On December 30, Gelonghui reported that CSPC PHARMA (01093.HK) announced that its developed Gn RH receptor agonist, Long-acting Leuprolide Injection (SYH9016), has been approved by the National Medical Products Administration of China to conduct clinical trials in China.
This product is the first modified Leuprolide product approved for clinical trials in China. It utilizes the Group's long-acting delivery technology platform and is based on excipients with good biocompatibility. After subcutaneous injection, it forms a gel depot that allows for prolonged drug delivery. The product is administered once a month, and compared to the already marketed Leuprolide microsphere products, it does not require complex preparation before use. Its injection needle is finer and the injection volume is smaller, which is expected to reduce injection site pain and improve ease of use and patient compliance. Preclinical studies show that this product has good safety and efficacy.
The approved indications for this product include solid tumors. Additionally, the product can be used to treat endometriosis, central precocious puberty, among others, and has high clinical development value. The approval of this clinical trial is the first significant achievement in the Group's layout of long-acting Gn RH agonists, establishing a good foundation for the development of other Gn RH agonist products.
