By Fineline Cube 
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Category 2.2 drug QP001 (meloxicam) has received marketing approvals from China’s National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA). This milestone marks QP001 as the first daily 24-hour long-acting nonsteroidal anti-inflammatory drug (NSAID) in China and the first analgesic drug approved by the FDA to be manufactured in China. Additionally, it stands as the only long-acting NSAID injection available globally. The drug will be marketed under the trade names PuTanNing in China and Qamzova in the US.
Drug Development and Mechanism
QP001 is a me-better version of Boehringer Ingelheim’s Mobic (meloxicam), developed by Nanjing Delova Biotech Co., Ltd. Unlike traditional non-selective NSAIDs, QP001 is a selective cyclooxygenase-2 (COX-2) inhibitor. It reduces or blocks the synthesis of prostaglandins (PGs) in the affected area by inhibiting the upregulation of COX-2 activity at inflammation and pain sites, thereby exerting anti-inflammatory and analgesic effects.
Market and Licensing
Sino Biopharmaceutical secured exclusive rights to QP001 in mainland China through a licensing agreement with Delova Bio in March of this year. This strategic move underscores Sino Bio’s commitment to expanding its portfolio with innovative pain management solutions.-Fineline Info & Tech