Changchun High-Tech Industry (Group) Co.,Ltd. (000661.SZ) announced that its subsidiary Changchun GeneScience Pharmaceuticals Co., Ltd. (GeneScience Pharmaceuticals) has recently received a Drug Registration Certificate issued by China's National Medical Products Administration, approving the domestic launch of its Tibolone Tablets.
Tibolone Tablets is a tissue-selective estrogen receptor modulator developed by GeneScience Pharmaceuticals, classified as a Class 4 chemical drug oral tablet formulation. The medication is indicated for treating low estrogen symptoms caused by natural menopause and surgical menopause in women.
Tibolone is a synthetic steroid hormone with tibolone as its main active ingredient. The compound itself has weak hormonal activity and primarily depends on local tissue enzyme activity and tissue-specific metabolic mechanisms to exert different effects in various tissues. After oral administration, tibolone is rapidly metabolized into three compounds that produce its pharmacological effects. Two metabolites, 3α-OH-tibolone and 3β-OH-tibolone, exhibit estrogen-like activity, while the third metabolite, the Δ4-isomer of tibolone, possesses progestogenic and androgenic activity. These metabolites help improve clinical symptoms such as hot flashes that result from decreased estrogen levels in postmenopausal women.
The original Tibolone Tablets were developed by N.V. Organon. GeneScience Pharmaceuticals' Tibolone Tablets is a generic drug developed to address current unmet market and clinical needs. According to completed clinical trial results from a "single-center, randomized, open-label, two-sequence, four-period, fully replicated crossover bioequivalence study of single oral doses of Tibolone Tablets and Livial® in fasting/fed healthy Chinese postmenopausal female subjects," GeneScience Pharmaceuticals' Tibolone Tablets demonstrated bioequivalence compared to the original drug with good safety profile, providing additional treatment options for menopausal women experiencing low estrogen symptoms.