替勃龙片
Search documents
长春高新:关于子公司替勃龙片在境内获批上市的公告
Zheng Quan Ri Bao· 2025-09-29 10:50
Core Viewpoint - Changchun Gaoxin announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing of Teborone tablets in China [2] Company Summary - Changchun Gaoxin's subsidiary, Changchun Jinsai Pharmaceutical, has successfully obtained a drug registration certificate for Teborone tablets [2]
长春高新(000661.SZ):子公司替勃龙片在境内获批上市
Ge Long Hui A P P· 2025-09-29 08:34
Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received the Drug Registration Certificate approved by the National Medical Products Administration, allowing the launch of Tibralon Tablets in the domestic market [1] Company Summary - Jinsai Pharmaceutical has developed Tibralon Tablets, which are classified as a selective estrogen receptor modulator, specifically designed to treat low estrogen symptoms caused by natural or surgical menopause in women [1] - Tibralon Tablets are categorized as a Class 4 oral chemical drug [1]
长春高新:子公司替勃龙片和绒促卵泡激素α N02注射液在境内获批上市
Zheng Quan Shi Bao Wang· 2025-09-29 08:30
Group 1 - The core point of the article is that Changchun High-tech (000661) announced the approval of two drugs by the National Medical Products Administration for market launch in China [1] Group 2 - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received the drug registration certificate for Tebentafusp tablets, which has been approved for sale in the domestic market [1] - The company also announced that its subsidiary received the drug registration certificate for Follitropin αN02 injection, which has also been approved for sale in the domestic market [1]
长春高新(000661.SZ)子公司替勃龙片在境内获批上市
智通财经网· 2025-09-29 08:28
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]
长春高新子公司替勃龙片在境内获批上市
智通财经网· 2025-09-29 08:27
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]
长春高新:子公司替勃龙片在境内获批上市
Ge Long Hui· 2025-09-29 08:19
Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing of its drug, Teibolong Tablets, in China [1] Group 1: Company Information - Changchun Jinsai Pharmaceutical has developed Teibolong Tablets, which are classified as a selective estrogen receptor modulator [1] - The drug is categorized as a Class 4 oral chemical medication [1] - Teibolong Tablets are intended for the treatment of low estrogen symptoms caused by natural or surgical menopause in women [1]