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诺泰生物:两款药品获批,产品线拓展至辅助生殖、抗抑郁领域
Core Insights - ST诺泰 has received approval from the drug regulatory authority for two injectable drugs: Acetate Cetrorelix and Agomelatine, marking a significant milestone in the company's product pipeline [1][2] Group 1: Product Approval - Acetate Cetrorelix is a third-generation GnRH antagonist that offers unique clinical advantages in assisted reproductive technology compared to other similar drugs, such as GnRH agonists and other antagonists like Ganirelix [1] - Acetate Cetrorelix demonstrates superior onset speed, safety (prevention of OHSS), shorter treatment cycles, and better patient tolerance compared to GnRH agonists, and has milder injection reactions compared to other antagonists [1] - Agomelatine is a novel antidepressant with a unique dual mechanism of action, distinguishing it from common antidepressants like SSRIs and SNRIs, and is the only antidepressant that improves sleep quickly without affecting daytime functioning [1] Group 2: Market Position and Strategic Expansion - The approval of these two drugs represents ST诺泰's proactive expansion into reproductive health and mental health sectors, building on its existing pipeline of antiviral, cardiovascular, and immune-modulating agents [2] - The company's strategy aligns with national policies promoting childcare subsidies and the inclusion of assisted reproduction in health insurance, providing strong support for patient services and contributing to the high-quality development of the national population [2]
ST诺泰:注射用醋酸西曲瑞克、阿戈美拉汀片取得药品注册证书
Mei Ri Jing Ji Xin Wen· 2025-07-31 09:21
Group 1 - ST诺泰 announced the approval of the drug registration certificate for injectable acetic acid semaglutide and agomelatine tablets by the National Medical Products Administration [2] - In the fiscal year 2024, ST诺泰's revenue composition is 99.88% from the pharmaceutical manufacturing industry and 0.12% from other businesses [2]
ST诺泰(688076) - ST诺泰:关于自愿披露注射用醋酸西曲瑞克、阿戈美拉汀片获得药品注册证书的公告
2025-07-31 09:00
证券代码:688076 证券简称:ST 诺泰 公告编号:2025-059 江苏诺泰澳赛诺生物制药股份有限公司 关于自愿披露注射用醋酸西曲瑞克、阿戈美拉汀片获 得药品注册证书的公告 江苏诺泰澳赛诺生物制药股份有限公司(以下简称"公司"或"诺泰生物") 于近日收到国家药品监督管理局核准签发的注射用醋酸西曲瑞克、阿戈美拉汀片 的《药品注册证书》(证书编号:2025S02223、2025S02377),现将相关情况 公告如下: 一、《药品注册证书》的主要内容 1、药品名称:注射用醋酸西曲瑞克 剂型:注射剂 规格:0.25mg(按 C70H92C1N17O14计) 申请事项:药品注册(境内生产) 注册分类:化学药品 4 类 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 药品有效期:18 个月 包装规格:每盒 7 瓶,每盒 1 瓶 上市许可持有人:江苏诺泰澳赛诺生物制药股份有限公司 生产企业:江苏诺泰澳赛诺生物制药股份有限公司 药品批准文号:国药准字 H20254895 药品批准文号有效期:至 2030 年 7 月 21 日 审批结论 ...
ST诺泰(688076.SH)收到注射用醋酸西曲瑞克、阿戈美拉汀片药品注册证书
智通财经网· 2025-07-31 08:48
智通财经APP讯,ST诺泰(688076.SH)公告,公司近日收到国家药品监督管理局核准签发的注射用醋酸 西曲瑞克、阿戈美拉汀片的《药品注册证书》。 公告显示,醋酸西曲瑞克作为第三代GnRH拮抗剂,在辅助生殖技术中相较于其他同类药物(如GnRH激 动剂或其他拮抗剂如加尼瑞克)具有独特的临床优势。醋酸西曲瑞克在起效速度、安全性(OHSS预防)、 治疗周期缩短和患者耐受性上显著优于GnRH激动剂,且相较于其他拮抗剂(如加尼瑞克)注射反应更 轻,是辅助生殖中高效、灵活的选择。 阿戈美拉汀作为一种新型抗抑郁药,与SSRIs(如舍曲林、氟西汀)、SNRIs(如文拉法辛)、NaSSA(如米氮 平)等常见抗抑郁药相比,具有独特且创新的双重作用机制,是唯一兼具快速改善睡眠且不影响日间功 能的抗抑郁药。此外,阿戈美拉汀还有极低性功能障碍风险、对体重影响小、耐受性好、撤药反应少等 优势,在抑郁症伴失眠市场占据着重要的地位。 ...
ST诺泰(688076)7月30日主力资金净流出3686.75万元
Sou Hu Cai Jing· 2025-07-30 14:56
资金流向方面,今日主力资金净流出3686.75万元,占比成交额4.99%。其中,超大单净流出4517.51万 元、占成交额6.11%,大单净流入830.77万元、占成交额1.12%,中单净流出流入2257.57万元、占成交 额3.05%,小单净流入1429.18万元、占成交额1.93%。 通过天眼查大数据分析,江苏诺泰澳赛诺生物制药股份有限公司共对外投资了13家企业,参与招投标项 目192次,知识产权方面有商标信息13条,专利信息123条,此外企业还拥有行政许可397个。 来源:金融界 ST诺泰最新一期业绩显示,截至2025一季报,公司营业总收入5.66亿元、同比增长58.96%,归属净利润 1.53亿元,同比增长130.10%,扣非净利润1.52亿元,同比增长131.79%,流动比率1.062、速动比率 0.732、资产负债率47.86%。 天眼查商业履历信息显示,江苏诺泰澳赛诺生物制药股份有限公司,成立于2009年,位于连云港市,是 一家以从事医药制造业为主的企业。企业注册资本21318.38万人民币,实缴资本15690.785万人民币。公 司法定代表人为童梓权。 金融界消息 截至2025年7月30日收盘 ...
南京证券三分之一保荐项目被ST ST诺泰上市当年就财务造假|科创板6周年
Xin Lang Zheng Quan· 2025-07-25 09:34
Group 1 - The core viewpoint of the article highlights the significant changes and developments in the Sci-Tech Innovation Board (STAR Market) since its inception, emphasizing its role in optimizing the A-share market structure and supporting key technological advancements in China [1] - As of July 22, 2025, a total of 591 companies have been listed on the STAR Market, with a cumulative IPO fundraising amount of 927.156 billion yuan and a total market capitalization exceeding 7 trillion yuan [1] - The STAR Market has become an important platform for tackling key core technologies under a new type of national system [1] Group 2 - In the past six years, the leading underwriters for IPOs on the STAR Market include Guotai Junan and Haitong Securities, with a combined total of 213.777 billion yuan raised from 112 underwriting cases [2][5] - CITIC Securities follows with 167.069 billion yuan from 99 cases, while China International Capital Corporation (CICC) and CITIC Jianzhong Securities rank third and fourth, respectively, in terms of underwriting volume [5] - The overall low rate of serious issues among listed companies is noted, with only 7 out of 591 companies facing significant problems, resulting in a low incidence rate of 1.18% [5][6] Group 3 - Nanjing Securities has faced scrutiny due to its involvement with ST Nuotai, which was flagged for financial misconduct shortly after its IPO, raising concerns about the quality of its ongoing supervision [7][9] - The company earned 211 million yuan in underwriting fees from three IPO projects, with ST Nuotai being a significant contributor despite its subsequent financial issues [7][8] - The regulatory body has not penalized Nanjing Securities for its oversight failures, despite the serious nature of the financial discrepancies found in ST Nuotai's reports [9][12]
诺泰生物因财务造假戴帽ST 招商基金率先下调估值
Sou Hu Cai Jing· 2025-07-24 13:20
Core Viewpoint - Notai Bio (688076.SH) has been penalized for financial fraud, leading to a downgrade in valuation by fund companies after being designated as ST (Special Treatment) following its resumption of trading [2][7]. Group 1: Financial Fraud and Penalties - The China Securities Regulatory Commission (CSRC) confirmed that Notai Bio's 2021 annual report contained false records, resulting in a total fine of 76.2 million yuan for the company and several executives [2][6]. - Notai Bio's fraudulent activities included inflating revenue by 30 million yuan and profit by 25.95 million yuan, which accounted for 20.64% of the reported total profit for that year [4][5]. - The company was also penalized for providing misleading financial information in its bond issuance documents, leading to additional fines totaling 47.4 million yuan [5][6]. Group 2: Market Impact and Fund Valuation Adjustments - Following the ST designation, Notai Bio's stock closed at 44.51 yuan per share, with a total market capitalization of 14.07 billion yuan [3]. - On July 22, 2025, the valuation of Notai Bio's stock was adjusted to 32.78 yuan by the招商基金, reflecting a reduction of approximately 20% from its previous price of 40.98 yuan [8][9]. - As of the end of Q2 2025, 19 funds from 8 public fund companies held a total of 9.23 million shares of Notai Bio, with a combined market value of 344 million yuan, representing 2.93% of the total share capital [10].
上市首年就财务造假!诺泰生物被罚4740万,保荐机构南京证券难辞其咎
Jing Ji Guan Cha Wang· 2025-07-24 08:05
Core Viewpoint - The stock of NuoTai Bio (688076.SH) was officially changed to "ST NuoTai" following the announcement of a financial fraud case, leading to an 11% drop in stock price on the first trading day after the change [1][2]. Group 1: Financial Fraud Details - NuoTai Bio's financial fraud was revealed in the "Administrative Penalty Notice" issued by the China Securities Regulatory Commission (CSRC), indicating that the company had fabricated financial data in its 2021 annual report [2][3]. - The fraudulent activity involved a technology transfer to Zhejiang Huabei Pharmaceutical Co., which lacked the financial capability and operational capacity to pay for or utilize the technology, resulting in an inflated revenue of 30 million yuan and an inflated profit of 25.9516 million yuan, accounting for 20.64% of the reported profit [3][4]. - NuoTai Bio also included false financial data in its convertible bond issuance documents, continuing to use the fraudulent 2021 financial figures in its fundraising materials [3]. Group 2: Penalties and Consequences - The CSRC proposed penalties against NuoTai Bio, including a fine of 47.4 million yuan and warnings for the company and its executives, with total penalties amounting to 76.2 million yuan, setting a record for penalties on the STAR Market [4][5]. - The actual controllers of NuoTai Bio, Zhao Dezhong and Zhao Deyi, received fines of 13 million yuan and 5 million yuan respectively, while four senior executives were fined between 1.5 million and 3.3 million yuan [4][5]. Group 3: Role of Nanjing Securities - Nanjing Securities, the sponsor for NuoTai Bio's IPO and convertible bond issuance, is implicated in the fraud due to its confirmation of the accuracy of the financial disclosures in the listing and bond issuance documents [6]. - Nanjing Securities earned approximately 66.3854 million yuan in underwriting fees from the IPO and around 5.66 million yuan from the convertible bond project [6]. - The firm has faced multiple issues with its sponsored projects, including instances of financial fraud and information disclosure violations [7][8].
投资人要警惕了!证监会顶格处罚ST诺泰(688076),南京证券(601990)督导缺位并非偶然失手
Sou Hu Cai Jing· 2025-07-23 14:44
Core Viewpoint - The company NuoTai Bio (688076.SH) has been penalized by the China Securities Regulatory Commission (CSRC) for financial fraud and has officially been designated as ST (Special Treatment) due to its violations, which include fabricating financial data and misleading disclosures [1][3]. Group 1: Company Violations - NuoTai Bio was found to have falsely recognized 30 million yuan in revenue through fictitious technology transfers, inflating profits by 25.95 million yuan, which accounted for 20.6% of the disclosed amount [1]. - The company also fabricated significant content in its public offering documents, with the 2023 convertible bond prospectus continuing to use this false data, constituting a serious violation of issuance document integrity [1][3]. Group 2: Underwriter's Responsibility - Nanjing Securities (601990.SH), as the underwriter for NuoTai Bio, was deeply involved in its financing operations and failed to identify the discrepancies in the financial disclosures, despite confirming the accuracy of the information provided [3][6]. - The underwriter received a total of 66.3854 million yuan in underwriting fees for the IPO and an additional 5.66 million yuan for the convertible bond project, raising questions about its due diligence practices [3][6]. Group 3: Regulatory and Market Impact - Following the scandal, Nanjing Securities has faced scrutiny for its oversight quality, with over 40% of the 17 IPO and refinancing companies it has supervised in the past decade encountering issues such as financial fraud and disclosure violations [6]. - Despite achieving a record net profit of 1 billion yuan in 2024, Nanjing Securities reported an 11.6% decline in revenue in the first quarter of 2025, indicating potential weaknesses in its business performance [7]. Group 4: Future Outlook - NuoTai Bio's stock will be subject to additional risk warnings from the Shanghai Stock Exchange, but it does not currently face mandatory delisting due to major legal violations [8]. - Nanjing Securities' 5 billion yuan private placement plan has faced delays and scrutiny, with the validity of the plan extended to July 2026, leaving its future uncertain [8].
2.82亿主力资金净流入,CRO概念涨0.43%
今日涨跌幅居前的概念板块 截至7月23日收盘,CRO概念上涨0.43%,位居概念板块涨幅第6,板块内,35股上涨,美迪西、和元生 物、益诺思等涨幅居前,分别上涨8.83%、8.61%、7.86%。跌幅居前的有诚达药业、四川双马、谱尼测 试等,分别下跌13.12%、6.06%、3.73%。 | 代码 | 简称 | 今日涨跌幅 | 今日换手率 | 主力资金流量(万 | 主力资金净流入比率 | | --- | --- | --- | --- | --- | --- | | | | (%) | (%) | 元) | (%) | | 603127 | 昭衍新 药 | 6.43 | 9.22 | 20301.49 | 12.72 | | 688076 | ST诺泰 | 3.72 | 8.35 | 9287.12 | 8.59 | | 000813 | 德展健 康 | 3.57 | 7.73 | 8458.92 | 13.24 | | 300347 | 泰格医 药 | 0.66 | 3.12 | 7741.24 | 7.48 | | 603538 | 美诺华 | 4.20 | 15.91 | 3839.84 | 4.36 ...