Qilu Pharmaceutical's Innovative Drug QLH2405 Injection Granted IND Approval for Early Intervention in Alzheimer's Disease

On March 13, 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, QLH2405 Injection, received implied permission for clinical trials. The proposed indications are mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease.

Alzheimer's disease is the neurodegenerative disease with the highest incidence rate globally. Relevant statistical data indicates that currently, nearly ten million Alzheimer's patients are in China, accounting for 25%-30% of the global total. As a chronic and progressive neurodegenerative disease, Alzheimer's has a hidden onset, making the early intervention window particularly crucial.

Qilu Pharmaceutical Always Puts Patients First, Committed to Addressing Unmet Clinical Needs. QLH2405 Injection Targets the Early Stage of Disease Development, the Mild Cognitive Impairment Phase, Aiming to Explore New Approaches to Delay Disease Progression from the Source. The approval of this biologic for clinical use marks a further expansion of Qilu Pharmaceutical's R&D pipeline in the field of central nervous system (CNS) diseases and represents another significant milestone in neuroscience.

During the application process, Qilu Pharmaceutical Co., Ltd. strictly adhered to the relevant regulatory requirements for drug evaluation, systematically submitting a complete set of application materials, including pharmaceutical research, pharmacological and toxicological evaluations, and the proposed clinical trial plan. After receiving clinical approval, Qilu Pharmaceutical will continue to uphold the principles of science, rigor, and standardization, accelerating the advancement of clinical trials to comprehensively evaluate the safety and efficacy of QLH2405 injection in the target population.

In response to the increasingly severe trend of population aging in China, Qilu Pharmaceutical will continue to intensify its technical efforts in major disease areas such as Alzheimer's disease, adhering to innovation with compassion. It will continuously develop more high-quality drugs that are urgently needed in clinical settings, benefiting a wide range of patients and their families.