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 对外投资暨关联交易的核查意见 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"）首次公开发行股票 并在科创板上市及2022年度向特定对象发行A股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， 对公司对外投资暨关联交易事项进行了核查，具体情况如下： 一、关联交易概述 公司、君实工程、苏州君盟拟与上海安领科生物医药有限公司（以下简称"合 资公司"）及公司非执行董事冯辉签署《合资协议》，公司以标的无形资产作价人 民币3,059.78万元出资认购合资公司新增注册资本人民币14万元，其余部分计入 合资公司资本公积。 合资公司拟与四名天使轮投资人签署天使轮增资协议，天使轮投资人拟以 23,479,181美元和/或等值人民币出资认购合资公司新增注册资本人民币547,847 元。 | 股东名称/姓名 | 注册资本 （人民币元） | 持股比例 | | --- | ...

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 使用部分超募资金以集中竞价交易方式回购股份的核查意见 海通证券股份有限公司（以下简称"保荐机构"或"海通证券"）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"）首次公 开发行股票并在科创板上市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》及《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，对公司使用部分超募 资金以集中竞价交易方式回购股份的事项进行了核查，具体情况如下： 一、募集资金基本情况 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 55.50 元，募集资金总额为人民币 4,835,715,000.00 元；扣除不含税发行费用人 民币 338,736,673.27 元，实际募 ...

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 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: 2023年8月31日 狀態: 新提交 呈交日期: 2023年9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 | 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 ...

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 2023 年度持续督导半年度跟踪报告 | 保荐机构名称：海通证券股份有限公司 | 被保荐公司简称：君实生物 | | --- | --- | | 保荐代表人姓名：崔浩、陈新军 | 被保荐公司代码：688180.SH | 重大事项提示 2023 年上半年，公司实现营业收入 66,970.27 万元，较去年同期下降 29.21%； 实现归母净利润-99,741.24 万元，去年同期为-91,240.50 万元；实现扣非后净利 润-97,139.43 万元，仍为负值，尚未实现盈利。 报告期内公司营业收入及净利润较去年同期下降的主要原因系尽管报告期 内药品销售收入增加，但与礼来制药、Coherus 的合作协议相关的许可收入及特 许权收入减少，故本期营业收入同比下降。报告期内，公司研发投入约 9.48 亿 元，核心产品特瑞普利单抗多项适应症的 sNDA 获得 NMPA 受理，昂戈瑞西单 抗（重组人源化抗 PCSK9 单克隆抗）NDA 获得 NMPA 受理，多项创新药物的 临床试验申请获得 NMPA 或 FDA 批准，公司各项业务有条不紊的推进，不存 在重大风险。 ...

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 核心技术人员离职的核查意见 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"、"上市公司"或"公司"） 首次公开发行股票并上市及 2022 年度向特定对象发行 A 股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》和《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》等相关规定，对公司核心技术人员离职的事项进行了核查，具体情况 如下： 一、上市公司核心技术人员离职事项的具体情况； （一）冯辉先生离职的具体情况 公司执行董事、核心技术人员冯辉先生因个人原因，于 2023 年 8 月 31 日申 请辞去首席运营官及子公司所有内部职务，冯辉先生辞职后仍担任公司非执行董 事。冯辉先生辞任后，公司将聘请其担任公司技术咨询顾问，以确保相关研发工 作的平稳推进和顺利过渡。 冯辉先生自 2015 年 3 月起担任公司执行董事；2014 年 1 月起担任拓普艾莱 首席运营官；2016 年 6 月起担任上海君实生物工程有限公司 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2023-055 一、药品基本情况 药品名称：注射用 JS207 上海君实生物医药科技股份有限公司 自愿披露关于注射用 JS207 获得药物临床试验 批准通知书的公告 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《药物临床试验批准通知书》，注射用 JS207（项目 代号"JS207"）的临床试验申请获得批准。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，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： 申请事项：境内生产药品注册临床试验 受理号：CXSL2300423 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《中华人民共和国药品管理法》及有关规定，经审查，2023 年 6 月 19 日受理的注射用 JS207 临床试验申请符合药品注册的有关要求，同意 本品单药在晚期肿瘤开展临床试验。 二、药品的其他相关情况 JS20 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2023-056 上海君实生物医药科技股份有限公司 关于公司核心技术人员变动的公告 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。 重要内容提示： 上海君实生物医药科技股份有限公司（以下简称"公司"）执行董事、 核心技术人员冯辉先生因个人原因，于 2023 年 8 月 31 日申请辞去首席运营官及 子公司所任职务。辞职后，冯辉先生将调任公司非执行董事。公司将聘请其担任 公司技术咨询顾问，以确保相关研发工作的平稳推进和顺利过渡。 冯辉先生离职后，其负责的工作由公司执行董事、副总经理张卓兵先生 和公司执行董事、副总经理 SHENG YAO（姚盛）先生负责，冯辉先生的离职不 会对公司的技术研发和生产经营带来实质性影响，不会影响公司拥有的核心技术 及其专利权属完整性。 一、冯辉先生离职的具体情况 公司执行董事、核心技术人员冯辉先生因个人原因，于 2023 年 8 月 31 日申 请辞去首席运营官及子公司所任职务。辞职后，冯辉先生将调任为公司非执行董 事。公司将聘请其担任公司 ...

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 reported a total revenue of RMB 1.2 billion for the first half of 2023, representing a year-on-year increase of 25%[15]. - The company's operating revenue for the first half of 2023 was approximately ¥669.70 million, a decrease of 29.21% compared to ¥946.05 million in the same period last year[22]. - The net profit attributable to shareholders for the same period was approximately -¥997.41 million, compared to -¥912.41 million in the previous year[22]. - The net cash flow from operating activities showed a significant outflow of approximately -¥1.23 billion, compared to -¥458.23 million in the previous year[22]. - The company's net assets attributable to shareholders decreased by 10.44% to approximately ¥8.49 billion from ¥9.48 billion at the end of the previous year[22]. - The company reported a significant increase in net outflow of cash from operating activities, mainly due to milestone payments received in the previous year from the collaboration with Eli Lilly for the JS016 project[24]. - The company reported a 58.20% decrease in net cash flow from financing activities, totaling approximately CNY 534.92 million, primarily due to reduced inflows from minority shareholder investments[109]. Research and Development - The company is actively expanding its product pipeline, focusing on innovative therapies across multiple disease areas, and plans to maintain significant R&D investments[4]. - The company has allocated RMB 300 million for research and development in 2023, which is a 40% increase from the previous year[15]. - The research and development expenditure accounted for 141.64% of operating revenue, an increase of 29.36 percentage points compared to 112.28% in the previous year[23]. - The company has established a comprehensive technology system covering the entire lifecycle of protein drugs, including multiple technology platforms for antibody screening and development[31]. - The company has a robust pipeline with multiple innovative drug candidates at various stages of development, indicating strong future growth potential[78]. - The company has developed over 50 drug candidates since its establishment in December 2012, with nearly 30 products in clinical trials and over 20 in preclinical development[92]. - The company is focusing on expanding its product pipeline in five major therapeutic areas, including oncology and autoimmune diseases[90]. Product Development and Commercialization - The company is committed to the commercialization of approved drugs and expanding indications for existing products, which is expected to enhance its operational capabilities[4]. - The company aims to launch two new products by Q4 2023, focusing on innovative therapies for oncology and infectious diseases[15]. - The company has received regulatory approval for its flagship product, JS001, in three additional countries, expanding its market access[15]. - The sales revenue of Toripalimab (JS001) reached approximately 447 million CNY, representing a year-on-year growth of about 50%[37]. - Toripalimab has been approved for 6 indications in China, including treatments for melanoma, nasopharyngeal carcinoma, and urothelial carcinoma[37]. - The company has initiated over 40 clinical studies covering more than 15 indications globally, including lung cancer, nasopharyngeal carcinoma, and breast cancer[39]. - The company has received acceptance for sNDAs for four new indications during the reporting period, enhancing its product portfolio[37]. 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 strategically positioning itself to explore overseas markets to mitigate domestic payment pressures and ensure sustainable R&D investment[74]. - The company has established commercial partnerships for Tislelizumab in over 50 countries, including agreements with Coherus, Hikma, and Dr. Reddy's[97]. Risk Factors and Challenges - The company is facing risks associated with the long R&D cycles and high investment in the biopharmaceutical industry, which may lead to further short-term losses[4]. - The report includes forward-looking statements that involve known and unknown risks and uncertainties, which may lead to significant differences from actual results[7]. - The company has detailed various risk factors that may impact its operations and financial status in the report[4]. - The company has reported a risk of not achieving profitability due to high R&D costs and the lengthy approval process for new drugs[101]. Environmental and Social Responsibility - The company has invested ¥405 million in environmental protection during the reporting period[126]. - The company has established a dedicated environmental health and safety department to manage pollutant emissions effectively[131]. - The company has implemented measures to enhance resource efficiency and promote green practices, including the use of eco-friendly packaging materials[139]. - The company has not faced any administrative penalties related to environmental issues during the reporting period[135]. Shareholder and Governance Commitments - The company will ensure that any share reduction complies with the adjusted issue price in the event of dividends or capital increases[152]. - The company has committed to transparency and timely reporting of any changes in shareholding by its directors and senior management[154]. - The company has made a commitment to not occupy funds from the issuer and its subsidiaries, ensuring compliance with governance regulations[159]. - The company has outlined measures to stabilize its stock price, with a commitment period of 36 months starting from the listing date[157].

Financial Performance - For the six months ended June 30, 2023, the company's total revenue was approximately RMB 670 million, a decrease of about 29% compared to the same period in 2022, primarily due to a reduction in revenue related to overseas licensing transfers[2]. - The loss attributable to the company's owners was RMB 996 million, an increase of RMB 85 million compared to the same period in 2022[2]. - The company reported a net loss attributable to shareholders of RMB 996,421,000 for the six months ended June 30, 2023, compared to a loss of RMB 911,329,000 for the same period in 2022[70]. - The total comprehensive loss for the period was RMB 1,163,516 thousand, compared to RMB 1,101,333 thousand in the previous year, reflecting an increase of approximately 5.7%[54]. - The company reported a comprehensive loss of CNY 1,164,507,703.81 for the first half of 2023, compared to a loss of CNY 1,102,408,593.12 in the same period of 2022, indicating a worsening financial performance[92]. Revenue and Sales - During the reporting period, the sales revenue of the drug Tuoyi® (Tremelimumab) was approximately RMB 447 million, an increase of about 50% compared to the same period in 2022; the newly launched product Mindev® generated sales revenue of approximately RMB 110 million[2]. - The company achieved commercial drug sales revenue of RMB 625 million, a year-on-year increase of 103%, with key products contributing significantly: Tuoyi® sales reached RMB 447 million (up 50%), Mindev® at RMB 110 million, and Junmai Kang® at RMB 68 million[7]. - Pharmaceutical sales revenue was approximately RMB 641 million, an increase of about 108% year-over-year, driven by new indications for Tuoyi® and improved supply capacity for Junmai Kang®[38]. - The sales revenue of Tuoyi® (Tirzepatide) reached RMB 447 million during the reporting period[21]. - Junmai Kang® generated sales of RMB 68 million and has completed bidding in 25 provinces, with 172 hospitals now authorized to use the product[8]. Research and Development - Research and development expenses totaled approximately RMB 949 million, a decrease of about 11% compared to the same period in 2022, mainly due to the company's control over R&D investments in several early-stage pipelines[2]. - The company has nearly 30 drug candidates in clinical trials and over 20 candidates in preclinical development stages[3]. - The company is committed to expanding its product pipeline to include a wider range of drug types, including small molecules and nucleic acid drugs, targeting cancer and autoimmune diseases[6]. - The company plans to maintain significant R&D investments to support ongoing clinical trials and new drug applications, which may lead to further short-term losses[94]. - The company is committed to innovation, focusing on developing new drugs and increasing R&D investment to accelerate the clinical trial and market entry of innovative drugs[99]. Clinical Trials and Approvals - In January 2023, the oral nucleoside antiviral drug for COVID-19 (JT001/VV116) received conditional approval from the NMPA for the treatment of mild to moderate adult patients[3]. - In April 2023, the new drug application for JS002 (recombinant humanized anti-PCSK9 monoclonal antibody) was accepted by the NMPA[4]. - The combination therapy of Tifcemalimab and Tuoyi® is set to enter a Phase III clinical trial involving 756 patients across China, the US, and Europe, aiming to enhance treatment responses in cancer patients[10]. - The company has initiated Phase III clinical trials for JS005, a humanized anti-IL-17A monoclonal antibody, targeting moderate to severe plaque psoriasis and ankylosing spondylitis[11]. - The company is conducting multiple key registration clinical trials for Toripalimab across various indications, including postoperative adjuvant therapy and perioperative treatment for different cancer types[24]. Corporate Developments - In June 2023, the company announced plans to issue Global Depositary Receipts (GDRs) and apply for listing on the SIX Swiss Exchange, aiming to raise up to approximately RMB 3.4 billion for innovative drug R&D and other projects[5]. - The company entered into a shareholder agreement with Rxilient Biotech Pte. Ltd. to acquire a 40% stake in Excellmab, with plans to grant exclusive rights for the development and commercialization of Tremelimumab in several Southeast Asian countries[4]. - The company has established commercial partnerships for its drug Triplizumab with over 50 partners across regions including the Americas, Middle East, North Africa, and Southeast Asia[12]. - A commercialization agreement was signed with Dr. Reddy's for the exclusive development and commercialization of Triplizumab in multiple countries including Brazil, Mexico, and India[13]. - The company has optimized its commercialization team structure since 2022, significantly improving execution and sales efficiency[8]. Financial Position and Cash Flow - As of June 30, 2023, cash and bank balances decreased to approximately RMB 4,854 million from RMB 5,997 million as of December 31, 2022, primarily due to a net cash outflow from operating activities of approximately RMB 1,228 million and net cash outflow from investing activities of approximately RMB 160 million, partially offset by a net cash inflow from financing activities of approximately RMB 220 million[23]. - The company reported a net cash outflow from operating activities of approximately RMB 1,228 million for the six months ended June 30, 2023[23]. - The company plans to use the proceeds from the placement for drug R&D, pipeline expansion, and general corporate purposes, enhancing its competitiveness in the international market[50]. - The company’s cash flow from the placement is expected to support the development and commercialization of innovative drugs in international markets[50]. - The company reported a net asset value of RMB 8,804,291,000 as of June 30, 2023, down from RMB 9,794,250,000, a decrease of 10.09%[56]. Market and Industry Challenges - The company faces risks related to supply chain stability and potential increases in raw material costs, which could adversely affect profitability[96]. - The pharmaceutical industry is undergoing significant reforms, including cost control measures and new drug procurement policies, which may reshape the industry landscape and impact the company's development if it fails to innovate[98]. - The company’s core competitiveness is at risk due to the lengthy and costly nature of new drug development, which involves multiple complex stages[95]. - The company faces foreign exchange risk primarily from foreign currency assets and liabilities not denominated in its functional currency, with significant exposure to HKD, USD, EUR, and GBP[97]. - The company is committed to a cautious approach in R&D, with ongoing evaluations of projects to mitigate risks associated with unsuccessful drug development[95].