SINO BIOPHARM (01177) has announced that its subsidiary, Chia Tai Tianqing Pharmaceutical Group, has received clinical trial approval from the National Medical Products Administration (NMPA) for its self-developed Class 1 innovative drug TQB3205, a pan-KRAS inhibitor intended for the treatment of advanced malignant tumors. TQB3205 is an oral pan-KRAS inhibitor. Its core mechanism of action involves high-affinity binding to multiple KRAS mutant proteins. By inhibiting SOS1-mediated nucleotide exchange of KRAS, it blocks RAS activation and suppresses downstream ERK phosphorylation, thereby effectively inhibiting the proliferation of various KRAS-mutant tumor cells. The KRAS gene has the highest mutation frequency within the RAS family. Approximately 30% of cancer cases globally are associated with RAS gene mutations, with KRAS mutations accounting for 85% of all RAS mutations. These are prevalent in various cancers, including pancreatic cancer (90%), colorectal cancer (30%-50%), and non-small cell lung cancer (15%-20%). However, KRAS mutation subtypes differ significantly across tumor types, with common variants including G12C, G12V, G12D, and G13D. Currently, all five approved KRAS inhibitors worldwide target only the G12C single mutation subtype. The group's co-developed KRAS G12C inhibitor, Gelsorasib (brand name: Anfuning), received market approval from the NMPA in November 2024. Despite this, clinical needs in the KRAS field remain largely unmet, creating an urgent demand for pan-KRAS inhibitors that can cover a broader range of mutation subtypes. The group plans to accelerate the clinical development of TQB3205, aiming to overcome current therapeutic limitations and provide new treatment options for a wider population of patients with advanced malignant tumors harboring KRAS mutations.
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