By Fineline Cube 
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that the New Drug Application (NDA) for its in-house developed anesthetic ciprofol (HSK3486) has been accepted by the U.S. Food and Drug Administration (FDA). This marks a significant milestone in Haisco’s global expansion and underscores the growing influence of Chinese pharmaceutical innovation on the international stage.
HSK3486: A Promising Anesthesia Drug
HSK3486 is a Category 1 GABAA receptor agonist independently developed by Haisco. It has already garnered attention in China since being nodded by the National Medical Products Administration (NMPA) in February 2020. It has been approved for several indications, including “sedation and anesthesia in non-tracheal intubation surgeries/procedures,” “induction and maintenance of general anesthesia,” and “sedation during intensive care.” Its innovative mechanism and efficacy have positioned it as a promising option for improving clinical anesthesia practices.
Clinical Progress in the United States
In the United States, HSK3486 received approval for its Investigational New Drug (IND) application from the FDA in January 2021. This allowed it to bypass Phase 2 clinical trials and proceed directly to pivotal Phase 3 trials. Haisco successfully completed all clinical studies in 2024 and concluded Pre-NDA communications with the FDA, laying the groundwork for the NDA submission and acceptance.
Global Implications and Future Prospects
The acceptance of the NDA for HSK3486 by the FDA represents a major step forward for Haisco Pharmaceutical in its global development strategy. It highlights the company’s commitment to advancing anesthesia solutions and its capability to meet stringent international regulatory standards. As Haisco continues to pursue regulatory approvals and commercialization in key markets, HSK3486 has the potential to make a meaningful impact on global anesthesia practices and improve patient outcomes in surgical and intensive care settings.-Fineline Info & Tech