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国药现代(600420) - 关于药品通过仿制药一致性评价的自愿性信息披露公告
2025-06-04 09:30
证券代码:600420 证券简称:国药现代 公告编号:2025-042 上海现代制药股份有限公司 关于药品通过仿制药一致性评价的 自愿性信息披露公告 一、阿奇霉素片 (一)药品基本信息 药品名称:阿奇霉素片 通知书编号:2025B02440 剂型:片剂(薄膜衣) 规格:0.25g 注册分类:化学药品 原药品批准文号:国药准字 H20000477 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,上海现代制药股份有限公司(以下简称公司)及全资子公司国药集团 容生制药有限公司(以下简称国药容生)分别收到国家药品监督管理局核准签发 的《药品补充申请批准通知书》。现将相关情况公告如下: 上市许可持有人:上海现代制药股份有限公司 药品生产企业:上海现代制药股份有限公司 审批结论:根据《中华人民共和国药品管理法》、《国务院关于改革药品医 疗器械审评审批制度的意见》(国发〔2015〕44 号)和《关于仿制药质量和疗 效一致性评价工作有关事项的公告》(2017 年第 100 号)规定,经审查,本品 通过仿制药质量和疗效一致性评价。 (二) ...
国药现代(600420) - 关于全资子公司获得药品注册证书的公告
2025-06-04 09:30
证券代码:600420 证券简称:国药现代 公告编号:2025-043 上海现代制药股份有限公司 关于全资子公司获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,上海现代制药股份有限公司(以下简称公司)全资子公司国药集团容 生制药有限公司(以下简称国药容生)收到国家药品监督管理局核准签发的盐酸 咪达普利片《药品注册证书》。现将相关情况公告如下: 一、药品基本信息 药品名称:盐酸咪达普利片 剂型:片剂 规格:10mg 注册分类:化学药品 4 类 证书编号:2025S01648 药品批准文号:国药准字 H20254399 上市许可持有人:国药集团容生制药有限公司 药品生产企业:国药集团容生制药有限公司 申请事项:药品注册(境内生产) 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册,发给药品注册证书。 二、药品研发及市场情况 盐酸咪达普利片适用于治疗:1、原发性高血压;2、肾实质性病变所致继发 性高血压。 根据米内网数据库显示,盐酸咪达普利片 2024 ...
国药现代:子公司盐酸咪达普利片注册证书获批
news flash· 2025-06-04 09:10
Core Viewpoint - The company Guoyao Modern (600420) has received approval from the National Medical Products Administration for the registration of its product, Lisinopril Tablets, which is indicated for the treatment of primary hypertension and secondary hypertension due to renal parenchymal disease [1] Summary by Relevant Categories Product Approval - Guoyao Modern's wholly-owned subsidiary, Guoyao Rongseng, has obtained the drug registration certificate for Lisinopril Tablets, enhancing the company's competitiveness in the cardiovascular medication market [1] Market Potential - According to the Minet database, the projected sales for Lisinopril Tablets in public medical institutions across the country for 2024 is estimated at RMB 25.45 million [1] R&D Investment - The cumulative research and development investment for this project by Guoyao Rongseng amounts to approximately RMB 7.717 million [1] Financial Impact - The approval of the drug registration certificate is not expected to have a significant impact on the company's current operating performance [1]
国药现代:阿奇霉素片和二羟丙茶碱注射液通过仿制药一致性评价
news flash· 2025-06-04 09:10
Core Viewpoint - The company and its wholly-owned subsidiary have received approval for two generic drugs, which is expected to enhance market expansion and sales opportunities [1] Group 1: Drug Approvals - The company received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration for Azithromycin Tablets and Dihydrocodeine Injection [1] - Both drugs have passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 2: Market Potential - Azithromycin Tablets are indicated for infections caused by sensitive bacteria, with projected sales of 685 million yuan in public medical institutions and urban pharmacies in 2024 [1] - Dihydrocodeine Injection is used for treating bronchial asthma, with expected sales of 135 million yuan in public medical institutions in 2024 [1] - The successful evaluation is beneficial for product market expansion and sales [1]
国药现代(600420) - 关于控股子公司获得药品补充申请批准通知书的公告
2025-05-28 09:15
近日,上海现代制药股份有限公司(以下简称公司)控股子公司国药一心制 药有限公司(以下简称国药一心)收到国家药品监督管理局核准签发的《药品补 充申请批准通知书》,批准氟尿嘧啶注射液在已有规格 10ml:0.5g 的基础上新增 两个规格,发给药品批准文号。现将相关情况公告如下: 一、药品基本信息 药品名称:氟尿嘧啶注射液 剂型:注射剂 规格:10ml:0.25g、20ml:0.5g 注册分类:化学药品 通知书编号:2025B02363、2025B02347 药品批准文号:国药准字 H20258091、国药准字 H20258090 上市许可持有人:国药一心制药有限公司 药品生产企业:哈尔滨三联药业股份有限公司 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准增加 10ml:0.25g 和 20ml:0.5g 规格等申请事项。 证券代码:600420 证券简称:国药现代 公告编号:2025-041 上海现代制药股份有限公司 关于控股子公司获得药品补充申请批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性 ...
国药现代:国药一心氟尿嘧啶注射液新增规格获批
news flash· 2025-05-28 08:49
Core Viewpoint - The announcement indicates that Guoyao Modern's subsidiary, Guoyao Yixin Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the addition of two new specifications for Fluorouracil Injection, expanding its product offerings [1] Group 1: Product Information - The drug name is Fluorouracil Injection, with the new specifications being 10ml:0.25g and 20ml:0.5g [1] - The existing specification of 10ml:0.5g remains unchanged, and the drug is classified as a chemical drug [1] - The approval notification numbers for the new specifications are 2025B02363 and 2025B02347, with the corresponding drug approval numbers being Guoyao Zhunzi H20258091 and H20258090 [1] Group 2: Regulatory Approval - The approval was granted based on compliance with the relevant requirements of the Drug Administration Law of the People's Republic of China [1] - The drug is produced by Harbin Sanlian Pharmaceutical Co., Ltd., and the marketing authorization holder is Guoyao Yixin Pharmaceutical Co., Ltd. [1]
5月21日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-21 10:14
Group 1 - Huiyu Pharmaceutical's subsidiary received drug registration certificate for Carboxymethyl Sodium Injection, which is used for treating bleeding diseases in various medical fields [1] - Baihe Co., Ltd. announced a plan for a director to reduce holdings by up to 424,000 shares, representing 0.6625% of the total share capital [1] - Kingood Co., Ltd. received a notification from a global leading automaker for a wheel project, expected to start mass production in 2026 with a lifecycle of 10 years [1][2] Group 2 - Wanhua Chemical plans to repurchase shares worth between 300 million and 500 million yuan, with a maximum repurchase price of 99.36 yuan per share [2] - Warner Pharmaceutical's subsidiary received approval for Acetylcysteine raw material drug, primarily used for treating respiratory diseases [3] - ST Mingcheng plans to publicly transfer 45% equity of its subsidiary, aiming to optimize asset structure [4] Group 3 - Qixia Construction announced a plan to reduce up to 31.5 million shares, accounting for 3% of total share capital [5][6] - Zhejiang Rongtai intends to invest 20 million yuan to establish a wholly-owned subsidiary focused on intelligent robotics [7] - Yuandong Biological received drug registration for Chloral Hydrate Enema, used for sedation and seizure control in children [9] Group 4 - Jiemai Technology's subsidiary signed a strategic cooperation agreement with a solid-state battery company to produce high-safety composite conductive materials [10] - Xianju Pharmaceutical received drug registration for Progesterone Soft Capsules, used for treating functional disorders due to luteal deficiency [11] - Lanhua Kecai's subsidiary reported a temporary production halt, with the resumption date yet to be determined [13] Group 5 - Sinopharm Modern's subsidiary received drug registration for Tocilizumab Tablets, used for treating rheumatoid arthritis and other conditions [15] - Shanghai Bank announced the resignation of its vice president due to organizational adjustments [17] - Shanghai Pharmaceutical's Ephedrine Injection passed the consistency evaluation for generic drugs [19] Group 6 - Rundu Co., Ltd. received drug registration for Amlodipine and Olmesartan Tablets, aimed at treating hypertension [21] - Zhong'an Technology announced that 61 million shares held by its controlling shareholder will be auctioned [23] - Shanghai Washba plans to purchase patent assets and establish two subsidiaries focused on hydrogen energy and solid-state battery technologies [25] Group 7 - Nuo Cheng Jianhua's new drug Tafasitamab received approval for treating relapsed/refractory diffuse large B-cell lymphoma [26] - Benli Technology plans to use up to 200 million yuan of idle funds for cash management and financial investments [28] - Taiji Co., Ltd. intends to use 60 million yuan of idle funds to purchase financial products [29] Group 8 - Haishi Co. announced that its innovative drug Anreke Fen Injection received drug registration for treating postoperative pain [32] - Yulong Co. will have its stock delisted on May 27, 2025, following a decision by the Shanghai Stock Exchange [36] - Weifu High-Tech plans to establish a joint venture with Shanghai Baolong Automotive Technology [38] Group 9 - Xichang Electric Power expects a net profit reduction of approximately 5.4 million yuan due to adjustments in the time-of-use electricity pricing mechanism [39] - Alter signed a contract worth 6.8 billion yen for the development and procurement of large truck EV kits [41] - Zhonglian Heavy Industry plans to acquire controlling stakes in its financing leasing subsidiary through public bidding [42] Group 10 - Sanyou Medical's executive plans to reduce holdings by up to 1.44% of the company's shares [43] - Hangyang Co. plans to establish a subsidiary for large modular cryogenic equipment manufacturing with an estimated investment of 557 million yuan [44] - FAW Fuwi received a notification for a dashboard project from a well-known new energy brand, with total sales expected to reach 1.06 billion yuan [45]
国药现代(600420) - 关于全资子公司获得药品注册证书的公告
2025-05-21 08:01
证券代码:600420 证券简称:国药现代 公告编号:2025-040 药品名称:枸橼酸托法替布片 剂型:片剂 规格:5mg(按 C16H20N6O 计) 注册分类:化学药品 4 类 证书编号:2025S01252 上海现代制药股份有限公司 关于全资子公司获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,上海现代制药股份有限公司(以下简称公司)全资子公司国药集团容 生制药有限公司(以下简称国药容生),收到国家药品监督管理局核准签发的枸 橼酸托法替布片《药品注册证书》。现将相关情况公告如下: 一、药品基本信息 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册,发给药品注册证书。 药品批准文号:国药准字 H20254068 上市许可持有人:国药集团容生制药有限公司 药品生产企业:国药集团容生制药有限公司 二、药品研发及市场情况 枸橼酸托法替布片是一种新型的口服蛋白酪氨酸激酶抑制剂,临床适用于类 风湿关节炎、银屑病关节炎、强直性脊柱炎等。 米内网数据库显 ...
国药现代:全资子公司获得枸橼酸托法替布片药品注册证书
news flash· 2025-05-21 07:41
Core Viewpoint - The announcement indicates that China National Pharmaceutical Group Modern has received approval for a new drug, tofacitinib citrate tablets, which is expected to enhance its product portfolio in the oncology and immunomodulatory sectors [1] Group 1: Drug Approval and Market Impact - The full subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., has obtained the drug registration certificate for tofacitinib citrate tablets from the National Medical Products Administration [1] - Tofacitinib citrate tablets are a novel oral protein tyrosine kinase inhibitor, clinically applicable for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1] - According to the Meini Network database, the projected sales for public medical institutions in China for 2024 is approximately RMB 477 million [1] Group 2: R&D Investment and Competitive Position - The cumulative R&D investment for the development of tofacitinib citrate tablets by China National Pharmaceutical Group Rongsheng is about RMB 15.5368 million [1] - The approval of the drug registration certificate, which is considered equivalent to passing the consistency evaluation, will enrich the company's formulation product line in the oncology and immunomodulatory fields [1] - This development is expected to enhance the company's comprehensive market competitiveness in related medication areas [1]
动物疫苗概念上涨4.00%,6股主力资金净流入超千万元
Zheng Quan Shi Bao Wang· 2025-05-20 08:54
Core Viewpoint - The animal vaccine sector has shown a significant increase, with a 4.00% rise, ranking third among concept sectors, driven by notable gains in several stocks [1][2]. Group 1: Sector Performance - As of May 20, the animal vaccine concept increased by 4.00%, with 19 stocks rising, including *ST Xianfeng, which hit the daily limit, and others like Kexing Pharmaceutical, Ruipu Biological, and Kanghua Biological, which rose by 15.56%, 8.41%, and 6.70% respectively [1][2]. - The animal vaccine sector was among the top-performing sectors, alongside cultivated diamonds and pet economy, which rose by 4.10% and 4.08% respectively [2]. Group 2: Capital Inflow - The animal vaccine sector saw a net inflow of 67 million yuan, with 13 stocks receiving net inflows, and 6 stocks attracting over 10 million yuan in net inflows [2]. - Jinhe Biological led the net inflow with 36.88 million yuan, followed by Kexing Pharmaceutical, Dabeinong, and Plk, which received net inflows of 15.38 million yuan, 13.79 million yuan, and 13.60 million yuan respectively [2][3]. Group 3: Capital Flow Ratios - Stocks such as *ST Xianfeng, Kexing Pharmaceutical, and KQ Biotech had the highest net inflow ratios, at 14.17%, 6.56%, and 5.52% respectively [3]. - The top stocks in terms of capital inflow included Jinhe Biological with a turnover rate of 18.22% and a daily increase of 4.40%, and Kexing Pharmaceutical with a turnover rate of 3.46% and a daily increase of 15.56% [3][4].