China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel biologic product BIO-008. This marks a significant milestone in the development of the company’s innovative therapeutic biologic.
Development and Indications
BIO-008 is a monoclonal antibody (mAb) targeting Claudin18.2, developed in-house as a Category 1 therapeutic biologic. It is being developed to treat advanced solid tumors, a condition that poses significant challenges in cancer management.
Efficacy and Safety
The product has demonstrated promising activity both in vivo and in vitro, showcasing its potential to effectively target and treat advanced solid tumors. Additionally, BIO-008 has shown a good safety profile, which is crucial for its advancement to clinical trials and eventual use in patients.-Fineline Info & Tech
