Workflow
制药
icon
Search documents
恒瑞医药(600276.SH):1类创新药SHR-1918注射液药品上市许可申请获受理并纳入优先审评程序
智通财经网· 2026-02-24 09:59
SHR-1918注射液是公司自主研发的血管生成素样蛋白3(ANGPTL3)单克隆抗体,通过抑制ANGPTL3的 活性,从而降低血清中的甘油三酯(TG)和LDL-C水平。目前,全球范围内同靶点药物有再生元公司的 EVKEEZA®(evinacumab-dgnb) 获批上市。经查询EvaluatePharma数据库,该产品2025年全球销售额约 为2.16亿美元。截至目前,SHR-1918注射液相关项目累计研发投入约24,220万元(未经审计)。 智通财经APP讯, 恒瑞医药(600276.SH)发布公告,近日,公司子公司北京盛迪医药有限公司收到国家 药品监督管理局(以下简称"国家药监局")下发的《受理通知书》,公司1类创新药SHR-1918注射液的药 品上市许可申请获受理,且已被纳入优先审评程序。 ...
长春高新(000661.SZ):GenSci141软膏境内生产药品注册临床试验申请获批准
智通财经网· 2026-02-24 09:57
该药品适应症:用于改善因高促性腺激素性性腺功能减退症、5α-还原酶2缺乏症、雄激素合成减少的先 天性肾上腺皮质增生症、特发性的原因导致的儿童小阴茎。 智通财经APP讯,长春高新(000661.SZ)公告,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《药物临床试验批准通知书》,金赛药业GenSci141软膏境内 生产药品注册临床试验申请获得批准。 ...
鲁抗医药(600789.SH):米诺地尔搽剂获得药品注册证书
智通财经网· 2026-02-24 09:57
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(以下简称"赛特公司")收到国家药品监督管理局颁发的关于米诺地尔搽剂(以下简称"该药品") 的《药品注册证书》(批件号:2026S00478、2026S00479),该药品是按照新注册分类3类获批的仿制 药,视为通过仿制药质量和疗效一致性评价。 ...
康哲药业:磷酸芦可替尼乳膏增加特应性皮炎(AD)适应症新药上市许可申请获受理
Jin Rong Jie· 2026-02-24 09:57
康哲药业公告,旗下德镁医药已于2026年2月24日获得中国国家药品监督管理局(NMPA)受理磷酸芦 可替尼乳膏(产品)轻中度特应性皮炎(AD)的新药上市许可申请(NDA)。产品拟用于其他外用药 控制不佳或不建议使用时,非免疫功能受损的2岁及以上儿童和成人轻中度特应性皮炎的局部短期和非 持续性慢性治疗。此次增加AD适应症NDA获受理,是产品向多治疗领域拓展的关键里程碑。 ...
康哲药业:创新药磷酸芦可替尼乳膏增加特应性皮炎(AD)适应症中国上市许可申请获受理并获纳入优先审评
Zhi Tong Cai Jing· 2026-02-24 09:55
Core Viewpoint - 康哲药业's subsidiary, 德镁医药, is applying for an independent listing on the Hong Kong Stock Exchange and has received acceptance for a new drug application for a topical treatment for atopic dermatitis [1] Group 1: Product Development - 德镁医药 has received acceptance from the National Medical Products Administration (NMPA) for the new drug application (NDA) of phosphoric acid lukastin cream for the treatment of mild to moderate atopic dermatitis (AD) [1] - The product is intended for short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in children aged 2 years and older and adults, particularly when other topical medications are ineffective or not recommended [1] - The NDA has been included in the priority review list by the NMPA due to its compliance with the characteristics of pediatric medications, which is expected to expedite the review process for the AD indication [1] Group 2: Market Position - Phosphoric acid lukastin cream was approved by the NMPA in January 2026, becoming the first and only targeted drug approved in China for the treatment of vitiligo [1] - The acceptance of the NDA for the AD indication marks a significant milestone for the product, expanding its application into multiple treatment areas [1]
长风药业2月24日斥资99.74万港元回购2.7万股
Zhi Tong Cai Jing· 2026-02-24 09:55
长风药业(02652)发布公告,该公司于2026年2月24日斥资99.74万港元回购2.7万股股份,每股回购价格 为36.6-37.18港元。 ...
长风药业(02652.HK)2月24日耗资99.74万港元回购2.7万股
Ge Long Hui· 2026-02-24 09:53
格隆汇2月24日丨长风药业(02652.HK)发布公告,2026年2月24日耗资99.74万港元回购2.7万股,回购价 格每股36.6-37.18港元。 ...
康哲药业(00867.HK):创新药磷酸芦可替尼乳膏增加特应性皮炎(AD)适应症中国上市许可申请获受理并获纳入优先审评
Ge Long Hui· 2026-02-24 09:53
Core Viewpoint - Kangzheng Pharmaceutical (00867.HK) is applying for an independent listing of its subsidiary, Demy Pharmaceutical, on the Hong Kong Stock Exchange, with a focus on innovative medicines for skin health [1] Group 1: Product Development - Demy Pharmaceutical has received acceptance from the National Medical Products Administration (NMPA) for the New Drug Application (NDA) of phosphoric acid lukotini cream for the treatment of mild to moderate atopic dermatitis (AD) [1] - The product is intended for short-term and non-continuous chronic treatment of mild to moderate AD in children aged 2 years and older and adults, particularly when other topical medications are poorly controlled or not recommended [1] - The NDA has been included in the priority review list by the NMPA due to its compliance with the characteristics of pediatric medications, which is expected to expedite the review process for the AD indication [1] Group 2: Market Position - Phosphoric acid lukotini cream was approved by the NMPA in January 2026, becoming the first and only targeted drug approved in China for the treatment of vitiligo [1] - The acceptance of the NDA for the AD indication marks a significant milestone for the product, expanding its application into multiple therapeutic areas [1]
康哲药业(00867):创新药磷酸芦可替尼乳膏增加特应性皮炎(AD)适应症中国上市许可申请获受理并获纳入优先审评
智通财经网· 2026-02-24 09:53
智通财经APP讯,康哲药业(00867)发布公告,旗下德镁医药有限公司("德镁医药",专业聚焦皮肤健康 的创新型医药企业,正申请于香港联合交易所有限公司主板独立上市)已于2026年2月24日获得中国国家 药品监督管理局(NMPA)受理磷酸芦可替尼乳膏("产品")轻中度特应性皮炎("AD")的新药上市许可申请 (NDA)。产品拟用于其他外用药控制不佳或不建议使用时,非免疫功能受损的2岁及以上儿童和成人轻 中度特应性皮炎的局部短期和非持续性慢性治疗。且该项NDA因"符合儿童生理特征的儿童用药品新品 种、剂型和规格",已获得NMPA药品审评中心批准纳入优先审评品种名单,有望加快产品AD适应症上 市审评进程。 此外,磷酸芦可替尼乳膏已于2026年1月获得NMPA批准上市,成为中国批准的首款且唯一用于白癜风 治疗的靶向药。此次增加AD适应症NDA获受理,是产品向多治疗领域拓展的关键里程碑。 ...
美股异动|诺和诺德盘前续跌逾2% 实验效果不及礼来
Ge Long Hui· 2026-02-24 09:53
| NVO 诺和诺德 | | | | --- | --- | --- | | 39.630 4 -7.790 -16.43% | | 收盘价 02/23 15:59 美东 | | 38.790 + -0.840 -2.12% | | 盘前价 02/24 04:43 美东 | | 一 24 24 4 8 8 8 目 0 自选 | | ● 快捷交易 | | 最高价 41.090 | 开盘价 40.190 | 成交量 9866.4万 | | 最低价 39.340 | 昨收价 47.420 | 成交额 39.61亿 | | 平均价 40.148 | 市盈率TM 10.90 总市值 1769.48亿 ( ... ) | | | 振 幅 3.69% | 市盈率(静) 10.90 | 总股本 44.65亿 | | 换手率 3.09% | 市净率 5.778 | 流通值 1264.15亿 | | 52周最高 89.377 | 委 比 -- | 流通股 31.9亿 | | 52周最低 39.340 | 量 比 9.46 | 每 手 1股 | | 历史最高 143.542 股息TTM 1.826 | | | | 历史最低 -2. ...