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鲁抗医药子公司获得非那雄胺片药品注册证书
Zhi Tong Cai Jing· 2025-12-26 10:00
鲁抗医药(600789)(600789.SH)发布公告,近日,公司控股子公司山东鲁抗医药集团赛特有限责任公 司(简称"赛特公司")收到国家药品监督管理局颁发的关于非那雄胺片的《药品注册证书》(批件号: 2025S03900、2025S03901),该药品是按照新注册分类4类获批的仿制药,视为通过仿制药质量和疗效一 致性评价。 非那雄胺是一种合成的甾体类化合物,它是雄激素睾酮代谢成为双氢睾酮(DHT)过程中的细胞内酶II型 5α还原酶的特异性抑制剂。良性前列腺增生(BPH)或称作前列腺肥大取决于前列腺中睾酮向DHT的转 化。本品能非常有效地减少血液和前列腺内DHT。本品1mg规格适用于治疗男性秃发(雄激素性秃发), 能促进头发生长并防止继续脱发;5mg规格适用于治疗和控制良性前列腺增生(BPH)以及预防泌尿系统事 件,本品可使肥大的前列腺缩小,改善尿流及改善前列腺增生有关的症状。 ...
鲁抗医药(600789.SH)子公司获得非那雄胺片药品注册证书
智通财经网· 2025-12-26 09:57
非那雄胺是一种合成的甾体类化合物,它是雄激素睾酮代谢成为双氢睾酮(DHT)过程中的细胞内酶II型 5α还原酶的特异性抑制剂。良性前列腺增生(BPH)或称作前列腺肥大取决于前列腺中睾酮向DHT的转 化。本品能非常有效地减少血液和前列腺内DHT。本品1mg规格适用于治疗男性秃发(雄激素性秃发), 能促进头发生长并防止继续脱发;5mg规格适用于治疗和控制良性前列腺增生(BPH)以及预防泌尿系统事 件,本品可使肥大的前列腺缩小,改善尿流及改善前列腺增生有关的症状。 智通财经APP讯,鲁抗医药(600789.SH)发布公告,近日,公司控股子公司山东鲁抗医药集团赛特有限 责任公司(简称"赛特公司")收到国家药品监督管理局颁发的关于非那雄胺片的《药品注册证书》(批件 号:2025S03900、2025S03901),该药品是按照新注册分类4类获批的仿制药,视为通过仿制药质量和疗 效一致性评价。 ...
鲁抗医药:控股子公司获非那雄胺片《药品注册证书》
Xin Lang Cai Jing· 2025-12-26 09:37
鲁抗医药公告称,其控股子公司赛特公司收到国家药监局颁发的非那雄胺片《药品注册证书》,规格为 5mg、1mg,该药品按新注册分类4类获批仿制药,视为通过一致性评价。非那雄胺可减少血液和前列 腺内DHT,不同规格有不同疗效。2022 - 2025年上半年全国医院总销售额分别约4.69亿元、4.83亿元、 4.90亿元、3.43亿元。此次获证利于公司优化产品结构,不过药品产销受政策、市场等因素影响,存在 不确定性。 ...
鲁抗医药:控股子公司赛特公司获得非那雄胺片药品注册证书
Mei Ri Jing Ji Xin Wen· 2025-12-26 09:29
每经AI快讯,12月26日,鲁抗医药(600789)(600789.SH)公告称,公司控股子公司赛特公司收到国家 药品监督管理局颁发的非那雄胺片《药品注册证书》,该药品为按照新注册分类4类获批的仿制药,视 为通过仿制药质量和疗效一致性评价。本品能非常有效地减少血液和前列腺内DHT。本品1mg规格适用 于治疗男性秃发(雄激素性秃发),能促进头发生长并防止继续脱发;5mg规格适用于治疗和控制良性前 列腺增生(BPH)以及预防泌尿系统事件,本品可使肥大的前列腺缩小,改善尿流及改善前列腺增生有关 的症状。赛特公司累计研发投入约为人民币350万元。该药品的获批对公司优化产品结构、保持稳定生 产能力和满足市场需求有积极影响,但药品生产和销售受政策、市场环境等影响,存在不确定性。 ...
鲁抗医药(600789.SH):控股子公司获得药品注册证书
Ge Long Hui A P P· 2025-12-26 09:28
非那雄胺是一种合成的甾体类化合物,它是雄激素睾酮代谢成为双氢睾酮(DHT)过程中的细胞内酶 II 型 5α还原酶的特异性抑制剂。良性前列腺增生(BPH) 或称作前列腺肥大取决于前列腺中睾酮向 DHT 的转化。本品能非常有效地减少血液和前列腺内 DHT。 本品 1mg 规格适用于治疗男性秃发(雄激素性秃发),能促进头发生长并防止继续脱发;5mg 规格适用于 治疗和控制良性前列腺增生(BPH)以及预防泌尿系统事件,本品可使肥大的前列腺缩小,改善尿流及改 善前列腺增生有关的症状。 目前国内共有46个非那雄胺片生产批文。截至本公告日,共有24 家企业29个批文通过或视同通过仿制 药质量与疗效一致性评价审批。根据药智数据显示,非那雄胺片2022年、2023年、2024年、2025年上半 年全国医院总销售额分别约为4.69亿元、4.83亿元、4.90亿元、3.43亿元。 格隆汇12月26日丨鲁抗医药(600789.SH)公布,近日,公司控股子公司山东鲁抗医药集团赛特有限责任 公司收到国家药品监督管理局颁发的关于非那雄胺片的《药品注册证书》(批件号:2025S03900、 2025S03901),该药品是按照新注册分类4类 ...
鲁抗医药:非那雄胺片获得药品注册证书
人民财讯12月26日电,鲁抗医药(600789)12月26日公告,控股子公司赛特公司收到国家药监局颁发的 关于非那雄胺片的《药品注册证书》,该药品是按照新注册分类4类获批的仿制药,视为通过仿制药质 量和疗效一致性评价。 ...
深度 | 蔓迪港股递表,引爆防脱“新战局”
FBeauty未来迹· 2025-11-25 14:18
Core Insights - The core viewpoint of the article is that the power dynamics in China's anti-hair loss market have shifted from traditional daily chemical brands to pharmaceutical companies, driven by a growing consumer base and evolving market demands [4][5]. Market Dynamics - The anti-hair loss market in China has seen a significant transformation, with over 300 million people affected by hair loss, particularly among the 26-35 age group, indicating a shift from a minor issue to a widespread concern [4]. - Pharmaceutical companies, particularly those with OTC pipelines and dermatological resources, have emerged as the primary players in the market, leading to a dual oligopoly dominated by Sanofi's Mandi and Zhendong Pharmaceutical's Dafeixin [4][8]. - The market for anti-hair loss products has reached 5.247 billion yuan in sales within the first ten months of 2025, reflecting a year-on-year growth of over 47% [10][13]. Brand Strategies - Pharmaceutical companies are creating a new narrative of "anti-hair loss = medicine + consumer," leveraging high margins and professional barriers while extending their product lines into daily care categories [5][19]. - Brands like Mandi and Dafeixin are combining pharmaceutical and cosmetic products, promoting them through "scientific anti-hair loss salons" to capture consumer interest [6][9]. Competitive Landscape - Traditional daily chemical brands are struggling, with companies like Bawang reporting a significant decline in profits despite a slight revenue increase, highlighting a structural challenge in the market [8]. - The consumer focus has shifted from "shampoo for hair loss" to "medical treatment and scalp management," indicating a demand for more scientifically-backed solutions [9][10]. Emerging Trends - The average price of anti-hair loss products has risen to over 113 yuan, suggesting consumers are willing to invest more in effective scalp care solutions [13]. - New brands such as EHD and Off&Relax are gaining traction, with EHD leading in sales at 371 million yuan, showcasing a trend towards professional and functional care [16][18]. Future Directions - To compete effectively, beauty brands must transition from traditional narratives to scientific and medical language, focusing on the mechanisms behind hair loss and scalp health [19][23]. - The integration of devices with hair care products is emerging as a trend, with brands like Kérastase introducing scalp care devices that enhance treatment efficacy [25][27]. Conclusion - The anti-hair loss market is evolving into a sector characterized by scientific, medical, and long-term management approaches, with pharmaceutical companies redefining the rules and traditional brands being compelled to adapt [19].
新华制药股价下跌1.71% 子公司获非那雄胺片药品注册证书
Jin Rong Jie· 2025-08-06 19:57
Core Viewpoint - Xinhua Pharmaceutical's stock price decreased by 1.71% to 16.69 yuan, with a trading volume of 190,900 hands and a transaction amount of 321 million yuan [1] Company Overview - Xinhua Pharmaceutical is primarily engaged in the research, production, and sales of chemical raw materials, formulations, and pharmaceutical intermediates, covering various therapeutic areas including antipyretic and analgesic, cardiovascular, anti-infection, and nervous system [1] Recent Developments - On August 5, the company announced that its wholly-owned subsidiary, Xinda Pharmaceutical, received approval from the National Medical Products Administration for the registration certificate of Finasteride tablets, which are used to treat benign prostatic hyperplasia and are classified as a Category B drug under medical insurance [1] - Public data indicates that the sales revenue of this drug in Chinese public medical institutions is expected to be approximately 1.45 billion yuan in 2024 [1] Financial Flow - On the day of the stock price decline, the net outflow of main funds for Xinhua Pharmaceutical was 26.63 million yuan, with a cumulative net outflow of 90.37 million yuan over the past five days [1]
最高法披露骗保典型案例;480家药企竞逐第十一批集采 | 健讯Daily
Regulatory Changes - The National Health Commission has issued a notice prohibiting medical institutions from using misleading names for outpatient services that imply efficacy, emphasizing the need for clear and accurate naming practices [1] Drug Procurement - The National Medical Insurance Administration announced that 480 pharmaceutical companies are competing in the 11th batch of national drug procurement, with 55 drugs proposed for inclusion, averaging 15 companies per drug, and some drugs having over 40 participating companies [2] Legal Actions Against Fraud - The Supreme People's Court reported a significant increase in the prosecution of medical insurance fraud cases, with 1,156 cases involving 2,299 individuals concluded in 2024, marking a 131.2% year-on-year increase and recovering over 402 million yuan in lost funds [3] Drug Approvals - Innovent Biologics announced that its oral GLP-1R agonist IBI3032 has received FDA approval for clinical trials, with plans to initiate Phase I trials in mid-2025 targeting overweight or obese individuals [4] - Dyne Therapeutics received breakthrough therapy designation from the FDA for its investigational therapy DYNE-251 for Duchenne muscular dystrophy, with data expected by the end of 2025 [5] - Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, has received a drug registration certificate for Finasteride tablets, which are included in the national medical insurance drug list [6][7] Mergers and Acquisitions - Shanghai TuoJing announced the acquisition of 82% of Wuhan Kanglu Biological for 328 million yuan, focusing on advancements in molecular diagnostics [8] Financial Performance - Jiuzhou Pharmaceutical reported a 3.86% increase in revenue to 2.871 billion yuan and a 10.7% increase in net profit to 526 million yuan for the first half of 2025 [10] Strategic Investments - Yabao Pharmaceutical plans to acquire a traditional Chinese medicine project for 22 million yuan, enhancing its R&D pipeline and competitive edge [11] Shareholder Actions - Chenshin Pharmaceutical announced that a major shareholder plans to reduce their stake by up to 3% through market transactions, which is not expected to significantly impact the company's governance or operations [12]
新华制药:全资子公司获得非那雄胺片药品注册证书
Zheng Quan Ri Bao Wang· 2025-08-05 12:41
Core Viewpoint - Xinhua Pharmaceutical (000756) announced that its wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Finasteride tablets from the National Medical Products Administration [1] Company Summary - Xinhua Pharmaceutical's subsidiary has successfully obtained regulatory approval for Finasteride tablets, indicating a significant milestone in expanding its product portfolio [1]