FDA Awards Orphan Drug Status to 9MW2821

In a recent announcement from Shanghai, Mabwell, a biopharmaceutical firm identified by the stock code 688062.SH, has revealed that their innovative drug, coded 9MW2821, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). This drug is designed to target Nectin-4 and is aimed at treating esophageal cancer.

The FDA's Orphan Drug Designation is a status granted to drugs that treat rare diseases, specifically those affecting fewer than 200,000 individuals in the United States. This designation comes with several benefits for the developers, such as assistance with drug development, tax credits for part of the clinical trial expenses, and exclusive market rights for seven years upon approval.

Previously, the FDA had awarded 9MW2821 Fast Track Designation (FTD) for addressing advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Remarkably, this is the first globally to show clinical efficacy data for an esophageal cancer indication and is pioneering in its category.

About the drug 9MW2821, it is notable for being a site-specific conjugated novel Nectin-4-targeting Antibody-Drug Conjugate (ADC). Mabwell developed this using its robust ADC platform and an automated hybridoma antibody discovery platform. It is the first such candidate from Chinese companies to enter clinical trials. In China, several clinical studies have been conducted to assess 9MW2821's safety, tolerability, pharmacokinetic properties, and efficacy across various advanced solid tumors.

A phase III clinical trial has commenced to test 9MW2821 as a monotherapy in patients with locally advanced or metastatic urothelial carcinoma, who have previously undergone platinum-based chemotherapy and PD-(L)1 inhibitor therapy. Additionally, a phase I/II clinical trial is ongoing, evaluating 9MW2821 in combination with PD-1 inhibitors, with the first patient already enrolled. The drug has shown promising results, with FDA granting it both Fast Track and Orphan Drug Designations. Currently, it stands as the first therapeutic drug candidate globally to reveal clinical data for cervical cancer and esophageal carcinoma indications.

Mabwell, the company behind 9MW2821, is an innovation-driven biopharmaceutical entity with a comprehensive industry chain. Founded in 2017, Mabwell has developed an advanced research and development (R&D) system that includes target discovery, preclinical and clinical research, and manufacturing transformation. Their pipeline consists of 14 products at various stages of development, including 10 novel drug candidates and 4 biosimilars.

The company’s focus spans several therapeutic areas such as oncology, autoimmune diseases, metabolic disorders, ophthalmologic diseases, and infectious diseases. To date, three of Mabwell's products have received approval and been commercialized, one is pending marketing authorization, and three others are in pivotal trials. The company is also engaged in significant national and regional scientific and technological projects in China.

Mabwell's manufacturing capabilities are notable, with a robust in-house facility in Taizhou that complies with international GMP standards regulated by the NMPA, FDA, and EMA. Moreover, their large-scale manufacturing base in Shanghai is currently under construction.

Mabwell’s mission is encapsulated in their motto "Explore Life, Benefit Health," with a vision that emphasizes transforming innovative ideas into reality. This recent achievement with 9MW2821 underscores their commitment to developing effective and accessible therapies to meet global medical needs.