Breakthrough again! Danqing Pharmaceutical's POLQ inhibitor IND has been approved for both China and the United States
Time:2025-06-19
Breakthrough again! Danqing Pharmaceutical's POLQ inhibitor IND has been approved for both China and the United States
On June 18, 2025, Danatlas Pharmaceuticals announced that the IND application for its independently developed DNA polymerase theta (POLQ) inhibitor DAT-1604 has been approved by the National Medical Products Administration (NMPA). The project received IND approval from the US FDA on April 11, 2025.
Danqing Pharmaceuticals will officially launch a Phase I clinical trial of DAT-1604 dose escalation and dose expansion in the second half of 2025 to evaluate the safety and efficacy of treating patients with advanced or metastatic solid tumors.
Regarding DAT-1604
DAT-1604 is a novel and highly selective oral POLQ inhibitor independently developed by Danqing Pharmaceuticals. In preclinical studies, DAT-1604 has shown positive signals that can enhance the efficacy of existing DNA damage therapies, and can be used in combination with various DNA damage therapies such as PARP inhibitors, nuclear therapy, radiotherapy, chemotherapy, and ADC to achieve strong anti-tumor synergistic effects.
POLQ participates in DNA double strand break repair through microhomology mediated terminal junctions (MMEJ) and has a strong "synthetic lethality" relationship with HRD genes. Inhibition of POLQ can enhance the cytotoxicity of DNA damage therapy, increase genomic instability, promote the release of tumor neoantigens, and enhance immune response. So far, there is no POLQ inhibitor on the market worldwide.
About Danqing Pharmaceutical
Danqing Pharmaceutical is an innovation driven company dedicated to the research of DNA Damage Repair mechanisms and the development of new precision tumor targeted therapies for patients. The company has established a strong "First in Class&Best in Class" tumor precision drug development pipeline and advanced technology platform, with high-level professional functions such as target recognition, validation, drug discovery, translational medicine, and clinical re
