Shenzhen Chipscreen Biosciences Co., Ltd. has received approval from the National Medical Products Administration for a Phase III clinical trial of Chiauranib in combination with a PD-(L)1 monoclonal antibody and standard chemotherapy. This trial will evaluate the efficacy of the combination as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
Addressing Unmet Needs in ES-SCLC
ES-SCLC is an aggressive subtype of lung cancer that presents significant treatment challenges. While chemo-immunotherapy has improved survival outcomes, there remains a need for therapies that can further enhance long-term survival. Chiauranib's multi-pathway pharmacological mechanism offers a potential solution by targeting neuroendocrine tumors and synergizing with both immunotherapy and chemotherapy through its anti-angiogenic and immune-regulatory activities.
Chiauranib's Mechanism of Action
Chiauranib, a novel molecular entity developed by Chipscreen Biosciences, is a selective inhibitor of Aurora B, a key mitotic regulator. It also targets VEGFR to inhibit tumor angiogenesis and blocks CSF1R and DDR1 pathways to reduce immunosuppressive cell infiltration, thereby enhancing the tumor immune microenvironment. This triple-pathway mechanism allows Chiauranib to exert a comprehensive anti-tumor effect.
Ongoing Clinical Trials
In addition to the newly approved Phase III trial, a Phase III clinical trial of Chiauranib monotherapy for later-line treatment of small cell lung cancer has been completed, and pre-NDA communication is underway. Further clinical trials are in progress, evaluating Chiauranib in combination with chemotherapy for ovarian cancer, as well as single or combined treatments for triple-negative breast cancer, soft tissue sarcoma, and pancreatic cancer. An ongoing Phase Ib/II clinical trial in the United States is also assessing Chiauranib monotherapy for small cell lung cancer and solid tumors.
About Chipscreen Biosciences
Chipscreen Biosciences is committed to developing innovative drugs that address unmet clinical needs. With a focus on new mechanisms of action, the company has established a global industrial layout with R&D centers and production bases in China and the United States. Chipscreen's integrated technology platform, driven by AI-design and chemical genomics, supports the development of first-in-class and best-in-class innovative drugs.
