Haisco’s ciprofol wins FDA approval with Jiuzhou Pharma support

Haisco Pharmaceutical Group said its intravenous anesthetic Cipepofol Injection was approved by the U.S. FDA on June 1 for induction of general anesthesia in adults. The approval gives China its first innovative IV anesthetic cleared by the FDA and spotlights Jiuzhou Pharma’s CDMO work on the program.

Why it matters: - Haisco’s U.S. FDA approval for Cipepofol Injection opens a path to U.S. market access for an innovative intravenous anesthetic developed in China. - The clearance is the first U.S. FDA approval for an innovative IV anesthetic developed in China, a notable benchmark for Chinese drug innovation. - The approval also highlights the role of CDMO support in moving a drug program through manufacturing and regulatory requirements.

What happened: - Haisco Pharmaceutical Group announced on June 1 that Cipepofol Injection received U.S. FDA approval for induction of general anesthesia in adults. - Jiuzhou Pharma said it supported Haisco as the program’s CDMO partner throughout global development. - The approval was disclosed in Taizhou City, Zhejiang, China, on July 22, 2026.

The details: - Jiuzhou Pharma said its work on the Cipepofol program began in 2019. - The CDMO support included GMP manufacturing of clinical and registration API batches, quality risk assessment and regulatory support. - Jiuzhou Pharma said it also handled process development and optimization, technology transfer, quality studies, GMP manufacturing of clinical and registration batches, and commercial supply. - Jiuzhou Pharma said it integrated cross-functional teams to meet dedicated manufacturing requirements and U.S. FDA expectations. - Haisco sent Jiuzhou Pharma a message saying, “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.” - Jiuzhou Pharma said the collaboration reflected a long-term commitment to innovation across development, manufacturing, quality and regulatory activities.

Between the lines: - The approval suggests Haisco is pushing beyond domestic development toward global regulatory execution. - Jiuzhou Pharma’s role points to how integrated CDMO services can reduce friction between development, manufacturing and approval. - The result also serves as a proof point for Jiuzhou Pharma’s ability to support products aimed at U.S. regulatory standards.

What’s next: - Jiuzhou Pharma said it will continue strengthening its integrated CDMO capabilities and global delivery network. - The company said it aims to help pharmaceutical innovators accelerate drug development, global regulatory approvals and commercial supply. - Haisco said it will continue pursuing innovative medicines for global markets.

The bottom line: - Haisco gained a major U.S. regulatory win, and Jiuzhou Pharma used the approval to showcase its end-to-end CDMO platform.