Core Viewpoint - The announcement by Haishi Science (002653.SZ) regarding the acceptance of its new drug application (NDA) for HSK3486 by the FDA marks a significant step in the company's international drug development efforts, potentially offering a safer and more efficient anesthetic option for global patients [2]. Company Summary - Haishi Science received a notice from the FDA on July 30, indicating that the NDA for HSK3486 (环泊酚注射液) meets the necessary requirements for drug registration [2]. - HSK3486 is a first-class intravenous anesthetic developed independently by the company, which was approved for domestic market entry in December 2020 [2]. - The successful launch of HSK3486 in the international market could enhance the company's position in the global pharmaceutical industry [2]. Industry Summary - The acceptance of HSK3486 by the FDA represents a critical advancement in the field of anesthetics, potentially providing healthcare professionals with a new option for patient care [2]. - The development of innovative anesthetic drugs like HSK3486 aligns with the industry's ongoing efforts to improve patient safety and treatment efficacy [2].
海思科:创新药HSK3486获FDA上市许可申请受理