According to the official website of the Center for Drug Evaluation of the National Medical Products Administration (CDE), QLF3108, a new class I bispecific antibody tumor drug for injection developed by Qilu Pharmaceutical, has received clinical approval on July 24. The target indication for this drug is advanced solid tumors.
QLF3108 functions by activating T cells to specifically kill tumor cells. Through early design and screening, the drug's safety has been improved while enhancing its drug targeting. Preclinical research results demonstrate that QLF3108 exhibits significant anti-tumor activity both in vivo and in vitro, and it has a favorable safety profile.
The IBAC O2 organoids on chips, developed by Daxiang Biotech, enables the co-cultivation of multiple organoids and cells. It provides highly bionic, stable, efficient, and visualized detection results. Daxiang Biotech utilized the IBAC O2 chip to construct a tumor organoid immune co-culture model. This model effectively recreated the immune microenvironment of human tumors and evaluated the efficacy of QLF3108. The drug's mechanism of action and efficacy results were well-demonstrated. The IND declaration included crucial data, leading to its successful approval.
This is the first dual-antibody immune drug to be clinically licensed based on organoids on chips data. It is also the second anti-tumor drug to receive clinical licensing using organoids on chips evaluation data from Daxiang Biotech in the past month. The use of organoids on chips data for drug IND declarations is increasingly being adopted by pharmaceutical companies both domestically and internationally, and these declarations are receiving approval. This demonstrates the recognition and support of CDE and other drug review agencies towards the use of organoids on chips data for IND declarations.
Daxiang Biotech is a pioneering high-tech enterprise in China that has established itself as a leader in the organoid industry. Its primary goal is to drive the extensive use of organoids on chips in drug development and personalized precision medicine. Currently, Daxiang Biotech has formed long-term strategic collaborations with numerous prominent pharmaceutical companies both domestically and internationally. The evaluation technology for drugs, which is built on organoids on chips, has already been implemented in the research and development process of various anti-tumor medications.
In the future, an increasing number of Daxiang Biotech partners will transition from preclinical research to clinical application for drug evaluation data using organoid chips. Daxiang Biotech is also eager to collaborate with more pharmaceutical companies to advance the application of organoid chip technology in all aspects of drug development. This collaboration aims to enhance the success rate of drug development and expedite the overall drug development process.