Jiangsu Hengrui Pharmaceuticals (600276.SH) applied for the listing of a new indication for its class 1 new drug "Fumarate Tegiritexin"

On December 29th, according to the official website of the China Drug Evaluation (CDE), Hengrui's Tramadol Hydrochloride Injection (SHR8554) has been reported for a new indication, speculated to be postoperative pain in orthopedic surgery. It is understood that SHR8554 is a class 1 new drug independently developed by Jiangsu Hengrui Pharmaceuticals (600276.SH). It is a small molecule drug targeting the -opioid receptor (MOR) and can activate MOR receptors. Compared with classic MOR agonists, SHR8554 has a similar central analgesic effect while reducing the incidence of common gastrointestinal adverse reactions. It was first applied for market approval in July last year for the treatment of moderate to severe pain after abdominal surgery and is currently under review. In addition to moderate to severe pain after abdominal surgery, SHR8554 previously initiated a Phase II/III clinical trial for postoperative pain in orthopedic surgery. The recruitment of subjects was completed in February last year, and it is speculated that this indication is the one being reported for market approval.