Shandong Xinhua Pharmaceutical Co., Ltd. has announced that it recently received a Drug Clinical Trial Approval Notice for its LXH-2103 injection from the National Medical Products Administration.

Shandong Xinhua (SEHK: 00719) submitted a request for a pre-clinical trial communication meeting with the Center for Drug Evaluation of the NMPA in November 2025 regarding this product. The CDE provided feedback on the submitted questions in March 2026. The company subsequently filed its clinical trial application for the injection in March 2026, which was accepted in April, leading to the formal approval notice received in June 2026. The review conclusion authorizes the commencement of clinical trials.

The LXH-2103 injection is a Class 1 innovative drug developed by Shandong Xinhua for the treatment of moderate-to-severe post-operative pain. It is a novel analgesic designed to address the variability in efficacy and safety observed with traditional opioids, such as hydrocodone, codeine, and tramadol, which is often caused by CYP2D6 gene polymorphism.

Research indicates that LXH-2103 exhibits properties of a biased μ-opioid receptor agonist. This profile is expected to allow it to bypass the impact of CYP2D6 genetic variations while offering significant potential for effective pain relief and a favorable safety advantage.