SINO BIOPHARM (01177) announced that China’s National Medical Products Administration (NMPA) has approved a clinical trial application for TQB3205, an oral “pan-KRAS inhibitor” classified as a national Category 1 innovative drug. The candidate was independently developed by the Group’s subsidiary, Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ), and is intended for the treatment of advanced malignant tumours.

TQB3205 is designed to bind multiple KRAS-mutant proteins with high affinity, blocking SOS1-mediated nucleotide exchange, inhibiting downstream ERK phosphorylation, and thereby suppressing proliferation of a broad spectrum of KRAS-mutant tumour cells. This mechanism contrasts with currently marketed KRAS therapies, all five of which target only the G12C mutation.

KRAS is implicated in approximately 30% of global cancer cases, and accounts for 85% of all RAS gene mutations. High KRAS mutation rates are observed in pancreatic cancer (about 90%), colorectal cancer (30%–50%) and non-small-cell lung cancer (15%–20%). Given the heterogeneity of KRAS subtypes—such as G12C, G12V, G12D and G13D—the approval positions TQB3205 to potentially address a wider patient population with unmet clinical needs.

The Group previously achieved NMPA approval in November 2024 for its KRAS G12C-specific inhibitor garsorasib (trade name: Anfangning). The new pan-KRAS candidate underscores the company’s strategy to broaden its oncology portfolio and advance treatment options for patients with diverse KRAS mutations.