CMS (00867) announced that its self-developed innovative drug CMS-D002 capsule received a Drug Clinical Trial Approval Notice from China's National Medical Products Administration (NMPA) on September 25, 2025, with the company receiving the notification on September 26. NMPA has approved the clinical trial to evaluate the safety and efficacy of CMS-D002 in treating uterine fibroids.
CMS-D002 is a small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist. GnRH is a decapeptide hormone synthesized by hypothalamic neuroendocrine cells and serves as a crucial factor regulating reproductive hormone release. CMS-D002 competitively binds to GnRH receptors in the pituitary gland, blocking the pituitary-gonadal axis at the central nervous system level, reducing the release of endogenous follicle-stimulating hormone (FSH) and luteinizing hormone (LH), thereby inhibiting downstream secretion of estrogen, progesterone, and testosterone to alleviate the progression of sex hormone-related diseases.
CMS-D002 demonstrated excellent efficacy and safety in preclinical studies. Previously, CMS-D002 received NMPA's Drug Clinical Trial Approval Notice on February 6, 2024, with the company steadily advancing Phase I clinical research for endometriosis. Recently, CMS-D002 has again received NMPA approval for clinical trials, with the indication scope expanded to include uterine fibroids. Beyond endometriosis and uterine fibroids, CMS-D002 may be developed for treating diseases such as prostate cancer in the future.
Uterine fibroids (UFs) are formed by the proliferation of uterine smooth muscle tissue and represent the most common benign tumor in women. The etiology remains unclear but may be related to genetic susceptibility and sex hormone levels, with risk factors including age, race, obesity, and diet. UFs occur in women aged 15 to 59, most commonly in those aged 30 to 44, with an overall incidence rate showing an annual upward trend and a prevalence rate of up to 25% among women of reproductive age.
Current treatment options for uterine fibroids include surgical and pharmaceutical interventions. While surgical treatment can significantly improve symptoms in uterine fibroid patients, it poses safety concerns such as blood loss and urinary incontinence. Pharmaceutical treatments include symptomatic therapy and endocrine therapy. Symptomatic treatment drugs can only improve symptoms like pain or anemia associated with uterine fibroids but cannot reduce fibroid volume. Endocrine treatments such as GnRH receptor agonists and progesterone receptor modulators can significantly reduce fibroid volume by lowering patients' estrogen and progesterone levels. However, GnRH receptor agonists may cause symptom exacerbation during early treatment (known as the flare effect), while progesterone receptor modulators carry adverse reactions including liver damage and anti-glucocorticoid effects. Therefore, current pharmaceutical treatment for uterine fibroids still faces significant unmet clinical needs.
Compared to GnRH receptor agonists, GnRH receptor antagonists have no "flare effect" and can rapidly competitively bind to GnRH receptors and block their activation, quickly suppressing FSH and LH release, subsequently inhibiting downstream estrogen secretion and alleviating uterine fibroid progression. Partial suppression can be achieved at lower doses, while complete suppression occurs at higher doses. Additionally, due to the reversible action of antagonists, patients' gonadal function is expected to return to normal after drug discontinuation when endogenous GnRH rebinds to receptors.
As an oral non-peptide small molecule GnRH receptor antagonist, CMS-D002, combined with its excellent preclinical performance, is expected to provide superior treatment options for patients. CMS-D002 will further enrich the company's product portfolio, providing differentiated medication choices for Chinese patients and meeting clinical demands for drugs with good efficacy, safety, and patient compliance, ultimately benefiting patients.
CMS-D002 will effectively strengthen the company's capabilities in gynecological therapeutics, leveraging existing expert networks and market resources to enhance competitiveness and market position in this field. The company is actively preparing to conduct relevant clinical trials, striving to bring this product to market as soon as possible.