证券代码：688180 证券简称：君实生物 公告编号：临 2024-022 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用于肾细胞癌一线治疗 的新适应症上市申请获得批准的公告 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《药品注册证书》，特瑞普利单抗（商品名：拓益®， 产品代号：JS001）联合阿昔替尼用于中高危的不可切除或转移性肾细胞癌患者 的一线治疗的新适应症上市申请获得批准，是我国首个获批的肾癌免疫疗法。由 于药品获得上市批准后的商业化容易受到一些不确定性因素的影响，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 证书编号：2024S00501、2024S00502 上市许可持有人：上海君实生物医药科技股份有限公司 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准新增适应症，具体为："本品联合阿 ...

[Table_Page] 年报点评|生物制品 证券研究报告 [君Table_实Title]生 物-U(688180.SH)/君实生物 公[Ta司bl评e_I级nve st] 买入-A/买入-H 当前价格 26.79元/9.72港元 (01877.HK) 合理价值 52.09元/19.37港元 前次评级 买入/买入 业绩稳定增长，PD-1 海外商业化可期 报告日期 2024-04-06 [Table_Summary] 核心观点： *港元兑人民币汇率按0.92 [相Tab对le_市Pic场Quo表te] 现 ⚫ 公司发布2023年年度报告：公司2023年实现收入15.03亿元，同比 12% 增长 3.4%；归母净利润-22.83 亿元，同比减亏 1.05 亿元；扣非归母 0% 04/23 06/23 08/23 10/23 12/23 02/24 04/24 -13% 净利润-22.98亿元，同比减亏1.53亿元。公司目前有3款药品商业化， -25% 药品销售收入增长推动业绩增长，核心品种特瑞普利单抗2023年实现 -38% 销售收入约9.19亿元，同比增长约25%。 -50% 君实生物-U 沪深300 ⚫ 国际 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2024-021 上海君实生物医药科技股份有限公司 自愿披露关于昂戈瑞西单抗注射液 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》，公司产品昂戈瑞西单抗注射液（重 组人源化抗 PCSK9 单克隆抗体注射液，产品代号：JS002）的两项新适应症上市 申请已获得受理。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：昂戈瑞西单抗注射液 申请人：上海君实生物医药科技股份有限公司 规格：150 mg（1 ml）/支（预充式注射器）、150 mg（1 ml）/支（预充式自 动注射器） 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。 适应症：（一 ...

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3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4月2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 | 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 | A | | 於香港 ...

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].

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 ...

上海君实生物医药科技股份有限公司 2023 年度社会责任报告 1 编写依据 本报告是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"或"我们"）参照上海证券交易所《上海证券交易所科创板股票上市规则》 《社会责任报告编写指南》等相关法律法规及规范性文件的要求，结合公司所属 行业特点以及报告期内公司履行社会责任的实际情况进行编写。 报告内容 本报告重点披露了公司的经济、社会和环境等方面表现的相关信息，反映了 公司 2023 年度履行社会责任的实际情况，以帮助利益相关方了解君实生物的社 会责任实践活动和绩效。 报告范围 本报告的时间范围为 2023 年 1 月 1 日至 2023 年 12 月 31 日（以下简称"报 告期"），部分内容超过该范围。报告的组织范围为公司及公司下属子公司。 确认及批准 本报告经管理层确认后，于 2024 年 3 月 28 日获董事会通过。 发布形式 本报告网络版可在上海证券交易所（www.sse.com.cn）、香港联合交易所有 限公司网站（www.hkex.com.hk）和上海君实生物医药科技股份有限公司 （www.junshipharma.com）查阅下载。 2 ...