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新诺威(300765) - 国投证券股份有限公司关于石药创新制药股份有限公司2024年度募集资金存放与使用情况的专项核查报告
2025-03-20 13:15
2024 年度募集资金存放与使用情况的专项核查报告 (一)募集资金金额、资金到账时间 国投证券股份有限公司 关于石药创新制药股份有限公司 1、首次公开发行募集资金情况 石药创新制药股份有限公司经中国证券监督管理委员会《关于核准石药集团 新诺威制药股份有限公司首次公开发行股票的批复》(证监许可[2019]288号)核 准,并经深圳证券交易所《关于石药集团新诺威制药股份有限公司人民币普通股 股票在创业板上市的通知》(深证上[2019]133号)同意,公司公开发行的人民币 普通股股票已于2019年3月22日在深圳证券交易所创业板上市交易。公司首次公 开发行人民币普通股(A股)50,000,000股,发行价格24.47元/股,募集资金总额 1,223,500,000.00元,保荐机构(主承销商)国投证券扣除承销及保荐费用 71,271,300.00元后,于 2019年3月19日将1,152,228,700.00元划至公司募集资金专 户。再行扣除审计验资费用、律师费用、信息披露费用及发行手续费合计 9,819,490.53元后,募集资金净额为1,142,409,209.47元。 国投证券股份有限公司(以下简称"国投证券 ...
新诺威(300765) - 关于续聘会计师事务所的公告
2025-03-20 13:15
证券代码:300765 证券简称:新诺威 公告编号:2025-020 石药创新制药股份有限公司 关于续聘会计师事务所的公告 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。 石药创新制药股份有限公司(以下简称"公司")于 2025 年 3 月 19 日召开了 第六届董事会第二十二次会议及第六届监事会第十七次会议,审议通过了《关于 聘请公司 2025 年度会计师事务所的议案》,同意续聘信永中和会计师事务所(特 殊普通合伙)为公司 2025 年度财务报告及内部控制审计机构,聘期一年,自公 司股东大会审议通过之日起生效。本事项尚需提交公司股东大会审议通过,现就 具体情况公告如下: 一、拟聘任会计师事务所事项的情况说明 信永中和会计师事务所(特殊普通合伙)(以下简称"信永中和")具备证券 业从业资格,其在担任公司审计机构期间,严格遵守国家相关的法律法规,坚持 独立审计原则、客观、公正地为公司提供了优质的审计服务,公允合理地发表独 立审计意见,切实履行了审计机构职责。 成立日期:2012 年 3 月 2 日 组织形式:特殊普通合伙企业 为保持审计工作的连续性,公司拟续聘信 ...
新诺威(300765) - 2024年度监事会工作报告
2025-03-20 13:15
石药创新制药股份有限公司(以下简称"公司")监事会根据《公司法》、《公 司章程》及《监事会议事规则》等相关法律法规和规章制度的规定,认真履行监 督职责,切实维护公司利益和广大股东权益。现将 2024 年度公司监事会工作报 告如下: 石药创新制药股份有限公司 2024 年度监事会工作报告 一、监事会会议情况 2024 年度,公司共召开 9 次监事会议,会议情况如下: 1、2024 年 01 月 23 日,第六届监事会第八次会议召开,审议通过了如下议 案: (1) 《关于公司符合发行股份及支付现金购买资产并募集配套资金相关法律 法规规定条件的议案》 (2) 《关于公司发行股份及支付现金购买资产并募集配套资金暨关联交易方 案的议案》 (3) 《关于公司发行股份及支付现金购买资产并募集配套资金构成关联交易 的议案》 (4) 《关于本次交易预计构成重大资产重组,但不构成重组上市的议案》 (5) 《关于<石药创新制药股份有限公司发行股份及支付现金购买资产并募 集配套资金暨关联交易预案>及其摘要的议案》 (6) 《关于本次交易符合<上市公司重大资产重组管理办法>第十一条和第 四十三条规定的议案》 (7) 《关于本次交易符合 ...
新诺威(300765) - 关于召开2024年年度股东大会的通知
2025-03-20 13:15
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。 根据《中华人民共和国公司法》(以下简称"《公司法》")和《石药创新制 药股份有限公司章程》(以下简称"《公司章程》")等相关规定,经石药创新制 药股份有限公司(以下简称"公司")第六届董事会第二十二次会议审议通过,决 定于 2025 年 4 月 15 日(星期二)召开 2024 年年度股东大会。本次股东大会采 用现场投票与网络投票相结合的方式进行,现就召开公司 2024 年年度股东大会 的相关事项通知如下: 一、召开会议的基本情况 1. 股东大会届次:2024 年年度股东大会。 3. 会议召开的合法、合规性:经公司第六届董事会第二十二次会议审议通过 《关于提请召开公司 2024 年年度股东大会的议案》,同意召开本次股东大会, 本次会议的召开符合《公司法》及《公司章程》等相关规定。 证券代码:300765 证券简称:新诺威 公告编号:2025-027 石药创新制药股份有限公司 关于召开2024年年度股东大会的通知 2. 股东大会的召集人:公司董事会。 4. 会议召开的日期、时间: (1)现场会议召开时间:2025 ...
新诺威(300765) - 监事会决议公告
2025-03-20 13:15
证券代码:300765 证券简称:新诺威 公告编号:2025-014 石药创新制药股份有限公司 第六届监事会第十七次会议决议公告 本公司及监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。 一、监事会会议召开情况 石药创新制药股份有限公司(以下简称"公司"或"上市公司")第六届监事会 第十七次会议(以下简称"本次会议")于 2025 年 3 月 19 日在公司会议室以现场 方式召开,会议通知于 2025 年 3 月 9 日以专人送出、电话通知等方式送达全体 董事。 会议由公司监事会主席张继勇先生主持。本次会议应出席监事人数 3 人,实 际出席监事人数 3 人。出席监事的资格、人数及召集、召开符合《中华人民共和 国公司法》和《石药创新制药股份有限公司章程》等有关规定。 二、监事会会议审议情况 经与会监事充分讨论,本次会议审议并通过了如下议案: (一)审议并通过《关于公司<2024 年度监事会工作报告>的议案》 经审议,监事会同意通过公司《2024 年度监事会工作报告》。 本议案需提交股东大会审议并表决。 具体内容详见公司同日刊载于中国证监会指定创业板信息披露网站巨潮资 讯网 ...
新诺威(300765) - 董事会决议公告
2025-03-20 13:15
证券代码:300765 证券简称:新诺威 公告编号:2025-013 石药创新制药股份有限公司 第六届董事会第二十二次会议决议公告 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。 一、董事会会议召开情况 石药创新制药股份有限公司(以下简称"公司")第六届董事会第二十二次会 议(以下简称"本次会议")于 2025 年 3 月 19 日在公司会议室以现场加通讯表决 相结合的方式召开,会议通知于 2025 年 3 月 9 日以专人送出、电话通知等方式 送达全体董事。 会议由公司董事长姚兵先生主持,公司监事与高级管理人员列席了本次会议。 本次会议应出席董事人数 9 人,实际出席董事人数 9 人。出席董事资格、人数以 及召集、召开程序等均符合《中华人民共和国公司法》等法律法规和《石药创新 制药股份有限公司章程》的规定,本次会议合法有效。 二、董事会会议审议情况 经与会董事充分讨论,本次会议审议并通过了如下议案: (一)审议并通过《关于公司<2024 年度总经理工作报告>的议案》 经审议,董事会同意通过公司《2024 年度总经理工作报告》,2024 年度公司 总经理带领管 ...
新诺威(300765) - 关于2024年度利润分配预案的公告
2025-03-20 13:15
证券代码:300765 证券简称:新诺威 公告编号:2025-021 石药创新制药股份有限公司 关于 2024 年度利润分配预案的公告 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。 一、审议程序 (一)董事会审议情况 公司于 2025 年 3 月 19 日召开了第六届董事会第二十二次会议,会议以 9 票赞成、0 票反对、0 票弃权的表决结果,审议通过了《关于 2024 年度利润分配 预案的议案》,本议案尚需提交股东大会审议并表决。 (二)监事会审议情况 公司于 2025 年 3 月 19 日召开了第六届监事会第十七次会议,会议以 3 票赞 成、0 票反对、0 票弃权的表决结果,审议通过了《关于 2024 年度利润分配预案 的议案》,本议案尚需提交股东大会审议并表决。 (三)独立董事专门会议审议情况 公司于 2025 年 3 月 19 日召开了第六届董事会第十次独立董事专门会议,公 司独立董事就 2024 年度利润分配预案出具了审核意见。独立董事认为:公司 2024 年度利润分配预案在保证公司正常运营和长远发展的前提下,综合考虑了股本现 状、盈利能力、财务状况 ...
新诺威(300765) - 2024 Q4 - 年度财报
2025-03-20 13:10
Financial Performance - The net profit attributable to shareholders for 2024 was CNY 53.73 million, a decrease of 87.63% compared to the previous year[3]. - The company's operating revenue for 2024 was CNY 1,980,753,000, a decrease of 21.98% compared to CNY 2,538,713,470 in 2023[19]. - The net profit attributable to shareholders for 2024 was CNY 53,726,319, representing an 87.63% decline from CNY 434,435,597 in 2023[19]. - The net cash flow from operating activities for 2024 was negative CNY 1,235,054,400, a decrease of 271.26% compared to CNY 721,139,552 in 2023[19]. - The total assets at the end of 2024 were CNY 6,022,115,000, a decrease of 19.41% from CNY 7,472,208,450 at the end of 2023[19]. - The basic earnings per share for 2024 was CNY 0.0384, down 87.65% from CNY 0.3110 in 2023[19]. - The company reported a significant drop in net profit excluding non-recurring items, which was CNY 42,341,883, down 94.31% from CNY 743,672,985 in 2023[19]. - The total revenue for 2024 was approximately ¥1,980,753,001.9, representing a decrease of 21.98% compared to ¥2,538,713,472.3 in 2023[72]. - The revenue from functional foods and raw materials accounted for ¥1,840,312,457.8, which is 92.91% of total revenue, down 24.90% from ¥2,450,349,584.8 in the previous year[72]. Research and Development - Research and development expenses for the year totaled CNY 842.20 million, an increase of CNY 170.80 million, representing a year-on-year growth of 25.44%[3]. - The company is focusing on the development of biopharmaceuticals, including ADCs and mRNA vaccines, as part of its innovation strategy[30]. - The company aims to strengthen its research and development capabilities, with a commitment to meeting clinical needs and advancing antibody therapies[32]. - The number of R&D personnel increased to 415 in 2024, representing an 8.36% growth from 383 in 2023[88]. - R&D investment accounted for 42.52% of total revenue in 2024, up from 26.45% in 2023[88]. - The company has over 20 products in the research pipeline, with several achieving important progress during the reporting period[81]. - The company invested 842.2 million yuan in R&D in 2024, an increase of 25.44% compared to the previous year[53]. Biopharmaceutical Development - The pipeline for biopharmaceutical innovation now exceeds 20 projects, with several products making significant progress during the reporting period[4]. - The company received approval for the launch of Enlansumab injection and Omalizumab injection in 2024, with additional projects entering critical clinical trial phases[4]. - The company has established a biopharmaceutical innovation platform, extending its business chain into the field of innovative biopharmaceuticals[38]. - The company is developing a biosimilar to Omalizumab (Zhiluo®), which has shown high similarity in quality, safety, and efficacy compared to the original drug in clinical studies[41]. - SYS6010, a breakthrough therapy for EGFR mutation-positive advanced non-small cell lung cancer (NSCLC), is under development and has shown significant efficacy compared to standard treatments[42]. - The company has multiple ongoing clinical trials for various drugs, including SYS6023 (ADC) for advanced solid tumors and SYS6016 (mRNA vaccine) for RSV-related lower respiratory diseases[42]. - The company has received approval for two mRNA vaccine products for emergency use in China, enhancing its product portfolio[47]. Market and Competitive Landscape - The biopharmaceutical industry in China is experiencing strong growth driven by policy support, increasing market demand, and technological advancements, with the market expected to outpace global growth rates[32]. - The company is the largest producer of synthetic caffeine globally and serves major international beverage companies such as PepsiCo, Coca-Cola, and Red Bull[40]. - The company is focusing on developing new products such as uracil and theobromine to create differentiated advantages in the market[56]. - The company has established stable partnerships with over 200 chain pharmacy enterprises across nearly 30 provincial administrative regions, forming a nationwide sales network[68]. - The company has a strong market influence and brand recognition in the functional food and raw materials sector, supported by its extensive R&D experience[47]. Governance and Management - The company emphasizes information disclosure, adhering to regulations to provide accurate and timely information to investors[139]. - The governance structure of the company aligns with regulatory requirements, with no significant discrepancies identified[143]. - The company operates independently from its controlling shareholders in terms of business, assets, personnel, and finance, ensuring a complete separation in operations[144]. - The company has established a strategic focus on building a comprehensive biopharmaceutical innovation platform through its investment in Giant Stone Bio[119]. - The company has a clear governance structure with separate decision-making and supervisory bodies, ensuring independent operations[145]. Environmental and Social Responsibility - The company strictly adheres to environmental protection laws and regulations, including the Environmental Protection Law and various pollution prevention standards[188]. - The company has completed the integration of its subsidiary, Giant Stone Biological Pharmaceutical Co., Ltd., into unified management[183]. - The company has made continuous investments in environmental protection to ensure compliance with pollution discharge standards[196]. - The company has engaged qualified third-party monitoring agencies to ensure compliance with environmental standards[195]. - The company is committed to sustainable development, increasing investments in environmental protection and clean production technologies[123]. Shareholder Engagement and Dividends - The profit distribution plan approved by the board includes a cash dividend of CNY 0.20 per 10 shares, with no bonus shares issued[5]. - The company approved a cash dividend of RMB 3.2 per 10 shares, totaling RMB 374,161,265.28, based on a share capital of 1,169,253,954 shares[177]. - The cash dividend distribution accounted for 100% of the total distributable profit of RMB 1,334,850,119.75[178]. - The annual shareholders' meeting had a participation rate of 75.44% on April 9, 2024, indicating strong investor engagement[148]. Challenges and Risks - The company faces market competition risks, particularly in the innovative drug sector, where rapid product updates may threaten existing advantages[124]. - Raw materials constitute a significant portion of operating costs, and any price increases could adversely affect profitability if not managed effectively[127]. - Exchange rate fluctuations pose a risk to the company's operations, particularly in its export business, which is a key source of revenue and profit[128]. - The pharmaceutical industry faces increasing regulatory scrutiny, which may raise operational costs and impact future profitability if quality standards are further tightened[125].
新诺威20250306
2025-03-07 07:47
Summary of Key Points from the Conference Call Company Overview - **Company**: 新诺威 (Xinnoway) - **Industry**: Biopharmaceuticals, specifically focusing on ADC (Antibody-Drug Conjugates), long-acting drug delivery systems, and GMP-certified assets Core Competencies - **ADC Platform**: Xinnoway's ADC platform is among the top tier in China, with a focus on HER2 ADC, TROP2 ADC, and EGFR ADC, which have lower toxicity and side effects [5][7] - **Market Leadership**: Xinnoway holds over 60% market share in the global caffeine market, maintaining a strong position despite price fluctuations [2][5][21] - **Product Pipeline**: The company has a rich product pipeline through its subsidiary, 巨石生物 (Giant Stone Biotech), including approved PD-1 monoclonal antibodies and omalizumab, with a focus on EGFR ADCs [2][6] Product Highlights - **Clinical Trials**: Xinnoway's EGFR ADC is undergoing clinical trials for combination therapy after PD-1 resistance, having received Fast Track designation in the U.S. [2][12] - **Sales Performance**: Omalizumab sales reached 450 million yuan in 2023, driven by aggressive promotion [2][14] - **MR Vaccines**: The company is developing vaccines for RSV and shingles, with RSV vaccine currently in Phase I clinical trials [2][16][17] Financial Outlook - **Market Valuation**: Optimistic estimates suggest Xinnoway's market cap could reach 100 billion yuan, with conservative estimates around 18 billion yuan [4] - **Revenue Growth**: Expected revenue stabilization between 1 to 1.5 billion yuan annually, contributing 400 to 500 million yuan in profit [18] Strategic Developments - **Acquisition Impact**: The acquisition of 百克生物 (Baike Biotech) for 7.6 billion yuan is anticipated to significantly enhance revenue and net profit, with multiple long-acting injection platforms expected to contribute to performance from 2026 to 2027 [18] - **Long-acting Injection Development**: Xinnoway has deep expertise in long-acting formulations, including monthly dosing for psoriasis treatment and ongoing clinical trials for oral formulations [3][19] Collaborations and Partnerships - **Strategic Collaborations**: Xinnoway has engaged in partnerships with AstraZeneca for lipid-lowering drugs and BeiGene for MAT2A inhibitors, showcasing its early-stage development capabilities [20] Market Position and Future Prospects - **Caffeine Business Stability**: Xinnoway's caffeine business remains robust, with a steady demand from major clients like Coca-Cola and Pepsi, and a recovery in export prices [21] - **Overall Outlook**: Xinnoway is positioned as a competitive player in innovative drug development, with significant growth potential from its diverse product pipeline and strategic acquisitions [22]
新诺威:创新加码重塑估值,双轮发展助力巨头转型-20250305
Soochow Securities· 2025-03-05 03:46
证券研究报告·公司深度研究·医药生物 新诺威(300765) 创新加码重塑估值,双轮发展助力巨头转型 2025 年 03 月 05 日 买入(首次) | [Table_EPS] 盈利预测与估值 | 2022A | 2023A | 2024E | 2025E | 2026E | | --- | --- | --- | --- | --- | --- | | 营业总收入(百万元) | 2626 | 2502 | 1969 | 2392 | 2765 | | 同比(%) | 42.00 | (4.75) | (21.29) | 21.48 | 15.59 | | 归母净利润(百万元) | 726.28 | 755.56 | 53.92 | 136.27 | 211.15 | | 同比(%) | 84.70 | 4.03 | (92.86) | 152.71 | 54.94 | | EPS-最新摊薄(元/股) | 0.52 | 0.54 | 0.04 | 0.10 | 0.15 | | P/E(现价&最新摊薄) | 68.00 | 65.36 | 915.83 | 362.40 | 233.89 | [关键词: Ta ...