证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 FDA 创新药审评政策再松绑，利好创新药板 块 增持（维持） [Table_Tag] [Table_Summary] 投资要点 《降息等多因素支持科研上游持续复 苏，重点推荐皓元医药、奥浦迈等》 2026-02-01 东吴证券研究所 1 / 24 请务必阅读正文之后的免责声明部分 2026 年 02 月 23 日 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 行业走势 -10% -7% -4% -1% 2% 5% 8% 11% 14% 17% 20% 23% 2025/2/24 2025/6/22 2025/10/18 2026/2/13 医药生物 沪深300 相关研究 《分子胶海外风起，国内管线蓄势破 局》 2026-02-09 ◼ 本周（2.9-2.13 号，下同）、年初至今 A 股医药指数涨幅分别为-0.8%、 2.4%，相对沪深 300 的超额收益分别为-1.2%、1.8%；本周、年初至今 恒生生物科技指数涨跌幅分别为 4.8%、12.5%，相对于恒生科技指数跑 赢 7.3%、18.0%；本周 ...

Group 1: Market Overview - The A-share market is experiencing a wide range of fluctuations, with a focus on price-increasing sectors and export industry chains [6][9] - As of February 13, 2026, the major indices showed declines: the Shanghai Composite Index fell by 1.26% to 4082.07 points, and the ChiNext Index dropped by 1.57% to 3275.96 points [6][7] - The overall market sentiment is cautious, with expectations of a gradual return to intrinsic market dynamics as the National People's Congress approaches [6][8] Group 2: Industry Dynamics - Hansoh Pharmaceutical's (3692.HK) Amivantamab has been approved for marketing in the EU for specific types of lung cancer [27] - The world's largest offshore wind farm, Hornsea 3, is set to begin construction, with significant logistical preparations already underway [29] - The CWEA reported that China's wind power installation capacity is expected to grow significantly, with a 49.9% year-on-year increase anticipated for 2025 [31] Group 3: Company Updates - Dongfang Cable (603606.SH) has successfully shipped a large-scale underwater cable to the UK, valued at over 900 million RMB, for use in multiple offshore wind projects [37] - The actual controller of Youkeshu (300209.SZ) plans to increase his stake in the company, reflecting confidence in its business recovery [39] - The electric motorcycle industry is seeing accelerated growth due to new policies and market demand, with over 12.5 million units expected to be replaced under the "old for new" subsidy program in 2025 [33]

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [5] Core Insights - The underlying logic of the current pharmaceutical industry era is innovation and international expansion, with a focus on innovative drugs and technology-driven sectors [2][3] - The report highlights the strong performance of the CRO market and suggests a dual investment strategy focusing on both "0 to 1" technology innovation and low-position stocks [2][3] - The report emphasizes the ongoing trend of BD (Business Development) transactions in innovative drugs, with significant growth expected in 2026 [4][15] Summary by Sections 1. Key Events in the Pharmaceutical Industry During the Spring Festival - Innovative drug BD transactions have seen a strong start, with significant overseas development and registration progress for key products [13][14] - The total amount of BD transactions for innovative drugs in China for 2026 has already surpassed one-third of the total for 2025 [15] - The revision of the National Essential Medicines List Management Measures may signal changes in the essential medicines directory [28] 2. Pharmaceutical Market Review and Hotspot Tracking - The pharmaceutical sector's performance was relatively weak, with a weekly decline of 0.81%, ranking 20th among all industries [34][38] - The total trading volume for pharmaceuticals was 401.12 billion yuan, accounting for 3.83% of the total market, below the historical average of 7.09% [55] - The report notes a rising valuation level for the pharmaceutical industry, with a PE ratio of 29.25, which is below the historical average [52] 3. Stock Performance Review - The report lists the top-performing stocks, including Dongyangguang and Zhendemedical, while highlighting the underperformers like Huayuan Biology and *ST Sailong [58][59]

14,000 16,000 18,000 20,000 22,000 24,000 26,000 28,000 30,000 | 26705.94 | 0.52 | 4.20 | | --- | --- | --- | | 9070.32 | 0.42 | 1.76 | | 5367.52 | 0.13 | -2.69 | | 116.21 | -1.03 | -5.87 | | 4082.07 | -1.26 | 2.85 | | 14100.19 | -1.28 | 4.25 | | 4660.41 | -1.25 | 0.66 | | 49395.16 | -0.54 | 2.77 | | 22682.73 | -0.31 | -2.41 | | 6861.89 | -0.28 | 0.24 | | 25043.57 | -0.93 | 2.26 | | 8398.78 | -0.36 | 3.06 | | 10627.04 | -0.55 | 7.00 | 2026年2月20日星期五 ➢ 美重兵集结中东；美国暂搁置重大对台 军售。A股休市。上证指数收跌1.26%报 4082.07点，深证成指跌1.28 ...

Company News - Xiehe New Energy (00182.HK) expects a net profit decline of over 80% in 2025, compared to approximately 800 million yuan in the previous year, primarily due to a decrease in revenue and gross margin from power generation business and asset impairment [2] - Dingdang Health (09886.HK) anticipates a significant narrowing of net loss by over 80% for the fiscal year 2025, mainly due to a reduction in goodwill impairment; adjusted net profit is expected to be no less than approximately 5 million yuan, turning profitable year-on-year [2] - Honghui Group (00183.HK) issued a profit warning, expecting a substantial decrease in interim loss attributable to shareholders by 30% to 40% [2] - Huiju Technology (01729.HK) completed the placement of 108 million shares, raising approximately 1.635 billion HKD, with about 50% allocated for strategic investments and acquisitions, and 30% for global business development and overseas expansion [2] - Hansoh Pharmaceutical (03692.HK) received approval for the marketing of Amivantamab in the European Union for monotherapy [2] - Inspur Intelligent (03696.HK) has been included in the Hang Seng Composite Index constituent stocks [2] Buyback Activities - Xiaomi Group-W (01810.HK) repurchased 4.2824 million shares for 152 million HKD, with buyback prices ranging from 35.32 to 35.74 HKD [2] - Geely Automobile (00175.HK) repurchased 1.631 million shares for 27.5125 million HKD, with buyback prices between 16.69 and 16.99 HKD [2] - Kingsoft (03888.HK) repurchased 732,200 shares for 19.9956 million HKD, with buyback prices from 27.02 to 27.5 HKD [3] - NetEase Cloud Music (09899.HK) repurchased approximately 96,000 shares for 14.9974 million HKD, with buyback prices between 153.8 and 158.2 HKD [3] - Meitu Inc. (01357.HK) repurchased 2.057 million shares for 12.5085 million HKD, with buyback prices ranging from 6.04 to 6.1 HKD [3]

英矽智能(03696)获纳入恒生综合指数成份股 图达通(02665)获纳入恒生综合指数成份股 长风药业(02652)获纳入恒生综合指数成份股 翰森制药(03692)：甲磺酸阿美替尼片单药治疗于欧盟获批上市 【重大事项】 拨康视云-B(02592)：CBT-199新药临床试验申请已生效，临床试验被认定为可安全推进 石药集团(01093)：GLP -1/GIP受体双偏向性激动多肽长效注射液在美国获临床试验批准 石药集团(01093)：罗哌卡因长效注射液(SYH9089注射液)在中国获临床试验批准 复宏汉霖(02696)：HLX15-SC (重组抗CD38全人单克隆抗体注射液-皮下注射)用于多发性骨髓瘤治疗的1 期临床试验申请获美国FDA批准 【财报数据】 首钢资源(00639)发盈警 预计2025年度公司拥有人应占综合溢利约6亿港元至7亿港元 石四药集团(02005)发盈警，预期年度股权持有人应占溢利同比下降约45%至60% 好孩子国际(01086)发盈警 预期2025年纯利同比下降约35%至 45% 速腾聚创(02498)2025财年激光雷达产品销售持续增长 Q4首次单季实现盈利 ...

智通财经APP讯，翰森制药(03692)公布，于2026年2月12日，集团创新药甲磺酸阿美替尼片(中国商品 名：阿美乐®，海外商品名：Aumseqa®)单药治疗已于欧盟获批上市，用于：(i)具有表皮生长因子受体 (EGFR)外显子19缺失或外显子21(L858R) 置换突变的晚期非小细胞肺癌(NSCLC)成人患者的一线治疗， 以及(ii)晚期 EGFR T790M突变阳性NSCLC成人患者的治疗。此次批准由欧盟委员会(EC)基于欧洲药品 管理局(EMA)人用药品委员会(CHMP)的积极意见作出。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Hansoh Pharmaceutical Group Company Limited 翰森製藥集團有限公司 甲磺酸阿美替尼片 單藥治療於歐盟獲批上市 翰森製藥集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董 事會」）欣然宣佈，於二零二六年二月十二日，本集團創新藥甲磺酸阿美替尼片 （中國商品名：阿美樂®，海外商品名：Aumseqa®）單藥治療已於歐盟獲批上市， 用於：(i)具有表皮生長因子受體（「EGFR」）外顯子19缺失或外顯子21(L858R) 置換突變的晚期非小細胞肺癌（「NSCLC」）成人患者的一線治療，以及(ii)晚期 EGFR T790M突變陽性NSCLC成人患者的治療。此次批准由歐盟委員會(EC)基於 歐洲藥品管理局(EMA)人用藥品委員會(CHMP)的積極意見作出。 關於甲磺酸阿美替尼片 甲磺酸阿美替尼片是中國首個原研三代EGFR-TKI創新藥，此前已獲國家藥 品監督 ...

Core Insights - The global weight loss drug market has undergone significant changes in the past five years, with Novo Nordisk's semaglutide gaining approval for weight loss in the U.S. in 2021, marking the entry of GLP-1 weight loss drugs into the pharmaceutical industry [1] - By 2025, Eli Lilly's tirzepatide is projected to achieve $36.5 billion in sales, highlighting the commercial potential of the weight loss sector [1] - The competition has shifted from injectable forms to oral formulations, with Novo Nordisk's oral semaglutide receiving approval in December 2025, becoming the first oral GLP-1 obesity treatment [1][2] Group 1: Market Dynamics - The approval of oral medications signifies a breakthrough beyond the physical limitations of injection pens, enhancing Novo Nordisk's product line defensively [2] - A surge in prescription volume for oral semaglutide has been observed, with approximately 50,000 prescriptions per week by January 23, 2026 [1] - Eli Lilly is also advancing in the oral GLP-1 space with its orforglipron, which has shown positive results in clinical trials and is expected to launch in mid-2026 [2] Group 2: Competitive Landscape - Novo Nordisk's oral semaglutide is a peptide drug, while Eli Lilly's tirzepatide is a small molecule oral drug, showcasing differentiation in their approaches [3] - Small molecule products are expected to have simpler development processes and better cost control, potentially impacting market competition if safety and efficacy are validated [3] - Other pharmaceutical giants, including AstraZeneca and various domestic companies, are also developing oral GLP-1 drugs, indicating a broadening competitive landscape [3][4] Group 3: Clinical Developments - AstraZeneca's oral GLP-1 receptor agonist, elecoglipron, has achieved positive results in key Phase 2 trials and is moving towards Phase 3 development [3] - Domestic companies like HengRui Medicine and others are advancing their oral GLP-1 drug pipelines, with promising clinical trial results [4] - The oral weight loss drug market is expected to grow, but injectable forms will still play a role in the short term, with rising expectations for their effectiveness and safety [4][5] Group 4: Future Outlook - The core patent for semaglutide will expire in 2026 in several markets, paving the way for a wave of generic versions, which may lead to more affordable options for consumers [5] - The penetration of GLP-1 weight loss drugs is anticipated to expand beyond first-tier cities, reaching broader markets [5]

Group 1 - The mainland internet healthcare sector is entering a new phase driven by tech giants accelerating AI innovation and government policy support, such as the online initial diagnosis pilot program launched in Beijing [1] - Despite challenges in profitability, leading companies are leveraging AI ecosystems and innovative strategies for long-term sustainable growth [1] Group 2 - The company maintains a "Buy" rating for Alibaba Health (00241) with a target price of HKD 7.8, expecting a compound annual growth rate (CAGR) of 13% in revenue and 24% in adjusted net profit from FY2026 to FY2028, driven by growth in innovative drugs and healthcare products, deepening synergy with Alibaba Group (09988), and increasing AI application [1] - The company also favors Ping An Good Doctor (01833) with a "Buy" rating and a target price of HKD 20, anticipating a CAGR of 16% in revenue and 56% in adjusted net profit from FY2025 to FY2027, supported by deepening synergy with Ping An Insurance (02318) and ongoing AI empowerment [1] Group 3 - The company maintains an "Overweight" rating for the mainland healthcare sector, preferring leading innovative pharmaceutical companies and contract research, development, and manufacturing organizations (CRDMOs) [2] - The company is optimistic about internet healthcare firms that effectively utilize real-world data to optimize AI algorithms and enhance service quality [2] - Preferred stocks include BeiGene (06160), Innovent Biologics (01801), Hansoh Pharmaceutical (03692), China Biologic Products (01177), Hutchison China MediTech (00013), WuXi Biologics (02269), WuXi AppTec (02359), and Alibaba Health [2]