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 "十五五"聚焦脑机接口，抢占全球科技高地，建 议关注：微创脑科学、翔宇医疗、美好医疗等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 ◼ 泽璟制药人促甲状腺素β获批上市；百赫安®联合百泽安®与化疗有望成为 HER2 阳性晚期胃 食管腺癌新的一线标准治疗。1 月 8 日，泽璟制药宣布收到国家药监局核准签发的《药品注册 证书》，其自主研发的注射用人促甲状腺素β的新药上市申请获得批准，用于分化型甲状腺癌 患者在甲状腺全切或近全切除术后随访中的协同诊断，以进行血清甲状腺球蛋白（Tg）检测， 伴或不伴放射性碘（131I）全身显像（WBS）检查。该药物是我国首个获批用于分化型甲状腺 癌术后精准评估的创新产品；1 月 8 日，中关村生命科学园内企业百济神州宣布 3 期临床研究 HERIZON-GEA-01 的完整数据。该研究评估了在联合化疗的基础上，HER2 靶向双特异性抗体百 赫安®（泽尼达妥单抗）单药或再联合 PD-1 抑制剂百泽安®（替雷利珠单抗）作为 HER2 阳性 （HER2+）局部晚期或转移性胃食管腺癌（GEA）一线治 ...

证券研究报告 | 医药生物 | 2026年1月10日 www.hczq.com 华创医药投资观点&研究专题周周谈·第158期 海外脑机接口代表企业布局情况 本周专题联系人：李婵娟 陈俊威 | 华创医药团队： | | | --- | --- | | 首席分析师 郑辰 | 执业编号：S0360520110002 邮箱：zhengchen@hcyjs.com | | 联席首席分析师 刘浩 | 执业编号：S0360520120002 邮箱：liuhao@hcyjs.com | | 医疗器械组组长 李婵娟 | 执业编号：S0360520110004 邮箱：lichanjuan@hcyjs.com | | 中药和流通组组长 高初营 | 执业编号：S0360524070002 邮箱：gaochulei@hcyjs.com | | 分析师 王宏雨 | 执业编号: S0360523080006 邮箱: wanghongyu@hcyjs.com | | 分析师 朱珂琛 | 执业编号：S0360524070007 邮箱：zhukechen@hcyjs.com | 本报告由华创证券有限责任公司编制 报告仅供单创证券有限责任公司的客户 ...

www.hczq.com 证券研究报告 | 医药生物 | 2026年1月10日 华创医药投资观点&研究专题周周谈 · 第158期 海外脑机接口代表企业布局情况 本周专题联系人：李婵娟 陈俊威 华创医药团队： | 首席分析师 郑辰 | | | 执业编号：S0360520110002 | 邮箱：zhengchen@hcyjs.com | | --- | --- | --- | --- | --- | | 联席首席分析师 | | 刘浩 | 执业编号：S0360520120002 | 邮箱：liuhao@hcyjs.com | | 医疗器械组组长 | | 李婵娟 | 执业编号：S0360520110004 | 邮箱：lichanjuan@hcyjs.com | | 中药和流通组组长 | | 高初蕾 | 执业编号：S0360524070002 | 邮箱：gaochulei@hcyjs.com | | 分析师 | 王宏雨 | | 执业编号：S0360523080006 | 邮箱：wanghongyu@hcyjs.com | | 分析师 朱珂琛 | | | 执业编号：S0360524070007 | 邮箱：zhukeche ...

创新药已经突围成功。 "十五五"规划开局之年，医药行业在2026年将呈现创新药爆发、CXO回暖、中药转型、药店收缩、医院 洗牌、并购潮涌的总体格局，行业分化加剧，强者恒强。 创新药：20款重磅新药有望获批 在2025年，共有76个创新药物成功获批上市，数量较上年增长58%。与此同时，创新药对外授权交易活 跃，交易数量突破150起，累计交易总额更是高达1300亿美元以上，彰显了我国创新药产业的强劲发展 势头。 西部证券指出，2026年创新药行情将从"BD为王"转向"数据为王"，全球多中心临床试验数据读出将成 为核心催化。 随着临床数据和上市审批的加速，2026年，中国创新药出海会迎来爆发期。业内预测，2026年将有约20 款重磅新药有望在中国获批上市，涵盖肿瘤、感染性疾病、罕见病、自身免疫性疾病、神经系统疾病等 多个治疗领域。比如，BL-B01D1是百利天恒自主研发的全球首创EGFR×HER3双抗ADC，用于治疗复 发性或转移性食管鳞癌。作为全球首个被纳入优先审评的EGFR×HER3双抗ADC，它填补了PD-1/PD-L1 联合化疗失败患者的治疗空白。此外，BL-B01D1的鼻咽癌适应症也已获优先审评，预计20 ...

Core Viewpoint - The approval of the BCL-2 inhibitor Sotorakra by BeiGene marks a significant advancement in the treatment of hematologic malignancies, with potential implications for the competitive landscape of BCL-2 inhibitors in the market [1][3]. Company Developments - BeiGene's Sotorakra has received approval for two indications: treatment of adult patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL) [1]. - The approval came just eight months after the new drug application was accepted by the NMPA, indicating a rapid development timeline [1]. - Sotorakra is positioned as a next-generation BCL-2 inhibitor, designed to block the BCL-2 protein that aids tumor cell survival, and has shown strong efficacy and specificity in clinical trials [1][2]. Clinical Trial Results - Early clinical trials of Sotorakra combined with Zebutini have demonstrated unprecedented rates of undetectable minimal residual disease in treatment-naive CLL patients [2]. - Recent data from five clinical studies indicate significant clinical benefits for Sotorakra, suggesting its potential as a cornerstone therapy for various B-cell malignancies [2]. Market Landscape - The global BCL-2 inhibitor market is projected to reach $5.2 billion by 2028, with the Chinese market expected to reach 1.4 billion yuan [5]. - The approval of Sotorakra follows the approval of another BCL-2 inhibitor, Lisatoclax, from Ascentage Pharma, indicating a growing presence of Chinese companies in the BCL-2 space [3][5]. - The competitive landscape is intensifying as multiple Chinese pharmaceutical companies, including Innovent Biologics and Zai Lab, are developing BCL-2 inhibitors [3][4]. Financial Performance - BeiGene's Zebutini has become a significant revenue driver, with global sales reaching $1.3 billion in 2023, marking a 129% year-over-year increase [6]. - In the first half of 2025, BeiGene reported a revenue of 17.52 billion yuan, a 46% increase year-over-year, largely driven by Zebutini sales [6][7]. - The company is under pressure to identify the next blockbuster product as Zebutini's growth may slow down in the future [7].

12月18日晚间，百济神州有限公司（688235.SH、06160.HK）发布《关于聘任公司高级管理人员的公 告》，引发市场猜想。 根据公告，12月17日，经百济神州有限公司董事会审议通过，公司董事会同意聘任公司全球研发负责人 汪来担任公司总裁、全球研发负责人，负责管理公司研发、业务拓展以及业务联盟关系管理等职能。 公开资料显示，在汪来被任命为总裁之前，百济神州总裁一职由吴晓滨担任。百济神州并未在公告中官 宣原任总裁吴晓滨的变动。此前数年，吴晓滨一直是百济神州的核心人物，2025年6月以前，其同时担 任公司总裁、首席运营官兼中国区总经理。 12月19日，智通财经从百济神州获悉，吴晓滨职务并未发生变化，依旧任公司总裁兼首席运营官。 据百济神州11月12日晚间发布的2025年三季报，第三季度实现营收为100.77亿元，同比增长41.1%；净 利润为6.89亿元，同比扭亏为盈。前三季度营收为275.95亿元，同比增长44.2%；净利润为11.39亿元， 同比扭亏为盈。 具体来看，2025年第三季度，百济神州的拳头产品泽布替尼全球销售额为74.23亿元，营收规模在全球 同类BTK抑制剂中排名第一，其中美国市场销售额为 ...

生物医药ETF（512290）连续3日迎净流入，制药行业表现较好。 中信建投指出，制药行业表现较好，恒瑞医药艾速达（JAK1）提交了新的适应症上市申请；信达生物 首个中国原研IL-23p19单抗获批上市；百济神州索托克拉上市申请已获美国FDA受理并授予优先审评资 格；康方生物卡度尼利方案一线治疗晚期宫颈癌被作为全人群治疗的"首选方案"写入NCCN指南中国版 推荐；诺和诺德Amycretin糖尿病二期临床数据公布，司美格鲁肽阿尔茨海默症三期临床失败；美国第 二轮IRA谈判结果出炉；BioNTech更新PD-L1/VEGFTNBC临床数据。 生物医药ETF（512290）跟踪的是CS生医指数（930726），该指数从沪深市场中选取涉及生物技术、制 药、医疗设备等业务的上市公司证券作为指数样本，以反映生物科技与医药健康相关上市公司证券的整 体表现。该指数成分股具有较高的成长性和创新性，侧重于展示生物医药行业的综合发展水平。 （文章来源：每日经济新闻） ...

Investment Rating - The report recommends an "Outperform" rating for leading pharmaceutical and biotech companies with robust pipelines, as well as high-quality CXOs and internet healthcare firms [1]. Core Insights - The report highlights the strong performance of innovative drug leaders such as BeiGene and Innovent Biologics, which have shown significant revenue growth in Q3 2025, with BeiGene achieving USD 1.41 billion in revenue (up 41% year-on-year) and Innovent exceeding CNY 3.3 billion (up 40% year-on-year) [39][40]. - The CXO sector experienced a pullback in November, with notable declines in stocks like WuXi AppTec and Tigermed, attributed to profit-taking after strong performance in the first three quarters of 2025 and concerns over geopolitical risks [42]. - The report emphasizes the importance of upcoming clinical data readouts from major conferences such as ESMO Asia and ASH, which could serve as catalysts for stock performance [10]. Summary by Sections Top Picks - The report lists top picks including Hansoh Pharma, 3SBio, Kelun-Biotech, Innovent, Akeso, JD Health, and WuXi AppTec, all rated as "Outperform" [1][4][35]. Performance Overview - The Hong Kong stock picks portfolio gained an average of 5.2% in November 2025, outperforming the Hang Seng Healthcare Index, which declined by 0.1% [5][36]. - The top three performers in the portfolio were Hansoh Pharma (+12.9%), BeiGene (+10.2%), and Innovent (+10.0%) [5][36]. Market Trends - The innovative drug sector has shown resilience, benefiting from previous corrections and strong earnings catalysts from leading companies [39]. - The report notes that the recent implementation of key industry policies, including the 11th National Centralized Drug Procurement, has led to significant price reductions for selected products, impacting market dynamics [38]. Clinical Developments - Significant clinical progress is noted for companies like 3SBio, which is advancing its SSGJ707 (PD-1/VEGF) with Pfizer, planning to initiate multiple clinical trials [41]. - The report also highlights the potential of innovative therapies in oncology, with companies like BeiGene and Innovent expanding their product pipelines and market presence [32][40].

Macro and Strategy Research - The report highlights a divergence in the Federal Reserve's stance on interest rate cuts, with a 70% market expectation for a cut in December, although the actual impact may be similar whether it occurs in December or January [3][4] - In the U.S., retail sales showed a slowdown, particularly in the automotive sector, while investment in AI-related fields continues to support economic growth [3] - Domestic industrial profits have declined, with a notable drop in profits for mid and downstream industries, while upstream sectors benefited from stable raw material prices [4] Fixed Income Research - The report indicates a downward trend in the average issuance guidance rates for credit bonds in 2025, with a decrease of 151 basis points to 39 basis points compared to 2024 [5][7] - Credit bond issuance in 2025 decreased compared to the previous year, but net financing increased, indicating a shift in market dynamics [7] - The report emphasizes the importance of liquidity in the bond market, with a focus on the "debt and development" narrative, suggesting that credit risk is perceived to be low [7][8] Industry Research - The report discusses the State Council's initiative to promote provincial-level coordination of basic medical insurance, enhancing the system's security capabilities [13][17] - Recent FDA approvals for innovative treatments, such as BeiGene's Sotigalimab for lymphoma, highlight the ongoing advancements in the biopharmaceutical sector [14][15] - The report notes a decline in the SW pharmaceutical index, with a current P/E ratio of 51.78, indicating a significant premium over the CSI 300 index [16] - The report recommends focusing on investment opportunities in the innovative drug sector, particularly in diagnostics, vaccines, and related pharmaceutical companies [16]

Investment Rating - The report maintains a rating of "Buy" for the pharmaceutical and biotechnology industry [1]. Core Insights - The overseas small nucleic acid market is entering a harvest period, with a focus on domestic companies such as Yuyuan, Frontier, and Fuyuan [1][16]. - The A-share pharmaceutical index has increased by 2.67% this week and 16.72% year-to-date, outperforming the CSI 300 by 1.03% and 1.68% respectively [4][9]. - The report highlights significant advancements in small nucleic acid drug technologies, expanding their application beyond rare diseases to chronic conditions such as cardiovascular diseases and metabolic disorders [16][18]. Summary by Sections Industry Trends - The report notes that various pharmaceutical sectors, including raw materials (+4.27%), chemical pharmaceuticals (+4.19%), and medical devices (+2.30%), have seen stock price increases [4][9]. - Key companies with notable stock performance include Haiwang Biological (+38.2%) and Guangdong Wannianqing (+36.2%) [4][9]. Research and Development Progress - Significant drug approvals include the self-immune new drug "Pikangqibai" by Innovent Biologics and the BCL2 inhibitor "Sotokura" by BeiGene, both of which have received regulatory approval [4]. - The report emphasizes the importance of delivery systems in the development of small nucleic acid drugs, with a focus on companies like Yuyuan Pharmaceutical and Frontier Biotech [16][18]. Market Insights and Regulatory Dynamics - The report ranks promising sub-industries as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10][12]. - Specific stock recommendations include Yuyuan Pharmaceutical, Frontier Biotech, and Heng Rui Medicine among others, based on their innovative drug pipelines and market potential [12][18].