Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of LXH-1211 tablets, aimed at treating pulmonary arterial hypertension [1] Group 1: Clinical Trial Approval - The clinical trial application for LXH-1211 was accepted on July 10, 2025, and the drug has been approved for clinical trials targeting pulmonary arterial hypertension [1] - The approval process included a communication meeting request submitted in September 2024, with feedback received in December 2024, leading to the final approval in September 2025 [1] Group 2: Drug Mechanism and Design - LXH-1211 is a novel compound specifically designed for the clinical manifestations and pathological essence of pulmonary arterial hypertension [1] - The drug exhibits a dual mechanism of action: it stimulates soluble guanylate cyclase (sGC) to induce vasodilation and lowers pulmonary arterial pressure, while also inhibiting AMP-activated protein kinase (AMPK) to prevent vascular remodeling and fibrosis [1]
山东新华制药股份(00719.HK):获得药物临床试验批准通知书