Shandong Xinhua Pharmaceutical gets nod for LXH-1211 clinical trials

Shandong Xinhua Pharmaceutical Co., Ltd. announced today that it has received a notice of drug clinical trial approval from the National Medical Products Administration for its LXH-1211 tablets. The approval, received on July 10, 2025, allows the company to initiate clinical trials for the drug, which is intended to treat pulmonary arterial hypertension. The LXH-1211 tablets are classified as a Class 1 chemical drug and will be available in 0.5mg, 1mg, 2mg, and 5mg dosages.

LXH-1211 is a structurally novel compound designed to address the clinical manifestations and pathological mechanisms of pulmonary arterial hypertension. Research indicates a dual mechanism of action: stimulating soluble guanylate cyclase (sGC) to produce vasodilation and inhibiting AMP-activated protein kinase (AMPK) to prevent vascular remodeling and fibrosis.

The company will proceed with the clinical trials as per the approval requirements and plans to submit the clinical trial report and relevant documents to the National Medical Products Administration for production registration after completion. The development of pharmaceutical products involves various uncertainties, and the company will closely monitor the drug's registration progress.