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金城医药(300233.SZ):乳糖酸红霉素获得化学原料药上市申请批准通知书
Ge Long Hui A P P· 2025-08-05 08:55
Core Viewpoint - Jincheng Pharmaceutical's subsidiary, Beijing Jincheng Taier Pharmaceutical Co., has received approval from the National Medical Products Administration for the marketing application of Lactobionic Acid Erythromycin, indicating a significant development in the company's product portfolio and potential market opportunities [1] Company Summary - Jincheng Pharmaceutical's approval for Lactobionic Acid Erythromycin marks a milestone as it is currently the only company in China with this approval for the injectable form of the antibiotic [1] - The company is positioned in a competitive landscape with 17 enterprises holding marketing approvals for injectable Lactobionic Acid Erythromycin, but no original research products are available in the domestic market [1] Industry Summary - Lactobionic Acid Erythromycin is classified as a macrolide antibiotic, primarily used for treating severe infectious diseases, and was first approved in the U.S. in 1964 [1] - Global sales for Lactobionic Acid Erythromycin formulations are projected to grow from $44.75 million in 2022 to $72.45 million in 2024, indicating a positive market trend for this antibiotic [1]
金城医药(300233) - 关于子公司收到化学原料药上市批准通知书的公告
2025-08-05 08:42
证券代码:300233 证券简称:金城医药 公告编号:2025-054 山东金城医药集团股份有限公司 关于子公司收到化学原料药上市申请批准 通知书的公告 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之全资子公司北京金城泰尔制药有限公司 于近日收到国家药品监督管理局下发的《化学原料药上市申请批准通知书》(通 知书编号:2025YS00668)。现将相关情况公告如下: 一、药品的基本情况 化学原料药名称:乳糖酸红霉素 包装规格:5kg/瓶、7kg/瓶、10kg/瓶 化学原料药注册标准编号:YBY67722025 生产企业:北京金城泰尔制药有限公司 申请事项:境内生产化学原料药上市申请 本次乳糖酸红霉素获得《化学原料药上市申请批准通知书》,表明该原料药 已符合国家相关原料药审评技术标准,在符合药品生产质量管理规范要求后,可 在国内市场进行生产销售,将进一步丰富公司的产品线,有利于提升公司在化学 原料药领域的市场竞争力。药品的销售可能受到国家政策、市场环境变化等综合 因素影响,存在不确定性。敬请广大投资者注意风险,理性投资。 特此公告。 ...
公告精选:西藏旅游、南方路机等提示交易风险;中国石化预计上半年净利润同比下降…
Zheng Quan Zhi Xing· 2025-07-31 21:02
Key Points - Tibet Tourism may apply for suspension of trading if significant abnormalities occur in stock transactions [1] - Southern Road Machinery's stock price has deviated from its fundamental situation [1] - Industrial Fulian's major customers and products have not undergone significant changes [1] - Yingweike has established a relatively complete liquid cooling technology and product solution capability [1] - Victory Energy's operational situation remains normal with no significant changes in the internal and external business environment [1] - Qizheng Tibetan Medicine's operational situation is normal with no significant changes in the internal and external business environment [1] - Dongxin Co. states that its investment in Shanghai Lishuan's chip products is not applicable for large model computing clusters [1] - Guosheng Co. has obtained project filing related to PEEK from its wholly-owned subsidiary [1] - Action Education's actual controller proposed a mid-term dividend of 10 yuan per 10 shares [1] Mergers and Acquisitions - Darui Electronics plans to acquire 80% of Weiste's equity through capital increase and share acquisition [1] - Dashengda intends to acquire 30% equity of Thailand's Far East [1] Financing - Aoshikang plans to issue convertible bonds not exceeding 1 billion yuan for high-end printed circuit board projects [1] - Sixuan New Materials intends to raise no more than 466 million yuan through a private placement [1] - Changhua Chemical plans to raise no more than 230 million yuan for a carbon dioxide polyether project [1] Share Buybacks and Reductions - Fuanna plans to repurchase shares worth between 55.85 million and 104 million yuan [1] - Jiangnan Yifan's board member intends to increase his stake in the company [1] - Jieya Co. and its concerted parties plan to reduce their holdings by no more than 4.95% [1] - Other companies including Tongda Co., Haohan Deep, and Wanhu Chemical also plan to reduce their holdings [1] Operational Data - Sinopec expects a net profit decline of 39.5% to 43.7% year-on-year for the first half of the year [1] - Qingdao Bank reported a net profit of 3.065 billion yuan for the first half, up 16.05% year-on-year [1] - Daodaquan's net profit increased by 563.15% year-on-year, proposing a dividend of 1.76 yuan per 10 shares [1] - Zhengdan Co. reported a net profit increase of 120.35% year-on-year, proposing a dividend of 3 yuan per 10 shares [1] - Other companies reported varying profit changes, including losses and significant increases [1] Contracts and Major Investments - Sanhui Electric signed a framework contract for robot equipment sales [1] - Zhejiang University Network New's subsidiary won a smart engineering project worth 94.2712 million yuan [1] - New Aluminum Times plans to invest no less than 500 million yuan in a project for lightweight, high-strength auto parts [1] - Zhishang Technology will use part of its raised funds for a smart manufacturing production base in Vietnam [1]
海外市场频传捷报金城医药国际化提速
Zheng Quan Ri Bao· 2025-07-31 16:08
Core Viewpoint - Shandong Jincheng Pharmaceutical Group Co., Ltd. has made significant progress in expanding its overseas market, receiving key import licenses for its products in South Korea and Europe, indicating a rapid acceleration in its internationalization efforts [2][3]. Group 1: Product Approvals - Jincheng Tai'er Pharmaceutical Co., Ltd. received an import license for Progestin cream from the Korean Ministry of Food and Drug Safety (MFDS), marking its entry into the South Korean pharmaceutical market [2]. - The company also obtained a Certificate of Suitability (CEP) for Oseltamivir phosphate raw material from the European Medicines Agency, allowing it to sell in the European market [2][3]. - Additionally, the company received a DMF approval letter from the FDA for Posaconazole, which is crucial for entering the highly regulated U.S. raw material market [3]. Group 2: Market Potential - Progestin is the only marketed local estrogen with unique advantages, such as not stimulating endometrial proliferation and not increasing blood estrogen levels, with global sales projected to reach $104 million in 2024 [3]. - Oseltamivir, a leading antiviral drug, has a global sales figure exceeding $1 billion in 2024, with a raw material consumption of 92.31 tons, indicating a substantial market opportunity [3]. - The approval of Posaconazole is seen as a milestone for Jincheng Pharmaceutical to establish a presence in the U.S. and global antifungal raw material supply chain [3]. Group 3: Strategic Direction - The recent achievements in overseas market expansion reflect the company's transition from a focus on raw materials to a dual-driven model of "raw materials + formulations" [4]. - The company is actively exploring higher-level open cooperation and expanding into fields such as women's health technology and high-end anti-infection [4].
金城医药:子公司“普罗雌烯乳膏”获得韩国药品进口许可
Zhi Tong Cai Jing· 2025-07-31 09:52
Core Viewpoint - Jin Cheng Pharmaceutical's subsidiary, Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd., has received an import license for Progestin Cream from the Korean Ministry of Food and Drug Safety, marking a significant regulatory achievement for the company in the international market [1] Company Summary - Jin Cheng Tai Er has obtained the import license for Progestin Cream, which is the only marketed estrogen with strict local action, used for treating atrophic changes in the vulva, vestibule, and vaginal area, as well as associated symptoms such as discomfort, itching, burning, and dryness [1] - The product addresses conditions related to Genitourinary Syndrome of Menopause (GSM), which occurs due to decreased estrogen and other hormone levels in women during and after menopause [1] Industry Summary - Local estrogen application is recommended as the first-line treatment for GSM according to domestic and international guidelines, with Progestin Cream being one of the options available [1] - The global sales figures for Progestin formulations are projected to be $78.10 million in 2022, $94.34 million in 2023, and $103.86 million in 2024, indicating a growing market for this therapeutic category [1]
金城医药(300233.SZ):子公司“普罗雌烯乳膏”获得韩国药品进口许可
智通财经网· 2025-07-31 09:49
Core Viewpoint - The company Jin Cheng Pharmaceutical has received an import license for Progestin Cream from the Korean Ministry of Food and Drug Safety, marking a significant step in expanding its product offerings in the treatment of Genitourinary Syndrome of Menopause (GSM) [1] Company Summary - Jin Cheng Pharmaceutical's wholly-owned subsidiary, Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd., has obtained the import license for Progestin Cream [1] - Progestin is currently the only marketed estrogen with strict local action, used for treating atrophic changes in the vulva, vestibule, and vaginal ring, as well as associated symptoms such as discomfort, itching, burning, and dryness [1] Industry Summary - The conditions treated by Progestin Cream are caused by decreased levels of estrogen and other sex hormones in women during the perimenopausal and postmenopausal periods, collectively referred to as Genitourinary Syndrome of Menopause (GSM) [1] - Guidelines both domestically and internationally recommend local estrogen use as the first-line treatment for GSM, with Progestin Cream being one of the options [1] - According to IMS data, global sales of Progestin formulations are projected to be $78.10 million in 2022, $94.34 million in 2023, and $103.86 million in 2024 [1]
金城医药(300233.SZ):金城泰尔普罗雌烯乳膏获得韩国MFDS的药品进口许可
Ge Long Hui A P P· 2025-07-31 09:20
格隆汇7月31日丨金城医药(维权)(300233.SZ)公布,公司之全资子公司北京金城泰尔制药有限公司(简 称"金城泰尔")于近日收到韩国食品药品安全部(简称"韩国MFDS")下发的普罗雌烯乳膏药品进口许可 证。 ...
金城医药:金城泰尔普罗雌烯乳膏获得韩国药品进口许可证
Core Viewpoint - Jincheng Pharmaceutical's subsidiary, Beijing Jincheng Tail Pharmaceutical Co., has received an import license for Progestin Cream from the South Korean Ministry of Food and Drug Safety, marking a significant regulatory achievement for the company [1] Company Summary - Jincheng Pharmaceutical's subsidiary, Beijing Jincheng Tail Pharmaceutical Co., is now authorized to import Progestin Cream, which is currently the only marketed estrogen with strict local action [1]
金城医药:子公司获得韩国药品进口许可证
news flash· 2025-07-31 09:10
智通财经7月31日电,金城医药(300233.SZ)公告称,公司全资子公司北京金城泰尔制药有限公司近日收 到韩国食品药品安全部下发的普罗雌烯乳膏药品进口许可证。该产品为严格局部作用的雌激素,用于外 阴、前庭部及阴道环部的萎缩性病变,以及由此引发的自觉症状。普罗雌烯乳膏获得韩国MFDS的药品 进口许可,标志着该产品获得了在韩国的准入资格,对公司拓展韩国医药市场具有积极影响,有利于促 进产品在海外市场的销售。 金城医药:子公司获得韩国药品进口许可证 ...
金城医药(300233) - 关于子公司获得韩国药品进口许可证的公告
2025-07-31 09:06
山东金城医药集团股份有限公司 关于子公司获得韩国药品进口许可证的公告 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之全资子公司北京金城泰尔制药有限公司 (以下简称"金城泰尔")于近日收到韩国食品药品安全部(以下简称"韩国 MFDS")下发的普罗雌烯乳膏药品进口许可证,现将相关情况公告如下: 一、证书基本信息 企业名称:北京金城泰尔制药有限公司 证券代码:300233 证券简称:金城医药 公告编号:2025-053 普罗雌烯是当前唯一上市的严格局部作用的雌激素,用于外阴、前庭部及 阴道环部的萎缩性病变,以及由此引发的以下自觉症状:不适、外阴瘙痒、灼 热、干燥。这类疾病均因女性在绝经过渡期及绝经后期妇女因雌激素和其他性 激素水平降低引起的,统称绝经生殖泌尿综合征(以下简称"GSM")。国内外 相关指南将局部使用雌激素作为治疗 GSM 的首选方案,普罗雌烯乳膏为该方案 品种之一,作为严格局部作用的雌激素,该产品不刺激子宫内膜增生,没有增 加血雌激素水平的潜在风险。根据 IMS 数据查询,2022 年至 2024 年普罗雌烯制 剂全球销 ...