Qilu Pharmaceutical Accelerates Innovation Transformation with Three New Drugs Approved for Clinical Trials Within a Week

　　【Pharmaceutical Network Enterprise NewsRecently, Qilu Pharmaceutical's self-developed Class 1 new drug, Claudin18.2/CD3 bispecific antibody QLS31905, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. Currently, a Phase III clinical trial of QLS31905 in combination with chemotherapy for the first-line treatment of advanced pancreatic cancer is being conducted in China, and it is expected to become a new first-line immunotherapy option for patients with Claudin18.2-positive pancreatic cancer.
 

According to reports, in recent years, Qilu Pharmaceutical has consistently adhered to an innovation-driven development strategy. Currently, the company has successfully launched several innovative drugs, including Irulac tablets, Eparolizumab injection, and others. It also has over 100 innovative drugs in development, with more than 20 in clinical stages. Notably, since 2026, Qilu Pharmaceutical’s innovative drugs have seen frequent breakthroughs. Just before QLS31905 received orphan drug designation from the U.S. FDA, three new drugs were approved for clinical trials within a week.
 

On March 20, according to the disclosure on the CDE website, Qilu Pharmaceutical's self-developed Class 1 new drug QLS1317 tablet obtained clinical trial tacit approval for the targeted treatment of microsatellite-high instability (MSI-H) driven solid tumors.
 

Preclinical studies have shown that QLS1317 demonstrated potent anti-tumor activity in multiple in vivo efficacy models for MSI-H solid tumors. The approval of this drug for clinical trials further expands Qilu Pharmaceutical's product pipeline in the field of cancer treatment.
 

On March 13, according to the 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, obtained tacit approval for clinical trials. The proposed indications are mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease. Targeting the early stage of disease development, the mild cognitive impairment phase, this drug aims to explore new approaches to delay disease progression from the source.
 

It is reported that Qilu Pharmaceutical has three Alzheimer's disease drugs under development. Among them, the improved new drug Memantine Oral Soluble Film has been launched in China, and QLH2405 is the first Class 1 new drug for Alzheimer's disease to enter the clinical stage.
 

On the same day, Qilu Pharmaceutical's self-developed Class 1 new drug, QLS5308 for injection, also officially received the CDE clinical trial implied permission, intended for the treatment of advanced solid tumors.
 

QLS5308 for Injection is an innovative ADC drug that aims to provide a new treatment option for patients with advanced solid tumors through precise targeting and highly efficient killing mechanisms. Preclinical studies have shown that this product demonstrates favorable anti-tumor activity and safety profiles in multiple solid tumor models.
 

The industry believes that the current innovative drug pipeline of Qilu Pharmaceutical is experiencing a "gushing" trend, which is an inevitable result of its decades-long "high-intensity investment" and "strategic transformation." From three new drugs being approved for clinical trials in one week, to the introduction of several key pipelines worth 6 billion yuan, to numerous Class 1 new drugs under development, it fully demonstrates that this company is transitioning to innovation at an astonishing speed. In the future, it will continue to adhere to the development path guided by innovation, industrial upgrading, green low-carbon, global layout, and internal and external efforts, accelerating towards becoming a technology-leading, globally competitive innovative pharmaceutical health leader.
 

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