本文约 2 5 0 0 字，推荐阅读时长 1 5 分钟，欢迎关注新财富公众号。 1 引言 4月14日，美国商务部宣布启动对进口药品的国家安全调查。这一调查覆盖了所有进口药品，包括成 品仿制药、原研药以及用于生产这些药品的关键药用成分。此举属于特朗普政府根据1962年《贸易扩 展法》第232条对多个行业进行的关税调查的一部分。虽然调查尚未结束，预计结果将在270天内公 布，但业内普遍认为，这将赋予特朗普政府对进口药品和原料药征收关税的权力。特别是对中国等主 要药品出口国的影响，可能会带来严重的供应链中断及成本上升。 事实上，美国每年从中国进口药品总额约60亿美元，其中大量为抗生素、抗病毒及心血管药物等基础 药物。一旦关税进一步扩大实施，这些进口药品的成本预计将明显上升，对美国本土药品生产商带来 直接冲击。为应对这种风险，特朗普政府提出多项措施推动产业本土化。 分析师预计，如果对来自中国的API征收10%的关税，仿制药企业的利润将下跌2%-3%，创新药利润 下跌可能更严重。 2 美国关税筑墙， 中概股 跌宕 自2025年特朗普重新执政以来，美国政府出台了一系列针对生物医药产业的重要政策，核心目标是强 化美国医药产 ...

Regulatory Developments - The National Health Commission and other departments have released the 2025 National Random Supervision and Inspection Plan, which includes new regulatory areas such as internet diagnosis and treatment, and mental health, while explicitly targeting online medical fraud [1] - The regulatory focus on combating online medical fraud represents a significant upgrade in medical supervision, aiming to purify the medical online space [1] Pharmaceutical Approvals - Innovent Biologics announced that its third-generation EGFR TKI drug, Olitinib (Leratinib), has received approval from the National Medical Products Administration (NMPA) for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [2] - Olitinib is the only approved third-generation EGFR TKI based on a naphthalene structure, expanding treatment options for EGFR mutation-positive NSCLC patients [2] Market Regulation and Antitrust Issues - Xianju Pharmaceutical is facing a potential fine of approximately 195 million yuan for alleged monopolistic practices related to the pricing of dexamethasone phosphate raw materials, with the case still under review by the Tianjin Market Supervision Administration [3] - This incident highlights the regulatory authorities' emphasis on antitrust measures within the pharmaceutical industry, which could disrupt normal market operations [3] Combination Therapy Approvals - Pfizer announced that its oral targeted drug, Axi-cabtagene ciloleucel (Axitinib), has been approved for first-line treatment in combination with Toripalimab for high-risk, unresectable, or metastatic renal cell carcinoma (RCC) patients [4] - This approval marks the first and only approved first-line targeted and immune combination therapy for advanced kidney cancer in China, indicating a shift towards combination therapies in the treatment landscape [4]

Core Viewpoint - Junshi Biosciences (688180) reported a strong performance in Q1 2025, with total revenue of 501 million yuan, a year-on-year increase of 31.46%, and a net profit attributable to shareholders of -235 million yuan, improving by 17.01% compared to the previous year [1] Financial Performance - Total revenue for Q1 2025 reached 501 million yuan, up 31.46% from 381 million yuan in Q1 2024 [1] - Net profit attributable to shareholders was -235 million yuan, an improvement of 17.01% from -283 million yuan in the same period last year [1] - Gross margin increased to 81.24%, a rise of 13.44% year-on-year, while net margin improved to -51.86%, up 34.1% [1] - Total expenses (selling, administrative, and financial) amounted to 332 million yuan, accounting for 66.34% of revenue, a decrease of 19.38% year-on-year [1] - Earnings per share improved to -0.24 yuan, a 17.24% increase from -0.29 yuan [1] Cash Flow and Debt - Operating cash flow per share was -0.02 yuan, showing a significant improvement of 93.54% year-on-year [1] - The company’s cash and cash equivalents decreased by 44.69% to 2.522 billion yuan [1] - Interest-bearing liabilities increased by 10.32% to 3.325 billion yuan, with a debt-to-asset ratio of 30.52% [3] Business Model and R&D - The company’s business model is primarily driven by research and development, with a focus on innovative drug development [3] - Junshi Biosciences is advancing its dual-specific antibody JS207, which targets PD-1 and VEGF, with clinical trials approved for various cancers [5]

资金储备方面，截至2025年一季度末，君实生物货币资金及交易性金融资产余额合计约30.22亿元，充 足资金为后续高潜力管线快速推进提供保障。 目前，君实生物正在加快推进抗BTLA单.jpgcemalimab(TAB004/JS004)、抗IL-17A单抗(JS005)、PD- 1/VEGF双抗(JS207)等后期阶段管线的研发。早研管线亦储备不少潜在重磅产品，包括抗 Claudin18.2ADC(JS107)、PI3K-α口服小分子抑制剂(JS105)、抗CD20/CD3双特异性抗体(JS203)、抗 DKK1单抗(JS015)等早期阶段管线。君实生物计划于2025年推动多款管线进入关键注册临床。 今年3月，君实生物EGFR/HER3双抗ADC(JS212)获批临床。这是君实首个推进至临床阶段的双抗ADC 产品，也是全球第二个进入临床的EGFR/HER3双抗ADC。君实生物多项创新管线将在4月25日至30日期 间召开的2025AACR大会上"首秀"，其中DKK1抑制剂(JS015)用于胃肠道肿瘤的早期研究数据入选大 会"重磅研究"，Claudin18.2ADC(JS107)和创新双抗药物CD20×CD3双抗( ...

Financial Performance - The company's revenue for Q1 2025 was approximately ¥500.59 million, representing a year-over-year increase of 31.46% compared to ¥380.80 million in the same period last year[8]. - The net profit attributable to shareholders was a loss of approximately ¥234.88 million, an improvement from a loss of ¥283.03 million in the previous year[8]. - Total operating revenue for Q1 2025 reached ¥500,591,459.94, a 31.5% increase from ¥380,804,271.07 in Q1 2024[22]. - Net loss for Q1 2025 was ¥259,586,438.78, an improvement from a net loss of ¥299,647,965.46 in Q1 2024[22][23]. - Basic and diluted earnings per share for Q1 2025 were both -¥0.24, compared to -¥0.29 in Q1 2024[23]. Research and Development - Research and development expenses totaled approximately ¥350.58 million, accounting for 70.03% of the revenue, a decrease of 2.52 percentage points from the previous year[8]. - R&D expenses rose significantly to ¥350,575,453.92 in Q1 2025, compared to ¥276,292,124.92 in Q1 2024, marking a 27% increase[22]. - The company plans to accelerate the launch of multiple key registration clinical trials for early-stage pipelines by 2025, aiming to sustain revenue growth[17]. - The company has received approvals for clinical trial applications for JS212 and JS213, indicating ongoing development in its pipeline[17]. Cash Flow and Liquidity - The net cash flow from operating activities was a negative ¥24.33 million, an improvement from a negative ¥376.58 million in the same period last year[8]. - Cash flow from operating activities increased to ¥740,358,831.82 in Q1 2025, compared to ¥396,310,961.15 in Q1 2024, representing an increase of 86.7%[25]. - The company reported a significant increase in cash received from operating activities, indicating improved liquidity and operational efficiency[25]. - The ending cash and cash equivalents balance was $2.51 billion, down from $4.55 billion in the previous period[26]. Assets and Liabilities - Total assets at the end of the reporting period were approximately ¥10.90 billion, a slight increase of 1.07% from ¥10.78 billion at the end of the previous year[9]. - The total assets as of the latest reporting period amounted to ¥10,897,069,766.80, up from ¥10,781,960,410.10[20]. - Total liabilities increased to ¥5,227,909,703.20, compared to ¥4,849,830,645.95 in the previous period, reflecting a rise of 7.8%[20]. - The total equity attributable to shareholders decreased to ¥5,620,244,628.63 from ¥5,860,424,336.29, a decline of 4.1%[20]. Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 29,429[12]. - The total number of ordinary shareholders as of the reporting period was 29,429, with 29,420 being A-share ordinary shareholders[15]. - The top shareholder, HKSCC Nominees Limited, held 22.25% of the shares, totaling approximately 219.29 million shares[13]. Market and Product Development - The company plans to continue focusing on the commercialization of its pharmaceutical products to drive future revenue growth[11]. - The company's revenue growth was primarily driven by the sales of its core product, Toripalimab injection, which achieved sales revenue of approximately RMB 447 million, representing a year-on-year increase of about 45.72%[15]. - Toripalimab has been approved for 12 indications in mainland China, with 10 of these included in the national medical insurance catalog, enhancing its market accessibility[16]. - The company is focusing on enhancing its commercialization competitiveness through continuous global market expansion and operational management improvements[17].

上海君實生物醫藥科技股份有限公司 Shanghai Junshi Biosciences Co., Ltd.* ( 於中華人民共和國註冊成立的股份有限公司 ) 股份代號 : 1877 2024 年度報告 * 僅供識別 目錄 | 2 4 11 14 | 公司資料 摘要 主席報告 管理層討論及分析 | | --- | --- | | 59 | 董事、監事及高級管理層 | | 71 | 企業管治報告 | | 88 | 環境、社會及管治報告 | | 91 | 董事會報告 | | 113 | 獨立核數師報告 | | 117 | 綜合損益及其他全面收益表 | | 119 | 綜合財務狀況表 | | 121 | 綜合權益變動表 | | 123 | 綜合現金流量表 | | 126 | 綜合財務報表附註 | | 228 | 釋義 | 二零二四年年報 公司資料 執行董事 熊俊先生 （主席兼法定代表） 李寧博士 （副主席） 1 鄒建軍博士 （首席執行官兼總經理） 2 李聰先生 （聯席首席執行官） 張卓兵先生 姚盛博士 王剛博士14 李鑫博士 3 非執行董事 湯毅先生 馮輝博士 4 獨立非執行董事 張淳先生 馮曉源博士15 楊悅博士 ...

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 ...