Core Insights - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the marketing of Tebrostone tablets in China [1] Group 1: Product Information - Tebrostone tablets are a selective estrogen receptor modulator developed by Jinsai Pharmaceutical, classified as a Class 4 oral chemical drug, aimed at treating low estrogen symptoms in women due to natural or surgical menopause [1] - Tebrostone is a synthetic steroid hormone with weak hormonal activity, relying on local enzyme activity and specific metabolic mechanisms in different tissues to exert various effects [1] - Upon oral administration, Tebrostone is rapidly metabolized into three compounds that mediate its pharmacological effects, with two metabolites exhibiting estrogen-like activity and a third metabolite showing progestogenic and androgenic activity [1] Group 2: Market and Clinical Relevance - The Tebrostone tablets developed by Jinsai Pharmaceutical are a generic drug targeting unmet market and clinical needs [2] - Clinical trial results from a bioequivalence study indicate that Jinsai's Tebrostone tablets are bioequivalent to the original drug and demonstrate good safety, providing more treatment options for menopausal women experiencing low estrogen symptoms [2]

Core Insights - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for the marketing of its drug, Tebrostone Tablets [1] Group 1: Product Information - Tebrostone Tablets are a selective estrogen receptor modulator developed by Jinsai Pharmaceutical, classified as a Class 4 oral chemical drug, aimed at treating low estrogen symptoms in women due to natural or surgical menopause [1] - Tebrostone is a synthetic steroid hormone with weak hormonal activity, relying on local enzyme activity and specific metabolic mechanisms in different tissues to exert various effects [1] - Upon oral administration, Tebrostone is rapidly metabolized into three compounds that mediate its pharmacological effects, with two metabolites exhibiting estrogen-like activity and a third metabolite showing progestogenic and androgenic activity [1] Group 2: Market and Clinical Relevance - The Tebrostone Tablets developed by Jinsai Pharmaceutical are a generic drug targeting unmet market and clinical needs [2] - A completed bioequivalence study demonstrated that Jinsai Pharmaceutical's Tebrostone Tablets are bioequivalent to the original drug and have good safety profiles, providing more treatment options for menopausal women experiencing low estrogen symptoms [2]