Haisco wins FDA approval for Ciprofol with Jiuzhou Pharma support

Haisco Pharmaceutical Group said its cipepofol injection for adult general anesthesia induction has cleared the U.S. FDA, a first for a China-developed innovative intravenous anesthetic. Jiuzhou Pharma said it supported the program since 2019 with CDMO services covering manufacturing, quality and regulatory work.

Why it matters: - Haisco’s U.S. FDA approval for Cipepofol Injection opens a path to the American market for a China-developed intravenous anesthetic. - The approval is the first U.S. FDA clearance for an innovative intravenous anesthetic developed in China. - The result also underscores how CDMO partners can help drug makers move from development to global regulatory approval.

What happened: - On June 1, Haisco Pharmaceutical Group announced that Cipepofol Injection, also called CYPSEDO, was approved by the U.S. Food and Drug Administration for the induction of general anesthesia in adults. - Jiuzhou Pharma said it supported the program as Haisco’s CDMO partner throughout the development and registration process. - Haisco later told the Jiuzhou Pharma team: “We are pleased to announce that our NDA has been approved by U.S. FDA. We sincerely appreciate Jiuzhou Pharma's outstanding support and close collaboration throughout the program.”

The details: - Jiuzhou Pharma said it has supported the Cipepofol program since 2019. - The company said its work included GMP manufacturing of clinical and registration API batches, quality risk assessment and regulatory support. - Jiuzhou Pharma said it also coordinated cross-functional teams to support manufacturing readiness, consistent quality and timely batch delivery. - The company described its broader CDMO services as process development and optimization, technology transfer, quality studies, GMP manufacturing of clinical and registration batches and commercial supply. - Jiuzhou Pharma said its platform is backed by a quality management system and project execution capabilities. - Jiuzhou Pharma said it has 10 manufacturing sites and 7 R&D centers. - Jiuzhou Pharma said it supports small molecules, peptides, antibody-drug conjugates and oligonucleotide therapeutics across the product lifecycle. - Jiuzhou Pharma is the parent company of Raybow USA, Inc., in Brevard, North Carolina.

Between the lines: - The approval gives Haisco a reference point for future international filings and shows that a Chinese-origin anesthetic can clear the FDA’s review process. - Jiuzhou Pharma’s role suggests CDMO providers are increasingly part of the regulatory strategy, not just the manufacturing chain. - The collaboration also points to how integrated development, manufacturing and regulatory support can shorten the path from clinical supply to global commercialization.

What’s next: - Jiuzhou Pharma said it will continue assessing and expanding its CDMO capabilities and global delivery network. - The company said that effort is aimed at helping pharmaceutical innovators accelerate development, global regulatory approvals and commercial supply. - Haisco said it will continue expanding its global pipeline across anesthesia, pain management, metabolic diseases, respiratory and autoimmune disorders, neuroscience and oncology.

The bottom line: - Haisco’s FDA win gives the company a major regulatory milestone, while Jiuzhou Pharma gets a visible case study for its end-to-end CDMO model.