Haisco wins FDA approval for ciprofol with Jiuzhou Pharma support

Haisco Pharmaceutical Group says its Cipepofol Injection has won U.S. FDA approval for adult general anesthesia induction, a first for an innovative intravenous anesthetic developed in China. Jiuzhou Pharma backed the program from 2019 through manufacturing, quality and regulatory work tied to the U.S. filing.

Why it matters: - Haisco’s approval gives a China-developed innovative intravenous anesthetic a U.S. regulatory foothold. - The decision could help the company push more of its innovation pipeline into global markets. - The milestone also underscores the role of CDMO partners in getting complex drugs through manufacturing and regulatory hurdles.

What happened: - Haisco Pharmaceutical Group announced on June 1 that Cipepofol Injection, also called CYPSEDO, received U.S. FDA approval for induction of general anesthesia in adults. - Haisco described the product as the first innovative intravenous anesthetic developed in China to win U.S. FDA approval. - Jiuzhou Pharma said it supported the Cipepofol program as Haisco’s CDMO partner from 2019 through the U.S. approval. - Haisco told Jiuzhou Pharma: "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 provided end-to-end support that included GMP manufacturing of clinical and registration API batches, quality risk assessment and regulatory support. - Jiuzhou Pharma said it used cross-functional teams to handle manufacturing readiness, maintain consistent quality and deliver batches on time. - The company said its support helped the program move efficiently toward U.S. regulatory approval. - Jiuzhou Pharma says its CDMO services cover process development and optimization, technology transfer, quality studies, GMP manufacturing of clinical and registration batches, and commercial supply. - Jiuzhou Pharma operates with a quality management system and project execution capabilities intended to support drug development and manufacturing. - Jiuzhou Pharma was founded in 1973 and is listed in Shanghai under SSE: 603456. - Jiuzhou Pharma says it has 10 manufacturing sites and 7 R&D centers. - Jiuzhou Pharma says its platform supports 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 focuses on anesthesia and pain management, metabolic diseases, respiratory and autoimmune disorders, neuroscience and oncology. - Haisco says its pipeline includes innovative small molecules, biologics and high-value generics.

Between the lines: - The approval shows how drug makers increasingly rely on specialized manufacturing partners to meet U.S. FDA expectations. - Jiuzhou Pharma’s role suggests the CDMO market is becoming a strategic part of global drug launches, not just a back-end supply function. - Haisco’s framing of the approval points to a broader push by Chinese biopharma companies to compete in major regulated markets.

What's next: - Haisco can now advance Cipepofol toward broader U.S. commercialization steps tied to an approved anesthesia product. - Jiuzhou Pharma says it will keep building its integrated CDMO capabilities and global delivery network. - The company says it aims to help pharmaceutical innovators accelerate development, regulatory approvals and commercial supply. - Haisco says it will continue expanding its global pipeline and commercial footprint across key therapeutic areas.