SBP GROUP (01177.HK): FDA Approves IND Application for Self-Developed Class 1 Drug TQB6426 "GPC3 ADC" for Advanced Malignant Tumors

NewTimeSpace News: On September 3, 2026, Sino Biopharmaceutical Limited (stock code: 01177) announced that TQB6426, a national Class 1 innovative drug and a GPC3-targeting antibody-drug conjugate (ADC) independently developed by its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd., had received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for the treatment of advanced malignant tumors.

GPC3 is a glycoprotein located on the cell membrane that is barely expressed in normal adults but highly expressed in hepatocellular carcinoma (HCC), where it serves as a clinical diagnostic biomarker, and is also upregulated in lung squamous cell carcinoma and ovarian cancer. No GPC3-targeting ADC has been approved for marketing worldwide, with peer candidates generally in preclinical or early clinical exploration. Preclinical data showed that TQB6426 demonstrated solid target-binding capacity and tumor-cell-specific killing, with potent bystander killing activity and in-vivo antitumor activity in animals outperforming comparable products, indicating best-in-class (BIC) development potential. As an ADC, TQB6426 uses its GPC3-targeting antibody to deliver a cytotoxic payload precisely to tumor cells and extends killing to GPC3-negative tumor cells through a potent bystander effect, overcoming tumor heterogeneity and broadening antitumor coverage.

Liver cancer is the sixth most common cancer worldwide and the third leading cause of cancer-related death, with 870,000 new cases and 760,000 deaths globally in 2022, projected to nearly double to 1.52 million new cases and 1.37 million deaths by 2050 in the absence of effective interventions, with China accounting for approximately 42.4% of global cases. The disease is insidious in onset and progresses rapidly, with approximately 64% of patients diagnosed at intermediate or advanced stages and a 5-year recurrence rate of as high as 70% even after curative resection in early-stage patients. The group will accelerate the Phase I clinical trial of TQB6426 to assess its safety, tolerability, pharmacokinetic profile and preliminary efficacy in patients with advanced malignant tumors, with the aim of providing new treatment options for patients with hepatocellular carcinoma and other solid tumors globally.

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