证券代码：688197 证券简称：首药控股 | --- | --- | --- | --- | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

证券代码：688197 证券简称：首药控股 公告编号：2024-027 首药控股（北京）股份有限公司 关于参加2024年半年度制药及生物制品专场 集体业绩说明会的公告 息披露允许的范围内进行回答。 二、参会人员 公司参加本次说明会的人员有：公司董事长、总经理李文军先生，副总经 理、科学委员会主席孙颖慧女士，财务总监王亚杰女士，董事会秘书张英利女 士，以及独立董事江骥先生、刘学先生、杨国杰先生（如有特殊情况，参会人 员将可能进行调整）。 首药控股（北京）股份有限公司（以下简称"公司"）已于2024年8月26日在 上海证券交易所网站（www.sse.com.cn）及指定信息披露媒体发布了《2024年 半年度报告》。为便于投资者更加全面深入地了解公司本报告期整体运营情况、 创新药物研发进展及未来发展理念，公司将参与由上交所主办的2024年半年度 制药及生物制品专场集体业绩说明会。此次活动采用网络文字互动的方式举行， 投资者届时可登录上交所上证路演中心（http://roadshow.sseinfo.com/）参与线上 互动交流。 一、会议召开的时间、方式 （四）投资者可于9月13日（星期五）16:00前通过电子邮件 ...

Group 1: Clinical Trials and Drug Development - The company is currently conducting two key clinical trials for SY-5007, with the Phase II trial (CTR20232014) ongoing and the Phase III trial (NCT05278364) completed, both showing efficacy metrics exceeding preset values [2][3]. - The development of the fourth-generation ALK inhibitors is a priority project, addressing significant unmet clinical needs for ALK-positive non-small cell lung cancer patients [2][3]. Group 2: Research and Development Capabilities - The company has a robust preclinical drug development platform, which has led to multiple new drugs demonstrating good safety and tolerability in human trials [3]. - The design of SY-3505 was informed by potential toxicity analysis, balancing brain penetration and efficacy while maintaining a reasonable threshold for blood-brain barrier permeability [3]. Group 3: Financial Status - As of mid-2024, the company has a total cash and financial products amounting to 9.65 billion CNY, with projected R&D expenses between 200 million to 300 million CNY for the year, indicating sufficient funds to support ongoing projects [4]. Group 4: Investor Relations Activity - The investor relations activity included discussions on clinical trial results and registration pathways, with participation from various funds and securities firms [2]. - The meeting was held from August 26 to 30, 2024, in Beijing, with key company representatives present to address investor inquiries [2].

证券代码：688197 证券简称：首药控股 公告编号：2024-023 首药控股（北京）股份有限公司 关于增加闲置资金理财投资额度及投资范围的公告 本公司董事会及全体董事保证本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、准确性和完整性承担个别及连带责任。 首药控股（北京）股份有限公司（下称"公司"或"首药控股"）于 2024 年 4 月 26 日召开第二届董事会第三次会议及第二届监事会第三次会议，会议审议通 过了《关于使用部分暂时闲置募集资金进行现金管理的议案》《关于以自有资金 购买保本型银行理财产品的议案》。董事会同意公司使用额度不超过 4 亿元的闲 置募集资金进行现金管理，用于购买安全性高、流动性好的具有合法经营资格 的金融机构销售的投资产品（包括但不限于银行理财产品、券商理财产品及其 他投资产品等），以及使用最高额度不超过人民币 5 亿元的自有资金，投资安全 性高、流动性好、发行主体有保本约定的银行理财产品以进行日常资金管理； 同时同意在前述授权额度内，募集资金与自有资金分别循环滚动使用，使用期 限均自该次董事会审议通过之日起 12 个月（含）内。具体情况详见 2024 年 ...

证券代码：688197 证券简称：首药控股 公告编号：2024-024 首药控股（北京）股份有限公司 关于续聘会计师事务所的公告 本公司董事会及全体董事保证本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、准确性和完整性承担个别及连带责任。 重要内容提示： 首药控股（北京）股份有限公司（以下简称"公司"）于2024年8月22日召开 第二届董事会第五次会议，会议审议通过了《关于续聘2024年度财务报表及内 部控制审计机构的议案》。现将有关事项公告如下： 一、拟续聘会计师事务所的基本情况 （一）机构信息 1.基本信息 | 事务所名称 | | 天健会计师事务所（特殊普通合伙）（以下简称"天健所"） | | | --- | --- | --- | --- | | 成立日期 | 组织形式 2011年7月18日 | 特殊普通合伙 | | | 注册地址 | 浙江省杭州市西湖区灵隐街道西溪路128号 | | | | 首席合伙人 | 王国海 上年末合伙人数量 | | 238人 | | 上年末执业人员数量 | 注册会计师 | | 2,272人 | | | 签署过证券服务业务审计报告的注册会计师 | | ...

中信建投证券股份有限公司 关于首药控股（北京）股份有限公司 2024 年半年度持续督导跟踪报告 | 保荐机构名称：中信建投证券股份有限公 | 被保荐公司名称：首药控股（北京）股份有限 | | | --- | --- | --- | | 司 | 公司 | | | 保荐代表人姓名：杨慧泽 | 联系方式：010-56051417 联系地址：北京市朝阳区景辉街 16 号院 1 | 号 | | | 楼泰康集团大厦 层 10 | | | 保荐代表人姓名：李彦芝 | 联系方式：010-56051825 联系地址：北京市朝阳区景辉街 16 号院 1 | 号 | | | 楼泰康集团大厦 层 10 | | 2022 年 3 月 23 日，首药控股（北京）股份有限公司（以下简称"首药控股" 或"公司"）首次公开发行股票并在上海证券交易所科创板上市。中信建投证券 股份有限公司（以下简称"中信建投证券"或"保荐机构"）担任本次公开发行 股票的保荐机构。根据《证券发行上市保荐业务管理办法》，由中信建投证券完 成持续督导工作。根据《证券发行上市保荐业务管理办法》和《上海证券交易所 上市公司自律监管指引第 11 号——持续督导》等相关规定， ...

证券代码：688197 证券简称：首药控股 公告编号：2024-024 首药控股（北京）股份有限公司 2024年半年度募集资金存放与实际使用情况的专项报告 本公司董事会及全体董事保证本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、准确性和完整性承担个别及连带责任。 根据《上市公司监管指引第2号——上市公司募集资金管理和使用的监管要 求》《上海证券交易所科创板股票上市规则》《上海证券交易所科创板上市公 司自律监管指引第1号——规范运作》等有关规定，首药控股（北京）股份有限 公司（以下简称"首药控股"或"公司"）董事会对2024年半年度募集资金的存放 与实际使用情况专项报告如下： 一、募集资金基本情况 根据中国证券监督管理委员会2022年1月28日作出的《关于同意首药控股 （北京）股份有限公司首次公开发行股票注册的批复》（证监许可〔2022〕258 号），公司获准向社会公开发行人民币普通股37,180,000股，每股发行价格为 39.90元（人民币，下同），募集资金总额为1,483,482,000.00元，扣除承销及保 荐费用、发行登记费以及累计发生的其他相关发行费用（共计109,72 ...

证券代码：688197 证券简称：首药控股 公告编号：2024-020 一、董事会会议召开情况 首药控股（北京）股份有限公司（以下称"公司"）第二届董事会第五次会 议于2024年8月22日在公司会议室以现场方式召开。本次会议的通知于2024年8 月12日以专人送达、电子邮件等方式送达全体董事。会议应出席董事7人，实际 出席董事7人，全体监事、董事会秘书列席会议。会议由董事长李文军先生主持。 会议召集及召开程序符合《公司法》和《公司章程》的有关规定，会议决议合 法、有效。 二、董事会会议审议情况 （一）审议通过了《关于公司<2024 年半年度报告>及其摘要的议案》 表决结果：7 票赞成；0 票弃权；0 票反对。 公司《2024 年半年度报告》详见同日披露于上海证券交易所网站 （www.sse.com.cn，下同）的公告。 公司《2024年半年度报告摘要》详见同日披露于《中国证券报》《上海证券 报》《证券日报》及上海证券交易所网站的公告。 首药控股（北京）股份有限公司 关于第二届董事会第五次会议决议的公告 本公司董事会及全体董事保证本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 ...

Financial Performance - The company's revenue for the first half of 2024 was CNY 3,800,000, a decrease of 24% compared to CNY 5,000,000 in the same period last year[17]. - The net profit attributable to shareholders for the first half of 2024 was a loss of CNY 102,852,675.72, compared to a loss of CNY 93,113,938.36 in the previous year[17]. - The net cash flow from operating activities for the first half of 2024 was a negative CNY 97,140,764.73, compared to a negative CNY 91,191,453.53 in the same period last year[17]. - The total assets at the end of the reporting period were CNY 1,028,137,166.63, a decrease of 7.55% from CNY 1,112,111,011.82 at the end of the previous year[17]. - The net assets attributable to shareholders at the end of the reporting period were CNY 918,099,482.47, down 10.07% from CNY 1,020,952,158.19 at the end of the previous year[17]. - The basic earnings per share for the first half of 2024 were -CNY 0.69, compared to -CNY 0.63 in the same period last year[18]. - The total comprehensive income for the period was -102,407,809.84 RMB, compared to -92,699,775.40 RMB in the same period last year, indicating a decline of approximately 10.5%[152]. - The company reported a net loss of approximately ¥908.62 million, compared to a loss of ¥805.76 million in the previous period[144]. Research and Development - The research and development expenditure accounted for 2,818.46% of revenue, an increase of 795.29 percentage points compared to 2,023.17% in the previous year[18]. - R&D investment totaled ¥107,101,432.14, a 5.87% increase from the previous year, with R&D expenses accounting for 2,818.46% of operating income, an increase of 795.29 percentage points[46]. - The company has developed a pipeline of 24 innovative drugs with independent intellectual property rights, including 12 self-developed and 12 collaborative research projects[23]. - The company is developing multiple innovative drugs targeting various cancers, including SY-5007, a selective RET inhibitor, and SY-5933, a KRAS (G12C) inhibitor, both of which are in clinical stages[51]. - The company has established a comprehensive preclinical drug development system, including seven core platforms for drug design, screening, and evaluation[43]. - The company has established a top-tier clinical research network across nearly a hundred renowned medical institutions in China, enhancing the quality of clinical trials[56]. - The company has a strong focus on unmet clinical needs, aiming to develop first-in-class or best-in-class drugs while eliminating low-competitiveness products[51]. Market and Industry Outlook - In 2023, the Chinese anti-tumor drug market reached approximately RMB 269 billion, with a CAGR of 11.3% from 2018 to 2023[22]. - The anti-tumor drug market in China is projected to grow to RMB 398.5 billion by 2026 and RMB 581.7 billion by 2030, with a CAGR of 9.9% from 2026 to 2030[22]. - The number of new cases of lung cancer in China reached 1.0606 million in 2022, highlighting the significant market opportunity for anti-cancer therapies[21]. - The company aims to leverage emerging technologies such as gene editing and cell therapy to enhance drug development and meet clinical needs[21]. - The company is positioned to benefit from government policies supporting the development of innovative drugs, as outlined in recent national initiatives[21]. Risk Factors - The company has identified potential risk factors that may adversely affect its performance, which investors should be aware of[3]. - The management discussion and analysis section outlines various risk factors that could impact the company's operations[3]. - The company faces risks related to not being profitable, with accumulated losses impacting future operations and research funding[65]. - The company is exposed to competition from global biopharmaceutical companies, which may develop superior drugs affecting its pipeline products[66]. - The company faces risks related to the approval process for new drugs, which may lead to delays in market entry and impact business operations[70]. Corporate Governance - The board of directors confirmed that all members attended the meeting, ensuring the authenticity and completeness of the semi-annual report[4]. - The semi-annual report has not been audited, but the responsible persons have declared the financial report's accuracy and completeness[4]. - The company has not disclosed any special arrangements for corporate governance[10]. - The company has implemented an employee stock ownership plan in 2020 to retain key research personnel and mitigate the risk of talent loss[67]. Financial Management - The company reported total assets of 1,028.14 million yuan and equity attributable to shareholders of 918.10 million yuan as of the end of the first half of 2024, with no interest-bearing debt and a low asset-liability ratio[63]. - Cash and cash equivalents, along with liquid financial assets, amounted to 964.79 million yuan, sufficient to support operations until the initial commercialization phase[63]. - The company achieved cash management income of 11.49 million yuan during the reporting period through strategic investments with financial institutions[63]. - The company reported a net cash outflow from investment activities of -236,661,701.88 RMB, an increase from -156,018,679.41 RMB in the previous year, due to increased investment expenditures[77]. - The company has incurred net cash outflows from operating activities of -129.48 million yuan, -179.57 million yuan, and -97.14 million yuan for the years 2022, 2023, and the first half of 2024, respectively[72]. Shareholder Commitments - The company has committed to not transferring or entrusting the management of shares held prior to the IPO for 36 months from the date of listing[96]. - The company has a commitment to limit the annual reduction of shares held prior to the IPO to no more than 2% of the total shares during the fourth and fifth fiscal years post-listing[96]. - The company will ensure normal operations and sustainable development to protect the interests of investors, particularly small and medium-sized investors[102]. - The company has established a three-year shareholder dividend return plan to protect investor interests and provide stable returns[110]. Environmental Responsibility - The company invested 147,000 RMB in environmental protection during the reporting period[92]. - The company has implemented strict management of waste and pollutant emissions, ensuring that wastewater and waste gas emissions are below the maximum allowable concentrations[94]. - The company has completed upgrades to its hazardous materials storage facilities and conducted a comprehensive inspection of its environmental protection facilities during the reporting period[94]. Legal and Compliance - The company confirmed that the IPO prospectus and other disclosure materials do not contain false records or misleading statements, and it will legally repurchase shares if any significant omissions are found[117]. - The commitments made by the company are legally binding and subject to supervision by regulatory authorities[111]. - The company will disclose specific reasons for any failure to fulfill commitments in a timely and adequate manner[117].

中信建投证券股份有限公司 关于首药控股（北京）股份有限公司 增加闲置资金理财投资额度及投资范围的核查意见 中信建投证券股份有限公司（以下简称"中信建投证券"或"保荐机构"） 作为首药控股（北京）股份有限公司（以下简称"首药控股"或"公司"）首次 公开发行股票并在科创板上市的保荐机构，根据《证券发行上市保荐业务管理办 法》《上海证券交易所科创板股票上市规则》《上市公司监管指引第 2 号——上市 公司募集资金管理和使用的监管要求》《上海证券交易所科创板上市公司自律监 管规则适用指引第 1 号——规范运作》和《科创板上市公司持续监管办法（试 行）》等有关规定，对首药控股增加闲置资金理财投资额度及投资范围事项进行 了审慎核查，核查情况及核查意见如下： 一、本次调整的背景情况 公司于 2024 年 4 月 26 日召开第二届董事会第三次会议及第二届监事会第 三次会议，会议审议通过了《关于使用部分暂时闲置募集资金进行现金管理的议 案》《关于以自有资金购买保本型银行理财产品的议案》。董事会同意公司使用额 度不超过 4 亿元的闲置募集资金进行现金管理，用于购买安全性高、流动性好的 具有合法经营资格的金融机构销售的投资产品（包 ...