Qilu Pharmaceutical's Novel Drug QLS1317 Granted IND Approval for Targeted Therapy of MSI-H Solid Tumors

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(Source: Cailian Press)

On March 20, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, Qilu Pharmaceutical's self-developed Class 1 new drug QLS1317 tablet has obtained clinical trial implied permission for the targeted treatment of microsatellite instability-high (MSI-H) driven solid tumors. The approval of this product for clinical use is a critical step for the company in the field of precision oncology treatment and is expected to bring new treatment hope to patients with MSI-H solid tumors.

MSI-H tumors are tumors with a high degree of microsatellite instability phenotype, caused by defects in DNA mismatch repair (MMR), leading to mutations in short tandem repeats in the genome. The MSI-H phenotype is commonly seen in various solid tumors such as colorectal cancer, endometrial cancer, and gastric cancer. The incidence of MSI across all cancer types is approximately 3.5%, equivalent to about 600,000 new patients annually. Currently, the clinical needs for the treatment of solid tumors driven by high microsatellite instability (MSI-H) are far from being met.

In response to clinical needs, QLS1317 focused on differentiated design during its development process. Preclinical studies have shown that QLS1317 exhibits potent anti-tumor activity in multiple in vivo efficacy models targeting MSI-H solid tumors. In terms of safety, in vivo toxicology experiments indicate that QLS1317 has a wide safety margin, providing a favorable basis for the selection of subsequent clinical dosing and demonstrating promising prospects for clinical application.

QLS1317 tablets have been approved for clinical trials, further enriching Qilu Pharmaceutical's product pipeline in the field of cancer treatment. This is the third innovative drug from Qilu Pharmaceutical to receive clinical approval within a week, demonstrating the company's strong momentum in innovation.

In recent years, Qilu Pharmaceutical has focused on the research and development of innovative drugs with high-intensity investment as the foundation and clinical value as the guide. Through precise pipeline layout, it has achieved differentiated breakthroughs, building a product line covering areas such as oncology, autoimmune diseases, metabolism, cardiovascular, and central nervous system, continuously developing "global new" and "global good" drugs.