证券代码：688076 证券简称：ST诺泰 公告编号：2025-071 江苏诺泰澳赛诺生物制药股份有限公司 关于自愿披露醋酸阿托西班注射液获得 药品注册证书的公告 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。 规格：0.9ml：6.75mg、5ml：37.5mg（按C43H67N11O12S2计） 申请事项：药品注册（境内生产） 注册分类：化学药品4类 药品有效期：18个月 包装规格：2瓶/盒、4瓶/盒 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 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 局核准签发的醋酸阿托西班注射液的《药品注册证书》（证书编号：2025S03644、2025S03645），现 将相关情况公告如下： 一、《药品注册证书》的主要内容 药品名称：醋酸阿托西班注射液 剂型：注射剂 二、药品相关情况 醋酸阿托西班注射液是一种选择性缩宫素受体拮抗剂，可以竞争性结合子宫肌层缩宫素受体，适用于有 早产指征的妊娠妇 ...

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。 ...

Core Viewpoint - Anke Bio has received approval for its long-acting recombinant human follicle-stimulating hormone (FSH-CTP) injection, marking it as the first of its kind in China, which is expected to enhance the company's market position and revenue potential [1][2] Group 1: Product Approval and Market Impact - The FSH-CTP injection, branded as Shengnuo, is the first long-acting recombinant FSH approved in China, providing a significant market advantage due to the lack of similar competing products [1][2] - The product is designed for controlled ovarian stimulation (COS) in assisted reproductive technology, showing comparable clinical outcomes to short-acting FSH while reducing the frequency of injections, thus improving patient convenience and compliance [1] Group 2: Company Strategy and Future Outlook - Anke Bio aims to enhance its product pipeline and market competitiveness through the exclusive agency agreement for FSH-CTP, which is expected to contribute to revenue growth [2] - The company has prepared its sales team for the commercial launch of FSH-CTP, anticipating that the product will become a new profit growth point as market demand increases [2]

Suspension - Feilu Co., Ltd. is planning a change in company control, leading to the suspension of its stock [1] Capital Increase and Mergers - Yunnan Copper Industry has submitted an application to acquire 40% of Liangshan Mining, which has been accepted by the Shenzhen Stock Exchange [2] - Zhenghe Industrial plans to raise no more than 818 million yuan through a private placement for agricultural machinery component expansion, garden tool chain saw system project, micro chain system software and hardware integration R&D, and to supplement working capital [2] - iFlytek intends to raise no more than 4 billion yuan through a private placement for the Spark Education large model and typical products, and to supplement working capital; a shareholder, Yanzhi Technology, plans to subscribe for no less than 250 million yuan and no more than 350 million yuan [2] External Investment and Daily Operations - Wantai Biological Pharmacy's nine-valent human papillomavirus vaccine has received its first batch release certificate [3] - Hanyu Pharmaceutical's acetic acid atoziban injection has obtained marketing approval in Vietnam [4] - Zai Jian Pharmaceutical has received clinical trial approval for injectable ZG005, injectable ZGGS18, and the combination with hydrochloride gikaixin tablets [5] - Changchun High-tech's subsidiary has had its clinical trial application for injectable GenSci143 accepted [6] - Jinbo Co., Ltd. has received a notification from a leading OEM, selecting the company as a designated supplier for developing and supplying carbon-ceramic brake disc products [6] - Greeenmei has signed a strategic cooperation agreement with Weilan Lithium Core to create a high-energy battery materials and solid-state battery innovation consortium [7] - Anyuan Coal Industry plans to change its stock name to "Jiang Tung Equipment" [8] Performance Changes - Qianfang Technology reported a net profit of 170 million yuan in the first half of the year, a year-on-year increase of 1287.12% [9] - Sainuo Medical's net profit in the first half of the year increased by 296.54% year-on-year [10] - Jin Qilin reported a net profit of 108 million yuan in the first half of the year, a year-on-year increase of 226.14% [11] - Qianzhao Optoelectronics reported a net profit of 69.23 million yuan in the first half of the year, a year-on-year increase of 88.04% [12] - Miaokelando reported a net profit of 133 million yuan in the first half of the year, a year-on-year increase of 86.27% [12] - Hudian Co., Ltd. reported a net profit of 1.683 billion yuan in the first half of the year, a year-on-year increase of 48% [12] - GoerTek reported a net profit of 1.417 billion yuan in the first half of the year, a year-on-year increase of 15.65% [12] - Yunnan Ge Industry reported a net profit of 22.15 million yuan in the first half of the year, returning to profitability [12]

Core Viewpoint - Hanyu Pharmaceutical has received a marketing authorization for its product "Acetate Atosiban Injection" from the Vietnam Ministry of Health, indicating a significant expansion opportunity in the Southeast Asian market [1] Company Summary - Hanyu Pharmaceutical's product, Acetate Atosiban Injection, is a competitive antagonist of oxytocin receptors, specifically designed for pregnant women with indications of preterm labor [1] - The drug is intended to delay imminent preterm birth, demonstrating good clinical efficacy and minimal side effects [1] Industry Summary - The approval of Acetate Atosiban Injection in Vietnam highlights the growing demand for effective treatments in obstetrics, particularly for managing preterm labor [1] - This development may position Hanyu Pharmaceutical favorably within the pharmaceutical industry, especially in the context of expanding its product offerings in international markets [1]

Core Viewpoint - Shenzhen Hanyu Pharmaceutical Co., Ltd. has received marketing authorization for its product Atosiban Acetate Injection from the Vietnam Ministry of Health, which is expected to enhance the company's international market presence and competitiveness [1][2]. Group 1: Drug Information - Drug Name: Atosiban Acetate Injection [1] - Registration Number: 690110326625 [1] - Specification: 5ml:37.5mg [1] - Manufacturer: Shenzhen Hanyu Pharmaceutical Co., Ltd. [1] - Validity of Approval: Until July 17, 2030 [1] Group 2: Drug Application - Atosiban is a competitive antagonist of oxytocin receptors, indicated for pregnant women with signs of preterm labor, aimed at delaying imminent preterm birth [1]. Group 3: Impact on the Company - The approval of Atosiban Acetate Injection is expected to enrich the company's overseas product pipeline and expand its international market [1]. - The company plans to actively promote the sales of this drug in overseas markets, enhancing its international brand influence and overall competitiveness [1].

Core Viewpoint - The leading companies in the growth hormone sector, Changchun High-tech and Anke Bio, are facing declining revenues and are seeking new growth avenues through diversification into other therapeutic areas [1][2][3]. Group 1: Company Performance - Both Changchun High-tech and Anke Bio reported a decline in revenue and net profit for 2024, with Changchun High-tech experiencing its first annual revenue drop in nearly 20 years, showing a 5.66% decrease in revenue and a 44.95% drop in net profit for Q1 2025 [2][3]. - Anke Bio's revenue and net profit also fell by over 10% in the previous year, with a 4% decline in both metrics for Q1 2025 [2][3]. Group 2: Market Dynamics - The growth hormone market in China has expanded significantly, from $600 million in 2018 to $1.7 billion in 2022, capturing 34% of the global market share, surpassing the United States [2]. - The introduction of price-cutting measures in 2022 has pressured the revenues of the two leading companies, leading to a contraction in their growth hormone business [2][3]. Group 3: Product Development and Diversification - Changchun High-tech and Anke Bio are both attempting to diversify their product lines beyond growth hormones, with Changchun High-tech planning to expand into pediatrics, women's health, and anti-aging sectors [4][5]. - Changchun High-tech's subsidiary, GenSci, has seen over 76% of its revenue coming from growth hormones, while Anke Bio's growth hormone sales account for nearly 70% of its total revenue [3]. - Both companies have initiated clinical trials for new products, with Changchun High-tech focusing on innovative drugs and Anke Bio expanding into antiviral and oncology treatments [5].

Group 1 - China Energy Construction won a major coal-fired power project with a bid amount of approximately 14.586 billion yuan, involving six 660 MW supercritical coal-fired generating units and supporting environmental facilities, with a total construction period of about 36.5 months [1] - Taiji Industry plans to repurchase company shares with a total amount not less than 1 billion yuan and not exceeding 1.2 billion yuan, with a maximum repurchase price of 10.38 yuan per share [1] - Youxun Technology won a project from State Grid with a bid amount of approximately 176 million yuan, accounting for 17.44% of the company's audited revenue for 2024 [2] Group 2 - Daili New Materials established an investment fund with a total subscribed capital of 163.3 million yuan, with Daili contributing 10 million yuan, accounting for 6.12% of the fund [4] - Wanyi Technology received a government subsidy of 2.3475 million yuan, which has been confirmed and classified according to relevant accounting standards [6] - Anke Biotech received a drug registration certificate for Acetate Atosiban Injection, which is used for treating preterm labor [7] Group 3 - Renfu Pharmaceutical received a drug registration certificate for Progesterone Soft Capsules, which are used to treat functional disorders caused by progesterone deficiency [9] - Linyang Energy is a recommended candidate for a major contract with State Grid, with a total expected bid amount of approximately 165 million yuan [11] - Hongtian Technology plans to invest 200 million to 300 million yuan to establish a wholly-owned subsidiary in Gansu Province [28] Group 4 - Hunan Xiang Electric received a total of 40 million yuan in government subsidies, which accounts for 16.07% of the company's audited net profit for 2024 [44] - Nengke Technology plans to repurchase shares with a total amount not less than 10 million yuan and not exceeding 20 million yuan, with a maximum repurchase price of 43.00 yuan per share [46] - Xiamen XGMA received 10 million yuan in historical debt repayment, which is expected to increase the company's net profit for 2025 by 3.186 million yuan [48]