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一品红左卡尼汀口服溶液获注册证书 近期已有多款药品获批
Core Viewpoint - Yipinhong (300723) has received approval from the National Medical Products Administration for its oral solution of L-carnitine, indicating a significant step in expanding its product portfolio in the pharmaceutical market [1] Group 1: Product Approvals - Yipinhong's subsidiary has obtained a drug registration certificate for L-carnitine oral solution, which is indicated for primary systemic carnitine deficiency and related symptoms [1] - The approved L-carnitine oral solution is classified as a Category B product under the national medical insurance, with an estimated sales scale of approximately 1.257 billion yuan in 2024 [1] - In addition to L-carnitine, Yipinhong has received approvals for several other drugs, including escitalopram oxalate drops (estimated sales of 1.88 billion yuan in 2024) and clindamycin palmitate ester granules (estimated sales of 100 million yuan in 2024) [2][2] - The company has also received approval for oseltamivir phosphate capsules, which are used for the treatment and prevention of influenza in adults and children [2] Group 2: Innovative Drug Development - Yipinhong has disclosed that its innovative drug APH03621, a GnRH receptor antagonist for endometriosis treatment, has received clinical trial registration acceptance [3] - The company is advancing its gout drug AR882, with global Phase III clinical trials expected to complete enrollment by August 2025, and data from these trials anticipated in 2026 [3]
ST诺泰跌0.27%,成交额1.77亿元,后市是否有机会?
Xin Lang Cai Jing· 2025-09-23 08:33
Core Viewpoint - ST诺泰 is experiencing a decline in stock price and trading volume, with a market capitalization of 13.062 billion yuan and a trading volume of 177 million yuan on September 23 [1] Group 1: Business Overview - The company focuses on custom products, primarily in the CDMO (Contract Development and Manufacturing Organization) sector, which emphasizes the integration of process development and technical innovation [2] - ST诺泰 has developed a new GLP-1 receptor agonist for diabetes and weight loss, which has received clinical trial approval [2] - The company’s product, Thymosin Alpha 1 injection, is used for the treatment of chronic hepatitis B [3] - The company’s Oseltamivir Phosphate capsules have been approved for treating and preventing influenza [3] - As of the 2024 annual report, overseas revenue accounts for 63.12% of total revenue, benefiting from the depreciation of the RMB [4] Group 2: Financial Performance - For the first half of 2025, ST诺泰 achieved revenue of 1.048 billion yuan, a year-on-year increase of 26.07%, and a net profit attributable to shareholders of 310 million yuan, up 36.49% [8] - The company has distributed a total of 362 million yuan in dividends since its A-share listing, with 330 million yuan distributed over the past three years [9] Group 3: Market Activity - The stock has seen a net outflow of 12.16 million yuan from major investors today, with a continuous reduction in holdings over the past three days [5][6] - The average trading cost of the stock is 43.13 yuan, with recent accumulation activity noted, although the strength of this accumulation is weak [7] - The stock price is approaching a resistance level of 41.69 yuan, indicating potential for a pullback if this level is not surpassed [7]
ST诺泰跌1.87%,成交额2.15亿元,近3日主力净流入-8743.85万
Xin Lang Cai Jing· 2025-09-22 07:27
来源:新浪证券-红岸工作室 9月22日,ST诺泰跌1.87%,成交额2.15亿元,换手率1.63%,总市值130.97亿元。 异动分析 CRO概念+减肥药+肝炎概念+流感+人民币贬值受益 1、公司的定制类产品业务主要是CDMO业务,CDMO(合同研发与生产组织)更强调生产工艺的研发和技 术创新能力,是高技术壁垒的工艺研发能力与规模生产能力的深度结合。 2、2023年6月9日公司互动:公司自主研发的GLP-1受体激动剂抗糖尿病和减肥一类新药SPN0103-009注 射液已取得药物临床试验批准通知书。 3、公司旗下产品注射用胸腺法新用于治疗慢性乙型肝炎。 4、公司磷酸奥司他韦胶囊获批 药品批准文号:国药准字H20223349 药品批准文号有效期:至2027年05 月30日 磷酸奥司他韦胶囊为一款抗流感病毒药物,主要用于成人和1岁及1岁以上儿童的甲型和乙型流 感治疗,以及用于成人和13岁及13岁以上青少年的甲型和乙型流感的预防。 5、根据2024年年报,公司海外营收占比为63.12%,受益于人民币贬值。 (免责声明:分析内容来源于互联网,不构成投资建议,请投资者根据不同行情独立判断) 资金分析 今日主力净流入-35 ...
9月19日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-19 10:20
Group 1 - Honghe Technology plans to increase capital by 300 million yuan to its wholly-owned subsidiary Huangshi Honghe through debt-to-equity conversion, raising its registered capital from 700 million yuan to 1 billion yuan [1] - Huaxia Happiness has completed debt restructuring amounting to approximately 192.67 billion yuan, with a total of 24 billion yuan in overdue debts as of August 31 [1] - Chengyi Pharmaceutical's controlling shareholder plans to reduce its stake by up to 1.18%, amounting to 387,560 shares [1][2] Group 2 - Yuanwang Valley received a warning letter from the Shenzhen Securities Regulatory Bureau for failing to halt trading when its controlling shareholder's stake changed to a multiple of 5% [2] - Gongjin Co. received government subsidies of 8.9 million yuan, accounting for 11.13% of its latest audited net profit [3] - Maiwei Biotech's application for the listing of 9MW0813 injection has been accepted by the National Medical Products Administration [4] Group 3 - Jianfeng Group plans to repurchase shares worth between 20 million and 40 million yuan at a maximum price of 12.42 yuan per share [6] - Ankai Micro plans to invest 20 million yuan to acquire a 4% stake in Shiqi Future [7] - Pinming Technology's stock will continue to be suspended as it is actively pursuing a significant matter that may lead to a change in control [8] Group 4 - China Communications has signed new contracts worth 256.34 billion yuan from January to August, with domestic contracts totaling 206.05 billion yuan [18] - Round Express reported a revenue of 5.39 billion yuan in August, a year-on-year increase of 9.82% [38] - China Pacific Insurance's original insurance premium income reached 217.05 billion yuan from January to August, up 13.2% year-on-year [39] Group 5 - *ST Chuangxing's chairman is under investigation, and the general manager will act as the chairman during this period [40] - Fengshan Group signed a technical development contract with Tsinghua University for a project related to sodium-ion battery electrolytes [40] - Yongxin Optical stated that its optical components related to lithography machines account for less than 1% of its revenue [41] Group 6 - Tianyuan Dike's subsidiary received a government subsidy of 3.77 million yuan, representing 16.27% of its latest audited net profit [42] - Huaxiang Co. plans to issue convertible bonds to raise no more than 1.308 billion yuan for various projects [43] - Wolong Electric Drive reported that its robot-related products accounted for only 2.71% of total revenue in the first half of the year [44]
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
(文章来源:证券日报) 证券日报网讯 9月19日,一品红发布公告称,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》。 ...
ST诺泰跌2.47%,成交额2.25亿元,近5日主力净流入664.33万
Xin Lang Cai Jing· 2025-09-19 07:55
Core Viewpoint - ST诺泰 is experiencing a decline in stock price, with a recent drop of 2.47% and a total market capitalization of 13.347 billion yuan [1] Group 1: Business Overview - The company specializes in custom products, primarily in the CDMO (Contract Development and Manufacturing Organization) sector, which emphasizes the integration of process development and technical innovation capabilities [2] - ST诺泰 has developed a GLP-1 receptor agonist for diabetes and weight loss, which has received clinical trial approval [2] - The company’s product, Thymosin Alpha 1 injection, is used for the treatment of chronic hepatitis B [3] - The company’s Oseltamivir Phosphate capsules have been approved for treating and preventing influenza [3] - As of the 2024 annual report, overseas revenue accounts for 63.12% of total revenue, benefiting from the depreciation of the RMB [4] Group 2: Financial Performance - For the first half of 2025, ST诺泰 achieved revenue of 1.048 billion yuan, representing a year-on-year growth of 26.07%, and a net profit attributable to shareholders of 310 million yuan, up 36.49% [8] - The company has distributed a total of 362 million yuan in dividends since its A-share listing, with 330 million yuan distributed over the past three years [9] Group 3: Market Activity - The stock has seen a net outflow of 32.0395 million yuan today, with a continuous reduction in main funds over the past three days [5][6] - The average trading cost of the stock is 43.17 yuan, with the current price approaching a resistance level of 42.60 yuan, indicating potential for a price correction if this level is not surpassed [7]
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
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
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。 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,减少病毒在体内的复制,从而抑制流感病毒在人体内的传播以起到治疗 流行性感冒的作用。磷酸奥司他韦为世界卫生组织(WHO)推荐的基本药物,被美国和欧洲疾病预防控 制中心推荐为主要的抗流感病毒药物,同时也是《流行性感冒诊疗方案(2025年版)》明确的一线抗流感 病毒药物。 磷酸奥司他韦胶囊是属于国家医保乙类产品,并进入中国2018版基药目录。公司获 ...