[Table_Author] 分析师：王俐媛 执业证书号：S1030524080001 电话：0755-83199599 邮箱：wangly1@csco.com.cn 研究助理：徐伊琳 电话：0755-23602217 邮箱：xuyl@csco.com.cn 公司具备证券投资咨询业务资格 证券研究报告 医药生物 G 测序仪龙头押注技术跃迁 [Table_ReportDate] 2026 年 03 月 02 日 [Table_ReportType] 医药生物行业周报（2 月第 4 周） [Table_S 行业观点： ummary] 请务必阅读文后重要声明及免责条款 [Table_Industry] [Table_BaseData] | 一、 市场周度回顾 3 | | | | --- | --- | --- | | 二、 行业要闻及重点公司公告 4 | | | | 2.1 | 行业重要事件 | 4 | | 2.2 | 行业要闻 | 4 | | 2.3 | 公司公告 | 5 | 1) 区间回顾。2 月 9 日-2 月 27 日，医药生物板块跌 0.32%，跑输 Wind 全 A（3.89%）和沪深 300（1.44 ...

Core Insights - The National Medical Products Administration (NMPA) is focusing on supporting the innovative development of the biomanufacturing industry during the 14th Five-Year Plan period, transitioning from "follow-up innovation" to "systematic innovation" and from "scale-speed growth" to "quality-efficiency growth" [1] - In 2025, China approved 76 innovative drugs, showcasing its leading position in global R&D applications, with a trend towards complex frontier technologies, diversified innovation entities, and internationalized regulatory standards [1] - The medical device sector is also experiencing strong innovation, with 76 innovative medical devices approved in 2025, a 17% year-on-year increase, and a significant rise in priority approvals [1] Industry Developments - In 2026, the NMPA plans to strengthen drug safety risk management by enhancing risk prevention mechanisms and regulatory oversight across the entire drug clinical trial chain [2] - The focus will be on encouraging innovation while managing risks, particularly in the development of urgently needed drugs and the implementation of drug trial data protection systems [2] - The NMPA aims to improve the quality and efficiency of generic drug evaluations and strengthen post-marketing management of generic drugs [2] Regulatory Enhancements - The NMPA will enhance supervision of online drug sales and improve the drug information traceability system to increase risk management efficiency [2] - Specific attention will be given to new drug targets, AI-driven drug development, and cell and gene therapies, with expedited approval channels to accelerate the market entry of new and effective drugs [2]

Group 1: Company Overview - Chengdu Zeling Biopharmaceutical Technology Co., Ltd. (Zeling Bio) has submitted its prospectus for an IPO on the Hong Kong Stock Exchange, with Jefferies and CICC as joint sponsors [1] - The company recently completed a C round financing of nearly 600 million RMB, led by Daming Capital and Qiming Venture Partners, bringing its valuation to approximately 3.411 billion RMB [1] - Zeling Bio was founded in 2019 and focuses on innovative therapies for blood diseases, tumors, central nervous system disorders, and immune/inflammatory diseases [2] Group 2: Product Pipeline - Zeling Bio has established three technology platforms: ZeniFol for small molecule drug identification and optimization, ZeniMin for AI-driven drug development, and ZeniScreen for clinical-related screening and target discovery [2] - The company has a pipeline of eight products, including two core products in Phase III clinical trials, two candidates in clinical stages, and four in preclinical stages [3] Group 3: Key Products - The lead product, Malate Fluorotinib (FM), is a first-in-class triple-target inhibitor aimed at treating myeloproliferative neoplasms, including myelofibrosis and polycythemia vera [4] - FM is positioned against Novartis' Ruxolitinib, which has been a cornerstone therapy since its approval in the U.S. in 2011 [4] - Zeling Bio plans to submit a new drug application for FM to the National Medical Products Administration (NMPA) in 2027 and has initiated a Phase IIb head-to-head clinical trial against Ruxolitinib [6] Group 4: Financial Performance - Zeling Bio reported revenues of 19.66 million RMB and 7.12 million RMB for 2024 and the first three quarters of 2025, respectively, with significant losses of 91.66 million RMB and 119.04 million RMB during the same periods [9] - The primary reasons for the losses are high R&D expenditures and changes in the value of redeemable debt, with a significant focus on the two core products FM and PM [10] Group 5: Funding and Shareholding - The company has completed five rounds of financing, raising a total of 1.18 billion RMB, with investors including Qiming Venture Partners and Tencent [12] - Chen Lijuan holds a combined direct and indirect stake of 25.6%, making her the largest shareholder group [14]

Policy Developments - Jiangxi Province is promoting the development of brain-computer interface medical devices, emphasizing the need for regulatory compliance and collaboration among industry players to seize opportunities in emerging technologies [1] - The market for brain-computer interface medical devices is noted to have significant potential, with a strong development momentum in Jiangxi Province [1] Medical Device Approvals - In October, the National Medical Products Administration approved 204 medical device products, including 173 domestic Class III devices, 10 imported Class III devices, and 21 imported Class II devices [2] Pharmaceutical Logistics - The Shanghai Municipal Drug Administration encourages the development of modern pharmaceutical logistics, advocating for improved storage and management systems to enhance operational efficiency and reduce costs [3] Drug Approvals - Fangsheng Pharmaceutical announced that its Indobufen tablets received a drug registration certificate from the National Medical Products Administration, allowing for production [4] - Saito Bio's application for the chemical raw material drug Mometasone Furoate has been approved, indicating its use in treating asthma and skin conditions [5] - Tianyao Pharmaceutical received a drug registration certificate for Metoclopramide injection, which is used for treating nausea and vomiting [6] Capital Market Activities - Yingsi Intelligent submitted a listing application to the Hong Kong Stock Exchange, aiming to raise funds for its AI-driven drug development initiatives [7][8] - Rejuve Bio plans to repurchase shares worth between 100 million and 200 million yuan to support employee stock ownership plans [9] Industry Developments - AstraZeneca's Baxdrostat demonstrated significant reductions in 24-hour average systolic blood pressure in treatment-resistant hypertension patients during the Bax24 Phase III trial, achieving a reduction of 14.0 mmHg compared to placebo [10][11] - The drug showed good overall tolerability and consistent safety profiles, with a notable percentage of patients achieving target blood pressure levels [11] - Maiwei Bio's IL-11 monoclonal antibody 9MW3811 received approval for Phase II clinical trials targeting pathological scars, marking it as the first IL-11 targeted drug to enter clinical trials for this indication [12] - Aiwei Technology's subsidiary obtained a medical institution practice license, enabling it to provide third-party medical testing services [13] - Anke Bio signed an exclusive agency framework agreement with Boshengji for the PA3-17 injection product, aimed at enhancing its product portfolio in the innovative drug market [14][15]

Core Viewpoint - The stock of Heptagon Pharmaceuticals (02142) rose over 5%, currently up 5.46% at HKD 13.94, with a trading volume of HKD 17.1969 million, following the announcement of a strategic partnership with Evinova at the 8th China International Import Expo to enhance the efficiency of innovative biotherapy development through AI and digital technologies [1] Group 1 - Heptagon Pharmaceuticals and Evinova will leverage their respective strengths to build an AI-driven open ecosystem for drug development [1] - The company recently launched its first fully human AIHCAb model driven by the Hu-mAtrIx AI platform during a global R&D day event in Shanghai [1] - The AIHCAb model is based on proprietary HarbourMice platform data and integrates a fine-tuned large language model (LLM) for sequence generation, complemented by high-precision AI classification and drugability prediction models [1] Group 2 - The platform differs from traditional screening methods by achieving a closed-loop process of AI design, intelligent screening, and wet lab validation [1]

Core Insights - The article highlights the potential of AI-driven drug discovery, specifically focusing on the development of ISM5939, a small molecule inhibitor targeting ENPP1 to enhance tumor immunity and overcome resistance to existing therapies [1][2][3] Group 1: AI-Driven Drug Development - Insilico Medicine has published its third AI-driven drug development research in a Nature journal since 2025, showcasing the integration of advanced generative AI platforms in drug discovery [1][3] - The research emphasizes the use of AI to identify and validate the role of ENPP1 in various solid tumors, leading to the development of the highly specific oral ENPP1 inhibitor ISM5939 [2][3] Group 2: Mechanism and Efficacy of ISM5939 - ISM5939 targets ENPP1 to precisely regulate the STING signaling pathway within tumor tissues, restoring local immune activation and enhancing anti-tumor immune responses [1][6] - The study confirms that ENPP1 inhibitors can overcome dual resistance to immune checkpoint inhibitors and chemotherapy, providing new treatment hope for refractory cancer patients [1][6] Group 3: Clinical Development and Future Prospects - ISM5939 has shown promising preclinical data, demonstrating enhanced efficacy when combined with various therapies, including anti-PD-1 treatments and chemotherapy [9] - The FDA granted clinical trial approval for ISM5939 in November 2024, marking a significant milestone in its development [9] - The research team aims to inspire the industry with their findings, potentially leading to new generations of innovative cancer therapies [9][10]