Group 1 - The core point of the news is that President Trump signed an executive order aimed at reducing prescription drug prices in the U.S. to align with international standards, targeting a price reduction of 30% to 80% [1][3] - The U.S. pharmaceutical market is the largest globally, with American brand drug prices being over three times higher than those in other countries, despite the U.S. accounting for only 5% of the global population but bearing approximately 75% of global pharmaceutical profits [3][4] - Several Chinese innovative pharmaceutical companies, such as BeiGene and Junshi Biosciences, have successfully launched products in the U.S. market, with significant price disparities between the U.S. and China for their drugs [3] Group 2 - The implementation of Trump's drug pricing initiative faces uncertainty due to the existing U.S. laws that prohibit direct negotiations between the government and pharmaceutical companies, and the limited number of drugs eligible for negotiation each year [4] - The majority of U.S. drug spending is covered by commercial insurance, which stimulates pharmaceutical innovation and contributes to the economic growth of the industry [3][4] - The potential impact of the price reduction policy on the global innovative drug industry could be significant, as it may lead to a drastic contraction of the U.S. market size if Chinese prices are included in the U.S. reference pricing [3]

Core Insights - The "Innovation Drug Industry Special Session" held on May 8 showcased 18 leading biotech companies from the STAR Market, emphasizing China's technological strength and international vision in the innovative drug sector [1] Group 1: Industry Overview - The STAR Market has attracted over 30 innovative drug companies focusing on treatments for cancer, HIV, hepatitis B, and hepatitis C, establishing itself as a major listing venue for global biotech firms outside the US and Hong Kong [1] - Innovative drug companies on the STAR Market have significantly increased R&D investments, leading to breakthroughs in key technology areas such as antibody-drug conjugates and bispecific antibodies [2] Group 2: Company Performance - In 2024, STAR Market innovative drug companies collectively achieved approximately 61.7 billion yuan in revenue, a 56% year-on-year increase, while narrowing net losses by 62% [3] - Dize Pharmaceutical reported a revenue of 360 million yuan in 2024, marking a 294.24% increase, driven by its innovative drug targeting peripheral T-cell lymphoma [3] - Junshi Biosciences achieved a revenue of 1.948 billion yuan in 2024, a 30% increase, with product sales reaching 1.640 billion yuan, significantly up from 1.191 billion yuan in 2023 [4]

5月7日，君实生物今日收盘29.28元，下跌2.63%，最新市净率5.14，总市值288.61亿元。 本文源自：金融界 作者：行情君 截至2025年一季报，共有15家机构持仓君实生物，其中基金12家、其他3家，合计持股数18508.72万 股，持股市值55.71亿元。 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，2025年一季报，公司实现营业收入5.01亿元，同比31.46%；净利润-234876226.63 元，同比17.01%，销 ...

Investment Rating - The report maintains a "Buy" rating for Junshi Bioscience (688180) with a target price of 48.10 RMB, compared to the last closing price of 30.45 RMB [1][7]. Core Insights - Junshi Bioscience's revenue from Tuoyi has shown a significant year-on-year growth of 46%. The company is focusing on early data for DKK1 in gastrointestinal tumors [1][10]. - In Q1 2025, the company reported a revenue of 500 million RMB, representing a year-on-year increase of 31.46%. The core product, Toripalimab, achieved sales of 447 million RMB in the domestic market, up 45.72% year-on-year [4][10]. - The company has 30 billion RMB in cash on hand and has implemented a "quality improvement and efficiency return" action plan to enhance sales efficiency and focus resources on more promising R&D projects [4][5]. Financial Performance - The sales expenses for Q1 2025 were 226 million RMB, a year-on-year increase of 17.79%, accounting for 45% of total revenue, which is a decrease of 5 percentage points compared to Q1 2024. R&D expenses were 351 million RMB, up 26.89% year-on-year, while management expenses decreased by 21.32% to 97 million RMB [4]. - The net loss attributable to shareholders for Q1 2025 was 235 million RMB, with a non-recurring net profit loss of 239 million RMB, narrowing the loss by 48 million and 68 million RMB year-on-year [4]. Product Pipeline and International Expansion - Tuoyi has received approval for 12 indications in China, with 10 included in the national medical insurance catalog, four of which are exclusive indications [5]. - The company has made progress in international expansion, with Toripalimab approved in multiple countries including the USA, EU, India, UK, and Australia, and has established commercial partnerships in over 80 countries [5]. - Two early-stage pipelines, JS212 and JS213, have received clinical trial approvals, and VV116 has transitioned from conditional approval to regular approval for treating COVID-19 [5][6]. Future Projections - The report projects revenue growth for Junshi Bioscience, estimating revenues of 2.595 billion RMB in 2025, with a growth rate of 33.17% [10]. - The company is expected to narrow its net loss to 674 million RMB in 2025, with a projected diluted earnings per share of -0.68 RMB [10].

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]

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].