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ST诺泰:醋酸阿托西班注射液获药品注册证书
人民财讯12月9日电,ST诺泰(688076)12月9日公告,公司于近日收到国家药监局核准签发的醋酸阿托西 班注射液的药品注册证书。醋酸阿托西班注射液适用于有早产指征的妊娠妇女,用于推迟即将出现的早 产。 ...
诺泰生物:醋酸阿托西班注射液获药品注册证书
Xin Lang Cai Jing· 2025-12-09 11:28
诺泰生物公告称,近日收到国家药监局核准签发的醋酸阿托西班注射液《药品注册证书》。药品有 0.9ml:6.75mg、5ml:37.5mg两种规格,有效期18个月,批准文号有效期至2030年。该注射液为选择性 缩宫素受体拮抗剂,适用于有早产指征的妊娠妇女。获批是公司在辅助生殖药领域的拓展,利于提升竞 争力,但产品销售受多因素影响,短期内对业绩影响不确定。 ...
ST诺泰索赔持续推进 后续投资者仍可起诉
Xin Lang Cai Jing· 2025-12-09 08:09
受损股民可至新浪股民维权平台登记该公司维权:http://wq.finance.sina.com.cn/ 关注@新浪证券、微信关注新浪券商基金、百度搜索新浪股民维权、访问新浪财经客户端、 新浪财经首页都能找到我们! 近日,备受关注的投资者诉江苏诺泰澳赛诺生物制药股份有限公司(证券简称:ST诺泰(维权)、诺 泰生物,证券代码:688076)证券虚假陈述案持续推进。(厉健律师专栏) 原告代理人之一、曾代理投资者告赢130余家上市公司并获赔的浙江裕丰律师事务所厉健律师(证号: 13301200210145176)表示,我们正在分批代理投资者起诉诺泰生物。 案情回溯,2025年7月18日晚,ST诺泰发布关于收到《行政处罚事先告知书》的公告。证监会查明,诺 泰生物及相关人员涉嫌违法主要事实如下: 一、诺泰生物2021年年度报告存在虚假记载。2021年12月,诺泰生物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3,000万元。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,诺泰生物策划向浙 ...
诺泰生物索赔不容错过,部分案件已递交立案
Xin Lang Cai Jing· 2025-12-08 23:24
登录新浪财经APP 搜索【信披】查看更多考评等级 受损股民可至新浪股民维权平台登记该公司维权:http://wq.finance.sina.com.cn/ 关注@新浪证券、微信关注新浪券商基金、百度搜索新浪股民维权、访问新浪财经客户端、 新浪财经首页都能找到我们! 一、已有案件递交立案 7月18日,诺泰生物披露收到证监会下发的《行政处罚事先告知书》,并且监管查明公司存在严重的财 务造假行为。 上海沪紫律师事务所刘鹏律师代理的案件也已陆续递交立案,等待法院审理中。根据公司业绩来看,营 收净利均增长。其前三季度实现营业收入15.27亿元,同比增长21.95%;归属净利润4.45亿元,同比增 长26.92%。(刘鹏律师专栏) 上市公司信息披露违法违规行为不仅严重扰乱证券市场秩序,更是对股民合法权益的严重侵害。根据相 关法律法规,受损投资者可提起诉讼,要求上市公司赔付损失。 索赔条件为于2022年4月28日-2024年10月23日(含当日)之前买入,并在2024年10月24日之后卖出或仍 持有而亏损的还可加入。(诺泰生物维权入口) 二、财报造假被重罚 据事先告知书,该公司2021年年报存在虚假记载,虚增营业收入300 ...
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 ...
流感数据攀升带动药物需求激增,诺泰生物、康缘药业等多家企业加速入局
Zheng Quan Shi Bao· 2025-11-30 11:47
Core Insights - The flu activity in China is rapidly increasing, with the proportion of flu-like cases in southern provinces reaching 6.7% and northern provinces as high as 12%, significantly above previous years' levels [1] - The current flu outbreak is primarily driven by the H3N2 subtype, with a notable increase in demand for antiviral medications such as Oseltamivir and Baloxavir, leading to a surge in sales [1][2] - Domestic pharmaceutical companies, including Notai Bio, Kangyuan Pharmaceutical, and Jindike, are gaining market attention due to their antiviral product offerings and technological advancements [2][4] Industry Trends - The demand for flu medications has led to stock shortages in pharmacies, particularly for original research drugs [2] - Notai Bio has positioned itself competitively in the Oseltamivir market, with multiple drug registration certificates and an organized production line to meet the rising demand [2][3] - The market is transitioning from a dominance of Oseltamivir to a more diversified landscape with both traditional and innovative antiviral drugs being introduced [5] Company Highlights - Notai Bio has achieved significant sales growth for its Oseltamivir capsules, surpassing imported alternatives and establishing a strong online presence [3] - Kangyuan Pharmaceutical's products, such as the anti-viral injection and oral liquid, have shown resilience in sales despite overall revenue declines, indicating a strong growth potential in the flu season [4] - Jindike focuses on flu prevention with its quadrivalent flu vaccine, which has a production capacity of 20 million doses annually and is included in the national immunization program [4][5]
流感数据攀升带动药物需求激增,诺泰生物、康缘药业等多家企业加速入局
Group 1 - The flu activity in China is rapidly increasing, with sentinel hospitals in southern provinces reporting flu-like cases at 6.7%, up from 5.5% the previous week, and northern provinces reaching 12%, significantly higher than the same period from 2020 to 2023 [1] - The current flu strains include the H3N2 subtype, Victoria lineage, and H1N1, with significant antigenic variation leading to increased susceptibility in the population [1] - The demand for antiviral medications has surged, with sales of Oseltamivir increasing by 237% and Baloxavir by 180%, indicating a doubling of orders for flu-specific medications on platforms like Meituan and JD Health [1][2] Group 2 - Domestic pharmaceutical companies such as Nuotai Bio, Kangyuan Pharmaceutical, and Jindike are accelerating their entry into the flu treatment market, focusing on antiviral products [2] - Nuotai Bio has established itself as a competitive player in the Oseltamivir market, actively organizing production to ensure supply amid rising demand [2][3] - Kangyuan Pharmaceutical's products, including the antiviral injection and oral solution, have seen increased sales, with the oral solution contributing significantly to the company's revenue [4] Group 3 - The market is shifting from a dominance of Oseltamivir to a new phase where traditional and innovative treatments coexist, with new drugs like Marzula and Angladi being approved [5] - Companies with differentiated advantages and stable supply chains are expected to stand out in this competitive landscape, particularly those like Nuotai Bio that are deeply embedded in the global antiviral drug supply chain [5] - The upcoming flu peak is creating new growth opportunities for domestic pharmaceutical companies, driven by the increased demand for flu medications [5]
ST诺泰(688076.SH):公司奥司他韦生产线积极有序组织生产,全力备货
Ge Long Hui· 2025-11-27 09:43
格隆汇11月27日丨ST诺泰(688076.SH)在互动平台表示,近期全国流感高发,公司奥司他韦生产线积极 有序组织生产,全力备货,以保障奥司他韦能够及时供应给患者。 ...
避开药明,这些CDMO靠多肽突围
3 6 Ke· 2025-11-17 03:34
Core Insights - The CDMO industry is experiencing a competitive landscape characterized by "head concentration, niche breakthroughs, and increasing differentiation" with leading companies like WuXi AppTec dominating the market share [1] - The growth of the peptide CDMO sector is significantly driven by the expansion of GLP-1 drugs, which has led to substantial revenue increases for several companies [4][14] - The competition is shifting from cost advantages to technological depth, with companies focusing on specialized areas like peptide CDMO to carve out their niches [1][6] Industry Overview - WuXi AppTec services 8 out of 40 small molecule drugs approved by the FDA from 2024 to the first half of 2025, indicating its irreplaceable value in the global market [1] - Other CDMO companies, such as Kelaiying and Saintno Bio, are focusing on peptide CDMO and achieving above-average growth rates, forming a "high-growth camp" within the industry [1][4] - The CXO sector saw a 12% revenue growth year-on-year in Q1 to Q3 of 2025, with net profit increasing by 58%, highlighting a positive growth trend across the industry [2] Company Performance - Kelaiying reported a total revenue of 4.63 billion yuan in the first three quarters of 2025, with peptide and oligonucleotide segments growing by 72% year-on-year, and peptide revenue increasing by over 150% [4] - Saintno Bio's revenue grew by 54% year-on-year, with net profit increasing by 123%, primarily driven by its peptide business [4] - Notably, the combined sales of GLP-1 drugs from Novo Nordisk and Eli Lilly reached approximately $50.2 billion in the first three quarters of 2025, underscoring the market's potential [4] Technological Advancements - The shift from scale advantages to technological premiums is evident, as companies must innovate to meet the complex demands of new therapies [6] - Kelaiying is leveraging its expertise in small molecule CDMO to expand into peptide and other large molecule areas, enhancing its production capabilities [8] - Companies like Nuotai Bio and Saintno Bio are developing specialized technologies for peptide synthesis, which allows them to maintain competitive advantages in the market [10][11] Market Dynamics - The entry of numerous pharmaceutical companies into the GLP-1 market has rapidly expanded the global peptide market, benefiting the peptide CDMO sector [5] - The competition is expected to evolve as the market transitions from a shortage to an oversupply, necessitating a focus on technological innovation and ecosystem building [16] - Future growth in the peptide sector may be driven by innovations in multi-target peptide drugs and the application of AI in drug design [14][15]
每周股票复盘:ST诺泰(688076)海外业务占比约63%
Sou Hu Cai Jing· 2025-11-01 21:05
Core Viewpoint - ST Nuotai (688076) has experienced a decline in stock price, closing at 38.88 yuan, down 1.87% from the previous week, with a current market capitalization of 12.288 billion yuan [1] Group 1: Company Performance - The company has established a global business development team that covers serious medical markets and has deep collaborations with leading enterprises, expanding into traditional markets in Europe and America as well as emerging markets in Latin America and Asia-Pacific [1] - The company’s 601 workshop has commenced production, while the 602 workshop is currently undergoing validation batch production [1][5] - As of the 2024 annual report, overseas business accounts for approximately 63% of the company's revenue structure, indicating a higher proportion of international business compared to domestic [1][5] Group 2: Financial and Operational Insights - The increase in inventory during the third quarter is primarily due to the rise in stock for peptides and formulations, along with an increase in certain customized products [3][5] - Fixed assets have increased due to the transition of the peptide workshop and the Zhonghua Pharmaceutical Port project into fixed assets, with the oligonucleotide project progressing as planned [4] - The company has implemented measures such as foreign exchange hedging to mitigate risks associated with currency fluctuations [5] Group 3: Clinical and Regulatory Updates - The clinical progress of the company's semaglutide injection is currently uncertain, with the timeline for market launch being affected by various factors [4][5] - The company will disclose any relevant updates in accordance with legal regulations upon receiving progress results from the China Securities Regulatory Commission [2]