SBP GROUP (01177): TQB6426 "GPC3 ADC" clinical trial application approved by the FDA.

SBP GROUP (01177) announced that its subsidiary, Chongqing Zhifei Biological Products Co., Ltd. (Chongqing Zhifei), has independently developed the national class 1 new drug TQB6426, a "GPC3 antibody-drug conjugate (ADC)," which has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for use in advanced malignant tumors. GPC3 is a glycoprotein located on the cell membrane, which is almost not expressed in normal adult bodies but is highly expressed in hepatocellular carcinoma (HCC) and serves as a clinical diagnostic biomarker. Additionally, GPC3 is also upregulated in other cancers such as lung squamous cell carcinoma and ovarian cancer, making it a promising target for targeted and immunotherapy. Currently, there are no approved ADC drugs targeting GPC3 globally, and similar candidate products are in the preclinical and early clinical exploration stages, indicating a significant unmet clinical need. Preclinical research data shows that TQB6426 demonstrates good target binding capacity and tumor cell-specific cytotoxicity, outperforming similar products in terms of strong bystander killing activity and antitumor activity in animal models, showcasing its best-in-class (BIC) development potential. As an ADC, TQB6426 leverages a specific antibody targeting GPC3 for targeted delivery, accurately delivering the cytotoxic payload to tumor cells. After killing GPC3-positive tumor cells, it further kills GPC3-negative tumor cells through a powerful bystander killing effect, effectively overcoming tumor heterogeneity and expanding the scope of antitumor coverage. The high specific expression characteristics of GPC3 in solid tumors such as hepatocellular carcinoma provide an important biological basis for the drug to achieve "precise delivery and targeted killing."