treatment

SHANGHAI, July 12, 2024  -- Mabwell, a biopharmaceutical innovator listed as 688062.SH, has achieved a significant milestone with its latest development. The company's novel Antibody-Drug Conjugate (ADC), coded as 9MW2821, has recently been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). This designation is for the treatment of locally advanced or metastatic Nectin-4 positive triple negative breast cancer (TNBC).

The FDA's Fast Track Designation is designed to accelerate the development and review processes for drugs targeting serious conditions. This initiative aims to bring essential medicines to patients more swiftly. Therapeutics granted this status are more likely to receive priority review and expedited approval if they satisfy the required standards.

Remarkably, 9MW2821 has garnered several regulatory designations from the FDA within a short span of six months. Before this, it had received FTD for advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), and recurrent or metastatic cervical cancer (CC) that has progressed following prior platinum-based chemotherapy treatments. Additionally, it was also granted Orphan Drug Designation (ODD) for esophageal cancer (EC). These designations not only expedite 9MW2821's development but also set the stage for potential future priority reviews.

About 9MW2821

9MW2821 stands out as the first site-specific conjugated Nectin-4-targeting ADC developed by Mabwell. Utilizing Mabwell's advanced ADC platform and high-throughput hybridoma antibody discovery technology, 9MW2821 is also the first drug candidate from Chinese companies to enter clinical trials among Nectin-4-targeting ADCs. Globally, it is the pioneer in demonstrating clinical efficacy in treating CC, EC, and breast cancer. Earlier in 2024, 9MW2821 was granted FTD for advanced, recurrent, or metastatic ESCC in February. By May, it had secured ODD and FTD for treating esophageal cancer and recurrent or metastatic CC following prior platinum-based chemotherapy. Most recently, in July 2024, it gained FTD for locally advanced or metastatic Nectin-4 positive TNBC.

The mechanism of 9MW2821 involves site-specific antibody modification using proprietary conjugate technology linkers and an optimized ADC conjugation process. Post-injection, 9MW2821 binds specifically to the Nectin-4 protein on the cell membrane, is internalized, and then releases a cytotoxic drug, leading to the apoptosis of tumor cells.

About Mabwell

Mabwell (688062.SH) prides itself on being an innovation-driven biopharmaceutical company, encompassing the entire pharmaceutical industry chain. Since its inception in 2017, Mabwell has established a comprehensive R&D system that spans from target discovery to clinical research and manufacturing transformation. The company boasts 14 pipeline products at various stages, including 10 novel drug candidates and 4 biosimilars. Focusing on oncology, autoimmune diseases, metabolic disorders, ophthalmologic diseases, and infectious diseases, Mabwell has seen significant progress. Three of its products have been approved and commercialized, with another awaiting marketing authorization approval and three others in pivotal trials.

Moreover, Mabwell has been involved in several major scientific and technological projects, including a national project for "Significant New Drugs Development" and two National Key R&D Programmes. The company’s Taizhou facility adheres to international GMP standards and has passed the EU QP Audit. Additionally, large-scale manufacturing bases in Shanghai and Taizhou are under construction to support ADC commercialization.

Mabwell's mission is "Explore Life, Benefit Health," and it envisions transforming innovative ideas into reality.

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