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石四药集团:1类新药SYN045片计划开展二a期临床试验,以确定人体内量效关系

Core Insights - The company has made significant progress in the development of its innovative drug SYN045, which has received approval for Phase I clinical trials in three different dosages from the National Medical Products Administration of China [1] - The results from the completed clinical trials indicate favorable pharmacokinetic characteristics, enhanced safety, and tolerability compared to similar drugs, supporting the potential for long-term oral administration [1] - The company has submitted a total of 18 invention patents related to the SYN045 project, including 5 international patents and 13 domestic patents, with some already granted [1] Group 1: SYN045 Development - SYN045 is a highly selective PGI2 receptor agonist showing significant anti-pulmonary arterial hypertension effects in animal studies [1] - The company plans to conduct Phase IIa clinical trials based on the final results of Phase I to determine the dose-response relationship and explore efficacy and safety in patients [1] Group 2: Other Drug Developments - The company is developing an innovative anti-epileptic drug targeting the potassium ion channel KCNQ2/3, currently in the compound screening phase and preparing for toxicity evaluation [2] - An innovative drug for diabetic peripheral neuropathic pain is also under development, targeting AAK1, with compound screening currently underway [2] - The company is working on three new drug reformulation projects, with two completing pharmacokinetic-based formulation studies and one planned for IND submission within the year [2]