Phase III Trial for Chiauranib in First-Line Extensive Small Cell Lung Cancer Approved

SHENZHEN, China, Nov. 1, 2024 /PRNewswire/ -- On November 1, Shenzhen Chipscreen Biosciences Co., Ltd. (referred to as "Chipscreen Biosciences") and its subsidiary, Chengdu Chipscreen Pharmaceutical Ltd., received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration. The company's innovative drug, Chiauranib, in combination with PD-(L)1 monoclonal antibody and standard chemotherapy for first-line treatment of extensive stage small cell lung cancer (ES-SCLC), has been approved for phase III clinical trials.

Extensive stage small cell lung cancer (ES-SCLC) is known for its aggressive nature and poses significant treatment challenges. Recent advances in chemo-immunotherapy have improved patient outcomes in small cell lung cancer, but substantial progress in long-term survival rates is still required. Chiauranib, with its unique multi-pathway pharmacological effects, demonstrates anti-tumor activity specifically against neuroendocrine tumors, including small cell lung cancer. Its ability to enhance the effects of both immunotherapy and chemotherapy, through anti-angiogenesis and immune regulation, presents a promising new option. This new regimen, combining Chiauranib with first-line chemo-immunotherapy, aims to further improve long-term survival rates for patients with ES-SCLC and shows significant clinical potential.

In addition to the newly approved phase III clinical trial, Chiauranib's phase III trial as a monotherapy for later-line treatment of small cell lung cancer has been completed, and pre-NDA discussions are ongoing. Phase III trials for ovarian cancer, as well as phase II trials for triple-negative breast cancer, soft tissue sarcoma, and pancreatic cancer, are also in progress. Additionally, in the United States, a phase Ib/II clinical trial of Chiauranib monotherapy for small cell lung cancer and other solid tumors is underway.

Chiauranib is a novel molecular entity created and independently developed by Chipscreen Biosciences, protected by global patents. It acts as a selective Aurora B inhibitor, a vital mitotic regulator. The drug also targets VEGFR to inhibit tumor angiogenesis and blocks CSF1R and DDR1 pathways to limit the activity of immunosuppressive cells, thereby enhancing the tumor immune microenvironment. Its specific Aurora B inhibition is particularly effective against neuroendocrine tumors like SCLC, positioning it as an innovative small molecule anti-tumor drug candidate.

Chiauranib's comprehensive anti-tumor mechanism involves a triple-pathway action: inhibiting tumor angiogenesis, preventing tumor cell mitosis, and modulating the tumor microenvironment. The drug has shown superior efficacy and safety compared to other drugs with similar mechanisms.

Chipscreen Biosciences, driven by core technologies, is committed to innovative drug development with global competitiveness. As a trailblazer in China's drug innovation sector, Chipscreen focuses on developing breakthrough drugs with novel action mechanisms to meet urgent clinical needs. The company boasts an integrated industry chain from early exploratory research to commercialization, providing innovative Chinese medicines to patients worldwide.

With a global development strategy starting from early-stage research in China, Chipscreen leverages top scientists and experienced teams from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center. Utilizing AI-driven design and chemical genomics, Chipscreen has created a comprehensive technology platform spanning basic science to clinical application. The company has successfully launched first-in-class and best-in-class innovative drugs, with two drugs covering six indications already marketed globally. Additionally, Chipscreen is advancing several R&D projects with distinct advantages and global competitiveness in key areas such as malignant tumors, metabolic diseases, autoimmune diseases, central nervous system disorders, and antivirals.

Chipscreen Biosciences has established a global industrial framework with facilities in Shenzhen, Chengdu, Beijing, Shanghai, and the USA. Recognized as a national high-tech enterprise and an "innovative drug incubation base," Chipscreen has undertaken numerous significant national science and technology projects. The company holds over 680 invention patents worldwide, with more than 200 granted.