InventisBio (Shanghai) Co., Ltd (SHA: 688382), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for its candidate garsorasib (D-1553) has been accepted for review by China’s National Medical Products Administration (NMPA). The KRAS G12C inhibitor is intended for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed KRAS G12C mutation, particularly for patients who have experienced disease progression or intolerance after prior first-line systemic treatment.
Garsorasib marks the first of its kind to enter clinical trials in China and is the focus of global multi-center clinical studies across the US, Australia, South Korea, mainland China, and Taiwan. The targeted indications for the drug include NSCLC, colorectal cancer (CRC), and other cancers with the KRAS G12C mutation. In August of this year, Chia Tai Tianqing, a Chinese company, signed a licensing deal with InventisBio, securing exclusive rights for development, regulatory approval, manufacturing, and commercialization of the drug in mainland China.
Garsorasib is currently the subject of a global multi-center study for first-line NSCLC and CRC, either as a monotherapy or in combination with other treatments, with initial results indicating good safety and anti-tumor activity.- Flcube.com
