阿那曲唑
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以岭药业“盐酸美金刚”原料药上市获批
Zheng Quan Shi Bao· 2025-11-12 18:32
11月12日晚间,以岭药业(002603)发布公告称,公司全资孙公司衡水万洋收到国家药品监督管理局下 发的《化学原料药上市申请批准通知书》,由衡水万洋提交的"盐酸美金刚"化学原料药上市申请已获批 准。 无独有偶,就在十几天前,以岭药业还有另一款化学原料药上市申请获批。据公告,由衡水万洋提交 的"阿那曲唑"化学原料药上市申请已获国家药品监督管理局批准。 据介绍,盐酸美金刚(MemantineHydrochloride)是一种电压依赖性、中等程度亲和力的非竞争性NMDA 受体拮抗剂,它可以阻断谷氨酸浓度病理性升高导致的神经元损伤,治疗中重度至重度阿尔茨海默型痴 呆。 阿那曲唑(Anastrozole)是一种广泛应用于治疗雌激素相关肿瘤的药物。以岭药业表示,公司全资孙公司 北京以岭生物持有阿那曲唑片制剂批文,该产品为集采产品,预计今年可实现原料药制剂一体化生产, 有力提高原料药和制剂的市场竞争力。另外,公司将以本次国内获批为契机,根据出海规划,加速推进 阿那曲唑原料药的国际注册和海外销售,进一步打开欧美等海外市场。 2024《中国阿尔茨海默病报告》显示,全国现存痴呆患者约1690万人,患病率约1.19‰,随人口老龄 ...
以岭药业盐酸美金刚原料药获上市申请批准 用于治疗中重度至重度阿尔茨海默型痴呆
Zheng Quan Shi Bao Wang· 2025-11-12 11:53
11月12日晚间,以岭药业(002603)发布公告称,公司全资孙公司衡水万洋收到国家药品监督管理局下 发的《化学原料药上市申请批准通知书》,由衡水万洋提交的"盐酸美金刚"化学原料药上市申请已获批 准。 据介绍,盐酸美金刚(MemantineHydrochloride)是一种电压依赖性、中等程度亲和力的非竞争性NMDA 受体拮抗剂,它可以阻断谷氨酸浓度病理性升高导致的神经元损伤,治疗中重度至重度阿尔茨海默型痴 呆。 据2024《中国阿尔茨海默病报告》显示,全国现存痴呆患者约1690万人,患病率约1.19‰,随人口老龄 化呈现快速上升的趋势。米内网数据显示,中国抗痴呆市场规模15.6亿元,其中美金刚是一线治疗药 物,市场份额22%。2025年,中国盐酸美金刚市场容量预计达到3.4亿元,同比增长11%;销售量1.6亿 片,同比增长19%,销售呈现持续增长的趋势。 公告称,盐酸美金刚被我国和FDA批准用于中重度AD患者,是国内外指南推荐的一线药物。预计随着 中国人口老龄化的进程加快,盐酸美金刚的市场需求将稳步上升。目前国内已有多家盐酸美金刚原料供 应商,衡水万洋将以本次国内获批为契机,提升市场份额。 无独有偶,就在十 ...
以岭药业:收到化学原料药上市申请批准通知书
Zheng Quan Ri Bao Wang· 2025-10-29 13:41
Core Viewpoint - Yiling Pharmaceutical (002603) announced the approval of its subsidiary Hengtai Wanyang's application for the chemical raw material drug Anastrozole by the National Medical Products Administration [1] Group 1 - Yiling Pharmaceutical's wholly-owned subsidiary, Hengtai Wanyang Pharmaceutical Co., Ltd., received the approval notice for the listing application of Anastrozole [1]
以岭药业:孙公司获得阿那曲唑化学原料药上市申请批准
Zheng Quan Shi Bao Wang· 2025-10-29 08:28
Core Viewpoint - Yiling Pharmaceutical (002603) announced that its wholly-owned subsidiary, Wanyang Hengshui Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of Anastrozole, a drug used primarily for treating estrogen-related tumors, particularly in postmenopausal women with hormone receptor-positive breast cancer [1]. Company Summary - Yiling Pharmaceutical's subsidiary, Wanyang Hengshui, has successfully obtained a marketing approval for Anastrozole [1]. - Anastrozole is widely used in the treatment of estrogen-related tumors, especially in postmenopausal women with HR+ breast cancer [1].
以岭药业:全资孙公司阿那曲唑原料药获上市申请批准通知书
Xin Lang Cai Jing· 2025-10-29 08:24
Core Viewpoint - Yiling Pharmaceutical (002603.SZ) announced that its wholly-owned subsidiary, Wanyang Hengshui Pharmaceutical Co., Ltd., has received the approval notice for the listing application of Anastrozole chemical raw material from the National Medical Products Administration [1] Group 1: Product Approval - The listing application for Anastrozole, a drug widely used for treating estrogen-related tumors, particularly in postmenopausal hormone receptor-positive (HR+) female breast cancer patients, has been approved [1] - Yiling Pharmaceutical's wholly-owned subsidiary, Beijing Yiling Biotechnology Co., Ltd., holds the formulation approval for Anastrozole tablets, which are part of a centralized procurement product [1] Group 2: Production Integration - The company expects to achieve integrated production of raw materials and formulations for Anastrozole this year [1]