| --- | |-------| | | | | 君实生物(688180) 目标价: 60.26 昨收盘:24.70 拓益销售收入 24H1 同比增长 50%，公司运营效率显著提升 | --- | --- | --- | --- | --- | |-------------|---------------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

Financial Performance - For the six months ended June 30, 2024, the company's total revenue was approximately RMB 786 million, an increase of about 17% compared to the same period in 2023, primarily driven by a 50% increase in domestic sales of the core product Tuoyi® (Tremelimumab) to approximately RMB 671 million[6]. - The loss attributable to the company's owners decreased to RMB 646 million, a reduction of approximately RMB 351 million or about 35% compared to the same period in 2023[6]. - Revenue for the six months ended June 30, 2024, was RMB 786,056,000, an increase of 17.4% compared to RMB 669,703,000 for the same period in 2023[90]. - Gross profit for the same period was RMB 575,255,000, up 50.9% from RMB 381,190,000 in 2023[90]. - The net loss for the six months ended June 30, 2024, was RMB 688,445,000, compared to a net loss of RMB 1,125,338,000 in 2023, representing a 38.9% improvement[92]. - Basic and diluted loss per share improved to RMB 0.66 from RMB 1.01 in the previous year[92]. - Total assets as of June 30, 2024, were RMB 8,676,846,000, a slight decrease from RMB 8,887,308,000 at the end of 2023[94]. - The company's equity attributable to owners decreased to RMB 6,496,788,000 from RMB 7,170,822,000, a decline of 9.4%[96]. Research and Development - Research and development expenses for the reporting period totaled approximately RMB 546 million, a decrease of about 42% compared to the same period in 2023, due to cost control measures and a focus on more promising research pipelines[6]. - The company has expanded its innovative research areas to include small molecule drugs, peptide drugs, antibody-drug conjugates (ADCs), bispecific or multispecific antibody drugs, and nucleic acid drugs, covering five major therapeutic areas[7]. - The clinical research efficiency for the core product, Trelipilumab, has improved, with new indications moving from data readout to NMPA acceptance in as little as 36 days[13]. - The company is focusing on advancing early-stage pipelines, including Claudin18.2 ADC and PI3K-α oral small molecule inhibitors, to meet unmet clinical needs and expedite registration trials[20]. - The company has nearly 30 products in clinical trials and over 20 in preclinical development, covering five major therapeutic areas[26]. Product Approvals and Market Expansion - Tuoyi® received FDA approval in October 2023 and became the first Chinese innovative biologic included in the NCCN guidelines for nasopharyngeal carcinoma in December 2023[7]. - Three of the company's drugs have been included in the new National Medical Insurance Catalog, with Tuoyi® now covering six indications, including first-line treatments for nasopharyngeal carcinoma and esophageal squamous carcinoma[7]. - As of the announcement date, Tuoyi® has been approved for 10 indications in mainland China, with three new indications added to the national medical insurance catalog starting in 2024, making it the only anti-PD-1 monoclonal antibody for melanoma treatment in the catalog[12]. - The company has received regulatory acceptance for multiple new drug applications, including for Tuoyi® in combination with various treatments for advanced cancers[8]. - The company has established commercial partnerships in over 50 countries, including the Middle East, North Africa, Latin America, India, and Southeast Asia, to promote the commercialization of Trelipril monoclonal antibody[15]. Financial Position and Cash Flow - As of June 30, 2024, the company's cash and cash equivalents totaled approximately RMB 3,311 million, a slight decrease of RMB 467 million from December 31, 2023, indicating a relatively strong liquidity position to support development[6]. - The net cash inflow from financing activities during the reporting period was approximately RMB 739 million, while net cash outflows from operating and investing activities were approximately RMB 869 million and RMB 941 million, respectively[74]. - Cash and cash equivalents decreased by CNY 1,066,672,742.86 in the first half of 2024, compared to a decrease of CNY 1,143,174,210.62 in the first half of 2023[144]. - The company reported a significant increase in cash received from sales, totaling ¥840,718,464.86, up from ¥493,939,610.73 in the same period last year[142]. Corporate Governance and Management - The company held its annual general meeting and completed the election of the fourth board of directors and supervisory board in June 2024[8]. - The board of directors underwent changes, with Dr. Li Ning appointed as Vice Chairman and Dr. Zou Jianjun as the new General Manager and CEO on January 12, 2024[157]. - The audit committee consists of two independent non-executive directors and one non-executive director, overseeing financial reporting processes and internal controls[159]. Compliance and Ethical Standards - The company emphasizes compliance and ethical standards, aiming for high-quality sustainable development in a highly regulated pharmaceutical industry[25]. - The company is committed to enhancing its compliance culture and operational efficiency to support sustainable growth[25].

上海君实生物医药科技股份有限公司 2024 年半年度募集资金存放与实际使用情况专项报告 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、准确性和完整性依法承担法律责任。 根据中国证券监督管理委员会（以下简称"中国证监会"）《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指引第1号——规范运作》和《上海证券交易所科创板股 票上市规则》等相关规定，上海君实生物医药科技股份有限公司（以下简称"公 司"）董事会将公司2024年半年度（以下简称"报告期"）募集资金存放与实际 使用情况专项说明如下： 一、募集资金基本情况 （一）实际募集资金金额和资金到位时间 证券代码：688180 证券简称：君实生物 公告编号：临 2024-050 1、2020年首次公开发行A股股票募集资金 根据中国证监会于2020年5月20日出具的《关于同意上海君实生物医药科技 股份有限公司首次公开发行股票注册的批复》（证监许可〔2020〕940号），公 司获准向社会公开发行人民币普通股87,130,000股，每股发行价格为人民币55.5 ...

Financial Performance - The company has not achieved profitability during the reporting period, with operating income unable to cover R&D expenses and other costs[4]. - The company has not proposed any profit distribution or capital reserve transfer plans during the reporting period[5]. - The company reported a total revenue of RMB 1.2 billion for the first half of 2024, representing a 25% increase compared to the same period last year[15]. - The company's operating revenue for the first half of 2024 was approximately RMB 786.06 million, representing a year-on-year increase of 17.37% compared to RMB 669.70 million in the same period last year[22]. - The net profit attributable to shareholders was a loss of RMB 644.95 million, an improvement from a loss of RMB 997.41 million in the previous year[22]. - The basic earnings per share for the first half of 2024 was -0.65 RMB, compared to -1.01 RMB in the same period last year[23]. - The company's net cash flow from operating activities improved, with a net outflow of RMB 865.35 million, reduced from RMB 1.23 billion in the previous year[22][24]. - The gross margin for the first half of 2024 was reported at 65%, an improvement from 60% in the same period last year[15]. - The company aims to achieve a net profit margin of 20% by the end of 2024, up from 15% in the previous year[15]. - The net cash flow from investing activities was -948,475,498.83, compared to -166,151,224.66 in the previous period, indicating a significant increase in cash outflow[121]. - The net cash flow from financing activities increased to 742,383,551.08, up 232.02% from 223,598,222.16 in the previous period[121]. Research and Development - The company is actively expanding its product pipeline, focusing on innovative therapies across multiple disease areas, with ongoing clinical projects and R&D efforts[4]. - The company plans to continue significant R&D investments for preclinical studies, global clinical trials, and preparations for new drug launches[4]. - The company has allocated RMB 300 million for research and development in 2024, which is a 40% increase from the previous year[15]. - The R&D expenditure as a percentage of operating revenue decreased to 69.51%, down from 141.64% in the previous year, indicating a strategic focus on more promising projects[23][24]. - The company has nearly 30 products in clinical trials and over 20 products in preclinical development across five major therapeutic areas[33]. - The company has established a comprehensive technology system covering the entire lifecycle of protein drugs, including multiple technology platforms for antibody screening, human membrane receptor protein libraries, and antibody purification processes[29]. - The company has a robust R&D team with members from renowned institutions and multinational companies, enhancing its research capabilities[29]. - The company has developed an automated high-throughput screening platform for antibody selection, significantly increasing the initial range of clinical candidates[80]. - The company has a strong innovation capability, positioning itself as one of the few domestic enterprises with the potential to develop globally innovative drugs[82]. Product Development and Pipeline - The company is currently developing three new innovative drugs, with expected completion of clinical trials by the end of 2024[15]. - The company has received regulatory approval for two new drugs in the first half of 2024, which are expected to launch in Q3 2024[15]. - The company is actively pursuing new drug development in oncology, autoimmune diseases, chronic metabolic diseases, neurological diseases, and infectious diseases[33]. - The company has made significant progress in its drug pipeline, with multiple products receiving NMPA and FDA approvals for various indications[32]. - The company has received IND approvals for its innovative drug tifcemalimab, which is the world's first anti-BTLA monoclonal antibody entering clinical development[28]. - The company has received approval for Toripalimab in multiple indications, including its use in combination with chemotherapy for advanced nasopharyngeal carcinoma and renal cell carcinoma[84]. - The company is advancing its innovative drug pipeline, with Tifcemalimab being the first domestically developed anti-PD1 monoclonal antibody approved for clinical trials in the U.S. and China[94]. Market Expansion and Strategy - The company plans to expand its market presence in Europe and North America, targeting a 15% market share in these regions by 2025[15]. - The company is in discussions for potential acquisitions to enhance its product portfolio and market reach[15]. - The company is actively pursuing commercialization partnerships in over 50 countries, including regions like the Middle East, North Africa, and Latin America[103]. - The company is focusing on international market expansion, leveraging global collaborations to enhance its competitive edge[78]. - The company has established four major R&D centers in the US and China, enhancing R&D efficiency and reducing costs through a collaborative model[79]. Compliance and Governance - The company emphasizes compliance and integrity as fundamental principles, aiming to build a high-level compliance system and strictly adhere to relevant laws and regulations in the pharmaceutical industry[109]. - The company has not encountered any violations of decision-making procedures regarding external guarantees[7]. - The company has not reported any non-operational fund occupation by controlling shareholders or related parties[7]. - The company has committed to strict adherence to laws and regulations regarding shareholding and will bear responsibility for any losses caused by violations of these commitments[160]. Environmental and Social Responsibility - The company has established a dedicated environmental health and safety department to manage pollutant discharge effectively[143]. - The company has implemented measures to enhance resource efficiency and promote green practices, including the use of eco-friendly packaging materials[152]. - The company is actively responding to the national "3060" carbon neutrality goals by monitoring water usage and implementing water recycling projects[153]. - The company has established an environmental monitoring plan for 2024, with all monitored pollutant indicators meeting compliance standards[147]. - The company has not faced any administrative penalties due to environmental issues during the reporting period[148]. Shareholder and Financial Management - The company has committed to maintaining a robust profit distribution policy, ensuring shareholder returns remain a priority[172]. - The company will ensure that any share reduction price will not be lower than the issue price during the lock-up period[160]. - The company has established a lock-up period of 12 months for certain shareholders, during which they cannot transfer or manage their shares[160]. - The total amount of guarantees provided by the company is 375,456,000 RMB, which accounts for 57.96% of the company's net assets[180]. - The company has provided debt guarantees for entities with a debt-to-asset ratio exceeding 70%, amounting to 327,456,000 RMB[181].

海通证券股份有限公司 关于上海君实生物医药科技股份有限公司 使用自有资金支付募投项目人员费用， 使用自有外汇、银行承兑汇票支付募投项目所需资金 并以募集资金等额置换的核查意见 海通证券股份有限公司（以下简称"海通证券"或"保荐机构"）作为上海君实 生物医药科技股份有限公司（以下简称"君实生物"或"公司"）向特定对象发行股 票的持续督导保荐机构，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，对公司使用自有资金支付募投项目人员费用，使用 自有外汇、银行承兑汇票支付募投项目所需资金并以募集资金等额置换的事项进 行了核查，具体情况如下： 一、募集资金基本情况 （一）2020年首次公开发行A股股票募集资金 根据中国证券监督管理委员会（以下简称"中国证监会"）于2020年5月20 日出具的《关于同意上海君实生物医药科技股份有限公司首次公开发行股票注册 的批复》（证监许可〔2020〕940号），公司获准向社会公开发行人民币普通股 8,713.00万股，每股发行价格为人民币55.50元，募集资金总额为人民币483,571. ...

证券代码：688180 证券简称：君实生物 公告编号：临 2024-053 上海君实生物医药科技股份有限公司 关于使用自有资金支付募投项目人员费用及使用自 有外汇、银行承兑汇票支付募投项目所需资金并以 募集资金等额置换的公告 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、准确性和完整性依法承担法律责任。 上海君实生物医药科技股份有限公司（以下简称"公司"）于2024年8月30 日召开第四届董事会第二次会议、第四届监事会第二次会议，审议通过《关于使 用自有资金支付募投项目人员费用，使用自有外汇、银行承兑汇票支付募投项目 所需资金并以募集资金等额置换的议案》，同意公司根据募投项目实施情况使用 公司自有资金支付募投项目人员工资及费用，使用自有外汇、银行承兑汇票支付 募投项目所需资金，后续以募集资金等额置换，并从募集资金专户划转至公司相 关账户，该部分等额置换资金视同募投项目使用资金。公司保荐机构海通证券股 份有限公司（以下简称"保荐机构"）对本事项出具了明确的核查意见。 一、募集资金基本情况 （一）2020年首次公开发行A股股票募集资金 根据中国证券监督管理委 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2024-048 上海君实生物医药科技股份有限公司 自愿披露关于特瑞普利单抗一线治疗黑色素瘤的 新适应症上市申请获得受理的公告 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、准确性和完整性依法承担法律责任。 近日，上海君实生物医药科技股份有限公司（以下简称"公司"）收到国家 药品监督管理局核准签发的《受理通知书》，特瑞普利单抗（商品名：拓益®， 产品代号：JS001）用于不可切除或转移性黑色素瘤的一线治疗的新适应症上市 申请获得受理。由于药品的研发周期长、审批环节多，容易受到一些不确定性因 素的影响，本次新适应症上市申请能否获得批准存在不确定性，敬请广大投资者 谨慎决策，注意防范投资风险。现将相关情况公告如下： 一、药品基本情况 药品名称：特瑞普利单抗注射液 申请事项：境内生产药品注册上市许可 受理号：CXSS2400084、CXSS2400085 申请人：上海君实生物医药科技股份有限公司 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 本次新适应症的上市申请 ...

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2024年7月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 上海君實生物醫藥科技股份有限公司 呈交日期: 2024年8月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01877 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 219,295,700 | RMB | | 1 RMB | | 219,295,700 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 219,295,700 | RMB | | 1 RMB | | 219,295,700 | | 2. 股份分類 | 普通股 | 股份類別 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2024-047 上海君实生物医药科技股份有限公司 关于以集中竞价交易方式回购股份的进展公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 根据《上市公司股份回购规则》《上海证券交易所上市公司自律监管指引第 7 号——回购股份》等相关规定，公司实施回购期间，应当在每个月的前 3 个交易 日内公告截至上月末的回购进展情况。现将回购股份的进展情况公告如下： 截至 2024 年 7 月 31 日，公司通过上海证券交易所交易系统以集中竞价交易 方式已累计回购股份 815,871 股，占公司总股本比例为 0.0828%，回购成交的最高 价为人民币 41.69 元/股，最低价为人民币 29.03 元/股，支付的资金总额为人民币 30,883,207.73 元（不含印花税、交易佣金等交易费用）。本次回购股份进展符合法 律法规的规定及公司回购股份方案。 三、 其他事项 公司将严格按照《上市公司股份回购规则》《上海证券交易所上市公司自律监 管指引第 7 号——回购股 ...

一、药品基本情况 药品名称：特瑞普利单抗注射液 欧洲商品名：LOQTORZI® 适应症：特瑞普利单抗联合顺铂和吉西他滨用于复发、不能手术或放疗的， 或转移性鼻咽癌成人患者的一线治疗，以及特瑞普利单抗联合顺铂和紫杉醇用于 不可切除的晚期/复发或转移性食管鳞癌成人患者的一线治疗。 证券代码：688180 证券简称：君实生物 公告编号：临 2024-046 上海君实生物医药科技股份有限公司 自愿披露关于特瑞普利单抗获得欧洲药品管理局 人用药品委员会积极意见的公告 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、准确性和完整性依法承担法律责任。 近日，上海君实生物医药科技股份有限公司（以下简称"公司"）产品特瑞 普利单抗（欧洲商品名：LOQTORZI®）的上市许可申请获得欧洲药品管理局（以 下简称"EMA"）人用药品委员会（以下简称"CHMP"）的积极意见，建议批 准其用于治疗两项适应症：特瑞普利单抗联合顺铂和吉西他滨用于复发、不能手 术或放疗的，或转移性鼻咽癌成人患者的一线治疗，以及特瑞普利单抗联合顺铂 和紫杉醇用于不可切除的晚期/复发或转移性食管鳞癌成人患者的 ...