FF301 I. 法定/註冊股本變動 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: 2025年4月30日 狀態: 新提交 | 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 | | 2. 股份分類 | 普通股 | 股份類別 | A | | 於香港聯交所上市 (註1) | 否 | | | | --- | --- | --- | - ...

Core Viewpoint - Junshi Bioscience reported a strong revenue growth of 31.46% year-on-year for Q1 2025, driven by its core product, Toripalimab, which achieved a sales revenue of 447 million yuan, reflecting a 45.72% increase year-on-year [2] Group 1: Financial Performance - The company achieved a total revenue of 500 million yuan in Q1 2025, with a net loss of 235 million yuan, which is a reduction in loss compared to the previous year [2] - Cash and cash equivalents, along with trading financial assets, totaled 3 billion yuan as of March 31, 2025 [2] - Sales expenses increased by 17.79% year-on-year to 226 million yuan, accounting for 45% of total revenue, a decrease of 5 percentage points from Q1 2024 [2] Group 2: Product Development and Regulatory Approvals - Toripalimab has received approval for 12 indications in China, with 10 included in the national medical insurance directory, four of which are exclusive indications [3] - The company has made progress in international expansion, with Toripalimab approved in multiple countries including the US, EU, and Australia, and has established commercial partnerships in over 80 countries [3] - Two early-stage pipelines, JS212 and JS213, have received clinical trial approvals from the National Medical Products Administration [3] Group 3: Future Catalysts - Key catalysts for 2025 include data readouts for Toripalimab combined with Lenvatinib for first-line HCC, early clinical data for JS107, and early clinical data for JS015 targeting gastrointestinal tumors [4] - The company plans to submit for market approval for JS005 for psoriasis treatment by the end of 2025 [4] Group 4: Investment Recommendation - The target market value is estimated at 47.4 billion yuan, corresponding to a target price of 48.10 yuan per share, maintaining a "buy" rating [5] - Recent analyst coverage indicates a consensus target price of 48.1 yuan, with two institutions giving a buy rating [7]

2025 年 04 月 30 日 公司点评 买入/ 维持 君实生物(688180) 目标价: 48.10 昨收盘:30.45 拓益收入同比增长 46%，关注 DKK1 胃肠道肿瘤早期数据 ◼ 走势比较 (30%) (18%) (6%) 6% 18% 30% 24/4/30 24/7/11 24/9/21 24/12/2 25/2/12 25/4/25 ◼ 股票数据 总股本/流通(亿股) 9.86/7.65 总市值/流通(亿元) 300.14/232.81 12 个月内最高/最低价 (元) 38.36/23.08 相关研究报告 观点： 拓益销售收入保持高增速，公司运营效率显著提升，在手现金 30 亿 元。2025 年第一季度公司实现收入 5 亿元（同比+31.46%），其中，核心 产品特瑞普利单抗于国内市场实现销售收入 4.47 亿元（同比+45.72%）。 同时，公司积极落实"提质增效重回报"行动方案，提升销售效率，并将资 源聚焦于更具潜力的研发项目，与上年同期相比亏损减少。2025Q1 销售 费用 2.26 亿元（同比+17.79%），占总收入比重为 45%，较 2024Q1 下降 了 5pcts。研发费用 ...

Core Insights - The trend of license-out transactions involving Chinese pharmaceutical companies continues into 2025, with over 20 deals reported in Q1 alone, including significant agreements worth over $1 billion [2] - However, there is a concerning "return rate" of 40% for completed license-out transactions from 2020, indicating a growing trend of terminated collaborations [5] - The industry is experiencing a "clearing" phase after a surge in business development (BD) activities, with many companies facing challenges in maintaining partnerships [5][6] Group 1: Business Development Trends - In Q1 2025, notable transactions included Roche's $1 billion deal with Innovent Biologics and Lepu Biopharma's $1.2 billion collaboration with ArriVent [2] - Companies like InnoCare and Baillie Gifford have successfully capitalized on BD opportunities, with InnoCare's license-out deals exceeding $6 billion, contributing to its successful IPO [2] - The overall BD transaction volume is expected to reach new highs in 2025, driven by increased interest from global pharmaceutical companies in Chinese innovative drugs [2] Group 2: Challenges and Terminations - As of April 2025, 25 out of 62 completed license-out transactions from 2020 have been terminated, reflecting a 40% return rate [5] - Recent high-profile disputes include Novo Nordisk's $800 million claim against Henlius for alleged fraud and GAVI's termination of a pre-purchase agreement with Clover Biopharmaceuticals [6] - The primary reasons for these terminations include disappointing clinical data and strategic shifts by the buying companies, leading to increased competition and pressure on Chinese biotech firms [6][8] Group 3: Financial Implications - The milestone achievement rate for Chinese innovative drugs is only 22%, indicating that most companies only receive the initial payment, which typically constitutes 2%-5% of the total deal value [9][11] - The financial impact of terminated collaborations is significant, as companies lose potential milestone payments and face challenges in maintaining market confidence [9][12] - The NewCo model is emerging as a more favorable alternative, allowing for shared risk and deeper collaboration between Chinese firms and multinational corporations [13][14] Group 4: Future Outlook - The BD landscape is expected to see an increase in "return" events, as the market matures and companies face heightened scrutiny [15] - Successful future collaborations will require Chinese companies to demonstrate superior clinical data and competitive advantages in the global market [18][19] - The industry must balance the urgency of BD with long-term strategic planning to avoid reliance on potentially volatile partnerships [17][18]

| | | | And Income of the Resident of | | | --- | --- | --- | --- | --- | | 主要会计数据 | 2024年 | 2023年 | 本期比上年 | 2022年 | | | | | 同期增减(%) | | | 营业收入 | 194,831.73 | 150,254.99 | 29.67 | 145.349.27 | | 扣除与主营业务无关的业务收入 | 194.650.29 | 150.193.76 | 29.60 | 145.281.70 | | 和不具备商业实质的收入后的营 | | | | | | 北收入 | | | | | | 归属于上市公司股东的净利润 | -128.092.64 | -228.343.19 | 不适用 | -238.804.99 | | 归属于上市公司股东的扣除非经 | -128.988.79 | -229.755.88 | 不适用 | -245.019.76 | | 常性损益的净利润 | | | | | | 经营活动产生的现金流量净额 | -143.384.12 | -200.498.21 | 不适用 | -177 ...

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( ...

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 ...