FDA Grants Fast Track Designation to 9MW2821

Published : Tuesday, February 27, 2024, 10:00 pm

SHANGHAI, Feb. 27, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as "ESCC").

As of February 20, 2024, for the indication of esophageal cancer (EC), 9MW2821 has shown an ORR and DCR of 30% and 73.3%, respectively, in a Phase II clinical study at a dose of 1.25 mg/kg in 30 patients with advanced EC who have received monotherapy and completed at least one tumor assessment. Of those, 28 patients have undergone chemotherapy and immunotherapy. The study is still ongoing with further enrollment and evaluation. 9MW2821 is the world's first Nectin-4-targeting drug to disclose clinical efficacy data for the indication of EC.

9MW2821 is a site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell's ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first clinical stage Nectin-4-targeting ADC developed by Chinese company.

The drug 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.

In addition to EC, Mabwell is conducting clinical studies for multiple indications such as urothelial cancer (UC), Cervical Cancer (CC), with monotherapy for UC entering Phase III clinical study, combination therapy with PD-1 entering Phase I/II clinical study, and monotherapy for CC entering Phase II clinical study. As of now, more than 280 patients have been enrolled. 9MW2821 is also the first to disclose preliminary clinical efficacy data for the indication of CC among drugs with the same target in the world.

About EC

According to the global cancer burden data released by the International Agency for Research on Cancer (IRAC), there were 604 thousand new cases of EC worldwide in 2020, with 544 thousand deaths. In 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on JNCC, showing that there were 224 thousand new cases of EC in China (167.5 thousand in men, 56.5 thousand in women), with 187.5 thousand deaths (140.4 thousand in men, 47.1 thousand in women), ranking 7th and 5th, respectively, in terms of new cases and deaths. According to the statistics from the American Cancer Society, it is estimated that there will be 22,370 new cases of EC (17,690 in men, 4,680 in women), and 16,130 deaths (12,880 in men, 3,250 in women) in the United States in 2024. In China, ESCC is the most common histological type, accounting for about 85.79% of EC cases, while esophageal adenocarcinoma (EAC) and other types account for 11.00% and 3.21%, respectively. In the United States, EAC is the most common type of EC among White population, accounting for about 70% of EC cases, with ESCC accounting for about 30%, and ESCC is more common among African Americans.

Furthermore, according to IQVIA's report, in 2022, the number of prevalent patients with EC in China was 742 thousand, with approximately 70% being cases of advanced metastatic EC, of which about 80% (approximately 416,000 cases) were eligible for systemic treatment. The guidelines of the Chinese Society of Clinical Oncology (CSCO) recommends that PD-1 monoclonal antibody combined with platinum-based chemotherapy is the standard first-line treatment, and PD-1 or monotherapy chemotherapy is an optional second-line treatment. In actual clinical practice, there is a significant unmet clinical need after first-line treatment failure, since no preferred options are available.

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, 2 products have 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 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

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