Financial Performance - For the six months ended June 30, 2024, the total revenue of the group was approximately RMB 786 million, an increase of about 17% compared to the same period in 2023, primarily driven by an 11% increase in pharmaceutical revenue[4]. - The domestic sales revenue of the core product Tuoyi® (Tremelimumab) reached approximately RMB 671 million, representing a significant increase of about 50% compared to the same period in 2023[4]. - In the first half of 2024, the company achieved revenue of RMB 786 million, representing a 17% year-over-year increase[14]. - The core product, Tuoyi® (LOQTORZI®), saw domestic sales revenue grow approximately 50% year-over-year, totaling RMB 671 million[14]. - The company reported a net loss of RMB 688 million for the period, a 39% reduction compared to the loss of RMB 1,125 million in the same period last year[11]. - The company reported a total comprehensive loss of RMB (712,787) thousand for the six months ended June 30, 2024, compared to RMB (1,163,516) thousand for the same period in 2023[177]. - The company incurred a loss of RMB (688,445) thousand during the six months ended June 30, 2024, compared to a loss of RMB (1,125,338) thousand in the same period of 2023[177]. Research and Development - Research and development expenses totaled approximately RMB 546 million, a decrease of about 42% compared to the same period in 2023, due to cost control measures and optimization of resource allocation[4]. - The reduction in R&D expenses is attributed to the completion of major clinical trial endpoints for core products, leading to a natural decline in spending[4]. - The company has expanded its innovative research and development pipeline to include small molecule drugs, peptide drugs, antibody-drug conjugates (ADCs), and nucleic acid drugs, covering five major therapeutic areas[5]. - The product pipeline includes over 30 candidates in clinical trials and more than 20 in preclinical development, covering five major therapeutic areas including oncology and autoimmune diseases[31]. - The company is focused on advancing its pipeline of innovative therapies to address unmet medical needs in oncology[35]. - The company is committed to increasing R&D investments and accelerating the clinical trial and approval processes for innovative drugs to respond to industry and policy risks[150]. Regulatory Approvals and Market Expansion - Three drugs have been included in the new National Medical Insurance Catalogue, with Tuoyi® now covering six indications, including first-line nasopharyngeal carcinoma and first-line non-squamous non-small cell lung cancer[5]. - The company has received regulatory acceptance for multiple new drug applications, including the first-line treatment for advanced nasopharyngeal carcinoma and small cell lung cancer[7]. - As of the report date, Tuoyi® has been approved for 10 indications in mainland China, with two supplemental new drug applications (sNDA) under review[13]. - The company has established commercial partnerships in over 50 countries, including the Middle East, North Africa, and Latin America, to promote the commercialization of Tretinoin monoclonal antibody[20]. - The company is accelerating its internationalization efforts and has made significant progress in innovative therapies and drug commercialization[5]. Financial Position and Cash Flow - As of June 30, 2024, the group had a cash and cash equivalents balance of approximately RMB 3,311 million, a slight decrease of RMB 467 million from December 31, 2023, indicating a relatively ample liquidity position[4]. - The total assets of the company amounted to RMB 11,007 million, a 3% decrease from RMB 11,362 million at the end of the previous year[12]. - The company’s total equity as of June 30, 2024, was RMB 6,623,420 thousand, a decrease from RMB 9,794,250 thousand as of January 1, 2023[177]. - The net cash inflow from financing activities was approximately RMB 739 million, while the net cash outflow from operating activities was approximately RMB 869 million[85]. - The company’s cash flow from financing activities included borrowings of RMB 1,434,544 thousand for the six months ended June 30, 2024, compared to RMB 214,726 thousand in the same period of 2023[180]. Shareholder Structure and Governance - The company has a total of 14 board members, including 8 executive directors, 1 non-executive director, and 5 independent non-executive directors[122]. - The company has established various action agreements, including the 2017 and 2019 action agreements, which consolidate ownership among key stakeholders[129]. - The company continues to maintain a strong governance structure with significant insider ownership, which may influence future strategic decisions and market performance[134]. - The concert party agreements in place influence the perception of shareholdings among related parties, impacting overall governance and control[137]. Clinical Trials and Product Development - The company is currently marketing three drugs (Tuoyi®, Junmai Kang®, and Mindewi®) and has nearly 30 drug candidates in clinical trials, with over 20 in preclinical development[5]. - The company has multiple ongoing clinical trials for various cancer treatments, including non-small cell lung cancer and renal cell carcinoma[35]. - Tifcemalimab is being evaluated in over 30 studies across various cancer types, highlighting its potential as a cornerstone drug in immuno-oncology[56]. - The company has initiated a Phase III clinical trial (NCT06170489) for tifcemalimab combined with teriprizumab in treating cHL, aiming to recruit approximately 185 patients across over 50 centers in China[24]. Risks and Challenges - The company faces risks of not achieving profitability due to high R&D costs and operational expenses, with future earnings dependent on the progress of drug approvals and sales[143]. - The company has a risk of significant performance decline or losses due to ongoing R&D investments and costs associated with new drug registrations and market promotions[144]. - The company is exposed to financial risks related to foreign exchange fluctuations, particularly with assets and liabilities denominated in currencies such as HKD, USD, EUR, and GBP[147].

药品名称：WJ47156 片 一、药品基本情况 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》，WJ47156 片（项目代 号"JS125"）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： 证券代码：688180 证券简称：君实生物 公告编号：临 2024-060 上海君实生物医药科技股份有限公司 自愿披露关于 JS125 获得药物临床试验 批准通知书的公告 并通过诱导细胞周期阻滞、抑制血管生成、调节免疫反应和促进癌症细胞衰老凋 亡等来发挥抑制肿瘤作用，达到肿瘤治疗目的。 三、风险提示 申请事项：境内生产药品注册临床试验 受理号：CXHL2400678、CXHL2400680 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，2024 年 7 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 常州濟峰的背景 常州濟峰由誠承投資控股有限公司作為有限合夥人擁有約13.96%權益，而誠承投 資控股有限公司分別由梁允超先生及欒曉華先生最終擁有51%及49%權益。 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 補充公告 有關訂立重組框架協議的關連交易 茲提述本公司日期為2024年8月30日有關訂立重組框架協議的公告（「該公告」）。 除非本公告另有界定，否則本公告所用詞彙與該公告所界定者具相同涵義。 董事會謹此向本公司股東及潛在投資者提供有關Med-Fine Venture Fund I, L.P.、 常州濟峰及武漢濟峰（均為重組框架協議的訂約方）的額外資料，有關資料乃基於 他們所提供的資料或透過公開查閱獲得。 Med-Fine Venture Fund I, L.P.的 ...

2024 年 9 月 26 日，上海君实生物医药科技股份有限公司（以下简称"公 司"）控股子公司上海君拓生物医药科技有限公司（以下简称"君拓生物"）与南 京吉盛澳玛生物医药有限公司（以下简称"吉盛澳玛"）签署了《IAMA-001 鼻喷 剂型项目许可及合作协议》（以下简称"许可及合作协议"或"本协议"）。根据 许可及合作协议，吉盛澳玛授予君拓生物在大中华区（包括中国大陆、香港特别 行政区、澳门特别行政区及台湾地区）基于许可知识产权研发、改进、制造、生 产、使用、申报、注册、商业化和以其他任何方式利用 IAMA-001 小核酸免疫调 节剂鼻用喷雾剂型药物（以下简称"许可产品"）的独占许可权利，并与君拓生 物在大中华区外合作开发 IAMA-001 鼻喷剂型项目。君拓生物将根据项目进展向 吉盛澳玛支付相应首付款、里程碑款及销售提成。 本次交易未构成关联交易，亦不构成《上市公司重大资产重组管理办法》 规定的重大资产重组。 证券代码：688180 证券简称：君实生物 公告编号：临 2024-059 上海君实生物医药科技股份有限公司 关于控股子公司与吉盛澳玛签署 许可及合作协议的公告 本公司董事会及全体董事保证本公告内容不 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2024-057 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 欧盟委员会批准上市的公告 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®）获得欧盟委员会（EC）批准用于治疗两 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一线治疗。此项批准适用于欧 盟全部 27 个成员国以及冰岛、挪威和列支敦士登，特瑞普利单抗成为欧洲首个 且唯一用于鼻咽癌治疗的药物，也是欧洲唯一用于不限 PD-L1 表达的晚期或转 移性食管鳞癌一线治疗药物。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 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 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2024-058 上海君实生物医药科技股份有限公司 关于持股 5%以上股东减持股份计划的公告 本公司董事会、全体董事及相关股东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。 （1）拟通过集中竞价交易方式减持的，在任意连续 90 日内减持股份的总数 不超过公司总股本的 0.75%，自本公告披露之日起 15 个交易日后的三个月内进 行； 重要内容提示： 大股东的基本情况 截至本公告披露日，上海檀英投资合伙企业（有限合伙）（以下简称"上海 檀英"）及其一致行动人上海檀正投资合伙企业（有限合伙）（以下简称"上海檀 正"）合计持有上海君实生物医药科技股份有限公司（以下简称"公司"或"君 实生物"）股份 78,852,000 股，股份性质均为 A 股，占公司总股本的 8.00%。其 中，上海檀英持有公司 76,590,000 股，占公司总股本的 7.77%，上海檀正持有公 司 2,262,000 股，占公司总股本的 0.23%。 上述股份均为公司首次公开发行股票并在上海证券交易所科创板上市（以下 ...

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 2024 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 | 重大事项提示 2024 年上半年，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"）实现营业收入 78,605.63 万元，较去年同期增 长 17.37%；实现归母净利润-64,495.47 万元，去年同期为-99,741.24 万元；实现 扣非后归属于上市公司股东净利润-62,723.10 万元，随着公司核心产品拓益®的 销售收入快速增长，以及公司"提质增效重回报"行动方案的实施，持续加强费 用管控，优化资源分配，报告期内公司亏损同比有所收窄。 公司尚未实现盈利且存在累计未弥补亏损，未来盈利与否取决于在研药品 上市进度及上市后药品销售情况，而高昂的研发投入、商务推广成本及运营成本 又进一步给盈利带来不确定性，因此，公司短期存在不能盈利以及无法进行现金 分红的风险。 公司正在销售的药物共 3 款（拓益®、君迈康 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2024-056 上海君实生物医药科技股份有限公司 关于股份回购实施结果的公告 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。 | 回购方案首次披露日 | 2023/9/11，由公司控股股东、实际控制人之一兼 | | --- | --- | | | 董事长熊俊先生提议 | | 回购方案实施期限 | 公司第三届董事会第二十二次会议审议通过后 个月 | | | 12 | | 预计回购金额 | 30,000,000 元~60,000,000 元 | | 回购价格上限 | 元/股 58 | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 | | | □用于转换公司可转债 | | | □为维护公司价值及股东权益 | | 实际回购股数 | 股 815,871 | | 实际回购股数占总股本比例 | 0.0828% | | 实际回购金额 | 30,883,207.73 元 | | 实际回购价格区间 | 元/股~41.69 元/股 29.03 | 重要内容提示： 一、 ...

呈交日期: 2024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 (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 | 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8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 本月底法定/註冊股本總額： RMB 985, ...

Financial Performance - In the first half of 2024, the company achieved a revenue of RMB 6.71 billion, a year-on-year increase of approximately 17.37% [1] - The core product, Tuoyi®, saw a revenue increase of about 50%, with sales in over 5,000 medical institutions and 2,000 pharmacies nationwide [1] - The total operating costs decreased by 19.07% year-on-year, with a gross profit margin improvement compared to the same period last year [1] Clinical Pipeline Progress - Tuoyi® was included in the new national medical insurance catalog for three new indications: nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and non-small cell lung cancer [2] - The company has received NMPA approval for three supplemental new drug applications (sNDA) for Tuoyi® in the treatment of renal cell carcinoma, triple-negative breast cancer, and extensive-stage small cell lung cancer [2] - The company is conducting multiple Phase III clinical trials for its products, including the combination of Tifcemalimab and Tuoyi® for limited-stage small cell lung cancer [4][5] Cost Management and Profitability - The company has focused on cost reduction and efficiency improvement, resulting in a decrease in clinical, technical service fees, and employee compensation [2] - The net profit attributable to shareholders has improved compared to the previous year, with sufficient cash reserves of RMB 3.312 billion [2] International Expansion - Tuoyi® has received positive opinions from the European Medicines Agency (EMA) for its use in treating nasopharyngeal carcinoma and esophageal squamous cell carcinoma [3] - The company is actively pursuing commercialization in over 50 countries, including emerging markets, and has established partnerships for market entry [3] Production Capacity - The company has two commercial production bases in Suzhou and Shanghai, both of which have received GMP certification from NMPA [5] - The Suzhou base has a fermentation capacity of 4,500 liters and has passed FDA pre-license inspection, while the Shanghai base has a capacity of 42,000 liters [5] Sales and Market Strategy - The sales revenue for Tuoyi® in the domestic market reached RMB 6.71 billion in the first half of 2024, reflecting a growth of approximately 50% [6] - The company is optimizing its commercialization team structure to enhance execution and sales efficiency [6] - The inclusion of Tuoyi® in the national medical insurance catalog is expected to improve patient affordability and accessibility, further boosting commercialization efforts [6]