证券日报网讯 9月29日晚间，长春高新发布公告称，近日，公司子公司长春金赛药业有限责任公司收到 国家药品监督管理局核准签发的《药品注册证书》，其申报的替勃龙片已在境内获批上市。 （文章来源：证券日报） ...

格隆汇9月29日丨长春高新(000661.SZ)公布，子公司长春金赛药业有限责任公司（简称"金赛药业"）收 到国家药品监督管理局核准签发的《药品注册证书》，其申报的替勃龙片已在境内获批上市，替勃龙片 是金赛药业研发的一种组织选择性雌性激素活性调节剂，属于化学药品4类口服片剂，用于治疗妇女自 然绝经和手术绝经所引起的低雌激素症状。 ...

人民财讯9月29日电，长春高新（000661）9月29日公告，近日，公司子公司长春金赛药业有限责任公司 (简称"金赛药业")收到国家药品监督管理局核准签发的《药品注册证书》，其申报的替勃龙片已在境内 获批上市。 此外，公司公告称，公司子公司金赛药业收到国家药品监督管理局核准签发的《药品注册证书》，其申 报的绒促卵泡激素αN02注射液已在境内获批上市。 ...

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]

格隆汇9月29日｜长春高新公告，子公司长春金赛药业有限责任公司近日收到国家药品监督管理局核准 签发的《药品注册证书》，其申报的替勃龙片已在境内获批上市。替勃龙片是金赛药业研发的一种组织 选择性雌性激素活性调节剂，属于化学药品4类口服片剂，用于治疗妇女自然绝经和手术绝经所引起的 低雌激素症状。 ...