Mabwell Bioscience (SHA: 688062) announced today that the National Medical Products Administration (NMPA) has granted Investigational New Drug (IND) approval for its proprietary CDH17‑targeting Antibody‑Drug Conjugate (ADC), 7MW4911. The approval enables the company to initiate clinical trials in patients with advanced solid tumors.
Key Highlights
| Item | Detail |
|---|---|
| Company | Mabwell Bioscience (SHA: 688062) |
| Product | 7MW4911 (CDH17‑targeting ADC) |
| R&D Code | 7MW4911 |
| Regulatory Status | NMPA IND approval |
| Indication | Advanced solid tumors |
| Platform | IDDC antibody conjugation technology |
7MW4911: An Innovative CDH17‑Targeted ADC
- Target – Cadherin‑17 (CDH17), a membrane protein over‑expressed in multiple solid‑tumor types.
- Antibody – Mab0727, a high‑specificity anti‑CDH17 monoclonal antibody with rapid internalization and medium affinity across species (human/monkey).
- Linker – Novel cleavable linker that releases the payload only inside the tumor cell.
- Payload – Proprietary DNA Topoisomerase I inhibitor MF‑6, engineered to overcome multi‑drug resistance (MDR).
- Plasma stability – Extended half‑life.
- Controlled release – Precise drug delivery.
- Bystander effect – Enhanced activity against neighboring tumor cells.
Strategic Significance
- First‑in‑class CDH17‑targeted ADC in China, filling a critical unmet need in solid‑tumor therapy.
- IDDC Platform – Scalable antibody conjugation method that can be applied to other targets.
- Potential for Combination – Designed to synergize with checkpoint inhibitors and chemotherapy.
About Mabwell Bioscience
Mabwell Bioscience is a Shanghai‑based biopharmaceutical company focused on novel antibody‑drug conjugates and targeted therapies for oncology. The company leverages its proprietary IDDC platform to develop highly selective ADCs aimed at improving efficacy and reducing off‑target toxicity.
Forward‑Looking Statements
This release contains forward‑looking statements regarding the NMPA approval, clinical development plans, and potential market impact. These statements are based on current expectations and are subject to risks and uncertainties, including regulatory approval, clinical outcomes, and market acceptance.-Fineline Info & Tech
