Dragonboat Biopharmaceutical, a Shanghai-based subsidiary of Guilin Sanjin Pharmaceutical Co Ltd, is advancing the development of CDP-1, a biosimilar version of cetuximab, targeting multiple advanced cancer indications. The development program represents a significant effort to expand treatment options in oncology through biosimilar development.
Broad Therapeutic Applications
The investigational biosimilar is being evaluated for an extensive range of cancer indications, including advanced metastatic colorectal cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma. Additional target indications encompass penile squamous cell carcinoma, endometrial cancer, cervical cancer, and ovarian cancer, demonstrating the compound's potential broad clinical utility.
Mechanism of Action and Administration
CDP-1 is designed as a recombinant human-mouse chimeric monoclonal antibody that specifically targets the epidermal growth factor receptor (EGFR). The drug is administered through the intravenous route, consistent with the reference product's administration protocol. This targeting mechanism is crucial for inhibiting cancer cell growth and survival in EGFR-expressing tumors.
Company Capabilities and Pipeline
Dragonboat Biopharmaceutical maintains a comprehensive drug research and development center that supports the entire development process, from early discovery through biologics license application and manufacturing. The company's pipeline includes several other biological candidates (BC003, BC001, BC005, BC006, BC007, BC008, BC010, BC011, and BCT2101) targeting various conditions including solid tumors, tenosynovial giant cell tumors, asthma, gastric cancer, and pancreatic cancer.
Development Infrastructure
The company's development capabilities are supported by an in-house systemic platform and a fully integrated R&D center. This infrastructure enables Dragonboat to manage the complete development cycle, including preclinical research, IND applications, clinical research, and regulatory submissions, positioning the company as a significant player in China's growing biologics sector.