一、主要会计数据和财务指标 二、前10名无限售条件股东持股情况 前十大流通股东累计持有： 56490.16万股，累计占流通股比： 57.41%，较上期变化： -439.20万股。 | 名称 | 持有数量(万股) | 占总股本比例(%) | 增减情况(万股) | | --- | --- | --- | --- | | HKSCC NOMINEES LIMITED | 21929.12 | 22.29 | 不变 | | 熊俊 | 8785.40 | 8.93 | 不变 | | 上海檀英投资合伙企业(有限合伙) | 7145.93 | 7.26 | 不变 | | 苏州瑞源盛本生物医药管理合伙企业(有限合伙) | 4358.40 | 4.43 | 不变 | | 熊凤祥 | 4106.00 | 4.17 | 不变 | | 华夏上证科创板50成份ETF | 3025.34 | 3.08 | -505.06 | | 周玉清 | 2168.08 | 2.20 | 不变 | | 易方达上证科创板50ETF | 2158.33 | 2.19 | -86.91 | | 香港中央结算有限公司 | 1499.56 | 1.52 | 1 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2025-026 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®） 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批准。这是 特瑞普利单抗在中国内地获批的第 12 项适应症。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 特瑞普利单抗注射液是中国首个批准上市的以 PD-1 为靶点的国产单抗药物， 曾荣膺国家专利领域最高奖项"中国专利金奖"，至今已在全球（包括中国、美 国、欧洲及东南亚等地）开展了覆盖超过 15 个适应症的 40 多项由公司发起的临 床研究。正在进行或已完成的关键注册临床研究在多个瘤种范围内评 ...

王雨舟女士联系方式： 证券代码：688180 证券简称：君实生物 公告编号：临 2025-025 上海君实生物医药科技股份有限公司 关于聘任证券事务代表的公告 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 2025 年 4 月 25 日召开第四届董事会第八次会议，审议通过了《关于聘任证券事务代表的议 案》，同意聘任王雨舟女士为公司证券事务代表，任期自本次董事会审议通过之 日起至第四届董事会届满之日止。 王雨舟女士已取得上海证券交易所科创板董事会秘书资格证书，具备履行证 券事务代表职责所必需的专业知识、工作经验及相关素质，能够胜任相关岗位职 责的要求，其任职符合《中华人民共和国公司法》《上海证券交易所科创板股票 上市规则》等相关法律法规和规范性文件的规定。王雨舟女士的简历详见附件。 电话：021-61058800-1153 传真：021-61757377 邮箱：info@junshipharma.com 办公地址：上海市浦东新区平家桥路 100 弄 6 号 7 幢 1 ...

证券代码：688180 证券简称：君实生物 公告编号：临 2025-027 会议召开时间：2025 年 5 月 8 日（星期四）15:00-17:00 会议召开地点：上证路演中心（http://roadshow.sseinfo.com） 会议召开方式：网络文字互动 上海君实生物医药科技股份有限公司 关于参加 2024 年度科创板创新药行业集体业绩说明会 暨 2025 年第一季度业绩说明会的公告 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： 投资者可于 2025 年 4 月 28 日（星期一）至 2025 年 5 月 7 日（星期三） 16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过上海君实生 物医药科技股份有限公司（以下简称"公司"）邮箱 info@junshipharma.com 进 行提问。公司将在说明会上对投资者普遍关注的问题进行回答。 公司已分别于 2025 年 3 月 28 日和 2025 年 4 月 26 日在上海证券交易所网 站（www.sse.com.cn）披露公司 20 ...

Financial Performance - The company's revenue for Q1 2025 was CNY 500,591,459.94, representing a 31.46% increase compared to CNY 380,804,271.07 in the same period last year[3] - The net profit attributable to shareholders was a loss of CNY 234,876,226.63, an improvement from a loss of CNY 283,029,082.76 year-over-year[3] - The net cash flow from operating activities was a negative CNY 24,331,196.50, significantly improved from a negative CNY 376,577,871.82 in the prior year[3] - Total revenue for Q1 2025 reached ¥500.59 million, a 31.5% increase from ¥380.80 million in Q1 2024[17] - Net loss for Q1 2025 was ¥259.59 million, an improvement compared to a net loss of ¥299.65 million in Q1 2024[18] - Basic and diluted earnings per share for Q1 2025 were both -¥0.24, an improvement from -¥0.29 in Q1 2024[18] Research and Development - R&D expenses totaled CNY 350,575,453.92, accounting for 70.03% of revenue, a decrease of 2.52 percentage points from the previous year[3] - Research and development expenses rose significantly to ¥350.58 million, up 27% from ¥276.29 million in the same period last year[17] - The company continues to focus on expanding its research and development efforts to enhance product offerings and market presence[22] Assets and Liabilities - Total assets at the end of the reporting period were CNY 10,897,069,766.80, a 1.07% increase from CNY 10,781,960,410.10 at the end of the previous year[4] - The company's total liabilities increased to RMB 5.228 billion from RMB 4.850 billion, indicating a rise in financial obligations[14] - The total equity attributable to shareholders decreased by 4.10% to CNY 5,620,244,628.63 from CNY 5,860,424,336.29[4] - The total equity attributable to shareholders decreased to RMB 5.620 billion from RMB 5.860 billion, showing a decline in shareholder equity[14] Market and Product Development - The company reported an increase in commercial drug sales, contributing to the rise in revenue[6] - The company's revenue growth during the reporting period was primarily driven by the sales of commercialized drugs, with the core product, Toripalimab injection (brand name: Tuoyi®/LOQTORZI®), achieving sales revenue of approximately RMB 447 million, representing a year-on-year increase of about 45.72%[10] - Toripalimab received conditional approval for routine use in treating unresectable or metastatic melanoma after previous systemic therapy failure, and a new indication for first-line treatment of advanced hepatocellular carcinoma in combination with Bevacizumab was approved[10] - During the reporting period, Toripalimab was approved for marketing by the Australian Therapeutic Goods Administration and the Singapore Health Sciences Authority, with 12 indications approved in mainland China, 10 of which are included in the national medical insurance catalog[11] - The company plans to accelerate the registration clinical trials for multiple products by 2025 and enhance the development and application of late-stage pipelines to ensure sustained revenue growth[12] - The company is committed to expanding its global market presence and increasing the accessibility of approved products and indications included in the national medical insurance catalog[12] Shareholder Information - The number of ordinary shareholders at the end of the reporting period was 29,429[8] - The top shareholder, HKSCC NOMINEES LIMITED, held 22.25% of the shares, totaling 219,291,210 shares[8]

Core Viewpoint - Junshi Biosciences has received approval from the National Medical Products Administration for toripalimab as the first-line treatment for unresectable or metastatic melanoma, marking its 12th indication in mainland China [1][8]. Group 1: Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diverse R&D pipeline of over 50 drug candidates [12]. - The company has achieved significant milestones, including the approval of toripalimab, China's first domestically developed anti-PD-1 monoclonal antibody, in over 35 countries and regions [12][9]. - The company aims to provide world-class, trustworthy, affordable, and innovative drugs, with a mission of "In China, For Global" [13]. Group 2: Product and Clinical Study Insights - Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-1 interactions, enhancing the immune system's ability to target tumor cells [6]. - The supplemental NDA approval for toripalimab was based on the MELATORCH study, a Phase 3 clinical trial that demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) compared to dacarbazine [3][4]. - The MELATORCH study showed a median PFS of 2.3 months for toripalimab versus 2.1 months for dacarbazine, with a 29.2% reduction in disease progression or mortality risk [4]. Group 3: Market Context and Clinical Need - Melanoma is a highly aggressive cancer with a rising incidence rate in China, where traditional treatments have limited effectiveness [2]. - The approval of toripalimab addresses an urgent clinical need for first-line immunotherapy options in advanced melanoma, as no domestic anti-PD-1 monoclonal antibody had been previously approved for this indication [2][5]. - The results from the MELATORCH study are particularly relevant to Chinese patients, as the trial exclusively enrolled participants from China [5].

君实生物公告，2025年第一季度营收为5.01亿元，同比增长31.46%；净亏损2.35亿元，去年同期净亏损 2.83亿元。 ...

Financial Performance - For the year ended December 31, 2024, the total revenue of the group was approximately RMB 1,948 million, an increase of about 30% compared to the same period in 2023, primarily due to increased pharmaceutical sales, with core product Tuoyi® (Tremelimumab) domestic sales revenue reaching approximately RMB 1,501 million, a 66% increase year-on-year[7]. - The loss attributable to owners of the company decreased to approximately RMB 1,282 million, a reduction of about RMB 999 million or approximately 44% compared to the same period in 2023[8]. - Total revenue for 2024 reached RMB 1.948 billion, representing a year-on-year increase of approximately 30%[16]. - Core product Tuoyi® contributed RMB 1.501 billion in domestic sales, a year-on-year growth of 66%[16]. - The company achieved a significant reduction in net loss attributable to shareholders, with losses narrowing to RMB 2.356 billion in 2023 from RMB 2.582 billion in 2022[13]. - The company’s total comprehensive expenses for 2023 were RMB 2.608 billion, a slight decrease from RMB 2.651 billion in 2022[15]. - The company reported a basic loss per share of RMB (1,282,398) thousand for the year ended December 31, 2024, compared to RMB (2,281,624) thousand for the year ended December 31, 2023[119]. Research and Development - The total R&D expenditure for the reporting period was approximately RMB 1,275 million, a decrease of about 34% compared to 2023, mainly due to the implementation of cost control policies and optimization of resource allocation[8]. - The company has expanded its innovative R&D pipeline to include over 30 drugs in clinical trials and more than 20 drugs in preclinical development across five major therapeutic areas[9]. - The company is advancing its clinical pipeline with key products like Tifcemalimab and JS207, with Tifcemalimab undergoing two Phase III clinical trials[19]. - The company has conducted 92 clinical studies in 2024, enrolling over 2,100 participants, demonstrating increased clinical research efficiency[25]. - The company is actively pursuing new product development and market expansion strategies to strengthen its competitive position in the industry[160]. - The company is committed to increasing its innovation capabilities and accelerating the clinical trial and commercialization processes of new drugs[150]. Product Approvals and Market Expansion - The FDA approved the drug LOQTORZI® for the treatment of nasopharyngeal carcinoma in October 2023, marking it as the first drug of its kind in the U.S.[9]. - The company received NMPA approval for the sNDA of its drug in combination with other treatments for various cancers, including advanced liver cancer and triple-negative breast cancer, in 2024[10]. - The company’s drug LOQTORZI® has been approved in multiple countries, including India and Jordan, for treating nasopharyngeal carcinoma[10]. - The company’s drug Tuo Yi® has been included in the national medical insurance catalog for all 10 approved indications in mainland China, making it the only PD-1 monoclonal antibody for certain cancer treatments[11]. - The company has initiated commercial sales of Tuoyi® in the US and India, expanding its global market presence[17]. - Trelipilumab (LOQTORZI®) received FDA approval in October 2023 and will officially launch in the U.S. market in January 2024, becoming the only recommended first-line treatment for recurrent/metastatic nasopharyngeal carcinoma in the NCCN guidelines[31]. Financial Position and Liquidity - As of December 31, 2024, the group had a total cash and cash equivalents balance of approximately RMB 2,917 million, indicating a relatively strong liquidity position to support future development[8]. - The company has a cash and financial product balance of approximately RMB 2,917 million, indicating sufficient funding reserves[25]. - The company’s total assets amounted to RMB 11.362 billion as of December 31, 2023, while total liabilities reached RMB 4.022 billion[13]. - The company’s net asset value was RMB 7.340 billion as of December 31, 2023, down from RMB 9.794 billion in 2022[13]. - The company has incurred a net cash outflow of approximately RMB 1,443 million during the reporting period[148]. - The company expects to secure a credit facility of up to RMB 8,000 million to support its operations and project development, effective from the approval date of the 2024 annual general meeting until the 2025 annual general meeting[138]. Corporate Governance - The company has established a governance framework based on the corporate governance code outlined in the Stock Exchange Listing Rules[187]. - The board believes that the company has complied with all applicable principles and code provisions of the corporate governance code during the reporting period[188]. - The company has implemented a series of policies and processes to improve the board's governance capabilities[187]. - The board consists of 14 members, including 8 executive directors, 1 non-executive director, and 5 independent non-executive directors[193]. - The board has maintained compliance with listing rules by having at least three independent non-executive directors, representing over one-third of the board[198]. - The company has a strong leadership team with extensive experience in the pharmaceutical and medical fields, enhancing its strategic direction and operational efficiency[160]. Employee and Operational Efficiency - The company has 2,578 employees, with 620 dedicated to drug research and development, maintaining a gender balance with approximately 52% female employees[43]. - The company emphasizes employee career development through a unified performance management system and provides training resources to support professional growth[44]. - The company has optimized its commercialization team structure, significantly improving execution and sales efficiency[56]. - The company is focused on strategic research to mitigate risks associated with new drug development and will discontinue projects that do not meet expected outcomes[146]. Market Risks and Challenges - The company is at risk of not achieving profitability in the short term due to ongoing R&D investments and operational costs[144]. - The company faces potential financial risks from currency fluctuations, particularly related to assets and liabilities denominated in HKD and USD[148]. - The company is exposed to risks related to supply chain stability and potential disruptions in raw material supply[147]. - The company acknowledges the impact of macroeconomic factors, including uncertainties in international trade relations, on its overseas operations[151].

上海君实生物医药科技股份有限公司的主营业务是新药的研发及相关技术的转让和服务，新药的生产和 销售。公司的主要产品是特瑞普利单抗、氢溴酸氘瑞米德韦片、Tifcemalimab、阿达木单抗、昂戈瑞西 单抗、重组人源化抗IL-17A单克隆抗体、重组人源化抗PD-1、VEGF双特异性抗体、靶向 ANGPTL3mRNA的siRNA药物、重组人源化抗CGRP单克隆抗体、PI3K-α抑制剂、重组人源化抗 Claudin18.2单抗-MMAE偶联剂。公司拥有175项已授权专利，其中129项为境内专利，46项为境外专 利。公司专利覆盖新药蛋白结构、制备工艺、用途、制剂配方等，为公司产品提供充分的和长生命周期 的专利保护。 最新一期业绩显示，2024年年报，公司实现营业收入19.48亿元，同比29.67%；净利润-1280926434.36 元，同比43.90%，销售毛利率78.92%。 4月21日，君实生物今日收盘29.46元，上涨2.65%，最新市净率4.96，总市值290.38亿元。 股东方面，截至2025年2月28日，君实生物股东户数29351户，较上次增加260户，户均持股市值35.28万 元，户均持股数量2.76万股 ...

4月17日，君实生物今日收盘28.85元，下跌1.27%，最新市净率4.85，总市值284.37亿元。 股东方面，截至2025年2月28日，君实生物股东户数29351户，较上次增加260户，户均持股市值35.28万 元，户均持股数量2.76万股。 上海君实生物医药科技股份有限公司的主营业务是新药的研发及相关技术的转让和服务，新药的生产和 销售。公司的主要产品是特瑞普利单抗、氢溴酸氘瑞米德韦片、Tifcemalimab、阿达木单抗、昂戈瑞西 单抗、重组人源化抗IL-17A单克隆抗体、重组人源化抗PD-1、VEGF双特异性抗体、靶向 ANGPTL3mRNA的siRNA药物、重组人源化抗CGRP单克隆抗体、PI3K-α抑制剂、重组人源化抗 Claudin18.2单抗-MMAE偶联剂。公司拥有175项已授权专利，其中129项为境内专利，46项为境外专 利。公司专利覆盖新药蛋白结构、制备工艺、用途、制剂配方等，为公司产品提供充分的和长生命周期 的专利保护。 作者：行情君 最新一期业绩显示，2024年年报，公司实现营业收入19.48亿元，同比29.67%；净利润-1280926434.36 元，同比43.90%，销售毛利 ...