On June 1, Haisco Pharmaceutical Group announced that its proprietary innovative intravenous anesthetic, Cipepofol Injection (CYPSEDO®), received approval from the U.S. Food and Drug Administration (U.S. FDA) for the induction of general anesthesia in adults.

The approval marks a significant milestone for Haisco, making Cipepofol the first innovative intravenous anesthetic developed in China to receive U.S. FDA approval. It also highlights the company’s continued progress in advancing innovative medicines for global markets.

Jiuzhou Pharma’s End-to-End CDMO Support for Global Registration

Following the U.S. FDA approval, Haisco shared the following message with the Jiuzhou Pharma team:

This milestone reflects a long-term commitment to innovation and strong collaboration between the two companies throughout development, manufacturing, quality, and regulatory activities.

Jiuzhou Pharma is honored to have partnered with Haisco throughout its journey to U.S. FDA approval.

Since 2019, Jiuzhou Pharma has supported the global development of the Cipepofol program as Haisco’s CDMO partner, providing end-to-end services including GMP manufacturing of clinical and registration API batches, quality risk assessment, and regulatory support.

To meet the project’s dedicated manufacturing requirements and stringent U.S. FDA expectations, Jiuzhou Pharma integrated cross-functional teams to ensure manufacturing readiness, consistent quality, and timely batch delivery, enabling the program to progress efficiently toward U.S. regulatory approval.

Accelerating Innovation from Development to Commercial Supply

As an end-to-end CDMO partner, Jiuzhou Pharma provides integrated services spanning process development and optimization, technology transfer, quality studies, GMP manufacturing of clinical and registration batches, and commercial supply, backed by a robust quality management system and proven project execution capabilities.

Jiuzhou Pharma engages in continuous assessment and growth to strengthen its integrated CDMO capabilities and global delivery network to help pharmaceutical innovators accelerate drug development, global regulatory approvals, and commercial supply.

About Jiuzhou Pharma

Founded in 1973, Jiuzhou Pharma (SSE: 603456) is an innovation-driven global CDMO providing integrated drug development and manufacturing solutions for pharmaceutical companies, biotechnology companies, and research institutions worldwide.

With Ten manufacturing sites, Seven R&D centers and end-to-end capabilities spanning process development, GMP manufacturing and commercial supply, Jiuzhou Pharma supports small molecules, peptides, antibody-drug conjugates (ADCs) and oligonucleotide therapeutics across the product lifecycle.

Guided by its mission of “Caring for Life, Safeguarding Health,” Jiuzhou Pharma is committed to helping customers accelerate drug development and commercialization, bringing innovative medicines to patients worldwide.

About Haisco Pharmaceutical Group

Haisco Pharmaceutical Group (SZSE: 002653) is an international pharmaceutical company engaged in the discovery, development, manufacturing and commercialization of pharmaceutical products. The company focuses on therapeutic areas including anesthesia and pain management, metabolic diseases, respiratory and autoimmune disorders, neuroscience and oncology.

Haisco has built a diversified pipeline covering innovative small molecules, biologics and high-value generics, with multiple clinical-stage programs and several commercialized innovative products. Through continuous innovation and global expansion, the company is committed to delivering differentiated therapeutic solutions to patients worldwide.