CSPC PHARMA(01093): Octreotide long-acting injection (SYHX2008) has received clinical trial approval in the United States.

CSPC PHARMA (01093) announced that the long-acting injection of octreotide (SYHX2008) developed by the group has been approved by the Food and Drug Administration (FDA) in the United States for clinical trials. Octreotide is a first-line drug for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors. This product relies on the group's long-acting delivery technology platform, using biocompatible excipients to form a gel depot after subcutaneous injection, achieving long-acting drug delivery with only once-monthly dosing. Currently, the product has entered phase III clinical research in China. Clinical studies have shown that the product takes effect within a week of administration, without the need for prior injection of short-acting octreotide acetate, and demonstrates a significantly better biochemical control rate compared to already marketed octreotide microsphere formulations. In addition, the product uses a pre-filled needle design, allowing patients to self-administer subcutaneous injections, reducing the risk of nerve damage from intramuscular injections, significantly improving patient convenience and treatment compliance. The approved clinical indication for this product is acromegaly. This approval for clinical trials will effectively expand the group's product line coverage in the global market, strengthen the group's advantage in long-acting injection technology platform, and significantly enhance the group's competitive position and industry influence in the international peptide drug field.