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赛隆药业集团股份有限公司关于子公司获得化学原料药上市申请批准通知书的公告
赛隆药业集团股份有限公司 关于子公司获得化学原料药上市申请批准通知书的公告 登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:002898 证券简称:*ST赛隆 公告编号:2025-098 申请事项:境内生产化学原料药上市申请 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。 赛隆药业集团股份有限公司(以下简称"公司")全资子公司湖南赛隆药业有限公司于近日获得国家药品 监督管理局核准签发的右兰索拉唑《化学原料药上市申请批准通知书》,现将相关情况公告如下: 一、原料药基本信息 化学原料药名称:右兰索拉唑 通知书编号:2025YS01099 登记号:Y20240000786 受理号:CYHS2460643 化学原料药注册标准编号:YBY73162025 有效期:12个月 包装规格:1kg/袋 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品注册的有关要求, 批准注册。质量标准、标签及生产工艺照所附执行。 通知书有效期:至2030年12月10日 二、其他相关信息 右兰索拉唑注射剂用于治疗口服疗法不适用的伴有出血的胃溃疡、十二指肠溃疡 ...
*ST赛隆(002898.SZ):右兰索拉唑获得化学原料药上市申请批准通知书
Ge Long Hui A P P· 2025-12-12 12:51
格隆汇12月12日丨*ST赛隆(维权)(002898.SZ)公布,全资子公司湖南赛隆药业有限公司于近日获得国 家药品监督管理局核准签发的右兰索拉唑《化学原料药上市申请批准通知书》,右兰索拉唑注射剂用于 治疗口服疗法不适用的伴有出血的胃溃疡、十二指肠溃疡。 ...
*ST赛隆:子公司获得右兰索拉唑化学原料药上市申请批准通知书
人民财讯12月12日电,*ST赛隆(002898)12月12日公告,公司全资子公司湖南赛隆药业有限公司于近 日获得国家药品监督管理局核准签发的右兰索拉唑《化学原料药上市申请批准通知书》。右兰索拉唑注 射剂用于治疗口服疗法不适用的伴有出血的胃溃疡、十二指肠溃疡。 ...
赛隆药业:子公司获右兰索拉唑化学原料药上市申请批准
Xin Lang Cai Jing· 2025-12-12 12:28
赛隆药业公告称,其全资子公司湖南赛隆药业近日获国家药监局核准签发的右兰索拉唑《化学原料药上 市申请批准通知书》,通知书编号为2025YS01099,有效期至2030年12月10日。右兰索拉唑注射剂用于 治疗口服疗法不适用的伴有出血的胃溃疡、十二指肠溃疡。此次获批将丰富公司原料药产品管线,但生 产和销售情况存不确定性,公司将按进展披露信息。 ...
奥赛康20250807
2025-08-07 15:03
Summary of the Conference Call for Aosaikang Industry and Company Overview - The conference call focuses on Aosaikang, a company in the pharmaceutical industry, particularly in the fields of generic drugs and innovative drugs [2][3][4]. Key Points and Arguments Generic Drug Business - Aosaikang's generic drug business has shown signs of recovery following the PPI collection, with new generics like Rabeprazole and key products like Delafloxacin set to launch, contributing to cash flow [2][3]. - The chemical drug collection rules are becoming more predictable and moderate, leading to stable profit releases from the generic drug business [2][3]. Innovative Drug Development - Aosaikang's first innovative drug, Ligatinib (for EGFR mutation non-small cell lung cancer), is expected to launch in 2025, with a significant market potential but facing intense competition [2][3][5]. - The Claudin 18.2 monoclonal antibody is anticipated to be the first domestically produced drug in China, particularly promising in the gastric cancer field [2][3][5]. - Other innovative drugs, such as Mavacitamab and dual antibodies for ophthalmology, are progressing steadily, with plans to submit one application and launch one product each year [2][3][5]. Smart Platform Technology - The Smart platform utilizes masking peptide technology to control the release of active ingredients, addressing issues related to short half-lives and high toxicity of traditional cytokine therapies [2][4][6]. - This technology is applicable across various treatment modalities, including antibodies and ADCs, and has shown potential in multiple therapeutic areas [4][6]. Market Competition and Challenges - The domestic EGFR TKI market is highly competitive, with eight third-generation EGFR TKIs already available. Aosaikang faces competition from companies like Innovent Biologics, which has strong commercialization capabilities [3][13]. - The Claudin 18.2 market is also competitive, with existing products showing varying efficacy, but Aosaikang's combination therapies are expected to perform better [12]. Additional Important Insights - The engineering modifications in cytokine therapies aim to enhance efficacy by designing dual-function molecules and utilizing prodrug technologies to improve targeting and reduce side effects [9][10]. - Aosaikang's innovative platform is expected to significantly enhance immune therapy outcomes, with promising clinical data anticipated for products like SKG315 and SKG915 by the second half of 2025 [11]. - The overall outlook for Aosaikang is optimistic, with a recovery in the generic drug sector and a robust pipeline of innovative products supported by advanced technology platforms [14].
奥赛康24年报及25年一季报点评:创新转型快速推进,25年迎来商业化元年
Orient Securities· 2025-05-07 12:23
Investment Rating - The investment rating for the company is "Buy" (maintained) with a target price of 22.36 CNY [1]. Core Views - The company has achieved significant revenue growth, with a reported revenue of 1.778 billion CNY in 2024, representing a year-on-year increase of 23.15%. The net profit attributable to the parent company for the same year was 160 million CNY, a substantial increase of 207.92% [9]. - The first innovative product has been approved for market launch, marking 2025 as a year of commercialization for the company. The innovative transformation has been successful, with the drug Lapatinib (a third-generation EGFR inhibitor) approved for treating non-small cell lung cancer [9]. - The company has a promising pipeline with early-stage research products like IL-15 and ASKG712, which are expected to contribute to future growth [9]. Financial Performance Summary - The company's revenue is projected to grow from 1.443 billion CNY in 2023 to 3.217 billion CNY in 2027, with a compound annual growth rate (CAGR) of approximately 29.3% [7]. - The net profit attributable to the parent company is expected to increase from a loss of 149 million CNY in 2023 to a profit of 473 million CNY in 2027, reflecting a significant turnaround [7]. - The gross margin is expected to remain stable around 80.5% to 81.0% over the forecast period, indicating strong pricing power and cost control [7]. Valuation Summary - The absolute valuation of the company suggests a reasonable market value of 20.755 billion CNY, corresponding to a target price of 22.36 CNY per share [11]. - The forecasted price-to-earnings (P/E) ratio is expected to decrease from -110.6 in 2023 to 34.8 in 2027, indicating improving profitability [7]. - The price-to-book (P/B) ratio is projected to decline from 5.7 in 2023 to 4.0 in 2027, reflecting a more attractive valuation as the company becomes profitable [7].