Recently, the State Drug Administration approved the clinical application of XNW14010, a new class 1 anti-tumor drug from Evopoint Biosciences Co., Ltd. (hereinafter referred to as "Sinovent"), which is intended for the treatment of patients with Advanced solid tumors with KRAS G12C mutation.
As Sinovent's partner, Medicilon provided comprehensive preclinical research services (including pharmacokinetics and safety evaluation) for the development of XNW14010, providing strong support for the project's clinical approval.
Our Preclinical Pharmacokinetics Department has a number of professionals with rich theoretical knowledge and experimental experience for experiment design, experiment implementation, bioanalysis and data analysis. Our Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provide them with complete sets of pharmacokinetic evaluation and optimization services. Our acclaimed quality data collection and efficient experiment can meet our clients’ needs from early drug discovery to new drug filing.
Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.
Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.
XNW14010 is a highly selective small molecule KRAS G12C protein covalent binding inhibitor independently developed by Sinovent. KRAS is the subtype with the highest mutation rate in the RAS family, about 85%. KRAS G12C is a common mutant form of the KRAS gene. In China, KRAS G12C mutation accounts for approximately 14.5% of all KRAS mutations, most commonly in lung cancer, followed by colorectal cancer.
Preclinical experimental data show that XNW14010 has good anti-tumor activity in different tumor models, and presents a good dose-effect relationship, and has good oral pharmacokinetic characteristics and an ideal safety window.
Since the establishment of the cooperation project, Medicilon’s expert technical team and Sinovent’s R&D team have cooperated sincerely. According to the characteristics and application requirements of XNW14010, relevant tests have been designed scientifically and rationally, and the risk points of the tests have been strictly controlled. Finally, in the GLP laboratory environment and Under the operating standards, the pharmacokinetics and safety evaluation of XNW14010 was completed efficiently and with high quality, which accelerated the development process of new drugs and provided professional guarantee for the clinical approval of XNW14010.
Medicilon’s preclinical research service segment has accumulated years of experience in technology research and development and project cooperation, and can complete customized preclinical research for drugs with a wide range of indications from small molecule drugs to biotechnology drugs, bringing economic and economic benefits to customers.
Medicilon congratulates Sinovent XNW14010 for clinical approval, and looks forward to the early launch of XNW14010, which will benefit patients with advanced solid tumors with KRAS G12C mutation.
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E-mail: marketing@medicilon.com
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