格隆汇9月23日丨中国生物制药(01177.HK)宣布，公司全资附属公司礼新医药科技(上海)有限公司("礼新 医药")自主研发的国家1类创新药LM-2417"NaPi2b/4-1BB双特异性抗体"在中国开展的I期临床试验已顺 利完成首例患者入组，标志着这一创新疗法正式进入临床开发阶段。 本次临床研究为一项注射用LM-2417单药或联合其他抗肿瘤药物在晚期恶性实体肿瘤患者中的安全性、 耐受性、药代动力学特徵以及初步疗效的开放标签、剂量递增和剂量扩展的I/II期临床研究。集团将继 续快速推进项目的临床研究，期待早日为患者带来免疫治疗临床用药新选择。 LM-2417是礼新医药基於其自主研发的条件激活型4-1BB平台开发的一款NaPi2b/4-1BB双抗，能够特异 性结合肿瘤细胞表面的NaPi2b及免疫细胞表面的4-1BB。该机制可实现免疫细胞在肿瘤微环境中的精准 激活，从而增强抗肿瘤效应。与传统4-1BB激动剂不同，LM-2417通过NaPi2b依赖性方式选择性激活4- 1BB信号通路，有望显著降低非特异性免疫激活引发的毒性风险。 临床前数据表明，LM-2417不仅能诱导持久的抗肿瘤免疫记忆，还在与其他免疫治疗药物 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：002653 证券简称：海思科 公告编号：2025-103 海思科医药集团股份有限公司 关于创新药环泊酚注射液获得拓展 儿童人群批准的公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整，没有虚假记载、误导性陈述或重大遗 漏。 海思科医药集团股份有限公司（以下简称"公司"）子公司沈阳海思科制药有限公司于近日收到国家药品 监督管理局核准签发的《药品补充申请批准通知书》，现将相关情况公告如下： 一、药品基本信息 药品名称：环泊酚注射液 审批结论：经审查，本品此次申请事项符合药品注册的有关要求。 批准本品如下补充申请事项：1、用于儿童/青少年全身麻醉诱导和维持的用法用量；2、修订说明书安 全性信息。 二、研发项目简介 环泊酚注射液（思舒宁?）（以下简称"环泊酚"或"该产品"）是公司开发的全新的具有自主知识产权的1 类静脉麻醉药物，于2020年12月国内获批上市，在国内已获得"非气管插管手术/操作中的镇静和麻 醉"、"全身麻醉诱导和维持"、"重症监护期间的镇静"适应症的药品注册证书。 经国内外临床试验验证，环泊酚能显著降低注射部位的疼痛反应，耐受性 ...

Core Viewpoint - The approval of the innovative drug "普佑克" (recombinant human urokinase) for treating acute ischemic stroke (AIS) marks a significant breakthrough in China's thrombolytic therapy for stroke, reflecting the country's push for innovation in biomedicine [1][2]. Company Summary - Tian Shi Li Pharmaceutical Group has received approval from the National Medical Products Administration for its innovative drug "普佑克," which is now indicated for AIS treatment, following its previous approval for acute ST-segment elevation myocardial infarction [1]. - The drug has demonstrated a lower risk of bleeding compared to competitors, as evidenced by clinical trials published in reputable medical journals [1]. - The company has 31 innovative drug projects in development, including advancements in cell and gene therapy and bispecific antibodies, with three products recently receiving clinical approval [2]. Industry Summary - The biopharmaceutical industry in China is experiencing unprecedented growth, with a 59% year-on-year increase in the number of innovative drugs approved in the first half of 2025, totaling 43 approvals, of which 93% are domestic innovations [3]. - The integration of Tian Shi Li into China Resources Sanjiu is expected to enhance its capabilities in key therapeutic areas, optimizing its research and development pipeline [3]. - The Chinese government has implemented supportive policies for the development of innovative drugs, creating a favorable environment for the biopharmaceutical sector [3].

据悉，若代币发行成功，未来的融资所得将用于加速多项创新肿瘤抗体项目的临床及临床前研发。创胜 集团董事会主席钱雪明博士表示："我们专注创新药研发，尤其是在治疗肿瘤、骨质疏松和慢性肾病领 域。做药是一个漫长、高风险、高投入的过程，我们需要大量资金。通过华检医疗的链上RWA数字平 台，我们可以将创新药管线的IP装入美国SPV进行新型融资，这为我们提供了全新的资金渠道。" 消息面上，创胜集团与华检医疗(01931)就潜在的创新药管线资产RWA代币化相关事项订立战略合作协 议。创胜方将其旗下六个核心创新药管线资产（TST003, TST005, TST786, TST105, TST106及TST013） 整合至其美国实体，并利用华检医疗构建的ETHK全球创新药知识产权RWA交易所进行潜在RWA代币化 合作。 智通财经APP获悉，创胜集团-B(06628)尾盘涨逾10%，截至发稿，涨8.31%，报4.82港元，成交额 2072.25万港元。 ...

证券研究报告 2025年09月23日 作者： 分析师 杨松 SAC执业证书编号：S1110521020001 分析师 曹文清 SAC执业证书编号：S1110523120003 1 行业评级： 上次评级： 强于大市 强于大市 维持 （ 评级） 请务必阅读正文之后的信息披露和免责申明 摘要：中国创新药产业趋势已成，进军全球商业化 立足现在：进军全球商业化，大量优质项目将继续推高产业发展 行业报告 | 行业专题研究 医药生物 创新药产业趋势已成，进军全球商业化 政策端——全面支持"真创新"：从顶层设计到地方落地形成合力，全面支持创新。 人才端——梯队合理：战略层+执行层协同配置，成为药物研发各环节高效落地的关键保障，也代表中国本土Biotech正在构建自身可持续的研发引擎。 展望未来：提升创新度将进一步打开商业化价值空间，未来可期 产学研持续加深合作，为FIC分子产出蓄力。中国已成为全球靶点验证到IND路径中效率最高的国家之一。这种研发效率与成本优势，将推动产业迈向 更高创新度分子的开发，而更具创新度的分子也意味着更高的商业化价值。 建议关注： ①全球大单品：百济神州（H），科伦博泰生物(H)，信达生物（H），康方 ...

Investment Rating - The report assigns a "Buy" rating for the stock of Tian Shili (600535) based on its potential growth from the newly approved indication for its drug, Pu You Ke [1]. Core Viewpoints - The approval of Pu You Ke for the treatment of acute ischemic stroke is expected to create a second growth curve for the company, leveraging its established commercial framework and clinical evidence [2][3]. - Acute ischemic stroke has a high incidence rate, and Pu You Ke is positioned to meet unmet clinical needs, offering a safer alternative to existing treatments like alteplase [4][5][6]. - The company is committed to innovation, with a robust pipeline of 83 projects, including several promising drugs that could enhance its market position [7][8]. Financial Summary - The projected revenue for the company from 2025 to 2027 is expected to be 86.60 billion, 93.24 billion, and 100.81 billion respectively, with net profits of 11.96 billion, 13.31 billion, and 14.84 billion [10]. - The earnings per share (EPS) are forecasted to be 0.80 yuan, 0.89 yuan, and 0.99 yuan for the same period, with corresponding price-to-earnings (P/E) ratios of 19.62, 17.63, and 15.82 [10].

Group 1 - The company is covered for the first time by Guojin Securities, which gives a "buy" rating and forecasts revenue of 33.41 billion, 37.17 billion, and 41.70 billion yuan for 2025, 2026, and 2027 respectively, with year-on-year growth of +15.75%, +11.24%, and +12.21% [1] - The net profit attributable to the parent company is projected to be 4.63 billion, 4.75 billion, and 5.28 billion yuan for the same years, with year-on-year growth of +32.17%, +2.75%, and +11.17% [1] - The company has a solid position as a leading pharmaceutical player, with a steady increase in revenue and operating profit, and a significant rise in R&D investment, which accounted for 18.1% of revenue in H1 2025, up from 11.1% in 2020 [1] Group 2 - The company acquired Lixin Pharmaceutical for approximately 500 million USD, enhancing its oncology product pipeline [2] - The drug Anlotinib has been approved for 9 indications, and its combination with PD-1 has shown superior results in head-to-head trials against other treatments [2] - The company aims to license out innovative products as a key strategic goal, with promising candidates in oncology and respiratory fields, potentially generating recurring revenue from business development transactions starting in 2025 [3]

Summary of Key Points from the Conference Call on China's Innovative Drug Industry Industry Overview - The Chinese innovative drug industry is transitioning from a follower to a leader, showcasing significant advantages in R&D efficiency and cost control, particularly in popular technology areas such as bispecific antibodies (双抗) and antibody-drug conjugates (ADC) [1][2][3] - The approval speed of innovative drugs directly impacts market volume and competitive landscape, with early market entry being crucial [1][6] Core Insights and Arguments - **Market Dynamics**: The Chinese innovative drug sector is experiencing a shift in underlying logic, with improved liquidity in the Hong Kong stock market and increased risk appetite expected to boost the pharmaceutical sector, especially innovative drugs [1][8] - **International Recognition**: Chinese innovative drugs are gaining international recognition, exemplified by the $1.25 billion upfront payment for the PD-1 VGF bispecific antibody licensed to Pfizer by 3SBio, marking a significant milestone in outbound business development (BD) transactions [1][9] - **Policy Influence**: Healthcare policies are encouraging differentiated innovation, with diverse payment methods being explored, and the impact of drug price reduction policies being limited [1][4][5] Key Factors Affecting the Industry - **Types of Companies**: The innovative drug sector comprises Big Pharma and Biotech companies, with Big Pharma focusing on commercialization and Biotech emphasizing R&D innovation [1][7] - **Investment Sentiment**: The overall performance of the pharmaceutical sector has been weak from 2020 to 2024 due to investor preference for dividend stocks, but improvements in liquidity and risk appetite in 2025 are expected to enhance the performance of the innovative drug sector [1][8] Challenges and Opportunities - **Global Competition**: As the global source innovation enters a bottleneck, Chinese companies can leverage high efficiency to achieve competitive advantages, particularly in ADC and bispecific antibody fields where they hold significant market shares [1][20][22] - **Market Entry Timing**: The timing of market entry is critical, with first-in-class drugs capturing an average of 45% market share, while subsequent entrants see diminishing returns [1][18] Emerging Trends and Future Directions - **New Drug Development**: The focus on PD-1 bispecific antibodies and ADCs is expected to drive future growth, with several companies poised to launch significant products in the near term [1][31][32] - **Clinical Trial Efficiency**: Chinese companies demonstrate superior enrollment speeds in clinical trials, significantly reducing time and costs compared to international counterparts [1][16] Conclusion - The Chinese innovative drug industry is positioned for substantial growth driven by policy support, international recognition, and advancements in R&D efficiency. The upcoming years are likely to see increased BD activities and successful product launches, contributing to the sector's evolution and competitiveness on a global scale [1][10][32]

Group 1: Product and Market Potential - Puyouke is a first-class biological innovative drug approved under the "Major New Drug Creation" project, now gaining approval for acute ischemic stroke indication, marking its second indication in China [1] - Compared to other thrombolytic drugs, Puyouke has a unique thrombolytic mechanism with lower systemic bleeding risk and high safety, showing a significantly lower rate of symptomatic intracranial hemorrhage in clinical trials [1] - In 2019, there were 3.94 million new stroke cases in China, with ischemic strokes accounting for 2.87 million (72.8%), indicating a growing market for stroke treatment [2] Group 2: Industry Trends and Treatment Rates - The incidence of ischemic stroke in China increased from 117 per 100,000 in 2005 to 145 per 100,000 in 2019, with an annual growth rate of 4-6% [2] - The treatment rates for acute ischemic stroke in China are still low, with intravenous thrombolysis at 5.64% and endovascular treatment at only 1.45% in 2019-2020, suggesting significant room for improvement [2] Group 3: Company Innovation and Pipeline - Tianshili is focused on dual-engine innovation in traditional Chinese medicine and biological drugs, with 31 innovative drugs in its pipeline [3] - The company has made significant progress in both traditional and biological drug sectors, with multiple products in late-stage clinical trials [3] - Following its integration with China Resources Sanjiu, Tianshili aims to become a leading innovative pharmaceutical company in China, with a clear strategy for its research pipeline that has yet to be fully valued by the market [3]

Group 1: Huadong Medicine - Huadong Medicine's subsidiary received FDA approval for the clinical trial of HDM2017, a new antibody-drug conjugate targeting Cadherin17 for advanced malignant solid tumors [1] Group 2: Tianjin Tasly - Tasly's subsidiary received approval for the new indication of Pu You Ke for thrombolytic treatment of acute ischemic stroke, making it the only approved recombinant human urokinase product in China [2] Group 3: Yabao Pharmaceutical - Yabao Pharmaceutical decided to terminate the clinical trial of SY-009 and fully provision for asset impairment of 55.793 million yuan, which will reduce the company's profit for 2025 [3][4] Group 4: Zhixiang Jintai - Zhixiang Jintai signed exclusive cooperation agreements with Kangzhe Pharmaceutical for the commercialization of GR2001 and GR1801 monoclonal antibodies, with expected payments totaling approximately 510 million yuan [4] Group 5: Lepu Medical - Lepu Medical entered a strategic partnership with Hanhai Information to jointly develop the medical aesthetics business, aiming to enhance sales channels and improve performance amid industry competition [5]