证券代码：688180 证券简称：君实生物 上海君实生物医药科技股份有限公司 投资者关系活动记录表 □特定对象调研 □分析师会议 □媒体采访 业绩说明会 投资者关系活动 类别 □新闻发布会 □路演活动 □现场参观 □其他 国盛证券、东北证券、方正证券、广发证券、国金证券、华安证券、太 平洋证券、中金证券、浙商证券、中信证券、苏州之加歌投资管理有限 公司、循远资产、橡果资产管理有限公司、YONG RONG (HK) ASSET MANAGEMENT LTD.、永禧资产、Ariose Capital、广东民营投资股份有 限公司、前海扬子江基金管理（深圳）有限公司、知合、中航基金、中 信建投自营、湖南源乘私募基金管理有限公司、上海景熙资产管理有限 公司、东方证券、中航证券、信熹资本、湖南立青投资、深圳市尚诚资 产管理有限责任公司、建信基金、济南泾谷投资管理合伙企业（有限合 伙）、Franklin Templeton Investments (Asia) Ltd、南华基金、摩根基金管 理（中国）有限公司、上海道仁资产管理有限公司、开源证券、兴业证 券、泰康基金、曜川投资、北京正和新融资产管理有限公司、PINPOIN ...

一、 回购方案的基本信息 2023 年 9 月 8 日，上海君实生物医药科技股份有限公司（以下简称"公司"） 召开第三届董事会第二十二次会议，审议通过了《关于以集中竞价交易方式回购 公司股份方案的议案》，同意公司以集中竞价交易方式回购公司股份，回购资金总 额不低于人民币 3,000 万元（含），不超过人民币 6,000 万元（含）；回购价格不超 过人民币 58 元/股（含）；回购期限自公司董事会审议通过本次回购股份方案之日 起 12 个月内。具体内容详见公司于 2023 年 9 月 11 日在上海证券交易所网站披露 的《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方案 公告》（公告编号：临 2023-058）。 二、 回购方案的进展情况 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： 2024 年 3 月，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 102,459 股，占公司总股本比例为 0.0104%， ...

标题：关于上海君实生物医药科技股份有限公司的监管工作函 证券代码：688180 证券简称：君实生物 监管类型：监管工作函 涉及对象：上市公司,董事,中介机构及其相关人员 处分日期：2024-03-29 处理事由：关于上海君实生物医药科技股份有限公司的监管工作函 ...

Financial Performance - The company has not achieved profitability during the reporting period, with revenue not covering R&D expenses and other costs[4]. - The company reported a total revenue of RMB 1.5 billion for the fiscal year 2023, representing a year-over-year increase of 25%[17]. - The company's operating revenue for 2023 was CNY 150,254.99 million, representing a 3.38% increase compared to CNY 145,349.27 million in 2022[21]. - The net profit attributable to shareholders for 2023 was a loss of CNY 228,343.19 million, an improvement from a loss of CNY 238,804.99 million in 2022[21]. - The gross margin for the year was reported at 65%, indicating strong operational efficiency[17]. - The company expects revenue guidance for 2024 to be in the range of RMB 1.8 billion to RMB 2 billion, representing a growth of 20% to 33%[17]. - The company achieved revenue of 1.503 billion yuan in 2023, a year-on-year increase of 3.38%, primarily due to increased pharmaceutical sales[29]. - The company reported a significant increase in revenue, achieving a total of $1.5 billion for the fiscal year, representing a 20% year-over-year growth[177]. Research and Development - The company plans to maintain significant R&D investments for clinical trials and new drug applications, which may lead to further losses in the short term[5]. - The R&D expenditure for the year was RMB 300 million, accounting for 20% of total revenue, reflecting the company's commitment to innovation[17]. - Research and development expenses accounted for 128.95% of operating revenue in 2023, down from 164.04% in 2022, indicating a reduction of 35.09 percentage points[23]. - The company has a robust pipeline with nearly 30 products in clinical trials and over 20 products in preclinical development across five major therapeutic areas[43]. - The company has established four R&D centers in the US and China, enhancing research efficiency and reducing costs[96]. - The company has made significant advancements in its R&D capabilities, positioning itself as a leader in the development of globally innovative drugs[99]. - The company is focusing on innovative therapies for chronic metabolic diseases and infectious diseases, enhancing its market position[142]. Product Development and Pipeline - The company is actively expanding its product pipeline and exploring combination therapies to enhance its market position[4]. - The company plans to launch two new monoclonal antibody products in 2024, targeting a market size of approximately RMB 10 billion[17]. - The company has initiated a strategic partnership with a leading biotech firm to enhance its pipeline of antibody-drug conjugates[17]. - The company’s R&D pipeline is progressing efficiently, with multiple new indications for Toripalimab under review, including approvals for 7 indications by the NMPA[33]. - The company is advancing multiple late-stage pipeline projects, including a Phase III clinical study for tifcemalimab in combination with teriprizumab for limited-stage small cell lung cancer, with plans to enroll 756 patients[34]. - The company is actively pursuing potential acquisitions to bolster its product portfolio and market reach[17]. - The company has received IND approvals for Tifcemalimab, the world's first anti-BTLA monoclonal antibody entering clinical development, which is currently in Phase III trials[44]. Market Expansion and Strategy - The company aims to expand its market presence in Southeast Asia, with a target revenue contribution of 15% from this region by 2025[17]. - The company is committed to becoming a globally competitive biopharmaceutical company, focusing on overseas clinical trials and strategic partnerships to diversify revenue sources[168]. - The company plans to enhance its fermentation capacity for large molecule drugs and explore new production processes to reduce costs, supported by the launch of its Lingang industrialization base[168]. - The company is actively exploring new sales models and expanding its hospital coverage for Min De Wei® to improve patient access[58]. - The company is expanding its market presence, targeting E new regions for growth in the next year[179]. Financial Management and Governance - The board approved a profit distribution plan for 2023 that includes no profit distribution and no capital reserve increase[7]. - The management team remains stable, and cash flow is reported to be healthy, supporting ongoing operations[4]. - The company does not have any non-operating fund occupation by controlling shareholders or related parties[10]. - The company has implemented a restricted stock incentive plan for several executives, impacting their shareholdings and remuneration[175]. - The company has held 2 shareholder meetings and 8 board meetings during the reporting period, ensuring compliance with legal requirements and effective governance[170]. Regulatory and Compliance - The company emphasizes the importance of maintaining and expanding its regulatory approvals for drugs and candidates[9]. - The company has received regulatory approval for its lead product, JS001, in multiple international markets, enhancing its global footprint[17]. - The company has been included in the National Basic Medical Insurance Drug List, which may enhance product accessibility and affordability, potentially boosting sales[112]. - The company has received conditional approval for Dexamethasone Hydrochloride Tablets for treating mild to moderate COVID-19 in January 2023[101]. Clinical Trials and Studies - The company has completed multiple Phase III clinical studies for its drug Angorwesi monoclonal antibody in patients with primary hypercholesterolemia and mixed hyperlipidemia[35]. - The company has initiated a Phase III clinical study for tifcemalimab in combination with teriprizumab for the treatment of classical Hodgkin lymphoma (cHL), aiming to recruit approximately 185 patients across about 50 research centers in China[34]. - The company is advancing multiple clinical trials, including those for esophageal cancer and liver cancer, with several applications for market approval pending[56]. - The company has established commercial partnerships in over 50 countries, actively promoting the market entry of Toripalimab in various regions[31]. Talent and Human Resources - The company emphasizes talent development and has established a performance management system to support strategic goals and employee growth[38]. - As of the end of the reporting period, the company employed 2,568 staff, with 736 in drug research and development, 952 in product commercialization, and 562 in production[38]. - The average salary of R&D personnel increased to CNY 53.54 million from CNY 47.56 million in the previous period[106]. Challenges and Risks - There are significant risks associated with the company's reliance on successful drug development and regulatory approvals[9]. - The company faces risks related to long profit cycles typical in the biopharmaceutical industry, with profitability dependent on the progress of research products and their market performance[109]. - The overall success rate for biopharmaceuticals from clinical phase I to commercialization is only 11.5%, indicating high barriers to entry in the industry[89].

Financial Performance - For the year ended December 31, 2023, the total revenue of the group was approximately RMB 1,503 million, an increase of about 3% compared to the same period in 2022, primarily due to an increase in pharmaceutical product revenue[2]. - The company reported revenue of RMB 1,502,550 thousand for the year ended December 31, 2023, an increase of 3.4% compared to RMB 1,453,493 thousand in 2022[77]. - Pharmaceutical sales revenue was approximately RMB 1,190 million, up about 58% year-on-year, driven by new indications for Tuoyi® and improved supply capacity for Junmaikang®[51]. - The gross profit for the year was RMB 835,260 thousand, down from RMB 927,211 thousand in the previous year, reflecting a decrease of approximately 9.9%[77]. - The net loss for the year was RMB 2,533,882 thousand, slightly improved from RMB 2,582,095 thousand in 2022[79]. - The company incurred a loss before tax of RMB 2,489,887 thousand, compared to a loss of RMB 2,675,202 thousand in the previous year, indicating an improvement of approximately 6.9%[77]. - The company reported a basic loss attributable to shareholders of RMB 2,281,624,000 for the year ended December 31, 2023, compared to RMB 2,386,067,000 for 2022, indicating a slight improvement in performance[98]. Research and Development - Research and development expenses totaled approximately RMB 1,937 million, a decrease of about 19% compared to the same period in 2022, mainly due to the group's control over R&D investments in several early-stage pipelines[2]. - The company has nearly 30 products in clinical trials and over 20 in preclinical development across five major therapeutic areas[16]. - The ongoing clinical research for JS005, a humanized anti-IL-17A monoclonal antibody, has entered Phase III registration trials targeting moderate to severe plaque psoriasis[12]. - The company is advancing multiple late-stage pipeline projects, including a Phase III clinical study for tifcemalimab in combination with Teriprizumab for various cancers[11]. - The company is focused on innovative drug development, expanding from monoclonal antibodies to include small molecules, peptides, and nucleic acid drugs[16]. Product Approvals and Market Expansion - In January 2023, the oral nucleoside analog for COVID-19 treatment received conditional approval from the NMPA for adult patients with mild to moderate COVID-19[3]. - In December 2023, Tuoyi® was approved for a new indication as a perioperative treatment for adult patients with resectable IIIA-IIIB non-small cell lung cancer, becoming the first and only approved therapy of its kind in China[4]. - Treliprimab has been approved for 7 indications in China and is the first domestically developed PD-1 monoclonal antibody approved by NMPA[6]. - The company plans to commercialize Treliprimab in over 50 countries, including partnerships with Hikma and Dr. Reddy's for market expansion in various regions[8]. - The company has entered into a shareholder agreement to acquire a 40% stake in Excellmab, enabling exclusive rights for Treliprimab commercialization in several Southeast Asian countries[6]. Financial Position and Cash Flow - Cash and cash equivalents decreased from approximately RMB 5,997 million to approximately RMB 3,778 million, primarily due to net cash outflows from operating activities of about RMB 2,015 million[55]. - The company reported a significant increase in accounts receivable, which rose to RMB 483,226,004.74 in 2023 from RMB 238,185,594.33 in 2022, reflecting a growth of approximately 102.5%[111]. - The total liabilities as of December 31, 2023, were RMB 4,022,256,399.35, compared to RMB 2,782,035,912.21 in the previous year, indicating an increase of approximately 44.6%[114]. - The net cash flow from operating activities for 2023 was -2,004,982,096.97 RMB, compared to -1,776,200,913.10 RMB in 2022, indicating a decline in operational cash flow[118]. Strategic Initiatives and Future Outlook - The company plans to enhance production capacity for large molecule drugs and explore new production processes to improve cost competitiveness[50]. - The company aims to expand its product pipeline through licensing and collaboration with leading global pharmaceutical companies[50]. - The company plans to focus on new product development and market expansion strategies in the upcoming fiscal year[121]. - The company is actively exploring new indications for Treliprimab and has received orphan drug designation from TGA for its use in treating nasopharyngeal carcinoma[5]. - The company is committed to maintaining substantial R&D investments for clinical trials and new drug preparations, which may lead to further short-term losses[66].

上海君实生物医药科技股份有限公司 2023 年度独立非执行董事述职报告（LIEPING CHEN） 作为上海君实生物医药科技股份有限公司（以下简称"公司"）的独立非执 行董事，我根据《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》《上市公司独立董事管理办法》《上海证券交易所科创板股票 上市规则》（以下简称"《科创板上市规则》"）、《香港联合交易所有限公司证 券上市规则》（以下简称"《联交所上市规则》"）、《上海君实生物医药科技股 份有限公司章程》（以下简称"《公司章程》"）以及《上海君实生物医药科技 股份有限公司独立非执行董事工作制度》等法律、法规、规范性文件、公司制度 的要求，在 2023 年度工作中，认真履行职责，积极出席相关会议，认真审议董 事会各项议案，对重大事项发表了独立意见，维护了公司整体利益及全体股东的 合法权益。现将 2023 年度履行职责情况述职如下： 一、 独立非执行董事的基本情况 LIEPING CHEN（陈列平），1957 年 4 月出生，美国国籍。LIEPING CHEN （陈列平）博士于 1982 年获得福建医科大学医学学士学位，1986 年获北京协和 ...

RSM 容诚 审计报告 上海君实生物医药科技股份有限公司 容诚审字[2024]230Z0326号 容诚会计师事务所(特殊普通合伙) 中国 · 北京 您可使用手机"扫一扫"或进入"注册会计师行业统一监管平台（http://acc.mof.gov.cn）"进行查费 报告编码:京240C 目 录 | 序号 | 内 容 | 页码 | | --- | --- | --- | | I | 审计报告 | 1 - 7 | | 2 | 合并资产负债表 | 8 | | 3 | 合并利润表 | 9 | | 4 | 合并现金流量表 | 10 | | 5 | 合并所有者权益变动表 | 11 - 12 | | 6 | 母公司资产负债表 | 13 | | 7 | 母公司利润表 | 14 | | 8 | 母公司现金流量表 | ાર | | 9 | 母公司所有者权益变动表 | 16 - 17 | | 10 | 财务报表附注 | 18 - 132 | 审计报告 容诚审字[2024]230Z0326 号 上海君实生物医药科技股份有限公司全体股东: 一、审计意见 我们审计了上海君实生物医药科技股份有限公司(以下简称君实生物)财务 报表,包括2023 ...

公司代码：688180 公司简称：君实生物 上海君实生物医药科技股份有限公司 2023 年度内部控制评价报告 上海君实生物医药科技股份有限公司全体股东： 根据《企业内部控制基本规范》及其配套指引的规定和其他内部控制监管要求（以下简称"企业内 部控制规范体系"），结合上海君实生物医药科技股份有限公司（以下简称"公司"）内部控制制度和评 价办法，在内部控制日常监督和专项监督的基础上，我们对公司2023年12月31日（内部控制评价报告基 准日）的内部控制有效性进行了评价。 一. 重要声明 按照企业内部控制规范体系的规定，建立健全和有效实施内部控制，评价其有效性，并如实披露内 部控制评价报告是公司董事会的责任。监事会对董事会建立和实施内部控制进行监督。经理层负责组织 领导企业内部控制的日常运行。公司董事会、监事会及董事、监事、高级管理人员保证本报告内容不存 在任何虚假记载、误导性陈述或重大遗漏，并对报告内容的真实性、准确性和完整性承担个别及连带法 律责任。 公司内部控制的目标是合理保证经营管理合法合规、资产安全、财务报告及相关信息真实完整，提 高经营效率和效果，促进实现发展战略。由于内部控制存在的固有局限性，故仅能为 ...

上海君实生物医药科技股份有限公司 2023 年度独立非执行董事述职报告（ROY STEVEN HERBST） 作为上海君实生物医药科技股份有限公司（以下简称"公司"）的独立非执 行董事，我根据《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》"）、《上市公司独立董事管理办法》 《上海证券交易所科创板股票上市规则》（以下简称"《科创板上市规则》"）、 《香港联合交易所有限公司证券上市规则》（以下简称"《联交所上市规则》"）、 《上海君实生物医药科技股份有限公司章程》（以下简称"《公司章程》"）以 及《上海君实生物医药科技股份有限公司独立非执行董事工作制度》等法律、法 规、规范性文件、公司制度的要求，在 2023 年度工作中，认真履行职责，积极 出席相关会议，认真审议董事会各项议案，对重大事项发表了独立意见，维护了 公司整体利益及全体股东的合法权益。现将 2023 年度履行职责情况述职如下： 一、 独立非执行董事的基本情况 ROY STEVEN HERBST，1963 年 1 月出生，美国国籍。ROY STEVEN HERBST 博士1984年6月毕业于美国耶鲁大 ...

上海君实生物医药科技股份有限公司 董事会 2024 年 3 月 28 日 上海君实生物医药科技股份有限公司 董事会 2023 年度对独立非执行董事独立性 自查情况的专项报告 根据《上市公司独立董事管理办法》《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》等相关要求，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，就公司在任独立非执行董事的独立性情况进行评估并出具如下专 项意见： 经核查公司在任独立非执行董事 Roy Steven Herbst、钱智、张淳、冯晓 源、孟安明的兼职、任职情况以及其签署的独立性自查情况报告，上述人员 除在公司担任独立非执行董事、董事会专门委员会委员外，不存在在公司任 职以及在公司主要股东单位任职的情形，与公司以及主要股东之间不存在 利害关系、重大业务往来或其他可能妨碍其独立性的关系。因此，董事会认 为公司独立非执行董事符合《上市公司独立董事管理办法》《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》中对独立非执行董 事独立性的相关要求。 ...