Mabwell's Novel Nectin-4 Targeting ADC 9MW2821 Approved for 2 Clinical Trials by CDE of NMPA

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PR Newswire

Thu, Nov 14, 2024, 7:00 AM 5 min read

SHANGHAI, Nov. 14, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has received IND approval for two clinical studies. The first will explore its use in combination with a PD-1 monoclonal antibody in the treatment of perioperative urothelial carcinoma, while the second will investigate its combination with other antitumor agents for the treatment of advanced solid tumors.

The recent approval of a multi-drug combination treatment program for cervical cancer and esophageal squamous cell carcinoma, along with the expansion of 9MW2821's indication to include the perioperative stage for urothelial carcinoma, is anticipated to significantly broaden the therapeutic reach of 9MW2821, potentially benefiting a larger patient population.

9MW2821 is a novel Nectin-4 targeting ADC developed by Mabwell. It stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. Clinical studies for 9MW2821 are underway across a range of tumor indications:

Urothelial Carcinoma (UC):

Monotherapy has advanced to Phase III clinical trials and is included in the CDE's Breakthrough Therapy Designation (BTD) list.
Combination therapy with PD-1 has entered Phase III clinical trials.
Combination therapy with PD-1 for perioperative UC has been approved for clinical research.

Cervical Cancer (CC):

The first drug candidate targeting Nectin-4 to enter Phase III clinical trials globally.
Combination therapy with PD-1 and other drugs has been approved for clinical research.
Received FDA Fast Track Designation (FTD).

Triple-Negative Breast Cancer (TNBC):

Monotherapy (post-chemotherapy and topoisomerase ADC treatment) has entered Phase II clinical trials.
Combination therapy with PD-1 has entered Phase II clinical trials.
Received FDA FTD.

Esophageal Cancer (EC):

Monotherapy has entered Phase II clinical trials.
Combination therapy with PD-1 and other drugs has been approved for clinical research.
Received FDA FTD for esophageal squamous cell carcinoma (ESCC); received FDA Orphan Drug Designation (ODD).

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 15 pipeline products in different stages based on a world-class and state-of-the-art R&D engine, including 11 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology, immunology, bone disorders, ophthalmology, hematology and infectious diseases, etc. Of these, 3 products have been approved and commercialized, 1 product has been filed for MA, 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.

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