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上市首年就财务造假,诺泰生物及实控人等被罚7620万元,五年内不得申请再融资
Sou Hu Cai Jing· 2025-12-18 13:23
红星资本局12月18日消息,在科创板上市首年,就策划了业绩造假,并且凭借粉饰后的报表,再融资4.34亿元,这样"铤而走险"的事情就发生在医药外包 企业ST诺泰(688076.SH)身上。 12月17日晚,ST诺泰公告称,公司于近日收到中国证监会(简称"证监会")下发的《行政处罚决定书》,因存在公开发行文件编造重大虚假内容等违法 行为,公司及实际控制人赵德中等6人合计被中国证监会处以7620万元罚款。 造假手法揭秘: "技术转让"与增资形成资金闭环 经过证监会的调查,ST诺泰存在两大违法事实,一是2021年年度报告存在虚假记载;二是公开发行文件编造重大虚假内容。 具体来看,2021年12月,ST诺泰向浙江华贝药业有限责任公司(以下简称浙江华贝)转让药品技术及上市持有许可人权益(以下简称技术转让),并于 12月28日确认业务收入3000万元。 然而,浙江华贝既不具备支付技术转让款的资金实力,也不具备实际应用该技术的生产能力和销售渠道。同期,ST诺泰策划向浙江华贝增资。浙江华贝 向ST诺泰支付的技术转让款最终来自ST诺泰的增资款。 诺泰生物技术转让业务不具有商业实质,不应确认收入。该业务导致诺泰生物2021年年度报 ...
上市首年就财务造假!董事长申辩“非会计专业”被驳回,ST诺泰及实控人等被罚7620万元
Xin Lang Cai Jing· 2025-12-18 12:35
炒股就看金麒麟分析师研报,权威,专业,及时,全面,助您挖掘潜力主题机会! 上市首年就财务造假,3000万"技术转让"收入资金闭环曝光!董事长申辩"非会计专业"被驳回,公司及 实控人等被罚7620万元 红星资本局12月18日消息,在科创板上市首年,就策划了业绩造假,并且凭借粉饰后的报表,再融资 4.34亿元,这样"铤而走险"的事情就发生在医药外包企业ST诺泰(维权)(688076.SH)身上。 12月17日晚,ST诺泰公告称,公司于近日收到中国证监会(简称"证监会")下发的《行政处罚决定 书》,因存在公开发行文件编造重大虚假内容等违法行为,公司及实际控制人赵德中等6人合计被中国 证监会处以7620万元罚款。 造假手法揭秘: "技术转让"与增资形成资金闭环 经过证监会的调查,ST诺泰存在两大违法事实,一是2021年年度报告存在虚假记载;二是公开发行文 件编造重大虚假内容。 具体来看,2021年12月,ST诺泰向浙江华贝药业有限责任公司(以下简称浙江华贝)转让药品技术及 上市持有许可人权益(以下简称技术转让),并于12月28日确认业务收入3000万元。 然而,浙江华贝既不具备支付技术转让款的资金实力,也不具备实际应 ...
ST诺泰:行政处罚落地 轻装上阵推动稳健发展与创新布局
Core Viewpoint - ST诺泰 (688076.SH) has received an administrative penalty decision, but this has not negatively impacted its current business performance, with significant revenue and profit growth reported for the first three quarters of 2025 [2] Group 1: Financial Performance - For the first three quarters of 2025, the company achieved revenue of 1.527 billion yuan, representing a year-on-year increase of 21.95% [2] - The net profit attributable to shareholders reached 445 million yuan, up 26.92% year-on-year, while the net profit excluding non-recurring items was 437 million yuan, reflecting a 23.20% increase [2] Group 2: Business Growth and Strategy - The company's peptide raw material drug business continues to grow significantly, driven by the expanding GLP-1 market, and is a core driver of its performance [2] - The company is implementing a development strategy focused on time and technology leadership, with a foundation in peptide drugs and small molecule drugs, while strategically expanding into oligonucleotide business and cutting-edge fields like synthetic biology and AI drug development [2] Group 3: Innovation and R&D - The company has made a significant breakthrough in innovative R&D, with its subsidiary, Hangzhou Nuoao Biopharmaceutical Technology Co., Ltd., receiving acceptance for a clinical trial application for the new drug Semaglutide tablets, marking a milestone in oral peptide delivery technology for weight management [2] - Currently, there are no approved oral Semaglutide formulations for weight management in the domestic and international markets, indicating a substantial market opportunity for the company [2] Group 4: Market Position and Collaborations - As a leading enterprise in the peptide raw material drug sector, the company has overcome technical bottlenecks in large-scale production of long-chain peptide drugs, achieving single-batch production of over 10 kilograms for drugs like Semaglutide and Tirzepatide [3] - The company has established collaborations with several leading generic drug companies for the raw materials and formulations of Semaglutide and Tirzepatide, maintaining high growth in peptide raw material sales [3] - The company has also announced comprehensive coverage of its GLP-1 pipeline products, with ongoing development of new targets like Retatrutide, which is set to begin development in early 2024 with an investment of approximately 5.08 million yuan [3] Group 5: Oligonucleotide and New Technologies - The company is actively involved in the oligonucleotide field, with plans for commercial production capacity expected to be completed by 2025, aiming for an annual output of 1,000 kilograms of oligonucleotides and 200 kilograms of PEG-conjugated cyclic peptides [4] - Collaborations with companies like Novogene and DeepTech in synthetic biology and AI-enabled areas are accelerating the exploration of new business fields, positioning the company for high-quality development across multiple tracks [4]
诺泰生物:行政处罚落地 轻装上阵推动稳健发展与创新布局
值得注意的是,公司近日也在互动平台表示,对GLP-1管线产品进行了全面覆盖。在一代利拉鲁肽、二 代司美格鲁肽及双靶点替尔泊肽成功的基础上,进行管线设置,承上启下,布局未来。以三靶点 Retatrutide(瑞他鲁肽)为例,公司于2024年初就立项开发,目前研发投入约508万元。后续将同全球仿 制药客户积极合作,开发市场。 除多肽药物外,诺泰生物在寡核苷酸领域同样有所布局。从行业层面出发,自11月美国Arrowhead研 发,用于降甘油三酯的小核酸药物FDA获批以来,因适应症从罕见病向慢性病拓展,小核酸药物的市场 关注度加速提升。而在该领域,公司早已入局。寡核苷酸项目正按计划推进中,相关产能今年以来也在 陆续投产。据披露,公司寡核苷酸吨级商业化生产车间2025年内将完成建设,形成年产寡核苷酸1000公 斤、PMO 100公斤、PEG偶联环肽200公斤的优质产能,有望充分获益后续下游相关药物研发生产需求 的增长。 不仅如此,公司还先后与诺唯赞、深势科技在合成生物学及AI赋能层面达成合作,加速新业务领域开 拓。随着新产能的逐步落地和前沿技术领域的不断突破,诺泰生物有望在多肽药物、合成生物学、AI 制药等多赛道实现高 ...
吃口服司美前一定要看完这篇,不然效果大打折扣!
GLP1减重宝典· 2025-12-16 08:34
Core Viewpoint - The article emphasizes the importance of adhering to the recommended administration guidelines for oral semaglutide to achieve optimal therapeutic effects in weight loss and blood sugar control [12][14]. Administration Guidelines - The FDA recommends taking oral semaglutide before breakfast with no more than 4 ounces (approximately 120 milliliters) of water, followed by a minimum 30-minute wait before consuming breakfast or other medications [2]. - Taking the medication before any meal or after any meal is less effective due to shorter fasting periods compared to taking it before breakfast [3][5]. - If a person only eats lunch and dinner, taking the medication before lunch is acceptable; similarly, if only breakfast and dinner are consumed, taking it before dinner is also permissible [6]. Fasting and Water Intake - Longer fasting times before taking the medication result in higher plasma concentrations of semaglutide, leading to better clinical outcomes [5]. - Drinking excessive water to mask the bitterness of the pill is not advisable, as it may hinder the absorption of the active ingredient [9][10]. - It is crucial to wait at least 30 minutes after taking the medication before eating to avoid food interference with absorption [11]. Occasional Non-compliance - Missing a dose or occasionally not following the guidelines does not significantly impact overall efficacy, but consistent non-compliance can affect results [12][13]. Efficacy Comparison - Oral semaglutide (Rybelsus) and injectable semaglutide (Ozempic) are equally effective, with studies showing similar results in A1C reduction and weight loss among similar patient populations [15][17].
诺泰生物研发投入开花结果,2类新药口服司美格鲁肽片获临床受理
庞大的受众群体,是以司美格鲁肽为代表的"减重药物"被各界关注的主要原因。根据世卫组织数据,自 1990年以来,全球成人肥胖人数增加了一倍多,青少年肥胖人数增加了三倍,目前超重及肥胖人口已超 20亿。而《世界肥胖报告》则进一步指出,全球超重及肥胖成年人群将在2030年达到29亿人,2035年达 到33亿人。若不采取措施,预计到2030年全球因超重和肥胖产生的成本将达到每年3万亿美元。 近日,据国家药品监督管理局药品审评中心(CDE)网站查询结果,诺泰生物(688076.SH)全资子公司杭州 诺澳生物医药科技有限公司自主研发的2.2类新药司美格鲁肽片(共5个规格)临床试验申请,已于12月5日 获得CDE签发的《受理通知书》,含3mg/7mg/14mg/25mg/50mg共5个规格,均为口服制剂。 据公司官方公众号文章,此次获受理得的药物拟用于肥胖(BMI≥30kg/m2)或超重(BMI≥27kg/m2)且伴有 至少一种体重相关合并症的成年患者体重管理,且截至目前国内外尚无用于体重管理的口服司美格鲁肽 制剂获批上市。此次IND获受理,标志着公司在新型口服多肽递送技术平台、体重管理药物领域取得里 程碑成果,也是诺泰生 ...
2025国谈结果公布:“药王”进医保 5款百万抗癌药进商保
经济观察报· 2025-12-07 12:13
Core Viewpoint - The recent adjustments to the national basic medical insurance directory and the introduction of the commercial insurance innovative drug directory mark significant steps towards enhancing access to innovative treatments in China, particularly for high-cost therapies like CAR-T drugs [2][6]. Summary by Sections National Basic Medical Insurance Directory Adjustments - A total of 114 new drugs were added to the basic medical insurance directory, including 50 first-class innovative drugs [2]. - The total number of drugs in the basic medical insurance directory has increased to 3,253, comprising 1,857 Western medicines and 1,396 traditional Chinese medicines [3]. - New inclusions cover various fields such as oncology, chronic diseases, mental health, and pediatric medications, with several rare disease treatments also added [3]. Commercial Insurance Innovative Drug Directory - The commercial insurance innovative drug directory aims to include high-innovation drugs that exceed the basic insurance scope but offer significant clinical value and patient benefits [6]. - A total of 121 drugs underwent formal review for the commercial insurance directory, with 24 entering price negotiation, ultimately resulting in 19 drugs from 18 companies being included [6]. - Notable inclusions are five CAR-T therapies, which previously cost over one million yuan per injection, making them unaffordable for many patients [6]. Performance of Pharmaceutical Companies - Several leading pharmaceutical companies have reported their successes in the 2025 national medical insurance negotiations, with Heng Rui Pharmaceutical having 20 drugs included, contributing 7.554 billion yuan to their total revenue [5]. - Innovent Biologics announced that 7 of its new drugs were included in the updated national medical insurance directory, with 12 of its 17 innovative drugs now covered [5]. Specific Drug Inclusions - The directory includes drugs for Alzheimer's disease, such as the monoclonal antibodies from Eisai and Eli Lilly, and several rare disease treatments [7]. - Some high-profile drugs, like Novo Nordisk's semaglutide and Bristol-Myers Squibb's nivolumab, were not included despite passing the formal review [8]. Implementation Timeline - The new directory is set to be officially implemented nationwide on January 1, 2026 [9].
68周减重18.34 kg,司美格鲁肽片为何能突破多肽药物的口服易降解、难吸收?
GLP1减重宝典· 2025-11-13 10:41
Core Viewpoint - The successful development and market launch of oral semaglutide, a GLP-1 receptor agonist, represents a significant breakthrough in overcoming the challenges associated with oral administration of peptide drugs, enhancing patient compliance and treatment options [5][9]. Group 1: Development and Mechanism - Oral semaglutide has overcome multiple barriers, including instability due to gastric acid and digestive enzymes, large molecular size affecting absorption, and individual variability in efficacy [5][7]. - The use of SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) has been pivotal in enhancing the solubility and absorption of semaglutide, while also protecting it from degradation [7][9]. - Pharmacokinetic and pharmacodynamic studies have established optimal dosing methods, ensuring that the semaglutide tablet combined with 300 mg of SNAC achieves maximum bioavailability [7][9]. Group 2: Clinical Efficacy - Clinical studies have demonstrated that a 14 mg dose of oral semaglutide can significantly reduce HbA1c levels by approximately 2% and promote weight loss [9]. - In the OASIS 1 study, participants with obesity or overweight conditions experienced an average weight reduction of 17.4% (18.34 kg) with a 50 mg dose of oral semaglutide, indicating a more pronounced weight loss effect compared to previous studies [9]. Group 3: Mechanism of Action - Semaglutide acts as a "satiety manager" by directly suppressing appetite through central nervous system pathways, slowing gastric emptying, and stabilizing blood sugar levels, which collectively reduce food intake [10][12]. - The drug activates GLP-1 receptors in the hypothalamus and brainstem, enhancing satiety signals while inhibiting hunger signals [10][13]. - It also smooths blood sugar fluctuations by promoting insulin secretion and suppressing glucagon release, thereby reducing cravings for high-calorie foods [12][13].
司美格鲁肽片,如何突破多肽药物的口服易降解、难吸收?
GLP1减重宝典· 2025-11-05 05:00
Core Viewpoint - The successful development and market launch of oral semaglutide, a GLP-1 receptor agonist, represents a significant breakthrough in overcoming the challenges associated with oral administration of peptide drugs, which are typically unstable in gastric acid and difficult to absorb in the intestine [5][9]. Group 1: Development and Innovation - The oral formulation of semaglutide has addressed multiple obstacles, including instability due to gastric acid and digestive enzymes, large molecular size affecting absorption, and individual variability in efficacy [5]. - The use of SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) has been pivotal in enhancing the solubility and absorption of the peptide, as well as protecting it from degradation [7]. - Pharmacokinetic and pharmacodynamic studies have established the optimal administration method and dosage, ensuring that the semaglutide tablet combined with 300 mg of SNAC achieves maximum bioavailability [7]. Group 2: Clinical Efficacy - The disintegration and absorption of the semaglutide tablet occur rapidly, with drug absorption observable approximately one hour after administration, leading to the onset of its long-acting GLP-1 receptor agonist effects [9]. - Clinical studies have confirmed the titration method and clinical efficacy of semaglutide, showing that starting from a low dose and gradually increasing to an effective dose optimizes clinical outcomes [9]. - Research indicates that a 14 mg semaglutide tablet can significantly reduce HbA1c levels by approximately 2% and also contributes to weight loss [9]. Group 3: Industry Implications - The development of semaglutide tablets not only provides patients with a new and effective treatment option but also breaks down barriers for oral administration of peptide drugs, setting a new benchmark for the development of peptide-based medications [9]. - This innovation opens up new possibilities for the future development of more oral peptide drugs, potentially transforming the landscape of therapeutic options in the pharmaceutical industry [9].
智通港股解盘 | 月底魔咒再起恒指跌破关口 医药目录谈判引发资金涌入
Zhi Tong Cai Jing· 2025-10-31 12:50
Market Overview - The Hang Seng Index closed down 1.43%, breaking below the 26,000-point mark [1] - U.S. Treasury Secretary indicated that a U.S.-China trade agreement could be signed as early as next week [1] - Concerns over AI investment returns were highlighted after Meta's stock fell 11% due to significant AI spending [1] AI Sector Developments - AI giants like NVIDIA and Samsung are increasing capital expenditures, with Samsung planning to build an "AI factory" [2] - Despite strong demand in AI, stocks like Hua Hong Semiconductor fell over 7% due to fund managers adjusting positions at month-end [2] - Oracle's CDS costs have risen, indicating market concerns about the sustainability of AI investments [1][2] Healthcare and Pharmaceuticals - The National Medical Insurance Directory negotiations are ongoing, with a focus on high-value clinical areas like oncology and chronic disease [4] - Companies like Junshi Biosciences and Kelun-Biotech are seeing stock increases due to their participation in the negotiations [4][5] - The introduction of a commercial insurance innovative drug directory is expected to drive investments in the pharmaceutical sector [3] Shipping and Logistics - The Ningbo Containerized Freight Index rose by 12.6%, with 16 out of 21 routes showing price increases [7] - VLCC freight rates have reached over $120,000 per day, marking a ten-year high [7] Company-Specific Highlights - Zoomlion reported a revenue increase of 8.06% and a net profit increase of 24.89% in Q3 2025 [8] - The company plans to issue up to 6 billion HKD in convertible bonds to enhance global competitiveness [9] - Zoomlion's overseas revenue accounted for 57.36% of total revenue, reflecting a 20.80% year-on-year growth [9]