Jiuzhou Pharma supports Haisco’s U.S. FDA approval for ciprofol

Haisco Pharmaceutical Group won U.S. FDA approval for Cipepofol Injection, an intravenous anesthetic for adult general anesthesia, on June 1. Jiuzhou Pharma said it supported the program since 2019 with manufacturing, quality and regulatory work that helped move the drug through U.S. registration.

Why it matters: - Haisco’s approval makes Cipepofol the first innovative intravenous anesthetic developed in China to win U.S. FDA approval. - The decision gives Haisco a path into the U.S. market for an adult general anesthesia product. - The milestone also spotlights the role of CDMO partners in getting complex drugs through global regulatory review.

What happened: - On June 1, Haisco Pharmaceutical Group announced that Cipepofol Injection, also called CYPSEDO, received U.S. FDA approval for the induction of general anesthesia in adults. - Jiuzhou Pharma said it had supported the Cipepofol program as Haisco’s CDMO partner since 2019. - Haisco thanked Jiuzhou Pharma for support and close collaboration across the program.

The details: - Jiuzhou Pharma said its work covered GMP manufacturing of clinical and registration API batches, quality risk assessment and regulatory support. - Jiuzhou Pharma said it used cross-functional teams to support manufacturing readiness, consistent quality and timely batch delivery. - The company said those efforts were designed to meet dedicated manufacturing requirements and U.S. FDA expectations. - Jiuzhou Pharma described its broader CDMO offering as process development and optimization, technology transfer, quality studies, GMP manufacturing of clinical and registration batches, and commercial supply. - Jiuzhou Pharma said its integrated services are backed by a quality management system and project execution capabilities. - Jiuzhou Pharma was founded in 1973 and is listed on the Shanghai Stock Exchange under SSE: 603456. - Jiuzhou Pharma said it has ten manufacturing sites and seven R&D centers. - Jiuzhou Pharma said its capabilities cover small molecules, peptides, antibody-drug conjugates and oligonucleotide therapeutics. - Jiuzhou Pharma is the parent company of Raybow USA, Inc., in Brevard, North Carolina. - Haisco Pharmaceutical Group is listed in Shenzhen under SZSE: 002653. - Haisco said its pipeline spans innovative small molecules, biologics and high-value generics across anesthesia and pain management, metabolic diseases, respiratory and autoimmune disorders, neuroscience and oncology.

Between the lines: - The approval signals that Chinese-developed innovative drugs can clear the U.S. regulatory bar with support from domestic manufacturing and development partners. - Jiuzhou Pharma is positioning itself as a global CDMO that can move programs from development into commercial supply. - The announcement also shows how long development timelines can be for cross-border drug programs, with support beginning in 2019 before the 2026 approval.

What's next: - Haisco can now advance plans around the U.S. launch and broader global commercialization of Cipepofol. - Jiuzhou Pharma said it will keep strengthening its integrated CDMO capabilities and global delivery network. - Both companies are likely to lean on the approval as proof of execution for future international programs.