Zhitong Finance App News, China Biopharmaceutical (01177) announced that the national class 1 new drug TQB6426 “GPC3 Antibody Drug Conjugate (ADC)” independently developed by the group subsidiary Zhengda Tianqing Pharmaceutical Group Co., Ltd. (Chia Tai Tianqing) has been approved by the US Food and Drug Administration (FDA) for new drug clinical trials (IND) for advanced malignant tumors.
GPC3 is a glycoprotein located on the surface of cell membranes. It is hardly expressed in normal adults, but is highly expressed in hepatocellular carcinoma (HCC), and is a biomarker for clinical diagnosis. Furthermore, GPC3 expression is also elevated in cancers such as lung squamous cell carcinoma and ovarian cancer, and is a promising target for targeting and immunotherapy. Currently, no ADC drug targeting GPC3 has been approved for marketing in the world. All similar candidate products are in the pre-clinical and early clinical exploration stages, and huge clinical needs need to be met urgently.
According to pre-clinical research data, TQB6426 showed good target binding ability and tumor cell-specific killing function, superior to the potent bystander killing activity of similar products and anti-tumor activity in animals, showing the potential for best-in-class (BIC) development. As an ADC drug, TQB6426 relies on the antibody end that specifically targets GPC3 to achieve targeted delivery, accurately delivers cytotoxic payloads to tumor cells, and after killing tumor cells that express GPC3 positively, it further kills tumor cells that express GPC3 negative through strong bystander killing effects, effectively overcoming tumor heterogeneity and expanding anti-tumor coverage; while the specific high expression characteristics of GPC3 in solid tumors such as hepatocellular carcinoma provide an important biological foundation for the drug to achieve “precise delivery and targeted killing”.