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奥赛康:关于子公司马来酸奈拉替尼片获得药品注册证书的公告
2024-10-29 09:42
一、药品基本情况 项目名称:马来酸奈拉替尼片 证券代码:002755 证券简称:奥赛康 公告编号:2024-032 北京奥赛康药业股份有限公司 关于子公司马来酸奈拉替尼片 获得药品注册证书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整, 没有虚假记载、误导性陈述或重大遗漏。 北京奥赛康药业股份有限公司(以下简称"公司")的全资子公司江苏奥赛 康药业有限公司(以下简称"子公司")于近日收到国家药品监督管理局(以下 简称"药监局")核准签发的马来酸奈拉替尼片《药品注册证书》,相关情况如下: 于早期 HER2 乳腺癌患者的扩展辅助治疗药物。国家药品监督管理局于 2020 年 4 月批准马来酸奈拉替尼片进口上市,商品名为贺俪安®,NERLYNX®,规格为 40mg,适用于人类表皮生长因子受体 2(HER2)阳性的早期乳腺癌成年患者, 在接受含曲妥珠单抗辅助治疗之后的强化辅助治疗。 乳腺癌居全球恶性肿瘤发病率第一位,是女性恶性肿瘤患者死亡的主要原因, 也是中国女性发病率最高的癌症。奈拉替尼作为全球首个乳腺癌强化辅助口服治 疗药物已经被国际国内多个权威指南推荐。早期乳腺癌中 HER2+患者约占 20~3 ...
奥赛康:关于对控股子公司增资的公告
2024-10-08 09:07
证券代码:002755 证券简称:奥赛康 公告编号:2024-031 北京奥赛康药业股份有限公司 关于对控股子公司增资的公告 本公司及董事会全体成员保证公告内容真实、准确和完整,没有 虚假记载、误导性陈述或重大遗漏。 一、增资情况概述 AskGene Limited(以下简称"AskGene")是北京奥赛康药业股份有限公司(以 下简称"公司")的控股子公司,公司由全资子公司江苏奥赛康药业有限公司通过 其全资子公司Sea Glory Group Limited持有AskGene已发行股份。 Sea Glory Group Limited拟以现金2.2亿元人民币向AskGene增资,上海泰福 谨通企业管理合伙企业(有限合伙)拟以现金3,000万元人民币向AskGene增资。 本次增资完成后,公司持有AskGene已发行股份数的比例由59.07%提高到62.86%, 公司仍为AskGene的控股股东,AskGene仍将纳入公司合并报表范围。本次增资 资金主要用于AskGene日常运营、研发等。 公司第六届董事会第十五次会议审议通过了《关于对控股子公司增资的议 案》,本次增资事项不构成关联交易,也不构成《上市公司重大 ...
奥赛康:第六届董事会第十五次会议决议公告
2024-10-08 09:05
证券代码:002755 证券简称:奥赛康 公告编号:2024-030 公司董事会同意对控股子公司 AskGene Limited 增资,并授权公司管理层签 署、修订、接受与此次增资相关的协议、交易文件、法律文件或相关的交易安排。 具体内容详见公司同日披露于《证券时报》、《证券日报》和巨潮资讯网 (http://www.cninfo.com.cn)的《关于对控股子公司增资的公告》(公告编号:2024- 031)。 表决结果:9 票同意,0 票反对,0 票弃权。 二、备查文件 北京奥赛康药业股份有限公司 第六届董事会第十五次会议决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整, 没有虚假记载、误导性陈述或重大遗漏。 北京奥赛康药业股份有限公司(以下简称"公司")第六届董事会第十五次会 议于 2024 年 9 月 27 日以电子邮件、专人送达的方式通知各位董事。会议于 2024 年 10 月 8 日以现场表决的方式在南京江宁科学园科建路 699 号 A 楼 3102 会 议室召开。本次会议应到董事 9 人,实到董事 9 人。公司监事、高级管理人员列 席了会议。本次会议符合《中华人民共和国公司法》( ...
奥赛康:首次覆盖报告:创新转型兑现在即,老牌药企焕羽新生
Investment Rating - The report initiates coverage on Aosaikang (002755) with a rating of "Buy" [2][11]. Core Views - The company is transitioning towards innovation, with the potential for significant growth in its pipeline, particularly with ASKB589 leading the way in gastric cancer treatment [2][11]. - The negative impact of centralized procurement is gradually dissipating, and the company has reached a turning point in its performance, with a return to positive revenue growth in 2024H1 [8][27]. - The company has a robust pipeline of innovative drugs and is focusing on differentiated products to drive future growth [8][11]. Summary by Sections 1. Overview - Aosaikang has a strong foundation in generic drugs and is now entering a phase of innovation with multiple products expected to reach commercialization soon [11][23]. 2. Financial Performance - The company forecasts revenue growth from 1.65 billion in 2024 to 2.47 billion in 2026, with net profit expected to turn positive in 2024 [11][12]. - The earnings per share (EPS) are projected to be 0.12, 0.22, and 0.31 for 2024, 2025, and 2026 respectively [11][12]. 3. Product Pipeline - ASKB589, a Claudin 18.2 monoclonal antibody, is in Phase III clinical trials and is expected to lead the market in gastric cancer treatment [11][12]. - ASK120067, a third-generation EGFR-TKI, is nearing approval and is positioned to compete in a significant market [11][12]. - ASKC109, a new oral iron supplement, is in Phase III trials and is expected to address the limitations of existing treatments [11][12]. 4. Market Dynamics - The company is adjusting its product mix in response to the pressures of centralized procurement, with a notable shift from digestive drugs to oncology and chronic disease treatments [8][27]. - The competitive landscape for PPI drugs is changing, with new products like right lansoprazole entering the market [79][80]. 5. Research and Development - Aosaikang has established a strong R&D platform focusing on small molecule targeted therapies and innovative biological drugs, with significant investments in new drug development [23][72]. - The company is leveraging its proprietary technology platforms to enhance the development of cytokine-based therapies [72][73].
奥赛康:轻舟已过万重山,创新药扬帆起航
申万宏源· 2024-09-22 02:37
Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [4][75]. Core Insights - The impact of centralized procurement has largely cleared, with a performance turning point observed in H1 2024, as the generic drug segment begins to recover [3][17]. - The company is focusing on innovative drugs, with several potential high-value products nearing market entry, including ASK120067 for lung cancer and ASKB589 for gastric cancer [3][46]. - The company is expected to achieve profitability in 2024, with projected revenue growth rates of 18.8%, 15.1%, and 21.2% for 2024, 2025, and 2026, respectively [4][72]. Summary by Sections Market Data - Closing price: 10.20 CNY - Market capitalization: 9,467 million CNY - One-year high/low: 12.28/6.50 CNY [2]. Financial Forecasts - Expected revenues for 2024-2026 are 1.716 billion, 1.974 billion, and 2.393 billion CNY, respectively, with net profits projected at 81 million, 134 million, and 203 million CNY [4][72]. - The company anticipates a return to profitability in 2024, with significant growth in net profit expected in the following years [4][75]. Business Segments - The company’s main business segments include: - **Digestive Drugs**: Revenue expected to stabilize in 2024, with growth anticipated in subsequent years due to new product launches [70][71]. - **Oncology**: Revenue growth is expected to be stable in 2024, with a potential decline in 2025 due to procurement impacts, followed by recovery in 2026 [70][71]. - **Anti-infection**: Rapid growth is expected, with revenues projected to increase significantly in the coming years [70][71]. - **Chronic Diseases**: This segment is expected to see substantial growth, particularly with the introduction of new products [70][71]. Innovation Pipeline - The company has developed several innovative drugs, including ASK120067 and ASKB589, which are in advanced clinical stages and expected to contribute significantly to future revenues [3][46][62]. - The SmartKine® platform is being utilized to enhance the development of cytokine-based therapies, addressing previous challenges in this area [62][63]. Valuation - The company is valued using a price-to-sales (P/S) ratio, with a target market capitalization of 12.82 billion CNY, indicating a potential upside of 35% from current levels [4][75].
奥赛康:存量业务影响见底,创新管线临床推进顺利
Changjiang Securities· 2024-09-16 05:08
Investment Rating - The investment rating for the company is "Buy" and is maintained [3][4]. Core Views - The company's revenue for the first half of 2024 reached 923 million yuan, representing a year-on-year growth of 29.6%. The net profit attributable to shareholders was 75.59 million yuan, a significant turnaround from a loss of 158 million yuan in the same period last year, indicating that the company's generic drug business has reached a turning point and is back to growth [3][4]. - The company has a healthy cash flow with over 1.9 billion yuan in cash on hand as of June 30, 2024. R&D expenses have significantly decreased to 180 million yuan, down 44.2% year-on-year, mainly due to the completion of major clinical development phases for several new drugs. The company continues to focus on the development of innovative drugs and high-barrier complex formulations through both independent R&D and collaborative partnerships [3][4]. - The clinical progress of early-stage molecules is proceeding smoothly, showcasing potential for BIC (biological innovative compounds). ASKG712, a VEGF/ANG2 ophthalmic drug, has completed Phase I clinical trials and is currently in Phase IIa for treating diabetic macular edema. The company is also advancing two IL-15 cytokines in clinical trials [3][4]. Financial Summary - The company is projected to achieve net profits of 107 million yuan, 305 million yuan, and 369 million yuan for the years 2024, 2025, and 2026, respectively. Corresponding EPS (earnings per share) estimates are 0.12 yuan, 0.33 yuan, and 0.40 yuan [4][8]. - Total revenue is expected to grow from 1.443 billion yuan in 2023 to 2.319 billion yuan by 2026, with a gross profit margin increasing from 81% to 89% over the same period [8].
奥赛康:2024年半年度报告点评:净利润环比高速增长,今年有望扭亏为盈
Guoyuan Securities· 2024-09-06 11:08
Investment Rating - The report maintains a "Buy" rating for the company [6]. Core Views - The company has achieved significant revenue growth, with a 29.6% year-on-year increase in revenue for the first half of 2024, reaching 920 million yuan, driven by strong sales in anti-infection and chronic disease products [1]. - The company has reported a net profit of 75.59 million yuan for the first half of 2024, marking a turnaround with consecutive quarters of profitability [1]. - The company is focusing on cost management, resulting in improved profitability, with a notable reduction in management expenses by 6.2% year-on-year [1]. - The company is expected to experience a growth phase in its innovative transformation, with projected revenue growth rates of 13.03%, 20.90%, and 18.98% for 2024-2026 [1]. Financial Performance Summary - In the first half of 2024, the company achieved revenue of 920 million yuan, with a net profit of 75.59 million yuan and a non-recurring net profit of 55.14 million yuan [1]. - The revenue breakdown shows that the anti-infection segment generated 260 million yuan (up 132.31% year-on-year), while the chronic disease segment reached 160 million yuan (up 60.2% year-on-year) [1]. - The company has submitted a new drug application for an EGFR third-generation inhibitor for first-line treatment of non-small cell lung cancer, which was accepted by the National Medical Products Administration in August 2024 [1]. - The company’s operating costs increased by 22.0% year-on-year to 170 million yuan, while sales expenses rose by 22.7% to 520 million yuan, both growing slower than revenue [1]. - Research and development expenses decreased significantly from 330 million yuan to 180 million yuan (down 44.2% year-on-year) due to the completion of major clinical trials [1]. Earnings Forecast - The company is projected to achieve net profit growth rates of 122.85%, 120.45%, and 122.48% for the years 2024-2026, with corresponding earnings per share (EPS) of 0.04, 0.08, and 0.18 yuan per share [2].
奥赛康(002755) - 2024 Q2 - 季度财报
2024-08-29 08:07
Financial Performance - The company reported a significant increase in revenue for the first half of 2024, with total revenue reaching 500 million RMB, representing a 20% year-over-year growth[7]. - The company's operating revenue for the first half of 2024 reached ¥922,569,640.74, an increase of 29.60% compared to the same period last year[12]. - Net profit attributable to shareholders was ¥75,594,455.84, a significant turnaround from a loss of ¥158,452,330.29 in the previous year, representing a 147.71% increase[12]. - The net cash flow from operating activities was ¥296,715,646.64, a remarkable increase of 408.63% compared to the previous year[12]. - The company achieved operating revenue of 922.57 million yuan, a year-on-year increase of 29.60%[39]. - The net profit attributable to shareholders reached 75.59 million yuan, reflecting a significant year-on-year growth of 147.71%[39]. - The company reported a significant increase in profit tax expenses, rising 580.93% to ¥6,971,261.82 due to higher profits[61]. Market Expansion and Product Development - User data indicates that the company has expanded its customer base by 15%, now serving over 1 million active users[7]. - The company has provided a positive outlook for the second half of 2024, projecting a revenue growth of 25% compared to the first half[7]. - New product development includes the launch of two innovative drugs, expected to contribute an additional 100 million RMB in revenue by the end of the year[7]. - The company is actively pursuing market expansion, targeting a 30% increase in market share in the next 12 months[7]. - The company plans to enhance its online sales platform, expecting a 40% increase in online sales by the end of 2024[7]. - The company aims to continue expanding its market presence and product offerings in the pharmaceutical industry, focusing on innovation and high-tech barriers in drug development[22]. - The company is focusing on expanding its product offerings in oncology, anti-infection, and chronic disease areas, achieving good revenue growth in these segments during the first half of 2024[74]. Research and Development - The company operates a research and development-driven business model, focusing on the development, production, and sales of APIs and formulations in the pharmaceutical sector[24]. - The company has established several key research centers, including a national enterprise technology center and a provincial engineering center for targeted anti-tumor drugs, enhancing its R&D capabilities[22]. - The company is currently focusing on 48 major research projects, including 11 key innovative drugs that are publicly disclosed, with several others in preclinical research stages[31]. - The company has received approval for 5 new products in 2024, including injectable Ransoprazole and Eltrombopag Ethanolamine Tablets[27]. - The company is actively engaged in clinical trials for multiple innovative drugs, with several in advanced stages of development, including drugs for cancer and infectious diseases[32]. - The company has established a biopharmaceutical R&D platform since 2012, with research centers in the US and China[46]. - The company has implemented a comprehensive drug research and development evaluation mechanism to mitigate risks associated with the lengthy and complex drug development process[74]. Environmental Compliance and Sustainability - The company is committed to complying with various environmental protection laws and standards during its operations[79]. - The company has successfully maintained all emissions below the regulatory standards, indicating effective pollution control measures[80]. - The company continues to prioritize environmental compliance and sustainability in its operations[80]. - The company has implemented various employee incentive measures to enhance innovation and employee engagement[59]. - The company has established a dual emergency prevention mechanism to enhance internal safety risk management and reduce the occurrence of accidents[84]. - The company has invested a total of 5.23 million yuan in environmental governance and protection during the reporting period[86]. - The company has established an environmental self-monitoring plan in compliance with national guidelines, ensuring all monitoring results meet discharge standards[87]. Shareholder and Financial Management - The annual shareholders' meeting held on May 29, 2024, had an investor participation rate of 80.40%[77]. - The company announced no cash dividends, stock bonuses, or capital reserve transfers for the half-year period[78]. - The company has established a diversified investor communication mechanism to protect shareholder rights[91]. - The company reported a total of 201,000,000 CNY in entrusted financial management, with an outstanding balance of 91,500,000 CNY[101]. - The company maintained a total share count of 928,160,351 shares, with 100% being unrestricted shares[104]. - The company has not engaged in any major related party transactions during the reporting period[93]. Risk Management - The company has identified potential risks related to regulatory changes and market competition, with strategies in place to mitigate these risks[3]. - The company is actively responding to industry policy risks by adjusting its strategic deployment and product structure in light of recent regulatory changes[74]. - The company is focused on addressing quality control risks associated with its main injectable products, which have complex production processes[75]. - The company has implemented a comprehensive environmental risk management system, including regular inspections and maintenance of production and environmental protection facilities[84]. Corporate Governance - The financial report reflects the company's compliance with the accounting standards set by the Ministry of Finance, ensuring a true and complete representation of its financial status as of June 30, 2024[147]. - The company reported no significant doubts regarding its ability to continue as a going concern for the next 12 months[145]. - The company has not reported any penalties or rectification measures during the reporting period[93]. - The company has not experienced any bankruptcy restructuring or significant financial issues[91].
奥赛康:半年报监事会决议公告
2024-08-29 08:07
表决结果:3 票同意,0 票反对,0 票弃权。 证券代码:002755 证券简称:奥赛康 公告编号:2024-028 北京奥赛康药业股份有限公司 第六届监事会第十二次会议决议公告 本公司及监事会全体成员保证信息披露内容的真实、准确和完整, 没有虚假记载,误导性陈述或重大遗漏。 北京奥赛康药业股份有限公司(以下简称"公司")第六届监事会第十二次会议 于 2024 年 8 月 19 日以电子邮件、专人送达的方式通知各位监事,会议于 2024 年 8 月 29 日以现场表决的方式在南京江宁科学园科建路 699 号 A 楼 3102 会议室召开。 本次会议应到监事 3 人,实到监事 3 人。本次会议符合《中华人民共和国公司法》 (以下简称"《公司法》")、《中华人民共和国证券法》(以下简称"《证券法》")等 法律、行政法规、部门规章、规范性文件和《公司章程》的相关规定。 会议由监事会主席陈靖先生主持,经与会监事认真审议,一致形成如下决议: 一、审议通过《关于公司 2024 年半年度报告全文及摘要的议案》 经审核,监事会认为:董事会编制和审核《2024 年半年度报告》及《2024 年半 年度报告摘要》的程序符合法律、行 ...
奥赛康:半年度非经营性资金占用及其他关联资金往来情况汇总表
2024-08-29 08:07
| 小计 | - | - | - | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 总计 | - | - | - | | | | | | | | | 其他关联资金往来 | 资金往 来方名 | 往来方与上 市公司的关 | 上市公司核 算的会计科 | 2024 年期 初往来资 | 2024 年 1-6 月往来累计 发生金额 | 2024 年 1-6 月往来资金 | 2024 年 1-6 月偿还累计 | 2024 年 6 月末往来资 | 往来形 | 往来性质 (经营性往 | | | 称 | 联关系 | 目 | 金余额 | (不含利 息) | 的利息(如 有) | 发生金额 | 金余额 | 成原因 | 来、非经营 性往来) | | 控股股东、实际控 制人及其附属企业 | 无 | 不适用 | 不适用 | | | | | | | | | 上市公司的子公司 及其附属企业 | 无 | 不适用 | 不适用 | | | | | | | | | 其他关联方及其附 属企业 | 无 | 不适用 | 不适用 | | ...