Dainippon Sumitomo Pharma's (DSNKY.US) orally administered anti-tumor drug has applied for market approval in China.

On January 15th, the latest announcement on the official website of the China National Medical Products Administration Drug Evaluation Center (CDE) stated that the marketing application for the new drug PLX3397, a capsule containing pexidartinib hydrochloride submitted by Daiichi Sankyo (DSNKY.US), has been accepted. The product was officially designated for priority review by the CDE in October 2024, and is intended for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in adult patients with severe lesions or limited function that cannot be improved through surgery. Public information indicates that pexidartinib is a CSF1R small molecule inhibitor, which was previously approved by the US FDA in August 2019 for the treatment of symptomatic TGCT in adult patients. According to a FDA news release at that time, this was the first approved treatment for TGCT. TGCT, also known as pigmented villonodular synovitis, is a rare benign tumor with local invasiveness. It can affect joints, bursae, and tendon sheaths covered by synovium, leading to swelling, pain, stiffness, and reduced range of motion in joints or limbs. Currently, surgery is the standard treatment for TGCT. However, for patients with recurrent, refractory, or diffuse TGCT, surgery may not completely remove the tumor and may lead to severe joint damage and loss of function. Some patients may even consider amputation to relieve pain. Pexidartinib is an innovative oral CSF1R small molecule inhibitor that also inhibits the activity of c-kit and FLT3-ITD. The CSF1R-mediated signaling pathway is a major factor driving abnormal cell proliferation in the synovium.