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一品红:关于全资子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书的公告
Zheng Quan Ri Bao· 2025-09-19 10:14
Core Viewpoint - Yipinhong announced that its wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the supplemental application of Oseltamivir Phosphate Capsules [2] Group 1 - The approval pertains to the supplemental application for Oseltamivir Phosphate Capsules [2] - The announcement was made on September 19 [2] - The approval is a significant regulatory milestone for the company [2]
一品红(300723) - 300723一品红投资者关系管理信息20250919
2025-09-19 09:32
Company Overview - Yipinhong Pharmaceutical Group Co., Ltd. was established in 2002, focusing on drug research, production, and sales, particularly in pediatric and chronic disease medications [2][3] - The company has a total of 204 drug registration certificates, including 90 national medical insurance varieties and 27 national essential drug varieties [3] Pediatric Drug Segment - Pediatric drug revenue accounted for 61.65% of the pharmaceutical manufacturing business, with a revenue of 357 million CNY in the first half of 2025 [3][4] - The company holds 27 pediatric drug registration certificates and has 16 pediatric drug projects under research, covering diseases such as epilepsy and influenza [4][5] - The company aims to enhance its market share in pediatric drugs by leveraging policy support and increasing public awareness [4] Research and Development - The company has approximately 60 ongoing research projects, including 14 innovative drug projects and 28 products pending approval [3] - The innovative drug AR882 has shown promising results in clinical trials, with all global Phase III clinical trial enrollments completed by August 2025 [5][6] Financial Performance - The company experienced a decline in revenue and net profit in the first half of 2025, attributed to industry conditions and internal business adjustments [6] - The company implemented stock incentive plans to motivate employees and enhance performance, granting over 5 million shares to 160 employees [6] Marketing and Sales Strategy - The company is focusing on expanding its marketing network across 31 provincial regions in China and enhancing its presence in new retail channels [7][8] - New product registrations are expected to positively impact sales, with 14 new drug registration certificates obtained in 2025 [6][7] Raw Material Production - The company has established a raw material drug base, which is expected to reduce costs and improve self-sufficiency in raw materials [9] - Currently, the company has 10 registered raw material drug numbers and 4 projects under research [9]
A股午间公告:广和通发行H股获中国证监会备案
Ge Long Hui A P P· 2025-09-19 05:01
Group 1 - Yipinhong's wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical, received approval from the National Medical Products Administration for a supplemental application for Oseltamivir Phosphate Capsules, allowing the addition of a 45mg specification and changes to the excipient quantities in the formulation, as well as modifications to packaging materials and containers [1] - Guanghetong's issuance of up to 155 million overseas listed foreign shares (H shares) has been filed with the China Securities Regulatory Commission [1] - Zhenghai Magnetic Materials' "Zhenghai Convertible Bonds" will stop conversion after the trading session on September 19, with unconverted bonds being forcibly redeemed at a price of 100.5 yuan per bond, potentially leading to investment losses for investors [1] Group 2 - Qingxin Environment plans to purchase liability insurance for the company and its directors and supervisors, with a total premium not exceeding 150,000 yuan per year and a coverage period of 12 months [1]
午间公告:广和通发行H股获中国证监会备案
Zheng Quan Shi Bao Wang· 2025-09-19 04:36
Group 1 - Yipinhong's subsidiary Guangzhou Yipinhong Pharmaceutical received approval from the National Medical Products Administration for a supplemental application for Oseltamivir Phosphate Capsules, allowing the addition of a 45mg specification and changes to excipient quantities and packaging materials [1] - The drug is indicated for the treatment of influenza A and B in adults and children aged 1 year and older, and for the prevention of influenza A and B in adults and adolescents aged 13 years and older [1] Group 2 - Guanghe Tong has received approval from the China Securities Regulatory Commission for the issuance of no more than 155 million overseas listed foreign shares (H shares) [2] - Zhenghai Magnetic Materials' "Zhenghai Convertible Bonds" will stop conversion after the trading session on September 19, with remaining convertible bonds being forcibly redeemed at a price of 100.5 yuan per bond [2] - Investors may face potential losses if the bonds are forcibly redeemed [2] Group 3 - Qingxin Environment plans to purchase liability insurance for the company and its directors and senior management, with a total premium not exceeding 150,000 yuan per year for a duration of 12 months [3]
一品红:全资子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书
Xin Lang Cai Jing· 2025-09-19 04:07
一品红9月19日公告,全资子公司广州一品红制药有限公司于近日收到国家药品监督管理局核准签发的 关于磷酸奥司他韦胶囊的《药品补充申请批准通知书》。此次公司新增获得磷酸奥司他韦胶囊药品补充 申请批准通知书,标志着公司具备了在国内市场销售该规格药品的资格,将进一步丰富公司产品管线和 产品品类,对公司销售产生积极影响。 ...
一品红(300723.SZ)全资子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书
Ge Long Hui A P P· 2025-09-19 04:07
Core Viewpoint - The company has received approval from the National Medical Products Administration for the addition of a 45mg specification of Oseltamivir Phosphate capsules, expanding its product offerings in the antiviral market [1][2] Group 1: Product Approval - The company’s subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has been granted a drug supplement application approval notice for Oseltamivir Phosphate capsules, allowing the addition of a 45mg specification [1] - The approval includes changes to the excipient quantities in the formulation, packaging materials, and registration standards, with a validity period of 12 months [1] Group 2: Indications and Usage - The approved indications for Oseltamivir Phosphate capsules include treatment for adults and children aged 1 year and older for both type A and type B influenza, with a recommendation for use within 48 hours of symptom onset [1] - The capsules are also indicated for the prevention of type A and type B influenza in adults and adolescents aged 13 years and older [1] Group 3: Market Position and Sales - Oseltamivir Phosphate is a neuraminidase inhibitor recommended by the World Health Organization and is a first-line antiviral drug for influenza as per the 2025 Influenza Diagnosis and Treatment Plan [2] - The product is classified as a Category B drug under the national medical insurance and is included in the 2018 essential drug list in China [2] - Sales of Oseltamivir in Chinese urban public hospitals and county-level public hospitals are projected to be approximately 322.571 million RMB in 2024 [2]
一品红子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书
Zhi Tong Cai Jing· 2025-09-19 03:58
一品红(300723)(300723.SZ)发布公告,公司全资子公司广州一品红制药有限公司(简称"一品红制药") 于近日收到国家药品监督管理局核准签发的关于磷酸奥司他韦胶囊的《药品补充申请批准通知书》,经 审查,本品此次申请事项符合药品注册的有关要求,同意本品增加45mg规格,核发药品批准文号。同 时批准如下关联补充申请事项:1、变更处方中的辅料用量;2、变更包装材料和容器;3、注册标准变 更。变更后的生产工艺及质量标准照所附执行,有效期12个月,说明书及包装标签做相应修订,其他执 行原批准信息。 此次公司新增获得磷酸奥司他韦胶囊药品补充申请批准通知书,标志着公司具备了在国内市场销售该规 格药品的资格,将进一步丰富公司产品管线和产品品类,对公司销售产生积极影响。 ...
一品红全资子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书
Ge Long Hui· 2025-09-19 03:55
Core Viewpoint - The company has received approval from the National Medical Products Administration for the addition of a 45mg specification of Oseltamivir Phosphate capsules, expanding its product offerings in the antiviral market [1][2]. Company Summary - The company's wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has been granted a drug supplement application approval for Oseltamivir Phosphate capsules, allowing for a new 45mg specification alongside the existing 75mg [1]. - The approved indications for Oseltamivir Phosphate capsules include treatment for influenza A and B in adults and children aged one year and older, with a recommendation for use within 48 hours of symptom onset [1]. - The company has made changes to the excipient quantities, packaging materials, and registration standards as part of the approval process, with a validity period of 12 months for the new production process and quality standards [1]. Industry Summary - Oseltamivir Phosphate is a neuraminidase inhibitor recommended by the World Health Organization (WHO) and is a first-line antiviral drug for influenza as per the 2025 edition of the Influenza Diagnosis and Treatment Plan [2]. - The drug is classified as a Category B product under the national medical insurance scheme and is included in the 2018 version of the essential drug list in China [2]. - According to data from Minet, the sales revenue of Oseltamivir in Chinese urban public hospitals and county-level public hospitals is projected to be approximately 322.571 million RMB in 2024 [2].
一品红(300723.SZ)子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书
智通财经网· 2025-09-19 03:53
智通财经APP讯,一品红(300723.SZ)发布公告,公司全资子公司广州一品红制药有限公司(简称"一品红 制药")于近日收到国家药品监督管理局核准签发的关于磷酸奥司他韦胶囊的《药品补充申请批准通知 书》,经审查,本品此次申请事项符合药品注册的有关要求,同意本品增加45mg规格,核发药品批准 文号。同时批准如下关联补充申请事项:1、变更处方中的辅料用量;2、变更包装材料和容器;3、注册 标准变更。变更后的生产工艺及质量标准照所附执行,有效期12个月,说明书及包装标签做相应修订, 其他执行原批准信息。 此次公司新增获得磷酸奥司他韦胶囊药品补充申请批准通知书,标志着公司具备了在国内市场销售该规 格药品的资格,将进一步丰富公司产品管线和产品品类,对公司销售产生积极影响。 ...
一品红(300723) - 关于全资子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书的公告
2025-09-19 03:44
证券代码:300723 证券简称:一品红 公告编号:2025-061 一品红药业集团股份有限公司 关于全资子公司获得磷酸奥司他韦胶囊药品补充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。 一品红药业集团股份有限公司(以下简称"公司")全资子公司广州一品红 制药有限公司(以下简称"一品红制药")于近日收到国家药品监督管理局核准 签发的关于磷酸奥司他韦胶囊的《药品补充申请批准通知书》,现将有关事项公 告如下: 一、药品补充申请批准通知书主要信息 药品通用名称:磷酸奥司他韦胶囊 英文名/拉丁名:Oseltamivir Phosphate Capsules 剂 型:胶囊剂 注册分类:化学药品 规 格:45mg(按 C16H28N2O4计) 申请内容:增加 45mg(按 C16H28N2O4计)规格,涉及变更辅料型号(明胶空 心胶囊由 2#变更为 3#)、处方比例(总处方比例变化 4%)、包材来源及尺寸(变 更药用铝箔的供应商和尺寸规格,材质不变;变更药用复合硬片的尺寸,供应商 及材质不变)、设备厂家(变更过筛以及整粒工序的摇摆颗粒机厂家)及质量标 ...