Workflow
醋酸阿托西班注射液
icon
Search documents
历时11年研发 国内首款长效重组人卵泡刺激素获批上市
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]
8月21日晚间公告 | 万泰生物九价疫苗首次获批签发证明;千方科技、赛诺医疗、金麒麟等中报净利润大增
Xuan Gu Bao· 2025-08-21 11:59
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]
翰宇药业(300199.SZ):醋酸阿托西班注射液获得越南药品上市许可
Ge Long Hui A P P· 2025-08-21 09:27
格隆汇8月21日丨翰宇药业(300199.SZ)公布,近日,深圳翰宇药业股份有限公司收到越南卫生部药品管 理局下发的《药品注册证书》,公司产品"醋酸阿托西班注射液"的获得了越南的上市许可。阿托西班是 一种催产素受体竞争性拮抗剂,适用于有早产指征的妊娠妇女,用于推迟即将出现的早产,临床效果 好,副作用小。 ...
翰宇药业: 关于醋酸阿托西班注射液获得越南药品上市许可的公告
Zheng Quan Zhi Xing· 2025-08-21 09:14
三、对公司的影响 深圳翰宇药业股份有限公司董事会 证券代码:300199 证券简称:翰宇药业 公告编号:2025-038 深圳翰宇药业股份有限公司 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假记 载、误导性陈述或重大遗漏。 近日,深圳翰宇药业股份有限公司(以下简称"公司"或"翰宇药业")收到越南 卫生部药品管理局下发的《药品注册证书》,公司产品"醋酸阿托西班注射液"的获 得了越南的上市许可,现将具体内容公告如下: 一、药品基本情况 药品名称:醋酸阿托西班注射液 药品英文名称: Atosiban Acetate Injection 注册号:690110326625 规格:5ml:37.5mg 药品生产商:深圳翰宇药业股份有限公司 批件有效期:2030年7月17日 二、药品的其他情况 公司醋酸阿托西班注射液具有良好的市场前景,其获得上市许可将进一步丰富 公司海外产品管线,拓宽公司海外市场,公司将积极推动该药品在海外市场的销售, 提高公司的国际品牌影响力和综合竞争力。 阿托西班是一种催产素受体竞争性拮抗剂,适用于有早产指征的妊娠妇女,用 于推迟即将出现的早产,临床效果好,副作用小。 特此公告。 ...
生长激素龙头的“生长痛”:降价、竞品两头夹击,转型成效尚待观察
Mei Ri Jing Ji Xin Wen· 2025-05-29 06:18
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].
5月28日晚间重要公告一览
Xi Niu Cai Jing· 2025-05-28 10:18
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]