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ST葫芦娃(605199.SH):小儿肺热咳喘颗粒获准开展临床试验
智通财经网· 2025-09-15 10:10
Group 1 - The company ST HuLuWa (605199.SH) has received approval from the National Medical Products Administration for clinical trials of its pediatric product, "Pediatric Lung Heat Cough and Wheezing Granules," intended for use in treating influenza in children [1]
ST葫芦娃:小儿肺热咳喘颗粒获得药物临床试验批准通知书
Ge Long Hui· 2025-09-15 10:06
Core Viewpoint - ST HuLuWa (605199.SH) has received approval from the National Medical Products Administration for clinical trials of its pediatric lung heat cough and asthma granules, indicating a significant step in the development of this product [1] Company Summary - The clinical trial approval pertains to the improved formulation of the already marketed "Pediatric Lung Heat Cough and Asthma Granules" (National Drug Approval Number Z20033152) [1] - The new formulation aims to expand the therapeutic indications to include "lung heat syndrome caused by influenza" in addition to its original functions [1]
ST葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司关于获得药物临床试验批准通知书的公告
2025-09-15 10:00
证券代码:605199 证券简称:ST 葫芦娃 公告编号:2025-068 海南葫芦娃药业集团股份有限公司 关于获得药物临床试验批准通知书的公告 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、准确性和完整性承担法律责任。 海南葫芦娃药业集团股份有限公司(以下简称"公司")近日收 到国家药品监督管理局(以下简称"国家药监局")核准签发的关于 小儿肺热咳喘颗粒的《药物临床试验批准通知书》,同意本品开展临 床试验。现将有关情况公告如下: 一、药品基本情况 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,2025 年 7 月 2 日受理的小儿肺热咳喘颗粒临床试验申请符合药 品注册的有关要求,在进一步完善临床试验方案的基础上,同意本品 开展用于儿童流行性感冒的临床试验。 二、药品研发及相关情况 本次申请进行的临床试验是在公司持有的已上市的"小儿肺热咳 喘颗粒"(国药准字 Z20033152)基础上进行改良研制,在原功能主 治的基础上增加"流行性感冒属热毒袭肺证者"。 根据国家药监局关于发布《中药注册分类及申报资料要求》的通 告(2020 年第 68 ...
ST葫芦娃(605199.SH):小儿肺热咳喘颗粒获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-09-15 09:57
Core Viewpoint - ST HuLuWa (605199.SH) has received approval from the National Medical Products Administration for clinical trials of its pediatric lung heat cough and asthma granules, indicating a significant step in product development and potential market expansion [1] Company Summary - The clinical trial approval pertains to the improvement and development of the existing product "Pediatric Lung Heat Cough and Asthma Granules" (National Drug Approval Number Z20033152) [1] - The new formulation aims to enhance the original function by adding treatment for "lung heat syndrome caused by influenza" [1]
9月5日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-05 10:19
Group 1 - Huaneng Power announced that its shareholder Hunan Energy Group plans to reduce its stake by up to 20.31 million shares, not exceeding 1% of the total share capital [1] - Ankai Bus reported a production of 1,012 buses in August, a year-on-year increase of 68.06%, with sales of 773 buses, up 46.95% year-on-year [1] - Lianhuan Pharmaceutical received a drug registration certificate for Famotidine injection, classified as a Class 3 chemical drug [1][2] Group 2 - Dongrui Co. reported sales of 94,800 pigs in August, generating revenue of 160 million yuan, a month-on-month decrease of 5.48% [3] - Tiancheng Control's subsidiary received a notification for a passenger car seat assembly project, expected to start production in April 2026 [5] - ST Huluwa obtained a drug registration certificate for Cefodizime capsules, a third-generation broad-spectrum cephalosporin [6] Group 3 - Jiulong Biotech announced the resignation of its Vice Chairman and General Manager Liang Hongjun due to work adjustments [8] - Guanhua High-tech's shareholder plans to reduce its stake by up to 17.50 million shares, not exceeding 1% of the total share capital [9] - Hebei Steel received approval to issue bonds totaling up to 10 billion yuan [10] Group 4 - Yunnan Energy Investment's subsidiaries received a total of 309 million yuan in renewable energy price subsidies [12] - Zhenghong Technology reported sales of 16,800 pigs in August, with a revenue of 22.87 million yuan, showing a year-on-year increase in sales volume of 63.31% [14] - Jilin Aodong's subsidiary received a drug registration certificate for a solution used in asthma treatment [16] Group 5 - Aonong Biological reported a 26.84% year-on-year increase in pig sales volume in August, reaching 150,100 pigs [18] - Xingdesheng announced a share repurchase plan with a budget of 15 to 30 million yuan [20] - Yueyang Lin Paper's Chairman Ye Meng resigned due to work adjustments [22] Group 6 - Kangchen Pharmaceutical's controlling shareholder plans to reduce its stake by up to 4.78 million shares, not exceeding 3% of the total share capital [23] - Changchun Yidong's General Manager Liu Xiaodong resigned due to work adjustments [25] - Zhongzai Resources' subsidiary received a government subsidy of 12.75 million yuan [26] Group 7 - Tianyu Biological reported a 41.89% month-on-month increase in sales revenue from pig sales in August [27] - Changfei Optical's shareholder Draka Comteq B.V. reduced its stake from 10% to 5% [27] - Zhongchuan Technology's Chairman Wu Xingwang resigned due to work adjustments [28] Group 8 - Huakang Clean announced a successful bid for a medical service construction project valued at 131 million yuan [29] - Yuegui Co. plans to establish a wholly-owned subsidiary with a registered capital of 100 million yuan [31] - Baisheng Intelligent's Vice General Manager and Board Secretary Huang Lijun resigned for personal reasons [32] Group 9 - Jiangsu Shuntian will change its stock name to "Suhao Fashion" starting September 10, 2025 [34] - Jiahe Meikang's shareholder plans to reduce its stake by up to 1.3759 million shares, not exceeding 1% of the total share capital [35] - Heng Rui Pharmaceutical received approval for clinical trials of HRS-4729 injection [37] Group 10 - Changfei Optical's shareholder plans to reduce its stake by up to 110,000 shares, not exceeding 0.15% of the total share capital [39] - Yutong Bus reported sales of 4,260 vehicles in August, a year-on-year increase of 16.78% [40] - JinkoSolar received 646 million yuan in renewable energy subsidies in August, a 248% increase year-on-year [41] Group 11 - Beijing Lier signed a strategic cooperation agreement with SenseTime and Xiwang Technology for AI collaboration [43] - Gongdong Medical's controlling shareholder plans to reduce its stake by up to 3% [44] - Zhonghuan Hailu terminated its control change plan and resumed trading [46] Group 12 - Longzi Co. reported a tax payment of 22.27 million yuan due to a tax audit [48] - Guoguang Chain's controlling shareholder plans to reduce its stake by up to 2.99% [49] - Guoxin Technology successfully tested a new high-performance chip for automotive electronics [50] Group 13 - GF Securities reported a cumulative increase in borrowings exceeding 20% of its net assets [51] - China Construction Bank's subsidiary plans to increase capital by 3 billion yuan [52] - Jifeng Technology plans to establish a wholly-owned subsidiary with a capital of 50 million yuan [53] Group 14 - Jiantou Energy received approval for a stock issuance plan to specific investors [54] - Shanghai Laishi's executives plan to collectively increase their holdings by at least 6 million yuan [55] - Wencan Co. reported a fire incident at its subsidiary, with no casualties reported [56]
ST葫芦娃(605199.SH):公司收到头孢地尼胶囊的《药品注册证书》
Xin Lang Cai Jing· 2025-09-05 09:41
Core Viewpoint - ST HuLuWa (605199.SH) has received the drug registration certificate for Cefdinir capsules from the National Medical Products Administration, marking a significant milestone in its product development [1] Group 1: Product Development - Cefdinir is classified as a third-generation broad-spectrum cephalosporin antibiotic, effective against various infections sensitive to Cefdinir [1] - The company has invested a total of 4.4957 million yuan in the research and development of this product [1]
ST葫芦娃获得头孢地尼胶囊药品注册证书
Zhi Tong Cai Jing· 2025-09-05 09:18
Core Viewpoint - ST HuLuWa (605199.SH) has received the drug registration certificate for Cefdinir capsules from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product line [1] Company Summary - The approved drug, Cefdinir, is a third-generation broad-spectrum cephalosporin antibiotic, effective against various bacterial strains including Staphylococcus, Streptococcus, and Escherichia coli [1] - Cefdinir is indicated for treating multiple infections such as pharyngitis, tonsillitis, acute bronchitis, pneumonia, otitis media, and urinary tract infections among others [1] - The approval signifies that the drug meets the technical requirements for quality and efficacy consistent with reference formulations, and it is considered to have passed the consistency evaluation for generic drug quality and efficacy [1] Industry Summary - The approval of Cefdinir aligns with the growing demand for effective antibiotics in the healthcare sector, particularly for treating bacterial infections [1] - The regulatory approval process highlights the importance of compliance with quality standards in the pharmaceutical industry, which can impact market competitiveness [1]
ST葫芦娃(605199.SH):获得头孢地尼胶囊药品注册证书
Ge Long Hui A P P· 2025-09-05 09:16
Core Viewpoint - ST HuLuWa (605199.SH) has received the drug registration certificate for Cefdinir capsules from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product line [1] Group 1: Product Information - Cefdinir is a third-generation broad-spectrum cephalosporin antibiotic [1] - The drug is indicated for infections caused by various bacteria, including Staphylococcus, Streptococcus, and Escherichia coli, among others [1] - Specific infections treated by Cefdinir include pharyngitis, tonsillitis, acute bronchitis, pneumonia, otitis media, sinusitis, pyelonephritis, cystitis, and several skin and soft tissue infections [1]
ST葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司关于获得头孢地尼胶囊药品注册证书的公告
2025-09-05 09:15
证券代码:605199 证券简称:ST 葫芦娃 公告编号:2025-066 海南葫芦娃药业集团股份有限公司 关于获得头孢地尼胶囊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。 海南葫芦娃药业集团股份有限公司(以下简称"公司")近日收到国家药品监督 管理局(以下简称"国家药监局")核准签发的关于头孢地尼胶囊的《药品注册证 书》。现将有关情况公告如下: 上市许可持有人:海南葫芦娃药业集团股份有限公司 受理号:CYHS2302701 药品批准文号:国药准字 H20255295 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。质量标准、说明书、标签 及生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规范要求方可生 产销售。 二、药品研发及相关 一、药品基本情况 药物名称:头孢地尼胶囊 剂型:胶囊剂 注册分类:化学药品 4 类 规格:0.1g 三、投资风险 公司高度重视药品研发,并严格控制药品研发、制造及销售环节的质量及安全。 上述药品获 ...
ST葫芦娃(605199.SH)获得头孢地尼胶囊药品注册证书
智通财经网· 2025-09-05 09:08
Core Viewpoint - ST HuLuWa (605199.SH) has received the drug registration certificate for Cefdinir capsules from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product line [1] Company Summary - The newly approved Cefdinir is a third-generation broad-spectrum cephalosporin antibiotic, effective against various bacterial strains including Staphylococcus, Streptococcus, and Escherichia coli [1] - The drug is indicated for treating multiple infections such as pharyngitis, tonsillitis, acute bronchitis, pneumonia, otitis media, and urinary tract infections among others [1] - The approval was granted based on the drug meeting the technical requirements for quality and efficacy consistent with reference formulations, which also implies passing the consistency evaluation for generic drugs [1] Industry Summary - The approval of Cefdinir capsules reflects the ongoing regulatory support for antibiotic development in the pharmaceutical industry, particularly for broad-spectrum antibiotics [1] - The market for antibiotics is critical, given the rising concerns over antibiotic resistance and the need for effective treatments for bacterial infections [1]