证券代码：688221 证券简称：前沿生物 公告编号：2026-004 前沿生物药业（南京）股份有限公司 关于与葛兰素史克签署授权许可协议的公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 前沿生物药业（南京）股份有限公司（以下简称前沿生物或公司）与全球 生物制药企业葛兰素史克（GSK）达成一项独家授权许可协议（以下简称协议）。 根据该协议，葛兰素史克将获得两款小核酸（siRNA）管线产品在全球范围内的独 家开发、生产及商业化权利，其中一款候选药物已进入新药临床试验申请（IND） 阶段，另一款为临床前候选药物。 根据协议，公司将获得4,000万美元首付款及1,300万美元近期里程碑付款； 公司还将额外在两个项目中累计获得最高9.5亿美元的基于成功开发、监管及商业 化里程碑的付款，同时享有两款产品全球净销售额的分级特许权使用费。 根据协议，公司将负责两款在研产品的早期开发工作，具体包括：负责其 中一款产品在中国的I期临床试验推进，并完成另一款产品的IND支持性研究。葛 兰素史克将负责两款产品之后所有的全球 ...

根据协议，公司将获得4,000万美元首付款及1,300万美元近期里程碑付款;公司还将额外在两个项目中累 计获得最高9.5亿美元的基于成功开发、监管及商业化里程碑的付款，同时享有两款产品全球净销售额 的分级特许权使用费。根据协议，公司将负责两款在研产品的早期开发工作，具体包括：负责其中一款 产品在中国的I期临床试验推进，并完成另一款产品的IND支持性研究。葛兰素史克将负责两款产品之 后所有的全球临床开发、监管申报及商业化活动。 公司与葛兰素史克达成的授权合作，将为公司带来首付款及后续里程碑付款，有助于改善现金流、优化 财务结构，为核心管线研发投入、技术平台优化升级提供坚实的资金保障，助力公司进一步实现研发资 源的高效配置与战略聚焦。协议中基于净销售额的分级特许权使用费安排，使公司得以持续分享合作产 品未来在全球范围内可能实现的商业成果，形成潜在长期收入来源，持续为全体股东创造价值。本次与 全球领先的生物制药企业GSK达成此项协议，体现了公司在小核酸药物研发领域的技术实力与平台价值 正获得国际市场认可。此次合作将借助GSK在全球临床开发与商业化方面的资源与经验，加速公司管线 的国际化价值转化，并为后续推进产品商业 ...

前沿生物公告称，2026年2月16日与葛兰素史克签署协议，授予其两款小核酸管线产品全球独家开发等 权利，候选药分别处于IND阶段和临床前阶段。公司将获4000万美元首付款和1300万美元近期付款，还 可累计获最高9.5亿美元里程碑付款，并享有全球净销售额分级特许权使用费。公司负责早期开发，葛 兰素史克负责后续全球活动。交易未构成重大资产重组，已获董事会通过。此次合作或改善现金流等， 但产品获批和商业化存在风险。 ...

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]

机构观点 营收增长主要依赖核心产品艾可宁及新业务，但增速已降至个位数。净利润亏损同比增亏，主要因2024 年处置子公司收益缺失；研发费用投入1.38亿元至1.45亿元，同比微增，聚焦小核酸药物管线。公司坦 言新药研发周期长、风险高。 股票近期走势 近期股价波动明显，近5日下跌0.82%，反映市场对公司业绩及研发风险的谨慎情绪。 经济观察网前沿生物发布2025年业绩预告，预计营收1.4亿元至1.45亿元，同比增长8.13%至11.99%，增 速持续下滑；归属净利润亏损扩大至2.55亿元至2.9亿元。公司研发重心转向小核酸药物，多款产品处于 早期阶段。 财报分析 分析指出，公司核心产品放量受行业免费药物格局制约，小核酸药物虽为长期增长点，但均处临床前或 早期阶段，未来面临审批、竞争等多重风险。公司需突破盈利瓶颈。 以上内容基于公开资料整理，不构成投资建议。 ...

前沿生物（688221.SH）2月9日在投资者互动平台表示，FB7012为拟治疗高尿酸血症与痛风的小核酸药 物，截至目前尚处于临床前研究。公司将按照信息披露规则对在研项目的进展情况履行信息披露义务， 请持续关注公司公告。药品开发具有一定的不确定性，请您注意投资风险。 （文章来源：每日经济新闻） 每经AI快讯，有投资者在投资者互动平台提问：FB7012是否进入I期临床试验？试验结果如何？ ...

Investment Rating - The industry investment rating is "Positive" (maintained) [6] Core Insights - The report highlights the significant commercial value of extrahepatic delivery technology for small nucleic acid drugs, which is expanding from liver diseases to multiple disease areas. Domestic companies are rapidly developing multi-target drugs and extrahepatic delivery platforms, which are expected to accelerate the release of potential clinical value [3][8] - The report emphasizes that multinational corporations (MNCs) are intensifying their focus on next-generation delivery platforms, moving from "liver validation" to "multi-organ expansion." This shift is crucial as it addresses unmet clinical needs in various tissues such as fat, muscle, central nervous system, heart, and kidneys [8] - The report indicates that 2026 is a pivotal year for small nucleic acid therapies, with domestic innovative drugs expected to become core assets for transactions. Domestic companies have accumulated rich experience in chemical modifications and liver-targeted delivery technologies, covering high-value areas such as hyperlipidemia, hypertension, hepatitis B, and weight loss [8] Summary by Sections Industry Overview - The report focuses on the pharmaceutical and biotechnology industry in China, specifically on small nucleic acid drugs and their evolving delivery technologies [5][6] Investment Recommendations and Targets - The report lists several investment targets, including: - YK Pharma (688658, Buy) - Hengrui Medicine (600276, Buy) - Xinda Biopharma (01801, Not Rated) - Other companies such as Chengdu XianDao (688222, Not Rated), Reborn Biotech (06938, Not Rated), and others [3]

Core Viewpoint - Frontier Biotech has disclosed its performance forecast for the fiscal year 2025, expecting revenue growth while still facing net profit losses due to ongoing investments in R&D and operational costs [1] Group 1: Financial Performance - The company anticipates revenue between 140 million to 145 million yuan for 2025, representing a year-on-year increase of 8.13% to 11.99% [1] - The net profit attributable to shareholders, excluding non-recurring gains and losses, is expected to be a loss of approximately 288 million to 323 million yuan, which indicates a reduction in losses by about 4.31 million to 39.31 million yuan compared to the previous year [1] Group 2: Revenue Sources - Revenue is primarily derived from the sales of the anti-HIV innovative drug Aikening® and the recently approved far-infrared therapy patch [1] - The reduction in net profit losses is attributed to increased revenue and decreased operating expenses [1] Group 3: R&D Investments - The company plans to invest approximately 138 million to 145 million yuan in R&D for 2025, reflecting a year-on-year increase of 0.58% to 5.68% [1] - The focus of R&D is on small nucleic acid new drug development and early-stage research of other new drugs [1] Group 4: R&D Pipeline - Frontier Biotech is developing a multi-tiered R&D pipeline, with a focus on antiviral business and small nucleic acid innovative drugs as the core development line, supplemented by high-end generic drugs [1] - The company has submitted an IND application for the single-target small nucleic acid drug FB701, which has been accepted for clinical application approval [2] - The dual-target small nucleic acid drug FB7011 has entered supportive research for new drug clinical trial applications, and the preclinical candidate molecule for FB7023 has been identified [2] - The company has also initiated preclinical research for FB2004, a novel interferon-α2 mutant, in collaboration with Fudan University [2] - The generic drug FB3002 for treating musculoskeletal pain has received acceptance for its market approval application and is currently under review [2]

Core Viewpoint - Frontier Biopharmaceuticals (Nanjing) Co., Ltd. forecasts a revenue increase for 2025, while also projecting a higher net loss compared to the previous year, primarily due to the absence of investment gains from subsidiary disposals in 2024 [2][5]. Group 1: Performance Forecast - The company expects to achieve an operating revenue of approximately CNY 140 million to CNY 145 million in 2025, representing a year-on-year increase of 8.13% to 11.99% [2][5]. - The projected net loss attributable to shareholders is estimated to be between CNY 255 million and CNY 290 million, an increase in loss of approximately CNY 53.62 million to CNY 88.62 million compared to 2024 [2][5]. - The net loss excluding non-recurring gains and losses is expected to be between CNY 288 million and CNY 323 million, a reduction in loss of approximately CNY 4.31 million to CNY 39.31 million, mainly due to revenue growth and reduced expenses [2][5]. Group 2: Revenue Sources - Revenue is primarily derived from the sales of the innovative anti-HIV drug Aikening (generic name: Aibowei Tai), the agency product Viread (Tenofovir), and the newly approved far-infrared therapeutic patch (Xiaoyan Yipai) [2][5]. - The sales of Aikening are focused on the inpatient market, with continued growth in outpatient revenue, supported by its reputation as a preferred medication for hospitalized patients [5][6]. Group 3: R&D and Commercialization Progress - The company is focusing on the research and development of small nucleic acid drugs and has submitted IND applications for several candidates, including FB7013 and FB7011, which are in various stages of clinical development [7][8]. - The company has completed nationwide sales registration for the agency product Viread and has initiated commercial promotion for the far-infrared therapeutic patch [6][8]. - R&D expenses are projected to be between CNY 138 million and CNY 145 million, reflecting a year-on-year increase of 0.58% to 5.68%, as the company emphasizes early-stage development of new drugs [5][7].

证券日报网讯1月30日，前沿生物发布公告称，公司预计2025年度实现营业收入约14，000.00万元到 14，500.00万元，同比增加8.13%到11.99%，归属于上市公司股东的净利润亏损约25，500.00万元到亏 损29，000.00万元，增加亏损约5，361.74万元到8，861.74万元。 ...