| 国泰海通证券 | | --- | | GUOTAI HAITONG SECURITIES | 目 录 | | 每日报告精选（2025-10-09 09:00——2025-10-10 15:00） | 2 | | --- | --- | --- | |  | 策略观察：《成交活跃度升高，万得全 A 估值领涨》2025-10-09 | 2 | |  | 行业专题研究：传播文化业《中国规模最大、增速最快的潮玩集合品牌，产品与渠道双轮驱动》2025-10-102 | | |  | 行业跟踪报告：机器人《Figure 03 展示家庭应用场景，为规模化生产做准备》2025-10-10 | 3 | |  | 行业深度研究：医药《小核酸，大时代，靶向治疗新纪元》2025-10-10 | 4 | |  | 行业跟踪报告：建筑工程业《建筑铜金等矿产价值重估，降息预期催化资源品涨价》2025-10-10 | 5 | |  | 行业跟踪报告：投资银行业与经纪业《25H1 小结：高增之下，酝酿变化》2025-10-10 | 6 | |  | 行业跟踪报告：半导体设备《自强，先进制程设备的突破是核心》2025-10-0 ...

数据来源：沙利文 小核酸药物，即寡核苷酸药物，是由十几个到几十个核苷酸串联组成的短链核酸，作用于 premRNA或mRNA，通过干预靶标基因表达实现疾病治疗目的。 进入高速爆发期的小核酸药物，正逐渐成为市场关注的焦点。 01 什么是小核酸药物？ 核酸药物可主要分为小核酸药物和mRNA两大类。小核酸药物主要包括反义核酸（ASO）、小干扰 核酸（siRNA）、微小RNA（miRNA）、核酸适配体（Aptamer）和转运RNA（tRNA）碎片。mRNA产 品可分为mRNA疫苗和mRNA药物。 自二十世纪70年代以来，随着科学界对于机制的不断发现，小核酸药物开启早期的研发探索。1978 年哈佛大学科学家首次提出反义核酸的概念，1998年Andrew Fire和Craig Mello在线虫中首次揭示了 RNA干扰的作用机理（RNAinterference，RNAi），两人因此于2006年获得诺贝尔奖。 但在2010年左右，由于RNAi的不稳定性、潜在的免疫原性及递送系统的缺乏，研发迟迟未有突 破，导致大型制药企业纷纷撤资，行业发展遭遇瓶颈。2014年后，随着小核酸偶联递送系统Gal Nac的 发展，极大地促进和推动了小 ...

Core Viewpoint - The global small nucleic acid drug market is experiencing significant growth, with a projected increase from $4.6 billion in 2023 to $46.7 billion by 2033, driven by technological advancements and increased clinical approvals [1][2]. Market Growth - The global small nucleic acid drug market size grew from $2.7 billion in 2019 to $4.6 billion in 2023, reflecting a compound annual growth rate (CAGR) of 14.3% [2]. - The market is expected to accelerate growth starting in 2023, with a projected CAGR of 26.1% until it reaches $46.7 billion by 2033 [1][2]. Technological Advancements - Small nucleic acid drugs are becoming more mature, offering significant advantages over traditional small molecule and antibody drugs, including shorter development cycles, a wider range of targets, lasting effects, and higher success rates [1][3]. - These drugs act directly on the mRNA level, targeting "undruggable" targets that traditional drugs cannot reach, providing new treatment options for many difficult-to-treat diseases [1]. Shift in Focus - The trend is shifting from rare diseases to chronic and common diseases, with small nucleic acid drugs expanding into areas such as hyperlipidemia, hepatitis B, and hypertension [2][3]. - Currently, there are 22 approved small nucleic acid drugs globally, primarily focused on rare diseases, but recent data indicates a move towards more prevalent conditions [2]. Domestic Market Dynamics - Domestic innovative pharmaceutical companies are accelerating their entry into the small nucleic acid drug market, focusing on chronic diseases rather than following the traditional model of starting with rare diseases [3]. - Key therapeutic areas for domestic companies include cardiovascular diseases, hepatitis B, and cancer [3]. Investment Opportunities - Companies with proprietary technology platforms and advantageous pipelines are recommended for investment, including Reebio, Sanofi, Bowang Pharmaceutical, Yuyuan Pharmaceutical, CSPC Pharmaceutical, Tsinghua Tongfang, and Hengrui Medicine [4]. - Notable overseas companies include Alnylam, Ionis, and Arrowhead [4].

Summary of the Conference Call for Maiwei Bio Company Overview - **Company**: Maiwei Bio - **Industry**: Biopharmaceuticals, focusing on age-related diseases and chronic conditions Key Points and Arguments 1. **Collaboration Agreement**: Maiwei Bio has entered into a $1 billion collaboration agreement with Editum Bio, acquiring the RM7,141 project, which includes an upfront payment of $12 million, single-digit royalties, and double-digit Series A preferred equity in ClaxBio [2][3] 2. **Focus on Age-Related Diseases**: The company is concentrating on age-related diseases and chronic conditions, utilizing a dual-target small nucleic acid platform established over the past two to three years [2][4] 3. **ClaxBio's Role**: ClaxBio, established by Editum Bio, focuses on high-potential clinical pipeline projects and has successfully incubated companies like Bersani SpA, which was acquired by Eli Lilly for $1.9 billion [2][6] 4. **Research and Development Efficiency**: Maiwei Bio has approximately 400 R&D personnel, with over 100 dedicated to early-stage research, significantly enhancing R&D efficiency, allowing for candidate identification in just a few months [4][12][13] 5. **Patent Strategy**: The company has a comprehensive patent strategy for its siRNA delivery systems, including the dry lac delivery system and Link system, which have shown higher efficiency and lower costs in multiple models [4][18] 6. **Dual-Target Project**: The dual-target project primarily addresses cardiovascular diseases, aiming to achieve stronger synergistic effects through optimized combinations of different targets [10][23] 7. **Future Plans**: Maiwei plans to expand its dual-target approach and explore additional indications, including fat delivery systems, while maintaining a focus on cardiovascular diseases [11][15] 8. **Market Expectations**: Investors have high expectations for the siRNA molecules, as the recent business development validates the efficiency of the small nucleic acid drug development platform [14] 9. **Clinical Trial Timeline**: The project is currently in the early CMC stage, with plans to initiate clinical trials in the US and China in the second half of 2026 [16] 10. **Regulatory Progress**: The white介11 project for pathological scars is expected to receive approval by the end of this year, with initial efficacy data anticipated by mid-next year [25][27] Additional Important Information - **AI Integration**: Maiwei's technology platform is highly automated and AI-enabled, allowing for rapid screening and optimization of potential candidates, which can be replicated across other projects [19] - **Long-term Strategy**: The company emphasizes long-term value in its partnerships, focusing on the background and resource compatibility of potential collaborators [21][22] - **Competitive Advantage**: Maiwei's dual-target small nucleic acid molecules are designed to achieve significant synergistic effects, potentially outperforming existing products in the cardiovascular space [23][29] This summary encapsulates the essential insights from the conference call, highlighting Maiwei Bio's strategic initiatives, R&D capabilities, and market positioning within the biopharmaceutical industry.

Summary of Key Points from the Conference Call on Small Nucleic Acid Drugs Industry Overview - The small nucleic acid drug industry focuses on innovative therapies that degrade mRNA, making previously undruggable targets viable, particularly in cancer treatment [1][2][3] - Small nucleic acid drugs include various forms such as ASO (Antisense Oligonucleotides), siRNA (small interfering RNA), and miRNA (microRNA), each with distinct development challenges and therapeutic prospects [1][4] Core Insights and Arguments - **Clinical Advantages**: Small nucleic acid drugs can target previously inaccessible drug targets, especially in cancer, and have a longer half-life (up to six months in the liver), making them advantageous for chronic disease management [2][3] - **Delivery Technology**: The industry is seeing a shift towards innovative delivery systems, including third-generation systems (antibodies, peptides, fatty acids) to enhance liver and extrahepatic delivery [1][6][14] - **Market Competition**: Domestic companies are employing differentiated designs to navigate patent protections, with firms like Alnylam and Arrowhead leading in specific therapeutic areas [1][8][17] - **Therapeutic Areas**: Key focus areas include cardiovascular diseases, metabolic disorders, and central nervous system (CNS) diseases, with ongoing clinical trials showing promising results [2][17][18] Important but Overlooked Content - **Cost Challenges**: Despite the potential of small nucleic acid drugs, high production costs remain a significant barrier to replacing traditional oral medications [3][22] - **Safety and Efficacy**: While ASO has a lower barrier to entry, it raises safety concerns due to its mechanism of action. In contrast, siRNA offers higher safety and efficacy but requires advanced delivery technologies [5][6] - **Future Trends**: The future of the small nucleic acid sector will likely focus on delivery technology innovations and structural modifications to enhance drug efficacy and reduce competition [11][12] - **Clinical Data Validation**: Chinese companies need to validate their technologies through clinical data to establish competitive advantages and build robust patent barriers [15][20] Conclusion The small nucleic acid drug industry is poised for growth, driven by innovative delivery technologies and the ability to target previously undruggable diseases. However, challenges such as cost, safety, and the need for clinical validation remain critical for future success.

Investment Rating - The report indicates a positive outlook for the pharmaceutical and biotechnology sector, with a weekly increase of 1.4%, outperforming the Wind All A index (-1.37%) and the CSI 300 index (-0.81%) [3][8]. Core Insights - The report highlights the acceleration of business development (BD) in small nucleic acid drugs, with significant deals announced by Arrowhead Pharmaceuticals and Novartis, indicating a strong interest in this area from multinational corporations [3][12]. - The report emphasizes the importance of the World Conference on Lung Cancer (WCLC) held from September 6-9, where several key research advancements in lung cancer were presented, suggesting potential investment opportunities in innovative drug companies participating in the conference [3][11]. - The report notes the strong performance of specific stocks within the sector, such as Haichen Pharmaceutical (28.7%), Changchun High-tech (24.2%), and Baihua Pharmaceutical (21.3%), while also identifying underperformers like Shuyou Shen (24%) and Guangsheng Tang (15.8%) [3][11]. Market Weekly Review - The pharmaceutical and biotechnology sector saw a weekly increase of 1.4%, with the best-performing sub-sectors being other biological products (4.86%), chemical products (4.52%), and medical research outsourcing (3.78%) [3][8]. - Conversely, sectors such as hospitals (-2.31%), vaccines (-2.08%), and medical devices (-1.97%) experienced declines [3][8]. - Notable individual stock performances included significant gains for Haichen Pharmaceutical, Changchun High-tech, and Baihua Pharmaceutical, while Shuyou Shen and Guangsheng Tang faced substantial losses [3][11]. Industry News and Key Company Announcements - Arrowhead Pharmaceuticals announced a global licensing and collaboration agreement with Novartis for a siRNA therapy targeting Parkinson's disease, with an upfront payment of $200 million and potential milestone payments totaling up to $2 billion [3][15]. - A strategic collaboration was established between Novartis and Wobang Pharmaceuticals for cardiovascular products, with an upfront payment of $160 million and potential total milestone payments of $5.2 billion [3][13]. - The report also mentions various clinical trial advancements and approvals for several companies, including the approval of new indications for existing drugs and the initiation of new clinical trials [3][16].

Core Viewpoint - Ruizhi Pharmaceutical has successfully turned around its financial performance in the first half of 2025, achieving a revenue of 534 million yuan, a year-on-year increase of 14.75%, and a net profit of 25.38 million yuan, compared to a loss of 62.91 million yuan in the same period last year, marking a significant turnaround with a growth rate of 140.35% [1][2][8] Financial Performance - The company's gross profit margin improved significantly from 16.30% to 29.01%, an increase of 12.71 percentage points, indicating enhanced operational efficiency and cost control [2][3] - In Q2 2025, the company reported a revenue of 273 million yuan, up 18.2% year-on-year, and a net profit of 18.74 million yuan, reflecting a substantial quarter-on-quarter growth of 182% [3][4] Business Segments - The large molecule business segment saw remarkable growth of 54.68%, reaching 105 million yuan, driven by increased demand in areas such as ADC (antibody-drug conjugates) and bispecific antibodies [4][6] - The pharmacokinetics and pharmacodynamics segment generated 293 million yuan, a year-on-year increase of 13.44%, with the number of clients growing to 475 [4][6] - The chemical business segment's revenue remained stable at 131 million yuan, primarily due to intense competition and a shift of some clients towards biopharmaceuticals [4][6] Strategic Initiatives - Under the leadership of WOO SWEE LIAN, the company has restructured its organization and refocused its strategic priorities, enhancing its "full-package service" model to provide more efficient drug development solutions [6][7] - The company has established several strategic partnerships, including a ten-year collaboration with Saint No Pharmaceuticals to advance small nucleic acid drug development, leveraging each other's strengths [7][8] - The company is expanding its global presence, particularly in the U.S. and Europe, by increasing its business development team and participating in industry conferences [7][8] Industry Context - The global CRO market is experiencing a growth rate of approximately 8.5%, while the Chinese CRO market, although still in double digits, has shown signs of slowing compared to previous years [1][6] - Other CRO companies have also reported positive performance, indicating a broader recovery in the industry, with WuXi AppTec achieving a revenue of 20.8 billion yuan, up 20.64% year-on-year [7][8]