2025年，恒生医疗保健指数在经历下半年大回撤后依旧保住了50%以上的年度涨幅。相较之下，作为一家手握3款商业化创新药并拥有首创抗体靶向偶联药 物的创新药企，和黄医药(00013)却最终以8.56%的年度跌幅收场，显著跑输指数。 该公司股价在2025年最高涨幅仅36.36%，并且"跟跌不跟涨"。2025年下半年，其股价从30.75港元年内高点，一路跌至19.95港元区间低点，4个半月内最大跌 幅达到35.12%。 不过就在市场以为和黄医药股价会一路低迷下去时，其在2026年开年却走出了一波量价齐升的行情。 智通财经APP观察到，和黄医药在2026年前5个交易日持续发力，走出一段"五连阳"，区间内单日成交量最大达到1545.16万股，刷新自去年10月以来的单日 成交量记录。 港股通更趋向"右侧交易" 据智通财经APP观察，和黄医药股价自去年4月初因外部环境震荡影响跌破BOLL线下轨后，其后续股价大部分时间都在BOLL线的中轨至上轨之间浮动，这 一股价表现也契合了2025年港股创新药拉升行情。但25中报的披露成为了其二级市场反转的一个转折点。 去年8月7日美股盘前，和黄医药公布了其2025年中报业绩。财报显示，公 ...

本报告版权属于国投证券股份有限公司，各项声明请参见报告尾页。 1 2026 年 01 月 04 日 生物医药Ⅱ 新药周观点：2025 年约 101 款创新药 国内获批上市，行业蓬勃发展 本周新药行情回顾： 2025 年 12 月 29 日-2026 年 1 月 4 日，新药板块涨幅前 5：友芝友 （+12.45%）、艾迪药业（+8.07%）、永泰生物（+6.72%）、开拓药业 （+6.25%）、亚虹医药（+4.07%）；跌幅前 5：加科思（-15.53%）、 云顶新耀（-15.06%）、科笛（-11.73%）、歌礼制药（-8.64%）、康宁 杰瑞（-8.06%）。 本周建议关注标的： 考虑板块后续仍有多个催化值得期待，包括学术会议、数据读出、 多个 BD 兑现等，仍建议关注： 1）已获 MNC 认证未来海外放量确定性高的品种：三生制药、联邦制 药、科伦博泰等； 2）存在海外数据催化的品种：贝达药业、和黄医药、映恩生物等； 3）下一个可能海外授权 MNC 的重磅品种：复宏汉霖、石药集团、益 方生物等； 4）新的创新药技术突破领域：小核酸、体内 CAR-T、减脂增肌、自 免 CAR-T/双抗、基因疗法等。 本周国 ...

Core Viewpoint - Hutchison China MediTech Limited (HCM) announced that the new drug application for Savolitinib, intended for adult patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET gene amplification after failing at least two prior treatments, has been accepted by the National Medical Products Administration (NMPA) of China and granted priority review status [1] Group 1 - The new drug application is based on data from a single-arm, multi-center, open-label Phase II registration study conducted in China, which achieved the primary endpoint of objective response rate (ORR) assessed according to RECIST 1.1 [1] - The study details can be found on clinicaltrials.gov under registration number NCT04923932 [1] - Savolitinib was included in the NMPA's list of breakthrough therapies for this potential indication in 2023, recognizing it as a new treatment for serious diseases with significant advantages over existing therapies [1]

Investment Rating - The report does not explicitly state an investment rating for the biopharmaceutical industry, but it suggests a positive outlook based on upcoming catalysts and potential drug approvals. Core Insights - The biopharmaceutical sector is expected to see significant developments in 2026, with multiple domestic drugs anticipated to report key clinical data. This includes drugs from companies like Betta Pharmaceuticals, Hutchison China MediTech, and CanSino Biologics, which are expected to read out critical clinical data in 2026 [3][21]. - The report emphasizes that the long-term theme for the innovative drug sector is international expansion, with several sub-themes to focus on, including overseas business development (BD) licensing, key clinical trials, and unexpected overseas sales growth [3][18]. Summary by Sections Weekly New Drug Market Review - From December 22 to December 28, 2025, the top five gainers in the new drug sector were Dongyao Pharmaceutical (+23.15%), Beihai Kangcheng (+19.27%), Junshengtai (+16.41%), Shiyao Group (+6.95%), and Ailis (+5.78%). The top five losers were Gakos (-16.11%), Jiahe Biotech (-10.29%), Laika Pharmaceuticals (-9.33%), Yunding Xinyao (-8.98%), and Yongtai Biotech (-6.94%) [1][14]. Weekly Focused Stocks - The report suggests focusing on several stocks with high overseas expansion potential, including: 1. Companies with MNC certification and high overseas volume certainty: Sanofi, United Pharmaceuticals, and Kelun-Biotech. 2. Companies with overseas data catalysts: Betta Pharmaceuticals, Hutchison China MediTech, and InnoCare Pharma. 3. Potential heavyweights for overseas MNC licensing: Junshi Biosciences, Shiyao Group, and Yifang Biotech. 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat loss and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][18]. Weekly New Drug Approval & Acceptance Status - This week, 23 new drug or new indication applications were approved in China, and 10 new drug or new indication applications were accepted [4][19]. Weekly New Drug Clinical Application Approval & Acceptance Status - This week, 99 new drug clinical applications were approved, and 64 new drug clinical applications were accepted [5][24]. Key Domestic Market Events - Notable events include: 1. Xiansheng Zhaoming announced a global exclusive licensing agreement with Ipsen for an ADC drug, potentially worth up to $1.06 billion. 2. He Yu Pharmaceuticals received approval for its CSF-1R selective small molecule inhibitor. 3. Tongyi Pharmaceuticals announced a licensing agreement for a peptide conjugate drug for prostate cancer, with potential payments totaling around $2 billion [10]. Key Overseas Market Events - Significant overseas events include: 1. Novo Nordisk received FDA approval for a 25mg oral semaglutide tablet for weight loss. 2. Sanofi announced a cash acquisition agreement for Dynavax Technologies Corporation, valued at approximately $2.2 billion. 3. Agios Pharmaceuticals announced FDA approval for an oral PK activator for treating α or β thalassemia in adult patients [11].

创新药研发主体正扩展至更多传统大型药企，"出海"模式正从对外授权"独大"向"借船、买船、造船"多 条腿走路拓展 "创新药'爆款'产品往往源于基础研究的重大突破。加强基础研究，资金的大量支持、管线的持续积 累、高端人才的培育引进缺一不可。" 文 |《瞭望》新闻周刊记者 国产创新药正在经历"DeepSeek时刻"，以长期积累的创新努力迎来产品重大突破，引发全球关注——这 是近期业界和市场的明显感受。 国家医保局数据显示，2018～2024年我国一类创新药获批上市数量明显增加，2024年获批48种，是2018 年的5倍以上，今年截至10月已获批63种。目前，我国在研新药数量已居全球第二位。 与此同时，国产创新药通过各种方式实现"出海"，其种类和规模近几年持续大幅增加。 "中国创新药产业已由'引进模仿'转向'创新输出'"。国家医保局医药价格和招标采购司司长王小宁表 示。 创新药井喷之势由何而来？给业界带来怎样的影响？后劲如何？《瞭望》新闻周刊记者就此采访上海、 江苏、河北等地医药企业发现，在政策和技术双重红利助力下，生物医药创新周期缩短；创新药研发主 体正扩展至更多传统大型药企，"出海"模式正从对外授权"独大"向"借 ...

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 近日，北京鞍石生物科技股份有限公司（下称"鞍石生物"）的科创板IPO申请进入已问询状态。资料显 示，鞍石生物专注于"First In Class"及"Best In Class"抗肿瘤创新药物研发，重点布局肺癌、脑胶质瘤治 疗领域。 数据显示，公司核心产品MET抑制剂伯瑞替尼（商品名：万比锐®）自上市并纳入国家医保目录后，销 售收入显著增长。然而，在高增长背后，亏损持续扩大、现金流承压、市场竞争趋于红海、公司治理与 资本层面隐忧频现等问题仍悬而未决，公司未来发展仍面临诸多挑战。 大额商誉悬顶 核心产品市场竞争激烈 从财务数据看，2022年，鞍石生物尚未形成主营业务收入。2023年，公司主要产品伯瑞替尼于11月在国 内获得附条件批准上市，2023年、2024年及2025年一季度实现药品销售收入分别为1295.80万元、 7165.62万元及6404.25万元。 同期公司净利润分别为-1.64亿元、-2.83亿元、-4.79亿元和-9165.29万元，累计未弥补亏损达7.82亿元。 即使在产品开始创收的2023年和2024年，亏损额同比增幅 ...

Group 1 - The core viewpoint of the articles highlights the rapid development of Shanghai's Pudong New Area as a leading zone for socialist modernization, driven by technological innovation and a robust innovation ecosystem [1][2]. - Pudong's three leading industries—integrated circuits, biomedicine, and artificial intelligence—are projected to reach a scale of 832.3 billion RMB in 2024, accounting for 46% of Shanghai's total, with an average annual compound growth rate of 11.7% over the past three years [2]. - The Zhangjiang Fudan International Innovation Center exemplifies the transformation of traditional campuses into technology innovation parks, focusing on key industries and establishing a top-tier research hub [1][3]. Group 2 - Hutchison Whampoa Pharmaceutical (Shanghai) Co., as a benchmark enterprise in Pudong's biomedicine sector, has established a global innovation drug production base, which is expected to increase production capacity by over five times [2]. - Pudong has attracted over 4,000 enterprises in the biomedicine field, including nine of the world's top ten pharmaceutical companies, with nearly 2,000 research pipelines currently under development [2]. - The rapid growth of Zhiyuan Robotics, a humanoid robot mass production company, is attributed to Pudong's supportive industrial environment, talent policies, and the clustering of related industries [3][4]. Group 3 - The establishment of the Moli Community in Zhangjiang has led to the rapid gathering of over 150 large model enterprises, showcasing the area's commitment to fostering innovation in various high-tech sectors [4]. - Pudong has initiated the first batch of autonomous taxi operation licenses and has opened over 1,000 kilometers of advanced autonomous driving testing roads, further enhancing its technological landscape [4]. - The region is making strides in multiple emerging fields, including synthetic biology, satellite internet, new energy storage, and nuclear fusion, positioning itself at the forefront of industrial development [4].

形势越复杂，浦东的战略地位越凸显。 在经历一段压力期后，上海浦东重拾引领性增长。 2025年前三季度，浦东新区地区生产总值达到13536亿元，现价同比增长6%，分别高出上海、全国0.5个、0.8个百分点。 自2020年11月，浦东被赋予打造社会主义现代化建设引领区的这5年，恰逢纷繁复杂的国际国内环境和大国竞争博弈交织，以及新一轮科技革命和产业变革 的加速演进。"形势越复杂，浦东的战略地位越凸显。"上海浦发新区发改委主任肖林表示。 目前，《中共中央 国务院关于支持浦东新区高水平改革开放打造社会主义现代化建设引领区的意见》（下称中央《引领区意见》）明确的121项任务基本完 成。2024年浦东生产总值达1.78万亿元，比2020年现价增长34%，2025年前三季度人均生产总值达4.3万美元，超过意大利水平；全员劳动生产率达60.6万元/ 人；城乡居民人均收入达9.5万元。 在打造国内大循环的中心节点和国内国际双循环的战略链接的过程中，基于引领区建设而持续增强的科技创新策源功能、高端产业引领、高水平改革开放、 全球资源配置能力等，正在为浦东积蓄更多动能，也成为上海为全国发展大局挑大梁的一张重要"王牌"。 更多"从0到 ...

Group 1: Company Highlights - The new generation industrial-grade interactive humanoid robot "Spirit G2" is undergoing final factory testing, with a procurement contract exceeding 100 million yuan for delivery to Yujin Electronics' automotive parts factory [1] - ZhiYuan Robotics, founded in Pudong two years ago, has emerged as a leader in humanoid robot commercialization, reflecting the development of the Pudong New Area over the past five years [1][3] - As of September 2025, ZhiYuan Robotics has achieved significant growth in delivery volume, with thousands of units delivered across various sectors including research, education, interactive services, and industrial operations [4] Group 2: Industry Growth - The Pudong New Area has seen a remarkable economic performance, with a projected GDP of 1.78 trillion yuan in 2024, a nearly 35% increase from 2020, and a per capita GDP of $43,000, surpassing Italy [1][4] - The high-end industrial clusters in Pudong are thriving, with the integrated circuit, biomedicine, and artificial intelligence sectors reaching a combined scale of 832.3 billion yuan in 2024, growing at an average annual rate of 11.7% over the past three years [8] - The biopharmaceutical sector is also flourishing, with the innovative anti-tumor drug Fuzhuotini, developed by Huaneng Pharmaceutical, successfully entering over 30 countries and expected to reach a billion-dollar market [4][5] Group 3: Policy and Ecosystem Support - The supportive policies and innovation ecosystem in Pudong, including the "Qingchuang 15 Articles" talent policy, have fostered a conducive environment for startups and innovation [4][15] - The establishment of the Pudong New Area's "Going Global" service center has facilitated over 270 global service points, providing comprehensive support for enterprises looking to expand internationally [13] - The continuous improvement of the business environment in Pudong has led to a more than 40% increase in the number of market entities over five years, with over 200 new companies established daily [15][17]

Dale是一位晚期癌症患者，去年在上海接受了CAR-T药物治疗，并已实现完全缓解。CAR-T是最近十年发展 出来的新型治疗方式，相关开发企业集中于美国和中国。中国药物售价约120万，但也只有美国售价的三分之 一，医疗服务价格同样更低。这吸引了不少类似Dale的全球患者。 中国创新药与全球患者以不同的方式相遇。 "我带着大家庭去巴厘岛庆祝了我的重生。"新西兰人Dale De Penning最近在上海的一场分享会上说。 中国创新药与全球患者以不同的方式相遇：海外患者来中国寻药，同时，越来越多中国创新药出海了。中国 创新药获得了患者的初步认可，但在全球立足、立稳，一些重要关节还需要打通。 癌症患者来了中国 在来中国治疗之前，Dale曾接受过治疗。 Dale被确诊为弥漫性大 B 细胞淋巴瘤，之前在奥克兰医院接受过化疗、放疗等传统治疗方式，但无法让肿瘤 缩小到可做干细胞移植的标准。之后他多方搜索，决定来到上海，在上海曜影医院接受CAR-T药物治疗。 CAR-T细胞疗法，是一种个体化定制的细胞治疗，能通过对患者自身的免疫细胞——T细胞采集后进行体外基 因改造，从而加强其特异性识别和杀伤肿瘤的能力。它的制备条件苛刻。全球已 ...