登录新浪财经APP 搜索【信披】查看更多考评等级 申请事项：临床试验 受理号：CXZL2500020 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03月26日受理的肺热咳喘 颗粒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，同意开展用于成人流行性感冒的 临床试验。 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 药物名称：肺热咳喘颗粒 剂型：颗粒剂 肺热咳喘颗粒适用于清热解毒，宣肺止咳，化痰平喘。用于感冒，支气管炎，喘息性支气管炎，支气管 肺炎属痰热壅肺证者。流行性感冒属热毒袭肺证者。 三、产品上市尚需履行的审批程序 根据我国药品注册相关的法律法规要求，药物在取得药物临床试验批准通知书后，尚需开展临床试验并 经国家药监局审评，审批通过后方可生产上市。 四、投资风险 ...

Core Viewpoint - The company ST HuLuWa (605199) has received approval from the National Medical Products Administration for clinical trials of its new product, a modified version of the existing "Pediatric Lung Heat Cough and Asthma Granules," now targeting adult influenza patients [1] Group 1: Product Development - The new product is an improvement on the already marketed "Pediatric Lung Heat Cough and Asthma Granules" [1] - The modified formulation expands its indications to include "heat toxin attacking the lung syndrome" associated with influenza in adults [1] - The product is designed to clear heat and detoxify, relieve cough, and reduce phlegm and wheezing, applicable for conditions like cold, bronchitis, wheezing bronchitis, and bronchopneumonia [1]

日前,葫芦娃药业(000301.SZ)发布2024年年度报告。报告披露,2024年,葫芦娃药业研发投入24,953.98万 元,同比增长58.63%,累计获专利112项,强化技术壁垒。 在研项目涵盖中药与化药创新药 葫芦娃药业之所以新品获批不断,关键在于储备了一批研发项目。 更值得关注的是,报告期内,公司在研项目达 116个,涵盖中药与化药创新药。后续发展潜力,值得期待。 葫芦娃药业中国儿科药品的领军企业,致力于成为中国儿童健康领域守护者。葫芦娃药业2024年年度报 告表示,通过整合前沿科研成果与商业化转化能力,公司在中药现代化、儿童用药及大健康产品领域形成 差异化竞争力,为长期可持续发展注入持续发展动力。 12个新品获批上市 2024年,葫芦娃药业在研发上取得显著成效。 据年报披露,报告期内,葫芦娃药业及子公司广西维威获批12个新品上市(布洛芬混悬液、头孢地尼颗粒、 帕拉米韦注射液、硫酸特布他林雾化吸入用溶液、盐酸溴己新注射液、地氯雷他定片、孟鲁司特钠咀嚼 片等)。奥美拉唑肠溶胶囊、布洛芬颗粒等产品通过及视为通过一致性评价。 截止报告期末,葫芦娃药业共有112 项专利,其中发明专利 102 项,实用型专利8 ...

Core Viewpoint - The financial report of Pianzaihuang for 2024 reveals significant challenges, with a 26.07% year-on-year decline in net profit for Q4, marking the lowest level since 2019, and a record low revenue growth of 7.25% over the past decade, reflecting broader difficulties faced by the traditional Chinese medicine industry [2][8]. Industry Situation - The primary challenge for Pianzaihuang is the rising cost of raw materials, particularly natural cow bile, which has surged from 650,000 yuan per kilogram to 1,650,000 yuan per kilogram over the past two years [3]. - The overall Chinese medicine sector is experiencing a collective downturn, with Pianzaihuang being relatively better off compared to other companies like Zhongsheng Pharmaceutical and Taiji Group, which reported drastic profit declines [7][8]. Financial Performance - Pianzaihuang's Q4 net profit was 290 million yuan, down 26.07% year-on-year, while the annual revenue growth was only 7.25%, the lowest in a decade [2][4]. - The company attempted to mitigate rising costs by increasing prices by 28.8% in 2023, but revenue and net profit growth rates fell to 15.69% and 13.04%, respectively, in the same year [4][5]. Cost Structure - Direct material costs account for over 90% of the total costs in various product categories, including liver disease and cardiovascular medications, indicating a heavy reliance on raw materials [4][7]. - The cost of direct materials for liver disease medications reached 164.48 million yuan, representing 96.52% of total costs, while cardiovascular medications saw a 56.1% increase in material costs year-on-year [4]. Market Dynamics - The price of Pianzaihuang's product has reached the upper limit of consumer acceptance, with retail prices significantly lower than the official price, indicating challenges in passing on costs to consumers [5]. - The collective "explosion" in the Chinese medicine sector is attributed to policy changes, including the expansion of centralized procurement, which has led to significant price reductions and profit declines for many companies [9][15]. Future Outlook - The Chinese medicine industry must address the impacts of centralized procurement policies, which have resulted in price drops and profit squeezes, while also focusing on innovation and diversification to mitigate risks associated with raw material costs [16][17]. - Companies like Pianzaihuang are exploring diversification strategies, but the effectiveness of these efforts remains limited, highlighting the need for a more robust approach to research and development [17][18].

Core Viewpoint - Hainan Huhuwawa Pharmaceutical Group Co., Ltd. faces significant internal control issues, leading to a negative audit opinion and a stock trading suspension, with a change in stock abbreviation to "ST Huhuwawa" starting April 30, 2025 [1][3][5] Financial Performance - For the fiscal year 2024, the company reported a revenue of 1.414 billion yuan, a year-on-year decrease of 21.26%, and a net profit attributable to shareholders of -274 million yuan, a staggering decline of 2629.23% [10] - In the first quarter of 2025, the company achieved a revenue of 337 million yuan, down 28.42% year-on-year, with a net profit of approximately 24.35 million yuan, a decrease of 11.23% [10] Internal Control Issues - The audit report from Lixin Certified Public Accountants highlighted three major areas of concern regarding internal controls, including the lack of complete financial data related to restated financial statements and issues with accounts receivable from key clients [3][5] - The company has been criticized for significant deficiencies in its internal control over financial reporting, resulting in a negative opinion from the auditors [5] Management Changes - The company's general manager, Zhang Mingrui, resigned for personal reasons less than two months after taking office, marking a period of instability in leadership [2][6] - This resignation follows the earlier departure of Liu Jingping from the general manager position, who remains as chairman and has been a key figure in the company since its inception [7][8] Related Transactions - In 2024, the company purchased eight R&D projects from Hainan Zhongwang Medical Technology Development Co., Ltd. for 42.0537 million yuan, raising concerns due to familial ties between the company's actual controller and the legal representative of the vendor [4]

这是千亿级市场规模! 中国是全球第二大儿科用药市场,市场规模超千亿元。随着国家"三胎"政策的全面放开,儿科用药需求也 随之增加。 米内网数据显示,近年来我国儿科药市场销售额均保持增长态势,除2020年受疫情影响,其余年份销售额增 速均在6%以上,市场潜力十足。 因此,不少药企将目光从成人药转向儿药。海南葫芦娃药业集团股份有限公司是为数不多将儿药作为"主 业"的企业,较早深耕千亿级儿药市场。 打造儿童明星药品 2024年上半年,葫芦娃的小儿肺热咳喘颗粒,跻身中国三大终端六大市场儿科中成药TOP5品牌,并且销售 额增长率达到12.93%。 据悉,葫芦娃的小儿肺热咳喘颗粒,是依托当代著名儿科专家赵心波教授几十年的临床经验,萃取医圣张仲 景经典名方麻杏石甘汤和白虎汤的精华,吸收中医温病学家吴鞠通先生的银翘散精髓研发而成。 2016年,国内顶尖药学、病理学、毒理学等各领域专家,对小儿肺热咳喘颗粒进行了"会诊",从含量、标 准、口味、药效等方面,推动该药创新升级。 经过临床的检验,葫芦娃牌小儿肺热咳喘颗粒(4g)疗效良好,成为一款明星药,荣获"2024健康产业品牌 榜"西普金奖。 "葫芦娃药业集团要深耕儿药市场,首先就得 ...