证券研究报告|行业专题研究 2026 03 26 年 月 日 国盛医药小核酸药物行业专题 奇点已至：小核酸药物迈向平台多维布局新纪元 邮箱：zhangxue1@gszq.com 邮箱：lihuiyao@gszq.com 分析师 张雪 分析师 李慧瑶 执业证书编号：S0680526020006 执业证书编号：S0680526020005 打造极致专业与效率 奇点已至：小核酸药物迈向平台多维布局新纪元 螺旋向上：小核酸重构现代制药版图 小核酸是化学合成的短核酸序列，用于调节基因表达水平，通过mRNA转录水平调节达到治疗疾病目的提供了一种直接方法。小核酸药物主要包 括小干扰RNA(siRNA)、反义小核酸（ASO）和适配体等，通过不同的机制发挥作用，调节基因表达和蛋白质水平调控相应的蛋白质功能。小核酸 药物治疗突破不可成药限制，相较于小分子和抗体药物有给药周期长和安全性优势等差异化优势。 方兴未艾：商业化与BD共舞正酣 全球小核酸药物市场呈现强劲且持续的增长态势，从2019年的27亿美元增长到2024年的57亿美元，复合年增长率为16.2%。弗若斯特沙利文预计， 在技术进步持续、上市批准与临床验证不断增加的推动下， ...

执业证书编号：S0740519040001 Email：zhujq@zts.com.cn Email：liuzq04@zts.com.cn | 上市公司数 | 504 | | --- | --- | | 行业总市值(亿元) | 67,613.55 | | 行业流通市值(亿元) | 61,920.43 | 医保基金运行平稳向好、NVIDIA GTC 勾勒 AI+蓝图；波动下关 注个股α与防御板块配置机会 医药生物 证券研究报告/行业定期报告 2026 年 03 月 22 日 1、《重视涨价逻辑演绎；"十五五" AI+机遇》2026-03-15 志物检测列项》2026-03-13 评级： 增持（维持） 分析师：祝嘉琦 联系人：刘照芊 基本状况 行业-市场走势对比 重点公司基本状况 简称 股价 EPS PE 评级 （元） 2023A 2024A 2025E 2026E 2027E 2023A 2024A 2025E 2026E 2027E 药明生物 33.82 0.82 0.81 0.96 1.17 1.47 41.16 41.69 35.31 28.90 23.06 买入 三生国健 70.03 0.48 1.14 ...

特此公告。 前沿生物药业（南京）股份有限公司董事会 截至本公告披露日，公司已收到由GSK按协议约定支付的4,000万美元首付款。 公司与GSK达成授权合作的两款产品均处于早期研发阶段，后续药品的临床 前研究、临床试验开展、监管审批落地至商业化投产，周期长且涉及环节多，各 关键节点均存在不确定性，标的产品最终能否获得监管机构批准上市并实现商业 化成功，尚存在不确定性。此外，协议约定的里程碑付款及特许权使用费尚需以 达到特定里程碑为前提，在研产品能否最终获得监管批准并在海外市场成功商业 化存在一定风险，最终实际支付金额尚存在不确定性。 公司将与交易对方积极推进上述合作，并将按照信息披露规则对后续进展情 况履行信息披露义务。敬请广大投资者谨慎决策，注意防范投资风险。 证券代码：688221 证券简称：前沿生物 公告编号：2026-007 前沿生物药业（南京）股份有限公司 自愿披露关于收到与葛兰素史克签署的授权许可协 议首付款的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 2026年2月16日，前沿生物药业（南京）股份有 ...

证券代码：688221 证券简称：前沿生物 公告编号：2026-006 前沿生物药业（南京）股份有限公司 自愿披露关于 FB7013 注射液获得药物临床试验批准 通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 近日，前沿生物药业（南京）股份有限公司（以下简称"公司"）收到国家 药品监督管理局核准签发的《药物临床试验批准通知书》，同意公司FB7013注射 液拟用于原发性IgA肾病的治疗开展临床试验。现将相关情况公告如下： 一、《药物临床试验批准通知书》基本情况 产品名称：FB7013注射液 申请事项:境内生产药品注册临床试验 适应症：用于原发性IgA肾病的治疗 二、风险提示 根据国家药品注册相关的法律法规要求，药物在获得《药物临床试验批准通 知书》后，需要根据批准通知书的要求开展相应临床试验，并经国家药监局批准 后方可申请适应症上市。药品后续临床试验的研究进程、研究结果以及药品的审 评审批时间、审批结果和未来的市场环境及竞争形势均存在一定不确定性。本次 事项短期内对公司经营业务不会产生较大的影响，敬请广大投资 ...

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry as of March 16, 2026 [1] Core Insights - The report emphasizes the importance of products with price leadership amid rising costs in the supply chain due to geopolitical tensions and policy changes affecting raw material prices [2] - The report highlights the significant price increases in pharmaceutical raw materials, particularly vitamins and amino acids, which have seen price increases of 40.54% and 84.66% respectively since the beginning of the year [2] - The report notes the approval of China's first invasive brain-machine interface, marking a significant milestone in the medical device sector [5] - The report indicates a strong trend in China's innovative pharmaceuticals going global, with a notable increase in licensing-out transactions [6] Summary by Sections 1. Supply Chain Dynamics - The report discusses the impact of rising prices in upstream chemical products on pharmaceutical raw materials, stressing that the ability to pass on these costs is crucial for maintaining profitability [2] - It mentions that 90% of monitored products have seen price increases, with the chemical product price index rising by 28.52% since the beginning of the year [2] 2. Market Trends in Disposable Gloves - The report details the price increases in disposable nitrile gloves and PVC gloves due to rising costs of raw materials like butadiene and acrylonitrile, which have increased by 84.43% and 47.30% respectively [3] - It notes that the domestic utilization rate for nitrile gloves has improved, and export prices have been rising since late 2025 [3] 3. Regulatory Environment - The report highlights the impact of dual-use item management on the pricing of key materials, creating significant price disparities between domestic and international markets [4] - It suggests that stricter controls on resources like rare earths could enhance the competitive advantage of domestic medical products [4] 4. Innovations in Medical Devices - The report discusses the approval of the brain-machine interface by the National Medical Products Administration, which is expected to open new market opportunities [5] - It outlines the potential for significant market growth in this area, given the high number of spinal cord injury patients in China [5] 5. International Expansion of Chinese Pharmaceuticals - The report notes that there have been 39 licensing-out transactions in the innovative drug sector, with upfront payments totaling approximately $2.953 billion [6] - It emphasizes that the trend of Chinese pharmaceuticals going global continues to strengthen, with a focus on small nucleic acid drugs and dual antibodies [7] 6. Stock Recommendations - The report recommends focusing on raw material suppliers with price leadership, such as Zhejiang Medicine and Chuan Ning Biological, and highlights companies like Inco Medical and Blue Sail Medical in the disposable glove sector [8] - It also suggests monitoring companies involved in the invasive brain-machine interface and small nucleic acid drugs, indicating potential for growth in these areas [8]

Core Insights - The article discusses three significant business development (BD) deals in the small nucleic acid sector in China, highlighting a strategic shift in global pharmaceutical companies' evaluation of Chinese small nucleic acid assets [3][4][5][7]. Group 1: Overview of Recent Transactions - On February 2, 2026, Saintin Biotech entered a global R&D collaboration with Roche's Genentech, receiving a $200 million upfront payment and potential milestone payments up to $1.5 billion [3]. - On February 11, 2026, Rebio Biotech signed a global exclusive licensing agreement with Madrigal, securing a $60 million upfront payment with a total potential value of $4.4 billion [4]. - On February 23, 2026, Frontier Biotech announced an exclusive licensing agreement with GSK, receiving a $40 million upfront payment and a potential total value close to $1 billion [5]. Group 2: Strategic Implications of the Transactions - The rapid succession of these deals indicates that global pharmaceutical companies are reassessing the strategic value of Chinese small nucleic acid assets, moving beyond mere opportunistic licensing [7]. - The core of these transactions lies not in individual products but in the underlying platform capabilities, which are crucial for expanding into new therapeutic areas [10][11]. Group 3: Historical Context and Comparison - The article compares the current transactions to early RNAi industry deals, noting that the upfront payments for Chinese companies are significantly higher than those in the early 2000s, reflecting a shift in perceived value and confidence in technology [13][18]. - The historical context shows that early RNAi deals were primarily exploratory, while current transactions are based on established technology and the ability to produce competitive products [19][20]. Group 4: Risk and Payment Structures - The payment structures of the recent deals show a trend towards backend-weighted milestone payments, indicating that buyers are willing to take on more risk as they recognize the maturity of the technology [24][25]. - Saintin Biotech's high upfront payment suggests strong confidence in the maturity and quality of its LEAD™ platform, which is seen as a critical technology for future developments [26]. Group 5: Strategic Positioning of Global Pharma - The article highlights that global pharmaceutical companies are not merely testing the waters but are strategically positioning themselves to leverage small nucleic acid technologies as essential resources for future competition [28][32]. - Companies like Madrigal and Genentech are actively seeking to build technological moats and enhance their treatment capabilities through these partnerships, indicating a shift from passive to active engagement in the market [29][30]. Group 6: Innovation and Intellectual Property - The article emphasizes the importance of independent intellectual property systems for small nucleic acid platforms, which allow Chinese companies to compete effectively in the global market [36][37]. - The ability of Chinese firms to navigate existing patent landscapes and develop new delivery technologies is crucial for their competitive positioning [38]. Group 7: Conclusion on Market Dynamics - The rapid evolution of Chinese small nucleic acid companies from followers to key technology providers reflects a significant shift in the global innovation landscape, with these firms now being recognized for their differentiated capabilities [41][42].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The National People's Congress has designated innovative drugs as a "new emerging pillar industry," indicating a strategic shift for the biopharmaceutical sector from a nurturing phase to a core engine of economic growth [16][17]. - As of March 6, 2026, the total value of business development (BD) contracts for Chinese innovative drugs has reached $56.8 billion, with an upfront payment of $3.3 billion, representing 41% of the total for 2025 and exceeding the total for 2024 [17][21]. - Despite significant stock price corrections from 2025 highs, the fundamentals of quality companies remain solid, and the long-term growth logic for innovative drug exports is still intact [21]. Summary by Sections Industry Trends - The A-share pharmaceutical index has seen a year-to-date decline of 2.42%, underperforming the CSI 300 by 1.02% [9]. - The Hang Seng Healthcare Index has outperformed the Hang Seng Technology Index by 0.97% year-to-date [9]. R&D Progress and Company Dynamics - Recent approvals include HSK31679 for non-alcoholic fatty liver disease and the GLP-1 receptor agonist Enogratide, marking significant advancements in innovative drug development [17]. - The report highlights specific companies to watch, including: - PD1 PLUS: Sangamo Therapeutics, CanSino Biologics, Innovent Biologics, and Zai Lab [12]. - ADC: I-Mab Biopharma, Kelun-Biotech, and Baiyue Tianheng [12]. - Small nucleic acids: Frontier Biotechnologies, Fuyuan Pharmaceutical, and Yuyuan Pharmaceutical [12]. Market Performance - The report notes that the pharmaceutical index's price-to-earnings ratio is currently at 36.18, which is 2.24 times lower than the historical average [9]. - The report identifies top-performing stocks for the week, including Yahu Pharmaceutical (+40.65%) and Duoyi Pharmaceutical (+30.81%), while highlighting significant declines in stocks like Haixiang Pharmaceutical (-15.06%) and Furu Medical (-13.07%) [9].

Investment Rating - The report maintains a "Positive" outlook for the pharmaceutical and biotechnology industry [5] Core Viewpoints - Short-term fluctuations do not change the long-term growth trajectory of the innovative drug sector. Despite recent market volatility, the underlying logic for medium to long-term growth remains intact, driven by globalization, technological breakthroughs, and industry upgrades [8][12] - The focus has shifted from "can we go global" to "what progress has been made after going global," emphasizing the importance of overseas clinical deployment and milestone achievements for innovative drugs [13][14] - Breakthroughs in frontier technologies, particularly in small nucleic acids and CAR-T therapies, position Chinese companies to become core global assets [18][20] - The commercialization of innovative drugs is expected to lead to a profitability inflection point, with key companies entering a positive cycle of product volume growth and reinvestment in R&D [22] Summary by Sections 1. Short-term Fluctuations, Long-term Growth - The innovative drug sector has experienced significant volatility due to concentrated expectations and emotions, but the long-term growth trend remains unchanged [8][12] - The valuation of leading companies has reached reasonable levels, suggesting potential investment opportunities as market sentiment stabilizes [12] 1.1 Focus on Globalization Progress - The emphasis has shifted to the progress of products in overseas clinical trials, with a focus on key data readouts and milestone achievements [13][14] - Domestic bispecific antibodies are accelerating their global clinical trials, becoming core trading assets in the context of expiring patents for PD-(L)1 products [13] 1.2 Breakthroughs in Frontier Technologies - Chinese companies are leading in small nucleic acids and CAR-T therapies, with significant advancements in delivery technologies expanding treatment options beyond rare diseases [18] - In vivo CAR-T therapies have shown preliminary clinical effectiveness, with a growing number of transactions indicating a shift towards mainstream adoption [20] 1.3 Commercialization Driving Profitability - Leading innovative drug companies are entering a cycle of product volume growth that supports R&D reinvestment, with expectations for exceeding market performance in 2023 [22] - The upcoming earnings period in March-April 2026 is seen as a critical validation point for the sector [22] 2. Global New Drugs: Highlights in Autoimmunity and Oncology - The report highlights the approval of the world's first PD-L1/TGF-β bispecific antibody, showcasing the R&D capabilities of domestic companies [26][27] - The successful launch of innovative drugs in critical therapeutic areas reflects the growing strength of domestic pharmaceutical companies in addressing unmet medical needs [26][27]

- The report discusses a **quantitative timing model based on volume signals**, which evaluates market sentiment and timing by analyzing volume trends. The model's construction involves assessing the volume levels of major indices (e.g., Shanghai Composite, CSI 300, etc.) and assigning a cautious view when volume signals are weak. As of February 27, 2026, all major indices showed a "cautious" volume timing signal[24][25] - A **momentum sentiment indicator** is introduced, which calculates the proportion of stocks in the CSI 300 index with positive returns over a specific period (N days). The formula is: $ \text{CSI 300 N-day Upward Proportion} = \frac{\text{Number of CSI 300 stocks with positive returns in N days}}{\text{Total number of CSI 300 stocks}} $ This indicator is used to capture market sentiment, with higher values indicating optimism. As of February 27, 2026, the indicator was above 60%, reflecting high market sentiment[25][26][27] - A **momentum sentiment timing strategy** is applied by smoothing the momentum sentiment indicator using two moving averages (short-term and long-term). When the short-term average exceeds the long-term average, the model signals a bullish market view. Parameters used are N=230, N1=50, and N2=35. As of February 27, 2026, the short-term line was above the long-term line, maintaining a bullish outlook[27][29] - The report also introduces an **eight-moving-average sentiment indicator**, which evaluates the CSI 300 index's trend by comparing its closing price against eight moving averages (8, 13, 21, 34, 55, 89, 144, 233). The indicator assigns values based on the number of moving averages the index surpasses. If the index price exceeds more than five moving averages, the model signals a bullish view. As of February 27, 2026, the CSI 300 index was in a "sentiment prosperity zone," indicating positive sentiment[34][38] - **Cross-sectional volatility** is analyzed as a measure of alpha opportunities. The report highlights that cross-sectional volatility for CSI 300, CSI 500, and CSI 1000 stocks increased week-over-week, indicating an improved short-term alpha environment. Over the past quarter, cross-sectional volatility for CSI 300 and CSI 1000 was in the upper-middle range of the past six months, while CSI 500 was in the middle range[39][40] - **Time-series volatility** is also examined, showing a week-over-week decline for CSI 300, CSI 500, and CSI 1000 stocks, suggesting a deteriorating short-term alpha environment. Over the past quarter, time-series volatility for CSI 300 and CSI 500 was in the middle range of the past six months, while CSI 1000 was in the upper-middle range[40][43]

前沿生物 20260302 摘要 前沿生物布局小核酸药物平台，核心管理团队具备全链条管理能力，为 长期战略稳定与商业化推进提供支撑，若后续管线持续兑现，有望增强 核心竞争力。 公司以小核酸药物为核心，适应症覆盖 IgA 肾病、高尿酸与痛风、肿瘤 等，同时布局高端仿制药及相关医疗器械，产品矩阵持续完善，核心竞 争力持续提升。 小核酸药物具备候选靶点丰富、研发周期相对更短、临床开发成功率更 高等优势，平台化与批量化研发属性较强。2025 年全球小核酸相关交 易总额超过 310 亿美元，海外头部 MNC 正进行系统性布局。 公司在长效化药物开发方面积累成熟经验，递送端布局 Galenic 递送系 统，并自主研发 siRNA 递送载体，已提交国际发明专利申请。管线适应 症覆盖慢病与肿瘤等领域，部分靶点具备 FIC 潜力，其中以 IgA 肾病相 关的 FB7,013 与 FB7,011 为重点。 IgA 肾病强调早期、及时与长效干预。公司围绕补体系统靶点，布局三 款靶向补体机制的小核酸药物 FB7,013、FB7,011、FB7,014，主要探 索适应症为 IgA 肾病，同时具备向其他补体异常激活相关疾病拓展的潜 力。 ...