证券代码：688621 证券简称：阳光诺和 公告编号：2026-006 北京阳光诺和药物研究股份有限公司 自愿披露关于 ABA001 注射液临床试验申请获得受理 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。 近日，北京阳光诺和药物研究股份有限公司（以下简称"公司"）及全 资子公司北京阿尔纳科技有限公司收到国家药品监督管理局核准签发的《受 理通知书》，在研项目 ABA001 注射液的临床试验申请获得受理。 ABA001 注射液拟申报适应症为高血压。 申请事项：境内生产药品注册临床试验 受理号：CXHL2600091 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。自受理之日起 60 日内，未收到药审中心否定或质疑意见的，申 请人可以按照提交的方案开展临床试验。 二、药品的其他相关情况 本次递交的 ABA001 注射液为 1 类创新药，拟申报适应症为高血压。 1 由于药品的研发周期长、审批环节多，容易受到一些不确定性因素的影 响，敬请广大投资者谨慎决策，注意防范投资风险。现将相关情 ...

格隆汇1月21日丨阳光诺和(688621.SH)公布，近日，公司及全资子公司北京阿尔纳科技有限公司收到国 家药品监督管理局核准签发的《受理通知书》，在研项目 ABA001 注射液的临床试验申请获得受理。 ABA001 注射液拟申报适应症为高血压。 ABA001 注射液为靶向血管紧张素原(AGT)的信使RNA(mRNA)基因的小干扰核苷酸药物，偶联 N-乙酰 半乳糖胺(N-Acetylgalactosamine，GalNAc)递送系统，可精准地将药物递送至肝脏细胞，通过 siRNA 的 干扰沉默机制，从源头靶向沉默 AGT 的信使 RNA，阻断 AGT 蛋白的合成，从根本上抑制肾素-血管紧 张素-醛固酮系统(Renin-Angiotensin-Aldosterone System，RAAS)升高血压的作用，从而降低血压。同类 siRNA 药物 Zilebesiran 的临床研究已证实该机制的有效性与安全性，单次给药疗效可持续 24 周，为 ABA001 注射液的开发提供了充分的科学依据。非临床研究表明，本品 1mg/kg 即可显著降低血压，动 物耐受良好，具有较高的安全性，有望实现每 3 个月或半年给药一次的长 ...

Market Overview - The medical services sector increased by 0.18% on January 21, with Nanmo Biology leading the gains [1] - The Shanghai Composite Index closed at 4116.94, up 0.08%, while the Shenzhen Component Index closed at 14255.12, up 0.7% [1] Top Gainers in Medical Services - Nanmo Biology (688265) closed at 49.79, up 7.01% with a trading volume of 20,000 shares and a transaction value of 98.02 million [1] - Hite Biology (300683) closed at 29.67, up 5.74% with a trading volume of 107,800 shares and a transaction value of 32.2 million [1] - Dean Diagnostics (300244) closed at 26.46, up 5.59% with a trading volume of 796,300 shares and a transaction value of 2.13 billion [1] - ST Zhongzhu (600568) closed at 2.64, up 5.18% with a trading volume of 376,500 shares and a transaction value of 9.81 million [1] - Tongce Medical (600763) closed at 46.51, up 4.99% with a trading volume of 198,600 shares and a transaction value of 911 million [1] Top Losers in Medical Services - Digital Human (920670) closed at 18.72, down 4.44% with a trading volume of 74,500 shares and a transaction value of 143 million [2] - Hongbo Pharmaceutical (301230) closed at 46.36, down 1.88% with a trading volume of 131,200 shares and a transaction value of 614 million [2] - Chengda Pharmaceutical (301201) closed at 41.39, down 1.76% with a trading volume of 36,600 shares and a transaction value of 153 million [2] Capital Flow in Medical Services - The medical services sector saw a net inflow of 50.51 million from institutional investors, while retail investors experienced a net outflow of 375 million [2] - The sector's overall capital flow indicates a strong interest from institutional and speculative investors, with retail investors pulling back [2][3] Notable Capital Inflows - Sanbo Brain Science (301293) had a net inflow of 91.48 million, representing 9.03% of its total capital [3] - Tongce Medical (600763) saw a net inflow of 83.46 million, accounting for 9.16% of its total capital [3] - BGI Genomics (300676) recorded a net inflow of 51.81 million, which is 8.37% of its total capital [3]

人民财讯1月21日电，阳光诺和(688621)1月21日公告，公司及全资子公司北京阿尔纳科技有限公司收到 国家药品监督管理局核准签发的《受理通知书》，在研项目ABA001注射液的临床试验申请获得受理， ABA001注射液拟申报适应症为高血压。 ...

Core Viewpoint - The company expects its annual net profit attributable to shareholders for 2025 to be between 191 million and 229 million yuan, representing a year-on-year growth of 7.69% to 29.23% [1] - The net profit attributable to shareholders, excluding non-recurring gains and losses, is projected to be between 180 million and 216 million yuan, with a year-on-year increase of 8.84% to 30.61% [1] Group 1 - The main drivers of the performance growth are the deep layout of the innovative drug pipeline, realization of value from licensing collaborations, and synergistic support from the integrated service model [1] - The company focuses on innovative drugs with global independent intellectual property rights, covering areas such as peptides, small nucleic acids, cell therapy, and gene therapy [1] - Clinical progress of core pipelines like STC007 and STC008 has been promoted, contributing to the overall growth [1] Group 2 - Licensing collaborations and revenue sharing have become key drivers of profit growth, enhancing the company's profitability [1]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of January 19, 2026 [1] Core Insights - 2025 marked a significant year for Chinese innovative drugs going global, with a total transaction amount of $135.655 billion, including $7 billion in upfront payments and 157 deals, setting historical highs. The trend continues into 2026, with notable licensing agreements from companies like Yilian Biotech and Rongchang Biotech, indicating strong global competitiveness for Chinese innovative drugs [2] - Major companies are increasingly investing in the small nucleic acid field, with significant acquisitions and clinical approvals. For instance, China National Pharmaceutical Group acquired Hangzhou Hejiya Biopharmaceutical for 1.2 billion RMB, while international firms like Novartis and GSK are also advancing in this area [3] - The GLP-1 market is expected to grow despite new pricing systems, with ongoing collaborations and new product launches anticipated in 2026. The market for GLP-1 drugs is projected to remain robust due to the large patient population for weight loss and diabetes [4] - The oral autoimmune drug market is gaining attention, with promising results from Takeda's new TYK2 inhibitor for psoriasis. Other domestic companies are also advancing in this space, exploring new targets for oral small molecules [5] - The brain-computer interface sector is poised for industrialization, with companies like Neuralink set to produce devices in 2026. Domestic advancements and regulatory support are enhancing the potential for this technology in medical applications [6] - The ZAP-X radiation therapy device is expected to capture a significant market share in China, with rapid growth projected in non-invasive tumor radiation treatment, driven by increasing clinical recognition and adoption [8] Summary by Sections Industry Trends - The pharmaceutical sector is witnessing a resurgence in interest towards innovative drugs, with a notable increase in the innovative drug index by 8.97% since early January 2026, outperforming the CSI 300 index by 6.77 percentage points [2] Company Recommendations - Recommended companies include: - **Yuekang Pharmaceutical** and **Sunshine Nuohua** in the small nucleic acid space - **Yahong Pharmaceutical** and **Yifang Biotechnology** in the autoimmune sector - **Zhongsheng Pharmaceutical** in the GLP-1 market - **Baiyang Pharmaceutical** for ZAP-X radiation therapy - **Meihao Medical** for brain-computer interface technology [10] Market Opportunities - The non-invasive tumor radiation treatment market is projected to grow from 27.2 billion RMB in 2018 to 59.4 billion RMB by 2024, with a compound annual growth rate of 13.9% [8]

Summary of Conference Call Records Industry Overview - The conference call primarily discusses the biopharmaceutical industry, focusing on several key companies and their projected performance for 2025 and beyond. The overall sentiment reflects a robust growth trajectory within the sector. Key Companies and Their Projections 1. WuXi AppTec (药明康德) - Expected revenue for 2025 is 454.56 billion CNY, a year-on-year increase of 15.84% - Adjusted net profit is projected to be 149.57 billion CNY, up 41.33%, with total net profit reaching 191.51 billion CNY, a 102.65% increase [2] - The company has 24 GLP-1 drug candidates, with 15 in Phase II and III clinical trials, indicating strong pipeline growth [4] 2. Kanglong Chemical (康龙化成) - Anticipates revenue between 138.72 billion CNY and 142.4 billion CNY, reflecting a growth of 13%-16% - Adjusted net profit is expected to be between 17.68 billion CNY and 18.48 billion CNY, a growth of 10%-15% [2] 3. Sunway Pharma (阳光诺和) - Projected revenue between 1.192 billion CNY and 1.37 billion CNY, a growth of 10.57%-27.15% - Expected net profit between 190 million CNY and 229 million CNY, a growth of 7.69%-29.23% [2] 4. AstraZeneca (阿斯利康) - Focused on cardiovascular, ADC, next-generation IO, and cell therapy TCE areas - Key clinical data readouts expected in 2026, which may impact market dynamics [5] 5. Gilead Sciences (吉利德) - Key projects include Cloud Native Top two ADC, expected to show promising data in TNBC treatment and potential approval in the second half of the year [8] - Anticipates significant changes in the first-line triple-negative breast cancer market due to the SG molecule [8] 6. DZD Pharma (迪哲医药) - DZD6,008 shows significant efficacy in non-small cell lung cancer (NSCLC) with an ORR of 60% and PFS exceeding 10 months [3][16] Clinical Trials and Data Readouts - Multiple companies, including Gilead, AstraZeneca, and others, are set to release important clinical trial data in 2026, which could reshape competitive dynamics in the NSCLC market [16] - AstraZeneca's ADC project 18.2 is expected to have significant clinical data readouts in 2026, with a focus on large-scale Phase III trials [7] Strategic Collaborations and Market Expansion - WuXi Biologics (药明生物) has signed a strategic cooperation memorandum with Qatar Free Zone Authority to expand into the Middle East market [4] - The conference highlighted the increasing participation of Chinese companies in the global pharmaceutical market, particularly in the dual-antibody and ADC sectors [22] Emerging Trends and Innovations - The industry is witnessing a shift towards L2.0 and ADC combinations, which are expected to become the next wave of drug development [17][18] - The importance of speed and mechanism synergy in new drug development was emphasized, indicating that early-stage projects have a higher success rate [18] Conclusion - The biopharmaceutical industry is poised for significant growth, with several companies reporting strong projections and innovative clinical developments. The upcoming clinical data releases in 2026 are anticipated to have a substantial impact on market dynamics and competitive positioning within the sector.

Core Viewpoint - Beijing Sunshine Nuohuo Pharmaceutical Research Co., Ltd. has voluntarily disclosed its 2025 annual performance forecast, indicating a positive growth trajectory in revenue and profit for the upcoming year [2][10]. Performance Forecast - The expected operating revenue for 2025 is projected to be between 1,192.45 million yuan and 1,371.32 million yuan, representing a year-on-year increase of 10.57% to 27.15% [2]. - The anticipated total profit for 2025 is estimated to be between 195.79 million yuan and 234.94 million yuan, reflecting a year-on-year growth of 11.25% to 33.50% [2]. - The net profit attributable to the parent company is forecasted to be between 191.05 million yuan and 229.26 million yuan, indicating a year-on-year increase of 7.69% to 29.23% [2]. - The net profit after deducting non-recurring gains and losses is expected to be between 179.70 million yuan and 215.64 million yuan, with a year-on-year growth of 8.84% to 30.61% [2]. Previous Year Performance - In the previous year, the operating revenue was 1,078.47 million yuan [4]. - The total profit was 175.99 million yuan, and the net profit attributable to the parent company was 177.41 million yuan [4]. - The net profit after deducting non-recurring gains and losses was 165.11 million yuan [4]. Reasons for Performance Changes - The company's revenue and profit are expected to grow steadily due to the deepening layout of its innovative drug pipeline, realization of value from authorized collaborations, and synergistic support from its integrated service model [6]. - The focus on innovative drug research and development, particularly in areas with global intellectual property rights, has led to a pipeline matrix that includes over 20 first-class new drugs targeting major diseases [6]. - The integration of AI technology with unique technical platforms has further enhanced the company's core competitiveness, facilitating rapid advancement of its research pipeline [6][7]. - Authorized collaborations and revenue sharing have become key drivers of profit growth, with significant income generated from the licensing of pipelines like STC007 and STC008 [7].

Core Viewpoint - Sunshine Nuohua Pharmaceutical Research Co., Ltd. has received a first-instance judgment regarding a contract dispute over R&D expenses with Hunan Hengsheng Pharmaceutical Co., Ltd., which requires Hengsheng to pay 254,000 yuan in overdue R&D fees and corresponding penalties, while rejecting other claims from Sunshine Nuohua [1][2]. Group 1 - The court ruled that Hengsheng must pay Sunshine Nuohua 254,000 yuan within fifteen days from the judgment's effective date, along with a penalty calculated at a 5% annual interest rate from November 23, 2022, until actual payment [1]. - Sunshine Nuohua has fully provisioned for bad debts related to the overdue amount, indicating that the lawsuit will not negatively impact the company's current or future profits [2]. - The case is still within the appeal period, allowing Hengsheng to appeal to the Hunan Provincial High People's Court within fifteen days of receiving the judgment, introducing uncertainty regarding the final execution of the ruling [2].

阳光诺和(688621.SH)发布公告，公司预计2025年年度实现归属于母公司所有者的净利润为1.91亿元至 2.29亿元，与上年同期相比，增加1,364.26万元至5,185.30万元，同比增长7.69%到29.23%。 ...