Shijiazhuang Sihua Pharmaceutical Group’s Phase I Clinical Trial Application for Class I New Drug SYN-045 Has Been Accepted
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发布时间:2023-11-09
【概要描述】
Recently, Shijiazhuang Sihua Pharmaceutical Group’s Phase I clinical trial application for its Class 1 new drug SYN-045 was formally accepted by the National Medical Products Administration, making it the group’s second Class 1 chemical new drug to be submitted and approved for review.
Recently, the Phase I clinical trial application for SYN-045, a Class 1 new drug developed by Shijiazhuang Sihua Pharmaceutical Group, was officially accepted by the National Medical Products Administration. This marks the second Class 1 chemical new drug from the group to be submitted and approved for review.
According to reports, SYN-045 is a highly selective PGI2 receptor agonist. In the Group’s current preclinical studies on SYN-045, the compound has demonstrated exceptional target specificity and selectivity, with pronounced anti–pulmonary arterial hypertension efficacy in animal models, coupled with a low toxicity profile that supports long-term oral administration.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has vigorously implemented an innovation-driven development strategy, concentrating its strengths on tackling key scientific and technological challenges in the areas of innovative drugs, shortage medications, and treatments for rare diseases. The company has continuously accelerated its strategic planning and deployment in complex formulations, improved new drugs, and truly innovative medicines, marking a transition in its R&D efforts from generic drug development to a new phase of original, breakthrough innovation.
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