格隆汇9月19日丨一品红(300723.SZ)公布，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》。 根据《中华人民共和国药品管理法》及有关规定，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。 根据核准的药品说明书，公司获批的磷酸奥司他韦胶囊适应症为：1.用于成人和1岁及1岁以上儿童的甲 型和乙型流感治疗(磷酸奥司他韦能够有效治疗甲型和乙型流感，但是乙型流感的临床应用数据尚不 多)。患者在首次出现症状48小时以内使用。2.用于成人和13岁及13岁以上青少年的甲型和乙型流感的 预防。目前，公司拥有该药品75mg和45mg双规格。 磷酸奥司他韦为神经氨酸酶(NA)抑制剂，其作用机理为选择性抑制神经氨酸酶的活性，阻止病毒由被 感染细胞释放和入侵邻近细胞，减少 ...

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。 ...

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 ...

Group 1 - The core viewpoint of the articles indicates that Yipin Hong's stock has experienced significant fluctuations, with a year-to-date increase of 249.06% but a recent decline in the last five and twenty trading days [1][2] - As of August 31, the number of shareholders for Yipin Hong increased to 21,400, with an average of 19,553 circulating shares per person, reflecting a slight decrease [2] - The company reported a revenue of 584 million yuan for the first half of 2025, representing a year-on-year decrease of 36.02%, and a net profit loss of 73.54 million yuan, a decline of 258.30% [2] Group 2 - Yipin Hong has a total market capitalization of 26.898 billion yuan, with a trading volume of 137 million yuan and a turnover rate of 0.54% as of September 19 [1] - The company has been listed on the Dragon and Tiger list five times this year, with the most recent net purchase of 65.576 million yuan on July 21 [1] - The main business revenue composition of Yipin Hong includes 61.12% from children's medicine, 22.71% from chronic disease medicine, and 16.17% from other products [1][2] Group 3 - Since its A-share listing, Yipin Hong has distributed a total of 335 million yuan in dividends, with 151 million yuan in the last three years [3] - As of June 30, 2025, Yipin Hong's top ten circulating shareholders include a new entry, E Fund Medical Healthcare Industry Mixed A, holding 4.3661 million shares [3]

Market Performance - The pharmaceutical sector experienced a slight increase of +0.04% on September 15, 2025, underperforming the CSI 300 index by 0.20 percentage points, ranking 14th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, medical research outsourcing (+2.54%) and medical devices (+0.48%) performed well, while vaccines (-0.91%), medical consumables (-0.72%), and blood products (-0.51%) lagged behind [1] - Top three gainers in individual stocks were Furuide (+20.01%), Dezhan Health (+10.02%), and Zhaoyan New Drug (+10.01%), while the biggest losers were Nuocheng Jianhua (-8.20%), Yinkang Life (-5.21%), and Xinnuo Wei (-5.11%) [1] Industry News - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for the oral peptide therapy Icotrokinra (JNJ-2113), developed in collaboration with Protagonist, aimed at treating moderate to severe plaque psoriasis in patients aged 12 and older [2] - The ICONIC-LEAD pivotal Phase 3 study reported positive topline results, indicating that Icotrokinra significantly improved skin conditions in patients with moderate to severe plaque psoriasis and demonstrated good safety [2] Company News - Kanglong Chemical announced that its subsidiary, Kanglong Shaoxing, successfully passed the FDA's on-site quality inspection, marking the first time its Shaoxing active pharmaceutical ingredient production facility has passed the FDA's pre-approval inspection [3] - Haisco received a Class 1 innovative drug registration certificate from the National Medical Products Administration for Anruikefen injection, which has been approved for an additional indication to treat moderate to severe itching in adult patients with chronic kidney disease related to maintenance hemodialysis [3] - Yipinhong's subsidiary in Guangzhou received a drug registration certificate for Clindamycin Palmitate Granules, confirming compliance with registration requirements [3] - Shanghai Laishi announced that its controlling shareholder, Haiyingkang, has cumulatively increased its shareholding by 72,935,300 shares, representing 1.10% of the total share capital, with a total investment of approximately RMB 499.99 million from May 22, 2025, to September 15, 2025 [3]

Group 1 - The stock price of Yipinhong (300723) closed at 60.35 yuan on September 16, 2025, down 2.99% with a turnover rate of 1.55% and a trading volume of 64,800 shares, amounting to a transaction value of 393 million yuan [1] - On September 16, the net outflow of main funds was 45.6391 million yuan, while the net inflow from speculative funds and retail investors was 21.6322 million yuan and 24.0069 million yuan, respectively [1][3] Group 2 - Yipinhong's wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., received a drug registration certificate for Clindamycin Palmitate Granules from the National Medical Products Administration. This drug is classified as a Category 3 chemical drug with a specification of 1.5g and a shelf life of 48 months [1] - The drug is indicated for severe infections caused by sensitive anaerobic bacteria, streptococci, pneumococci, and staphylococci, particularly for patients allergic to penicillin. The product is also a Category B product under the national medical insurance scheme and is considered to have passed the consistency evaluation [1] - The expected sales scale of this drug in urban and county-level public hospitals in China for 2024 is approximately 100.3 million yuan. The approval of this product will enhance the company's product pipeline and strengthen its competitiveness in the anti-infection field [1]

证券日报网讯一品红（300723）9月16日在互动平台回答投资者提问时表示，公司合作方Arthrosi是一家 致力于代谢类疾病创新药物研发的公司，公司住所位于美国特拉华州。AR882是公司与Arthrosi合作研 发的1类创新药，是一种具备全球竞争力的新一代高效选择性尿酸转运蛋白(URAT1)抑制剂，旨在通过 抑制尿酸重吸收使尿液尿酸盐排泄正常化，从而降低血尿酸(sUA)水平，用于患者痛风和痛风石的治 疗。2025年8月，AR882全球(不含中国大陆地区)Ⅲ期临床试验完成全部受试者入组。目前，全球多中 心临床试验正在稳步推进中。药品研发具有周期长、投入高、风险大等特点，敬请广大投资者谨慎决 策，注意投资风险。 ...

Core Viewpoint - The stock of Yipinhong has experienced significant fluctuations, with a year-to-date increase of 257.15%, but a recent decline in the last five and twenty trading days, indicating potential volatility in the market [1]. Financial Performance - For the first half of 2025, Yipinhong reported a revenue of 584 million yuan, a year-on-year decrease of 36.02%, and a net profit attributable to shareholders of -73.54 million yuan, a decline of 258.30% [2]. - The company has distributed a total of 335 million yuan in dividends since its A-share listing, with 151 million yuan distributed over the past three years [3]. Stock Market Activity - As of September 16, Yipinhong's stock price was 60.93 yuan per share, with a market capitalization of 27.522 billion yuan. The stock saw a trading volume of 124 million yuan and a turnover rate of 0.48% [1]. - The stock has appeared on the "龙虎榜" (a list of stocks with significant trading activity) five times this year, with the most recent appearance on July 21, where it recorded a net purchase of 65.576 million yuan [1]. Shareholder Information - As of August 31, the number of shareholders for Yipinhong was 21,400, an increase of 0.49% from the previous period, with an average of 19,553 circulating shares per shareholder, a decrease of 0.49% [2]. - Among the top ten circulating shareholders, Yifangda Healthcare Industry Mixed A has entered the list as the eighth largest shareholder, holding 4.3661 million shares [3].

Core Viewpoint - Yipinhong (300723.SZ) announced that its wholly-owned subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has received the drug registration certificate for Clindamycin Palmitate Hydrochloride Granules from the National Medical Products Administration [1] Group 1: Product Approval - The drug is indicated for severe infections caused by sensitive anaerobic bacteria [1] - Clindamycin is also suitable for severe infections caused by sensitive strains such as Streptococcus, Pneumococcus, and Staphylococcus, specifically for patients allergic to penicillin or deemed unsuitable for penicillin use by a physician [1] - The approved instructions include specific dosage and administration guidelines for children [1] Group 2: Mechanism of Action - Clindamycin works by inhibiting bacterial protein synthesis through binding to the 23S rRNA of the 50S ribosomal subunit [1]

Group 1 - The core point of the article is that Yipinhong (300723.SZ) has received approval from the National Medical Products Administration for the drug registration certificate of Clindamycin Palmitate Granules, indicating a significant development for the company [1] - The approved indication for Clindamycin is for serious infections caused by sensitive anaerobic bacteria, as well as infections caused by sensitive strains of Streptococcus, Pneumococcus, and Staphylococcus, specifically for patients allergic to penicillin or deemed unsuitable for penicillin use by a physician [1] - The product's instruction clearly includes dosage and administration guidelines for children, highlighting its applicability in pediatric medicine [1] Group 2 - Clindamycin functions as an antibacterial drug by inhibiting bacterial protein synthesis through binding to the 23S rRNA of the 50S ribosomal subunit [1]