Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HRS-4642 in patients with advanced solid tumors harboring the KRAS G12D mutation. This marks a significant step in the company’s endeavor to address the unmet medical needs of patients with this specific genetic mutation.
HRS-4642, a proprietary liposome-formulated KRAS G12D inhibitor, is designed to bind specifically to the KRAS G12D protein, inhibiting the phosphorylation of MEK and ERK proteins, which are key drivers in tumor growth. This innovative approach positions HRS-4642 as a potential new treatment option with improved serum stability compared to conjugates based on the maleimide-Michael reaction.
The Phase I clinical trial is an open-label, multi-center study aimed at assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of HRS-4642. The trial will also determine the recommended Phase II dosage, marking a crucial milestone in the drug’s development.
HRS-4642 will be evaluated in combination with various drugs, including cetuximab, SHR-9839, SHR-A1921, SHR-A1904, chemotherapy ± bevacizumab, adebrelimab ± chemotherapy, or irinotecan liposome + chemotherapy. This comprehensive approach aims to explore the maximum therapeutic potential of HRS-4642 in different treatment settings.
To date, no similar drug has reached the clinical stage either domestically or internationally, highlighting the novelty and potential impact of Hengrui’s HRS-4642. The company’s commitment to innovation in oncology is further exemplified by its existing portfolio of drugs, such as adebrelimab, a PD-L1 monoclonal antibody approved in China for the first-line treatment of extensive stage small-cell lung cancer in combination with chemotherapy, and SHR-A1904, an antibody-drug conjugate (ADC) targeting Claudin18.2, currently in Phase I trials in China, the US, and Australia.
Jiangsu Hengrui Medicine’s pursuit of HRS-4642 underscores the company’s dedication to advancing cancer treatment and its role as a leader in bringing innovative therapies to patients in need.- Flcube.com
