Following its clinical trial approval in China this March, TQB3205, a Class 1 innovative oral Pan-KRAS inhibitor independently developed by Chia Tai Tianqing, a core subsidiary of Sino Biopharmaceutical (1177.HK), received approval from the U.S. Food and Drug Administration (FDA) on April 4 (local time), to conduct clinical trials for advanced malignant tumors. Simultaneously obtaining clinical access qualifications in the two major pharmaceutical markets of China and the US signifies that the preclinical data and innovative mechanism of action of TQB3205 have been recognized by authoritative international regulatory agencies, potentially providing a new "broad-spectrum treatment option" for patients with pan-KRAS mutations globally. 

The KRAS gene mutation is one of the most common driver genes in human cancers, associated with about 30% of cancer cases worldwide, and is particularly prevalent in high-incidence cancers such as pancreatic carcinoma (approx. 90%), colorectal cancer (30%-50%), and non-small cell lung cancer (15%-20%)^[1-2]. For a long time, the KRAS protein was considered an "undruggable" target due to its smooth surface, which lacks accessible binding pockets. Although inhibitors targeting the specific KRAS G12C mutation have been successfully marketed in recent years, all six KRAS inhibitors approved globally to date only target the single G12C mutation subtype. However, the KRAS mutation spectrum is complex and diverse, including common subtypes such as G12D, G12V, and G13D, representing a significant unmet clinical need. 

TQB3205 capsule is an oral Pan-KRAS inhibitor. Its core mechanism of action is to achieve high-affinity binding with various KRAS (off) mutant proteins, locking the KRAS protein in an inactive state, thereby blocking downstream signaling pathways (such as MAPK and PI3K-AKT). This ultimately leads to the effective inhibition of proliferation in various KRAS-mutant tumor cells, exerting a precise anti-tumor effect at the target level. 

In November 2024, the KRAS G12C inhibitor Garsorasib (Anfangning^®), developed in collaboration with InventisBio, was approved for marketing in China. Now, with TQB3205 successively receiving clinical trial approvals from both Chinese and US regulatory agencies, it marks the company's accelerated entry into the more challenging and high-potential golden track of Pan-KRAS. Globally, Pan-KRAS inhibitors have become a focal point for major pharmaceutical companies to compete in. Although no drug of this class has yet been approved for marketing worldwide, several candidate drugs have already entered the clinical stage. With its high activity, broad mutation spectrum coverage, and solid preclinical data, TQB3205 is expected to secure a favorable position in this cutting-edge global race, providing solutions for a broader population of patients with KRAS mutations. 

References:

[1] Wang Y, You M, Wang Y. Alternative splicing of the K-RAS gene in mouse tissues and celllines[J].Exp Lung Res, 2001, 27(3): 255-267.

[2] Parikh K, Banna G, Liu SV, et al.Drugging KRAS: Current perspectives and state-of-art review[J].J Hematol Oncol, 2022, 15(1): 152.

Declaration:

1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes. 

2. The company does not recommend any drugs and/or indications. 

3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific disease diagnosis and treatment information, please follow the advice or guidance of a physician or other healthcare professional. 

Forward-Looking Statements:

This press release contains certain forward-looking statements, including statements regarding the clinical development plan, expectations of clinical benefits and advantages, commercialization outlook, the likelihood of clinical benefit for patients, and potential commercial opportunities for [TQB3205]. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances. 

Source: WeChat Official Account of Chia Tai Tianqing Pharmaceutical Group Co., Ltd.