海思科医药集团股份有限公司关于创新药HSK3486获得FDA上市许可申请受理通知的公告

Core Viewpoint - HSK3486, a new intravenous anesthetic developed by the company, has received a notice of acceptance for its New Drug Application (NDA) from the FDA, marking a significant step in the company's internationalization strategy [1][3]. Group 1: R&D Project Overview - HSK3486 (环泊酚注射液, 思舒宁?) is a novel Class 1 intravenous anesthetic with independent intellectual property rights, approved for domestic use in December 2020 for various indications [2]. - The drug received FDA IND approval in January 2021, skipping Phase II trials and directly entering critical Phase III clinical trials [2]. - Clinical studies indicate that HSK3486 has a rapid onset and recovery, high anesthesia success rates, stable blood pressure control, and significantly reduced incidence of adverse reactions such as hypotension and respiratory depression [2]. Group 2: Significance of Acceptance - The FDA's acceptance of the NDA for HSK3486 represents a crucial milestone in the company's innovative drug development and international strategy [3]. - Successful market entry of HSK3486 is expected to provide a safer and more effective anesthetic option for patients globally [3].