报告中称，公司IBI363获批开展全球三期临床，逐步验证新一代IO基石潜力。IBI363是由信达生物研发 的全球首创PD-1/IL-2α-bias双特异性融合蛋白，同时具有阻断PD-1/PD-L1通路和激活IL-2通路两项功 能。2025年8月公司宣布IBI363的IND获FDA批准，开展治疗鳞状非小细胞肺癌首个全球关键三期临床 研究：招募约600名患者，比较IBI363单药与多西他赛在IO经治的肺鳞癌的疗效与安全性，研究的主要 终点为总生存期(OS)。此前363在2025年ASCO上363亮相三项口头报告：对"免疫耐药"、"冷肿瘤"等具 备亮眼的疗效数据。公司开发策略清晰：优先瞄准IO经治的空白市场，在肺癌、黑色素瘤和三线肠癌 将在2025年陆续开展注册临床;在一线的肺癌、肠癌开展PoC研究，预计在2026读出。公司同步开展联合 疗法拓宽适应症，验证新一代IO基石的潜力。 此外，信达生物综合管线矩阵丰富，多元化出海。心血管代谢及内分泌科来看：玛氏度肽、PCSK9已获 批，在研管线聚焦心血管相关的"四高"广阔人群;眼科：双抗分子有望通过差异化机制提升患者生存质 量;皮肤科及风湿科：匹康奇拜单抗(IL23p19 ...

机构：中邮证券 研究员：盛丽华/徐智敏 事件 公司发布25 年中期业绩公告，25H1 公司收入59.5 亿元，同比+50.6%，其中产品收入52.3 亿元，同比增 长37.3%。EBITDA 为14 亿元，净利润为12 亿元，在手现金146 亿元。 投资要点 双轮驱动助力收入高增。产品层面来看，公司现有16 款商业化品种，肿瘤和综合管线双轮驱动。肿瘤 管线来看，公司持续巩固国内领先地位，达伯舒中国PD-(L)1 市场市占率第一，2 项NDA+NSCLC 的围 手术期治疗三期提供未来增长动力。同时三款靶向药上市（ROS1、EGFR TKI、BTK 抑制剂）凸显协 同效应。公司综合管线慢病商业化顺利启航，PCSK9 单抗系国内首个进医保的PCSK9 单抗、IGF-1R 和 GCG/GLP-1 成功上市/获批，为国内同类的首个药物。 运营效率优化盈利持续攀升。公司2024H1/2024H2/2025H1 的EBITDA 分别为-1.6/5.7/14.1 亿元，净利润 为-1.6/4.9/12.1 亿元，盈利持续攀升。25H1 来看，公司运营效率进一步提升：毛利率86.8%，同比 +2.7pct，销售及管理费率44. ...

公司基本情况 证券研究报告：医药生物 | 公司点评报告 股票投资评级 买入|首次覆盖 个股表现 资料来源：Wind，中邮证券研究所 -50% 0% 50% 100% 150% 2024-10 2024-12 2025-03 2025-05 2025-07 2025-10 信达生物 恒生指数 | 最新收盘价（港元） | 104.70 | | --- | --- | | 总股本/流通股本（亿股）17.14/17.14 | | | 总市值/流通市值（亿港 | 1794/1794 | | 元） | | | 52 周内最高/最低价 | 109.10/ 28.65 | | 资产负债率(%) | 38.88 | | 市盈率 | 144.43 | | 第一大股东 | 俞德超 | 研究所 分析师:盛丽华 SAC 登记编号:S1340525060001 Email:shenglihua@cnpsec.com 研究助理:徐智敏 SAC 登记编号:S1340125080012 Email: xuzhimin@cnpsec.com 信达生物(1801.HK) 内生收入高增利润表现亮眼，全球化战略高效推进 事件 公司发布 25 年中期业 ...

诺和诺德的GLP-1药物司美格鲁肽，已成为全球医药市场的现象级产品，其商业成功甚至将这家丹麦公 司的市值一度推升至超越其本国GDP。 华东医药的策略极具代表性，其采取了"自主研发+外部引进"双线布局。在引进和仿制端，它已在国内 首批获准上市了诺和诺德上一代产品利拉鲁肽的生物类似药，并获批用于体重管理。 这一步的战略价值在于，它能提前教育市场、建立与医生的合作关系、并搭建起一支经验丰富的销售团 队，为后续司美格鲁肽的竞争铺平道路，同时产生稳定的现金流。 它越成功，在中国市场就越能吸引企业入局。据估算，中国的超重及肥胖人群已达数亿，潜在的市场规 模无可限量。 故事的转折点定于2026年，届时，司美格鲁肽在中国的核心化合物专利预计将失效。这为本土制药企业 打开了法律和市场的双重窗口。 事实上，一场"抢跑"早已开始。据不完全统计，目前国内已有至少八家企业的司美格鲁肽生物类似药申 请上市，另有超过十二家同类药物处于关键的II/III期临床试验阶段。一个高度拥挤的赛道已成定局。 然而，即将到来的竞争并非千篇一律的价格战，而是不同背景的入局者，采用不同商业策略的一场多线 战争。 第一类是以华东医药、齐鲁制药为代表的传统大型 ...

港股恒生指数涨0.04%，涨11点，报26840点；恒生科技指数涨0.63%。港股早盘成交2074亿港元。 上海电气（601727）(02727)涨15.72%，公司A股涨停，可控核聚变赛道近期利好频出。 华虹半导体(01347)涨6.75%再创新高，供应链本土化继续加速，本土代工需求有望迅速扩大。 江西铜业（600362）股份(00358)再涨11%，公司为国内铜冶炼龙头，第一量子旗下铜矿有望复产。 洛阳钼业（603993）(03993)再涨8%，刚果严控钴出口，钴价此前两日飙升逾11%。 恒生银行(00011)涨26%，汇丰建议将恒生银行私有化。 部分光伏股早盘走高。9月光伏产业链价格持续走高，上游价格涨幅高于下游。新特能源(01799)涨 4.52%；福莱特（601865）玻璃(06865)涨7.67%；协鑫科技(03800)涨3.73%。 高铁基建股涨幅居前。铁路投资进度再破纪录，"十五五"铁路发展规划编制工作已启动。中国中铁 （601390）(00390)涨9%；中国中冶（601618）(01618)涨6%；中国中车（601766）(01766)涨4.17%。 中兴通讯(00763)AH股齐涨，Co ...

Group 1 - Hong Kong's Hang Seng Index rose by 0.04%, gaining 11 points to close at 26,840 points, while the Hang Seng Tech Index increased by 0.63% [1] - Shanghai Electric (02727) surged by 15.72%, with its A-shares hitting the daily limit, driven by positive developments in the controllable nuclear fusion sector [1] - Huahong Semiconductor (01347) climbed 6.75%, reaching a new high as domestic supply chain localization accelerates, with local foundry demand expected to expand rapidly [1] - Jiangxi Copper (00358) increased by 11%, being a leading copper smelting company in China, with a potential resumption of production at a copper mine owned by First Quantum [1] - Luoyang Molybdenum (03993) rose by 8%, as cobalt prices surged over 11% in the previous two days due to strict export controls in the Democratic Republic of Congo [1] - Hang Seng Bank (00011) jumped 26% following HSBC's recommendation to privatize the bank [1] - Solar stocks saw gains in early trading, with prices in the photovoltaic industry chain continuing to rise in September, particularly in upstream sectors [1] - High-speed rail infrastructure stocks led the gains, with record railway investment progress and the initiation of the "14th Five-Year" railway development planning [1] Group 2 - ZTE Corporation (00763) saw both A and H shares rise, with the overseas debut of its Co-Sight super intelligent system indicating positive growth potential in the enterprise AI market [2] Group 3 - Mixue Group (02097) rose 8.96% despite market trends, making a forward-looking investment in fresh beer brand Fulu, expanding its "tea + coffee + fresh beer" portfolio [3] - The Hang Seng Biotechnology Index fell by 3.52%, with several constituent stocks like Innovent Biologics (09969) and Sino Biopharmaceutical (01177) experiencing declines of over 6% [3] - Smoore International (06969) dropped over 9%, having fallen more than 30% from its yearly high, with UBS projecting lower earnings than market consensus [3]

每经AI快讯，10月9日，港股创新药板块普遍回调，四环医药、诺诚健华跌超8%，科伦博泰生物跌超 6%，信达生物跌超5%。 ...

Core Insights - The Chinese immune checkpoint inhibitor industry is rapidly developing, with a projected market size of approximately 52.734 billion yuan in 2024, representing a year-on-year growth of 44.14% [1][4][8] - The primary driver of this growth is the innovative therapeutic mechanism of immune checkpoint inhibitors, which reactivate the immune system to identify and attack tumor cells, providing revolutionary treatment options for cancer patients with limited traditional therapies [1][4] Industry Overview - Immune checkpoint inhibitors enhance the immune system's ability to attack cancer cells by blocking immune checkpoint proteins, which are used by tumor cells to evade immune responses [2][5] - The industry has evolved through three stages: initiation, rapid development, and mature expansion, with significant policy support and market entry of domestic products since 2018 [3][4] Market Size - The immune checkpoint inhibitor market in China is expected to reach approximately 52.734 billion yuan in 2024, with a significant increase in clinical application driving market demand [1][8] Key Companies - Leading companies in the industry include Junshi Biosciences, Hengrui Medicine, Innovent Biologics, and BeiGene, which collectively hold over half of the market share [8] - Junshi Biosciences' core product, Toripalimab, has been approved for 12 indications and is the first domestic PD-1 inhibitor to receive FDA approval for kidney cancer treatment [9] - Akeso's dual antibody technology has led to significant advancements, with its PD-1/CTLA-4 dual antibody achieving notable efficacy in cervical cancer [11] Industry Development Trends 1. Continuous technological innovation is driving breakthroughs in precision treatment and combination therapies, with dual antibodies and ADCs becoming more prominent [12] 2. Market expansion and the shift of indications towards early-stage treatments are accelerating internationalization, with several domestic products gaining traction in overseas markets [13] 3. Policy and regulatory developments are promoting industry standardization, with support for new biological agents and reforms in medical insurance payment methods [13]

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9月30日 | | | | 狀態: 新提交 | | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | 公司名稱: | 信達生物製藥 | | | | | | 呈交日期: | 2025年10月8日 | | | | | | I. 法定/註冊股本變動 | | | | | | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | 於香港聯交所上市 (註1) | 是 | | 證券代號 (如上市) | 01801 | 說明 | 普通股 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) ...

Core Insights - The public fund industry has experienced a fruitful year in the structural bull market, with active equity funds making a significant comeback, particularly supported by the AI computing and innovative pharmaceutical sectors [1][2]. Group 1: Fund Performance - A total of 53 funds have achieved over 100% returns year-to-date as of September 30, with 42 of these being active equity funds, showcasing the fund managers' effective strategies in high-growth sectors [2][4]. - The top-performing fund, managed by Ren Jie, achieved a return of 194.49%, heavily investing in the overseas computing industry chain, with significant contributions from stocks like Shenghong Technology, which surged 581% this year [2][3]. - Other notable funds include Zhang Wei's fund with a 155.09% return, focusing on Hong Kong's innovative pharmaceuticals, and Feng Ludan's fund with a 140.86% return, both capitalizing on the AI industry chain [3]. Group 2: Commodity Performance - Gold ETFs have emerged as the standout performers in the commodity fund sector, with all 14 gold ETFs showing gains exceeding 40% year-to-date, driven by rising international gold prices [5][6]. - The highest-performing gold ETFs, managed by Zhao Xu and Rong Ying, reported returns of 41.48% and 41.47%, respectively, reflecting strong long-term investment value [5][6]. Group 3: Market Outlook - Looking ahead to Q4, several fund companies suggest maintaining a focus on growth sectors while also considering cyclical and consumer stocks, as the market has already seen significant gains [7][8]. - The ongoing AI technology innovation is expected to provide a premium valuation for related assets, despite potential short-term volatility [8][9]. - The overall market sentiment remains bullish, with continued optimism for emerging technologies and cyclical financial sectors, particularly in the context of the "anti-involution" policies that may enhance competition in the renewable energy sector [9].