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金城医药:吗啉硝唑氯化钠注射液获药品注册证书
Core Viewpoint - Jincheng Pharmaceutical's subsidiary has received a drug registration certificate for a new injection, indicating a significant development in its product portfolio and potential market expansion [1] Company Summary - Jincheng Pharmaceutical's subsidiary, Jincheng Jinsu, has been granted a registration certificate by the National Medical Products Administration for the injection of Morpholine Nitrosyl Sodium [1] - The newly approved drug is indicated for treating infections in adults (≥18 years) caused by sensitive bacteria, which may enhance the company's therapeutic offerings [1] Industry Summary - The approved drug targets several types of infections, including pelvic inflammatory disease caused by Streptococcus and Bacteroides, as well as appendicitis and mixed infections involving anaerobic and aerobic bacteria [1] - This development reflects ongoing advancements in the pharmaceutical industry, particularly in addressing complex bacterial infections [1]
金城医药(300233.SZ):吗啉硝唑氯化钠注射液取得药品注册证书
智通财经网· 2025-10-20 09:09
智通财经APP讯,金城医药(300233.SZ)公告,公司控股子公司广东金城金素制药有限公司(简称"金城金 素")的通知,金城金素收到国家药品监督管理局下发的吗啉硝唑氯化钠注射液药品注册证书。 公告显示,吗啉硝唑为5-硝基咪唑类抗菌药物,本品通过将奥硝唑中不稳定的氯离子改为较为稳定的吗 啉环,使其结构更稳定,且不良反应发生率更低。本品适用于敏感细菌引起的下列成人(≥18岁)感染:1. 由包括消化链球菌、脆弱拟杆菌、韦荣球菌、吉氏拟杆菌等引起的妇科盆腔炎(包括子宫内膜炎、输卵 管炎、输卵管卵巢脓肿、盆腔腹膜炎等);2.由包括拟杆菌属(脆弱拟杆菌、卵形/多型拟杆菌、单形拟杆 菌、普通拟杆菌、拟杆菌属),梭菌属(产气荚膜梭菌、双酶梭菌、丁酸梭菌及其他梭菌),梭杆菌属(具 核梭杆菌、可变梭杆菌),厌氧球菌(消化链球菌、韦荣球菌)等引起化脓性阑尾炎、坏疽性阑尾炎;3.由 于厌氧菌和需氧菌引起的混合性感染盆腔炎、阑尾炎等。 ...
实控人被罚150万元并四年禁入:金城医药的治理失效与业绩困局
Sou Hu Cai Jing· 2025-10-20 09:09
Core Viewpoint - The recent penalty imposed on Jincheng Pharmaceutical's actual controller and chairman, Zhao Yeqing, for manipulating the securities market highlights a lack of compliance awareness among the company's core members and reflects long-standing governance issues within the company, leading to a dual crisis of trust and development for the firm [1][4]. Regulatory Actions - In August of last year, Zhao Yeqing received a notice from the CSRC regarding an investigation into his alleged market manipulation, coinciding with a significant stock reduction by his father, Zhao Hongfu, which raised market suspicions about the motives behind the sell-off [2]. - The penalty announced in September this year significantly reduced the initial proposed fines from March, where Zhao was to forfeit illegal gains of 7.72 million yuan and face a fine of 23.16 million yuan, totaling 30.88 million yuan, to a mere fine of 1.5 million yuan, while maintaining a four-year market ban [2][3]. Company Performance - Jincheng Pharmaceutical has been experiencing a decline in both revenue and profit, with a reported revenue of 1.36 billion yuan in the first half of 2025, down 22.65% year-on-year, and a net profit of 43.38 million yuan, down 66.78% [6]. - The company's core product, the cephalosporin side-chain active ester series, saw a revenue decline of 32.20%, while the formulation products dropped by 29.04%, indicating a significant downturn in its primary revenue sources [6][7]. Financial Metrics - The company's gross profit margin fell to 36.13% in the first half of 2025, a decrease of approximately 4.49 percentage points from the previous year, with all major product lines experiencing a decline in gross margin [7]. - Jincheng Pharmaceutical's R&D investment as a percentage of revenue has been significantly lower than the industry average, with figures of 7.87% and 5.68% in 2023 and 2024, respectively, compared to the industry averages of 12.34% and 12.61% [9]. Strategic Challenges - The company has struggled with a lack of clear strategic direction, failing to effectively transition from its reliance on intermediate products to a more diversified portfolio, which has hindered its ability to adapt to industry trends towards innovative drugs and high-end formulations [11]. - Jincheng Pharmaceutical's international market expansion has also been slow, with overseas revenue declining from 774 million yuan in 2019 to 685 million yuan in 2024, and further down to 708 million yuan in the first half of 2025, indicating a loss of market share [12].
金城医药:吗啉硝唑氯化钠注射液取得药品注册证书
Zhi Tong Cai Jing· 2025-10-20 09:06
公告显示,吗啉硝唑为5-硝基咪唑类抗菌药物,本品通过将奥硝唑中不稳定的氯离子改为较为稳定的吗 啉环,使其结构更稳定,且不良反应发生率更低。本品适用于敏感细菌引起的下列成人(≥18岁)感染:1. 由包括消化链球菌、脆弱拟杆菌、韦荣球菌、吉氏拟杆菌等引起的妇科盆腔炎(包括子宫内膜炎、输卵 管炎、输卵管卵巢脓肿、盆腔腹膜炎等);2.由包括拟杆菌属(脆弱拟杆菌、卵形/多型拟杆菌、单形拟杆 菌、普通拟杆菌、拟杆菌属),梭菌属(产气荚膜梭菌、双酶梭菌、丁酸梭菌及其他梭菌),梭杆菌属(具 核梭杆菌、可变梭杆菌),厌氧球菌(消化链球菌、韦荣球菌)等引起化脓性阑尾炎、坏疽性阑尾炎;3.由 于厌氧菌和需氧菌引起的混合性感染盆腔炎、阑尾炎等。 金城医药(300233)(300233.SZ)公告,公司控股子公司广东金城金素制药有限公司(简称"金城金素")的 通知,金城金素收到国家药品监督管理局下发的吗啉硝唑氯化钠注射液药品注册证书。 ...
金城医药(300233.SZ):吗啉硝唑氯化钠注射液收到药品注册证书
Ge Long Hui A P P· 2025-10-20 08:54
Core Viewpoint - Jincheng Pharmaceutical has received a drug registration certificate from the National Medical Products Administration for its product, Morinazole Sodium Chloride Injection, which is a new antibacterial drug with lower adverse reaction rates and broader applications in treating various infections [1] Group 1: Product Details - Morinazole is a 5-nitroimidazole class antibacterial drug that improves stability by replacing the unstable chloride ion in ornidazole with a more stable morpholine ring [1] - The drug is indicated for adult infections caused by sensitive bacteria, including gynecological pelvic inflammatory diseases and mixed infections of appendicitis [1] Group 2: Indications - The product is suitable for treating pelvic inflammatory diseases caused by bacteria such as Streptococcus, Bacteroides, and Clostridium [1] - It also addresses purulent appendicitis and necrotizing appendicitis caused by anaerobic and aerobic bacteria [1]
金城医药(300233) - 关于子公司收到药品注册证书的公告
2025-10-20 08:48
证券代码:300233 证券简称:金城医药 公告编号:2025-068 (消化链球菌、韦荣球菌)等引起化脓性阑尾炎、坏疽性阑尾炎;3.由于厌氧菌 和需氧菌引起的混合性感染盆腔炎、阑尾炎等。 本品仅在中国上市销售,米内网显示 2022 年至 2024 年国内公立医疗机构吗 啉硝唑氯化钠注射液销售额分别为人民币 4.88 亿元、4.25 亿元和 3.37 亿元。 截至本公告披露日,国内吗啉硝唑氯化钠注射液已批准上市的厂家包括石家庄四 药有限公司、贵州科伦药业有限公司、成都倍特药业股份有限公司和广东金城金 素制药有限公司等多家企业。 三、对公司的影响及风险提示 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 山东金城医药集团股份有限公司于近日收到控股子公司广东金城金素制药 有限公司(以下简称"金城金素")的通知,金城金素收到国家药品监督管理局 下发的吗啉硝唑氯化钠注射液药品注册证书(证书编号:2025S03110),现将相 关情况公告如下: | 产品 | 剂 | 注册 | 规格 | 包装 | 药品批准 | 上市许 可持有 | 审批结论 | | --- | --- | ...
金城医药:关于子公司获得药品补充申请批准通知书的公告
Zheng Quan Ri Bao· 2025-10-17 14:12
Core Viewpoint - Jincheng Pharmaceutical announced that its wholly-owned subsidiary, Beijing Jincheng Tail Pharmaceutical Co., Ltd., has received a drug supplement application approval notice from the National Medical Products Administration for the product named Progesterone Cream [2] Group 1 - The approval is significant for the company's product portfolio and may enhance its market position in the pharmaceutical industry [2] - The product, Progesterone Cream, is expected to contribute to the company's revenue growth following the approval [2]
金城医药(300233.SZ):普罗雌烯乳膏获得药品补充申请批准通知书
Ge Long Hui A P P· 2025-10-17 08:18
Core Viewpoint - Jincheng Pharmaceutical's subsidiary, Beijing Jincheng Tail Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for a supplemental application regarding the product Progestin Cream, which is the only marketed local estrogen for specific gynecological conditions [1] Group 1 - The product Progestin Cream is indicated for atrophic changes in the vulva, vestibule, and vaginal ring, as well as associated symptoms such as discomfort, vulvar itching, burning, and dryness [1]
金城医药:子公司获得药品补充申请批准通知书
Xin Lang Cai Jing· 2025-10-17 08:18
Core Viewpoint - The approval of the supplementary application for Progesterone cream by Beijing Jincheng Taier Pharmaceutical Co., Ltd. enhances product competitiveness but will not significantly impact current performance [1] Group 1: Regulatory Approval - Beijing Jincheng Taier Pharmaceutical Co., Ltd. received a notification from the National Medical Products Administration regarding the approval of a supplementary application for Progesterone cream [1] - The approval involves changes in the types and quantities of excipients, processes, and quality standards [1] Group 2: Market Data - According to IMS data, global sales of Progesterone formulations are projected to be $78.0961 million in 2022, $94.3352 million in 2023, and $104 million in 2024 [1] - The approval is expected to improve the product's competitiveness in the market [1]
金城医药:子公司获得普罗雌烯乳膏药品补充申请批准通知书
Mei Ri Jing Ji Xin Wen· 2025-10-17 08:15
Core Viewpoint - Jincheng Pharmaceutical's subsidiary received approval for changes to the formulation and quality standards of Progestin Cream, which may enhance product competitiveness but will not significantly impact current financial performance [1] Company Summary - Jincheng Pharmaceutical's wholly-owned subsidiary, Beijing Jincheng Tail Pharmaceutical Co., Ltd., has received a notification from the National Medical Products Administration regarding the approval of a supplemental application for Progestin Cream [1] - The approved changes include modifications to the types and amounts of excipients, process changes, and quality standard adjustments [1] Industry Summary - Progestin is a strictly local acting estrogen used for the treatment of menopausal genitourinary syndrome [1] - The approval of the supplemental application is expected to improve the product's competitiveness in the market [1]