Following its approval for clinical trials in China in March, TQB3205, an innovative Class 1 oral Pan-KRAS inhibitor independently developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (a core subsidiary of Sino Biopharmaceutical Co., Ltd., received approval from the U.S. Food and Drug Administration (FDA) on April 4th (local time) to conduct clinical trials for advanced malignant tumors . The simultaneous acquisition of clinical access qualifications in both the U.S. and Chinese pharmaceutical markets signifies that TQB3205's preclinical data and innovative mechanism of action have been recognized by internationally authoritative regulatory agencies, potentially providing a new "broad-spectrum treatment option" for pan-KRAS mutation patients worldwide.

KRAS gene mutations are among the most common driver genes in human cancers, associated with approximately 30% of cancer cases worldwide, particularly prevalent in high-incidence cancers such as pancreatic cancer (approximately 90%), colorectal cancer (30%-50%), and non-small cell lung cancer (15%-20%) [1-2] . For a long time, due to the smooth surface of the KRAS protein and the lack of easily accessible binding pockets, it was considered an "untreatable" target. Although inhibitors targeting specific KRAS G12C mutations have been successfully marketed in recent years, all six currently approved KRAS inhibitors globally target only the single G12C mutation subtype. The KRAS mutation spectrum is complex and diverse, including common subtypes such as G12D, G12V, and G13D, indicating a significant unmet clinical need for treatment.

TQB3205 capsules are an oral Pan-KRAS inhibitor. Its core mechanism of action is to bind with a high affinity to various KRAS(off) mutant proteins. By locking the KRAS proteins in an inactive state, it blocks downstream signaling pathways (such as MAPK and PI3K-AKT), ultimately achieving effective inhibition of the proliferation of various KRAS mutant tumor cells and precisely exerting anti-tumor effects at the target level.

Anfangning® ) , developed in collaboration with Yifang Bio, was approved for marketing in China. Now, with TQB3205 receiving clinical trial approvals from regulatory agencies in both China and the United States, the company is accelerating its entry into the more challenging and potentially lucrative Pan-KRAS market. Globally, Pan-KRAS inhibitors have become a focal point for major pharmaceutical companies. Although no similar drugs have yet been approved for marketing globally, several candidate drugs have entered clinical trials. With its high activity, broad mutation spectrum, and solid preclinical data, TQB3205 is expected to occupy a favorable position in this cutting-edge global market, providing solutions for a wider range of KRAS-mutant patients.

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