1885 医药生物 2026 年 01 月 04 日 版 行业 《本周申万医药生物指数下跌 0.2%，关注 对外授权及新品上市 -- 医药行业周报 (2025/12/22-2025/12/26) 》 2025/12/29 《本周申万医药生物指数下跌 0.1%，关注 国内药企出海动态——医药行业周报 (2025/12/15-2025/12/19)》 2025/12/22 证券分析师 张静含 A0230522080004 zhangjh@swsresearch.com 陈田甜 A0230524080013 chentt@swsresearch.com 联系人 陈田甜 A0230524080013 chentt@swsresearch.com 申万宏源研究微信服务号 本期投资后示 2.1%，关注脑机接口产业 ―― 医药行业周报（2025/12/29-2026/01/02） 请务必仔细阅读正文之后的各项信息披露与声明 本 周 申 万 医 药 生 物 指 数 T 看好 相关研究 市场表现：本周申万医药生物指数下跌 2.1%，同期上证指数上涨 0.13%，万得全 A ● （除金融石油石化） 下跌 0.3%。本周医药生物指 ...

疗效明确全面：在食蟹猴IgA肾病模型中，FB7013呈现出显著的剂量依赖性疗效，尿总蛋白肌酐比值 (uPCR)和尿总蛋白(uTP)呈剂量依赖性降低，肾小球滤过率(eGFR)呈剂量依赖性升高；高剂量治疗8周 后，肾小球系膜区系膜细胞数量减少36%，肾小球内IgA沉积减少43%，有效改善肾脏病理损伤，为临 床获益奠定坚实基础。 (原标题：前沿生物FB7013临床试验申请获受理，IgA肾病治疗添中国原研新力量) 2025年12月31日，前沿生物药业(南京)股份有限公司(证券代码：688221，以下简称"公司")自主研发的 靶向补体系统凝集素途径关键蛋白MASP-2靶点的siRNA药物FB7013药品注册临床试验申请获得国家药 品监督管理局受理。这款具有同类首创(First-in-Class)潜力的创新药，有望为全球IgA肾病患者带来全新 治疗希望！ First-in-Class创新机制，直击疾病源头 作为全球首个申请临床、作用于MASP-2靶点的siRNA药物，FB7013的研发紧扣IgA肾病的核心病理机 制，通过特异性抑制MASP-2蛋白活性，从源头阻断凝集素途径的异常激活，减少补体介导的肾脏损 伤，为IgA肾病 ...

前沿生物12月31日公告，12月22日，公司向国家药品监督管理局提交了公司自主研发的一款靶向补体系 统凝集素途径关键蛋白MASP-2靶点的siRNA药物（产品代码：FB7013）临床试验申请，2025年12月31 日，公司收到国家药品监督管理局核准签发的受理通知书，FB7013的临床试验申请获得受理。 ...

Group 1: Macroeconomic Outlook - The report anticipates a positive macroeconomic environment for 2026, with a GDP growth target of around 5%, supported by consumption and investment recovery, and resilient exports [3] - The policy stance is expected to be proactive and expansionary, with measures to boost consumption, infrastructure, and stabilize the real estate sector [3] - A strategic focus on A-shares is recommended, particularly in sectors related to AI, new productivity, self-sufficiency, and international expansion [3] Group 2: Fixed Income and Real Estate - The real estate sales index has shown a decline, with a current index of 41.7, indicating a year-on-year decrease of 6.2 points [5] - The overall demand for real estate remains weak, with the high-frequency index reflecting ongoing challenges in the sector [5] - The bond market is expected to experience fluctuations, with the 10-year government bond yield projected to range between 1.5% and 1.9% [3] Group 3: Light Industry Manufacturing - The report highlights Han Gao Group's strong position in the home hardware sector, with a comprehensive product matrix and diversified sales system [9] - The company is expected to achieve net profits of 709 million, 883 million, and 1.073 billion yuan from 2025 to 2027, reflecting growth rates of 33.4%, 24.5%, and 21.6% respectively [9] Group 4: Building Materials - Yao Pi Glass is positioned as a leader in the automotive glass market, with significant growth expected in TCO glass technology due to the industrialization of perovskite batteries [10] - Revenue projections for Yao Pi Glass are 5.56 billion, 5.90 billion, and 6.34 billion yuan for 2025 to 2027, with net profits of 160 million, 190 million, and 250 million yuan respectively, indicating a growth rate of 26.2% [10] Group 5: Retail and Duty-Free Industry - The duty-free industry is experiencing improvements due to the implementation of favorable policies, with expectations for stable performance in Q4 2025 [11] - Key players in this sector include China Duty Free Group, Meilan Airport, and Hainan Development, which are anticipated to benefit from the policy changes [11] Group 6: Pharmaceutical and Biotechnology - Frontier Biotech reported record quarterly sales, with a 47.6% increase from the previous quarter, driven by its innovative HIV drug and other products [13] - The company is focusing on expanding its market presence in grassroots medical institutions and enhancing its R&D pipeline for small nucleic acid drugs [15][16] Group 7: Semiconductor Industry - AMD's Q3 2025 revenue reached $9.2 billion, a 35.6% year-on-year increase, exceeding previous guidance [17] - The company is expected to launch new data center CPU/GPU products in 2026, with significant growth projected in revenue from 2025 to 2027 [19] Group 8: Power Equipment - Daikin Heavy Industries reported a 99.25% year-on-year increase in revenue for the first three quarters of 2025, with net profits growing by 214.63% [20] - The company is expected to benefit from its leadership in offshore wind tower production, with projected net profits of 1.09 billion, 1.66 billion, and 2.48 billion yuan from 2025 to 2027 [20]

Investment Rating - The report maintains a "Buy" rating for the company [3][6]. Core Insights - The company achieved its highest quarterly revenue of 44.73 million, representing a year-on-year growth of 10.22% and a quarter-on-quarter increase of 47.6%. The revenue growth is primarily driven by the innovative HIV drug Aikening and the sales of the agent product, Veklury [1]. - The company is actively expanding its marketing network into lower-tier cities and county-level markets, enhancing the accessibility of its products in grassroots medical institutions. The focus is on solidifying Aikening's position as the preferred medication in the inpatient market while targeting high-potential outpatient patients [2]. - The company is advancing its small nucleic acid pipeline, with two drugs, FB7013 and FB7011, showing First-in-Class potential targeting the complement system. The initial indication for these drugs is IgA nephropathy, with potential expansion into other diseases related to complement system activation [2][3]. Financial Summary - The company's total revenue for Q1-Q3 reached 103 million, with a year-on-year increase of 12.80%. The R&D expenses for Q3 were 35.93 million, accounting for 80.33% of operating revenue, maintaining a stable investment in R&D [1]. - Projected revenues for 2025, 2026, and 2027 are estimated at 161 million, 190 million, and 223 million respectively, with growth rates of 24.0%, 18.4%, and 17.2% [5][3]. - The company is expected to continue its revenue growth trajectory as its products penetrate deeper into the market, particularly with Aikening [3].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has shown steady progress in its complement pipeline research, particularly with FB7011 demonstrating superior efficacy in head-to-head comparisons [5] - The revenue for Q1-Q3 2025 reached 103 million yuan, reflecting a year-on-year growth of 12.80%, while the net profit attributable to the parent company was -160 million yuan, an increase of 17.39% [4] - The company is expected to maintain a long-term competitive edge due to its small nucleic acid pipeline research and development [4] Financial Summary - For 2025, the company is projected to achieve a revenue of 143 million yuan, with a year-on-year growth of 10.2% [8] - The net profit attributable to the parent company is forecasted to be -176 million yuan in 2025, improving from -201 million yuan in 2024 [8] - The gross margin for Q1-Q3 2025 was reported at 34.84%, an increase of 1.35 percentage points [4] - The estimated EPS for 2025 is -0.47 yuan, with a corresponding P/E ratio of -30.9 times [8] Pipeline Development - FB7011 has shown significant efficacy in preclinical studies, achieving over 95% inhibition of MASP-2 and CFB protein expression in a crab-eating monkey model [5] - Compared to the positive control Iptacopan, FB7011 demonstrated a 16% greater reduction in uPCR and an 18% greater reduction in uTP [5] - The upcoming 2025 ASN Kidney Week will feature updates on FB7011's preclinical efficacy data [6]

Core Insights - Frontline Bio (688221.SH) reported steady growth in performance for the first three quarters of 2025, achieving revenue of 103.37 million yuan, a year-on-year increase of 12.80% [1] - In Q3 2025, revenue reached 44.73 million yuan, showing a significant quarter-on-quarter growth of 47.58%, driven primarily by the sales of the innovative anti-HIV drug Aikening® and the agency product Viread® [1] - The company has increased its R&D investment, with R&D expenses amounting to 83.87 million yuan in the first three quarters, focusing on the small nucleic acid drug field and advancing long-acting anti-HIV drugs and high-end generics [1] Small Nucleic Acid Drug Development - The company is developing two small nucleic acid drugs, FB7013 and FB7011, targeting complement diseases, both of which have First-in-Class potential [2] - FB7013 targets the MASP-2 pathway and has shown promising preclinical results, with a single subcutaneous injection maintaining target protein reduction for 16 weeks in healthy monkeys, and is expected to submit an IND application by the end of 2025 [2] - FB7011, a dual-target drug, has demonstrated over 95% inhibition efficiency for both target proteins in preclinical studies, with significant improvements in key indicators in IgA nephropathy models, and is also expected to have a favorable safety profile [3] Upcoming Events and Future Directions - The company will present the latest preclinical efficacy data for FB7011 and FB7013 at the 2025 ASN Kidney Week in Houston, a leading global nephrology conference [3] - Additional small nucleic acid drug developments include FB7023 for dyslipidemia, which has completed pharmacological studies in transgenic mice, and early-stage products targeting hyperuricemia, tumors, and type 2 diabetes, all of which are in preclinical stages [4] - The company aims to leverage its research capabilities showcased at international conferences to enhance product competitiveness and continue breakthroughs in treatment options for complement and metabolic diseases [4]

Core Insights - The company reported a revenue of 103.37 million yuan for the first three quarters of 2025, representing a year-on-year growth of 12.80% [1] - In Q3 2025, the company achieved a revenue of 44.73 million yuan, with a quarter-on-quarter increase of 47.58%, primarily driven by the sales of its innovative HIV drug and the代理产品缬康韦 [1] - The company invested 83.87 million yuan in R&D during the first three quarters, accounting for 81.13% of its revenue [1] R&D Focus - The company is concentrating its R&D efforts on small nucleic acid drugs, while also advancing the development of long-acting anti-HIV drugs and high-end generic drugs [1] - Two small nucleic acid drugs, FB7013 and FB7011, with First-in-Class potential have been developed, with FB7013 completing GMP batch production and non-clinical studies proceeding as planned [1] - FB7011 has completed efficacy studies in a monkey model for IgA nephropathy [1] Product Development and Commercialization - The company is advancing the R&D of FB3002 and other chemical drug hot melt adhesive products, with its subsidiary obtaining a production license for FB3002 [2] - In the pain management sector, the company has initiated commercial production of two specifications of far-infrared therapeutic patches and is expanding its online marketing channels [2] - New institutional investors, including E Fund Medical Healthcare Mixed Securities Investment Fund and E Fund Taihe Growth Stock Pension Product, have entered the company's top ten shareholders list, holding 2.06% and 1.67% of shares respectively [2]

Investment Rating - The report assigns an "Accumulate" rating for the company for the first time [2]. Core Insights - The company focuses on developing, producing, and selling new drugs that address significant unmet clinical needs, aiming to become a leading global biopharmaceutical enterprise [8]. - The company has a strong pipeline in the field of IgA nephropathy, with three small nucleic acid drugs that have first-in-class or best-in-class potential [8]. - The projected revenue for the company is expected to grow significantly, with estimates of 210 million, 322 million, and 454 million yuan for the years 2025, 2026, and 2027 respectively [8]. Summary by Sections Company Overview - The company, established in 2013 and listed on the Shanghai Stock Exchange in 2020, specializes in long-acting anti-HIV products, new technology small nucleic acid products, and high-end generic drugs [12][19]. - The company has developed the first approved HIV fusion inhibitor, which has shown significant clinical value and is included in the latest treatment guidelines [35][48]. Market Performance - The company has seen stable revenue growth, with sales increasing from 85 million yuan in 2022 to an estimated 129 million yuan in 2024, reflecting a year-on-year growth of 109.22% and 34.82% respectively [19][21]. - The global HIV drug market is projected to grow from 36.22 billion USD in 2024 to 66.16 billion USD by 2034, with a compound annual growth rate (CAGR) of 6.21% [27][31]. Financial Forecast - The company’s revenue is projected to grow significantly, with estimates of 210 million yuan in 2025, 322 million yuan in 2026, and 454 million yuan in 2027, indicating a revenue growth rate of 62.5%, 53.2%, and 40.8% respectively [6][8]. - The net profit is expected to improve from a loss of 239 million yuan in 2025 to a loss of 123 million yuan in 2027, showing a trend towards reduced losses [6][8]. Product Pipeline - The company has a robust pipeline in IgA nephropathy, with three small nucleic acid drugs targeting the complement system, which is crucial in the disease's pathogenesis [8][49]. - The company’s lead product, a long-acting HIV drug, has demonstrated superior efficacy and safety compared to existing treatments, positioning it well in the market [35][46].

Investment Rating - The investment rating for the company is "Buy" (initial coverage) [2] Core Views - The company is focusing on innovative drug development, particularly in small nucleic acid technology and long-acting HIV treatments, which are expected to drive future growth [5][30] - The core product, Aikening (艾可宁), has shown stable sales growth and is positioned to expand its market presence, especially in the HIV treatment sector [7][26] - The company has a clear and stable shareholding structure, with a significant stock incentive plan aimed at enhancing long-term growth [16][21] Summary by Sections 1. Company Overview - Founded in 2013 and listed on the Shanghai Stock Exchange in 2020, the company has developed Aikening, a key HIV treatment, which was approved in 2018 [5][14] - The company is building a pipeline that combines innovative drugs and high-end generics, enhancing its competitive edge [5][30] 2. Financial Performance - Revenue has grown from 0.47 billion yuan in 2020 to an estimated 1.43 billion yuan in 2025, with a CAGR of approximately 29.1% [22] - The net profit attributable to shareholders is projected to improve from a loss of 329 million yuan in 2023 to a loss of 176 million yuan in 2025 [8][22] - The gross margin is expected to stabilize around 32.7% in 2025, reflecting improved operational efficiency [8][27] 3. Product Pipeline - The company is advancing its small nucleic acid drug pipeline, targeting chronic diseases with several candidates in clinical development, including treatments for IgA nephropathy and dyslipidemia [6][34] - Aikening is the first long-acting HIV drug approved globally, and the company is working on a comprehensive long-acting treatment regimen [7][30] 4. Strategic Initiatives - The company has launched a stock incentive plan to align the interests of management and shareholders, focusing on innovation and commercialization [21][19] - The research team is experienced, with a strong background in drug development, which supports the company's long-term innovation strategy [19][20]