China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced the withdrawal of its clinical filing for the Category 1 chemical drug G201-Na in assisted reproduction from the National Medical Products Administration (NMPA). The decision was made citing drug approval policies and program progress.
Drug Profile and Mechanism
G201-Na is a small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by blocking the binding of endogenous GnRH to GnRH receptors, inhibiting the synthesis and release of gonadotropins such as luteinizing hormone and follicle-stimulating hormone. This action reduces the levels of sex hormones like testosterone and estradiol, thereby maintaining normal reproductive system function.
Current Clinical Studies
The drug is currently undergoing clinical studies in China for the treatment of prostate cancer that requires androgen castration and for uterine fibroids. These ongoing studies aim to further evaluate the safety and efficacy of G201-Na in these indications.
Significance of the Withdrawal
The withdrawal from the assisted reproduction filing reflects Yiling Pharmaceutical’s strategic focus on aligning its drug development programs with current regulatory policies and prioritizing areas with the greatest potential for success. This decision allows the company to concentrate its resources on other promising indications for G201-Na.-Fineline Info & Tech
