Sino Biopharmaceutical Ltd (HKG: 1177), a prominent biopharmaceutical company in China, has announced that its candidate garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd, has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation covers two indications: the treatment of locally advanced or metastatic pancreatic ductal adenocarcinoma with a KRAS G12C mutation that has not responded to first-line treatment, and in combination with cetuximab for the treatment of locally advanced or metastatic colorectal cancer (CRC) that has failed second-line standard treatment, including regimens with oxaliplatin, irinotecan, 5-fluorouracil, and anti-VEGF monoclonal antibodies. Both indications require that the tumors are KRAS G12C mutation positive and are not amenable to surgical resection.
Garsorasib marks the first therapy of its kind to enter clinical trials in China, targeting non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) with KRAS G12C mutations. Sino Bio’s subsidiary, Chia Tai Tianqing, entered into a licensing agreement with InventisBio in August of the previous year, securing exclusive rights for the development, regulatory approval, manufacturing, and commercialization of the drug in mainland China. The company is currently awaiting regulatory decisions for the treatment of locally advanced or metastatic NSCLC with a KRAS G12C mutation in this region.- Flcube.com
