理解 MNC 供应链的壁垒 医药生物 最近 12 月市场表现 -9% -2% 4% 11% 18% 25% 医药生物 沪深300 上证指数 分析师 华挺 SAC 证书编号：S0160523010002 huating@ctsec.com 联系人 宋田田 songtt@ctsec.com 证券研究报告 行业投资策略周报 / 2025.11.24 投资评级:看好(维持) 相关报告 1. 《关注小核酸产业链带来的投资机遇》 2025-11-17 2. 《疾病专题报告（四）-双抗在自免领域 潜力大》 2025-11-11 3. 《 MNC 在 小 核 酸 领 域 积 极 布 局 》 2025-11-10 理解 MNC 供应链的壁垒 核心观点 请阅读最后一页的重要声明！ ❖ 医药 MNC 供应链体系具有极高的准入壁垒。MNC 供应商认证周期通 常需要多年，需经历技术、质量、EHS 及合规等多部门交叉审计，且一旦纳 入合格供应商名录，便会形成强锁定效应——变更供应商需启动复杂的影响 评估与再验证流程，成本高昂，因此新进入者即便技术达标，也难以在短期内 撼动既有供应格局，具有较强的先发者优势。 ❖ MNC 对供应链的要求远 ...

编辑丨王多鱼 排版丨水成文 近十年来，中国科学家在 细胞出版社 （Cell Press） 旗下期刊上的论文数量实现了跨越式增长，研究主题从单一学科拓展到交叉前沿，合作网络从国内延伸至全 球，展示了中国科研在原创性、系统性与开放性上的全面提升。无论是在生命科学、物质科学，还是在能源、医学与人工智能等交叉领域，中国科学家的声音都 越来越清晰、越来越有分量。 2024 年，中国科学家的研究产出数量持续提升，以中国机构为第一完成单位、发表在 细胞出版社 （Cell Press） 旗下研究型期刊上的研究论文数量继续快速增 长， 总发文量达到 2446 篇，较上一年增加了 17.6%，是 2020 年发表量的近 4 倍 。 近日， 细胞出版社 （Cell Press） 评选出了" 细胞出版社 2024 中国年度论文 "， 生命科学领域、物质科学领域、医学领域、交叉学科领域和可持续发展五个领 域，每个领域 10 篇，共计 50 篇，全部入选论文详见： 细胞出版社2024中国年度论文奖重磅公布：十年见证中国科研前进之路！ 本文将介绍入选 " 细胞出版社 2024 中国年度论文 "的 医学 领域 10 篇论文，排名不分先后。生 ...

每经记者｜金喆 每经编辑｜魏官红 H 复宏汉霖孰 0.0 ● ● . . . ● ● · ● 12 : . . . . o o : 。 · C . . . . o C :00 l 'el 根据丁香园Insight数据库统计，6月13日到6月18日，国家药品监督管理局药品审评中心共收到6家上市公司提交的9个化学新药、生物制品新药申请。 一周新药申请 本周，恒瑞医药（600276.SH）、信达生物（01801.HK）、石药集团（01093.HK）各申报2个临床申请；亚盛药业-B（06855.HK）、复宏汉霖 （02696.HK）、康方生物-B（09926.HK）各递交1个临床申请。 按申请类别划分，本阶段申报类别全部为抗肿瘤药物。 《掘金创新药》由每日经济新闻联合丁香园Insight数据库共同推出，旨在解读新药研发进展与趋势，剖析产品竞争力与市场前景，洞察医药资本脉络，见证 医药产业高质量发展。 | 药品名称 | 药品类型 | 申请 | CDE 源企业 | 成分治疗 | 成分最高 | | --- | --- | --- | --- | --- | --- | | | | 内容 | | 令流域 | 进度 | | 重 ...

截至本公告日期，全球范围内尚无靶向PD-1的单克隆抗体药品获批用于胃癌新辅助/辅助治疗。根据 IQVIA MIDAS最新数据，2024年，靶向PD-1的单克隆抗体药品于全球的销售额约为457.04亿美元。 复宏汉霖(02696)午后涨超6%，截至发稿，涨4.94%，报66.95港元，成交额6313.55万港元。 消息面上，复宏汉霖近日宣布，创新型PD-1抑制剂H药斯鲁利单抗被中国国家药品监督管理局(NMPA) 药品审评中心(CDE)正式纳入突破性治疗品种，联合化疗用于新辅助/辅助治疗胃癌。H药针对该适应症 的3期临床研究达到了主要终点，作为胃癌围手术期以免疫单药取代术后辅助化疗的治疗方案，有望为 患者带来生存获益与生活质量提升的双重突破。 ...

截至本公告日期，全球范围内尚无靶向PD-1的单克隆抗体药品获批用于胃癌新辅助/辅助治疗。根据 IQVIA MIDAS最新数据，2024年，靶向PD-1的单克隆抗体药品于全球的销售额约为457.04亿美元。 智通财经APP获悉，复宏汉霖(02696)午后涨超6%，截至发稿，涨4.94%，报66.95港元，成交额6313.55 万港元。 消息面上，复宏汉霖近日宣布，创新型PD-1抑制剂H药斯鲁利单抗被中国国家药品监督管理局 （NMPA）药品审评中心（CDE）正式纳入突破性治疗品种，联合化疗用于新辅助/辅助治疗胃癌。H药 针对该适应症的3期临床研究达到了主要终点，作为胃癌围手术期以免疫单药取代术后辅助化疗的治疗 方案，有望为患者带来生存获益与生活质量提升的双重突破。 ...

Summary of Fosun Pharma's APAC Healthcare Corporate Day 2025 Company Overview - **Company**: Fosun Pharma (2196.HK) - **Industry**: Pharmaceuticals and Healthcare Key Points Industry and Market Dynamics - **VBP Impact**: The company noted ongoing impacts from the Volume-Based Procurement (VBP) policy on its generic drug portfolio, leading to a decline in total sales by **5.5% year-over-year** in Q3 [3] - **Sales Performance**: The pharmaceutical segment, which includes a large generic portfolio with sales exceeding **Rmb20 billion**, is facing further price cuts due to VBP renewal [3] Financial Performance - **Sales Figures**: Innovative products generated **Rmb6.7 billion** in sales, reflecting an **18% year-over-year** growth for the first nine months of 2025, partially offsetting the decline in generics [3] - **Device Business Recovery**: The device segment is showing signs of recovery, driven by increased demand for aesthetic equipment and flu vaccines [3] Growth Strategy - **CAGR Target**: The company aims for a **20% compound annual growth rate (CAGR)** for its innovative product sales from 2025 to 2027, supported by several key drivers [4] - **Biosimilars and New Products**: The growth strategy includes expanding its biosimilar portfolio and launching new products such as denosumab and pertuzumab, alongside overseas commercialization efforts [4] Research and Development - **R&D Investment**: Fosun Pharma has allocated approximately **Rmb6 billion** annually for R&D, with the majority focused on drug development, including biologics and innovative therapies [7] - **Efficiency in R&D**: The company has improved the efficiency of its R&D spending, with a focus on cutting duplicated projects based on clinical data [7] Risks and Valuation - **Price Target**: The 12-month price targets are set at **HK$27.35** and **Rmb37.63**, indicating potential upsides of **22.0%** and **33.3%** respectively [9] - **Key Risks**: Upside risks include better-than-expected sales from innovative drugs and aesthetic devices, while downside risks involve pricing pressures on generics and potential slower growth from Sinopharm [8] Additional Insights - **Asset Divestiture**: The company is considering divesting assets, although Gland Pharma is not currently prioritized for this strategy [2] - **Commercial Insurance**: Yescarta has been included in the commercial insurance drug list, which is expected to facilitate patient access [2] This summary encapsulates the critical insights from Fosun Pharma's recent corporate day, highlighting the company's strategic focus on innovation amidst regulatory challenges in the pharmaceutical landscape.

Core Insights - Shanghai Junshi Biosciences Co., Ltd. (复宏汉霖) announced key updates on its investigational product HLX43, a PD-L1 targeted antibody-drug conjugate for non-small cell lung cancer (NSCLC) treatment at the 2025 International Lung Cancer Frontier and Innovation Forum [1] - HLX43 has received orphan drug designation from the FDA for thymic epithelial tumors, indicating its potential in treating advanced/metastatic solid tumors [1] - The company plans to initiate at least eight Phase III clinical trials for HLX43, with lung cancer indications prioritized [1] Company Developments - CEO Dr. Zhu Jun emphasized the commitment to developing HLX43 despite limited resources, highlighting lung cancer as the leading malignancy in both global and Chinese contexts [2] - Junshi has successfully launched nine products globally, including the first approved PD-1 monoclonal antibody for first-line treatment of small cell lung cancer [2] - Goldman Sachs issued a research report covering Junshi, projecting HLX43 as a core driver for the company's global innovation pipeline and assigning a "buy" rating with a 12-month target price of HKD 100.70 per share [2] Clinical Data - As of October 22, 2025, 174 advanced NSCLC patients were enrolled in the study, with 89 receiving 2.0 mg/kg and 85 receiving 2.5 mg/kg of HLX43 [3] - The overall efficacy of HLX43 was promising, with an objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 75.8% in squamous NSCLC patients [3] - In non-squamous patients, the ORR increased to 48.6% and the DCR reached 94.3% [3] Treatment Potential - Among previously treated squamous NSCLC patients who had undergone docetaxel therapy, the ORR was 38.5% and the DCR was 84.6%, indicating HLX43's significant potential in this population [4] - Docetaxel is currently the standard second-line treatment for squamous NSCLC, with an ORR slightly above 10%, suggesting HLX43 may redefine treatment standards for this disease [4]

Group 1 - The rise of targeted and immunotherapy has fundamentally reshaped the treatment landscape for lung cancer, with new therapies such as antibody-drug conjugates (ADC), bispecific antibodies, T-cell engagers (TCE), and tumor vaccines emerging rapidly [1] - Fuhong Hanhlin has successfully launched 9 products in the lung cancer field, benefiting over 900,000 patients globally, including the world's first approved PD-1 monoclonal antibody for first-line treatment of small cell lung cancer, which is now available in nearly 40 countries [1] - The company plans to advance at least 8 Phase III clinical studies focused on lung cancer for its product HLX43, which combines the effects of PD-1 and ADC, and aims to expand into other cancers such as cervical, esophageal squamous cell, and colorectal cancers [1] Group 2 - HLX43, as the second ADC targeting PD-L1 globally, has shown promising treatment effects in advanced non-small cell lung cancer (NSCLC), with objective response rates (ORR) of 33.3% in previously treated squamous cell carcinoma patients and 47.4% in EGFR wild-type non-squamous NSCLC patients [2] - The drug demonstrated an ORR of 30% in patients with brain metastases and a disease control rate (DCR) of 90%, indicating its potential effectiveness across various patient subgroups [2] - Safety data for HLX43 indicates low hematological toxicity, providing a solid foundation for subsequent large-scale clinical studies [2]

Group 1 - The 2025 International Lung Cancer Frontier and Innovation Forum was held in Shanghai, focusing on key topics such as clinical prevention and control of lung cancer, breakthroughs in non-small cell lung cancer (NSCLC), and new advancements in immunotherapy for small cell lung cancer (SCLC) [1] - The rise of targeted and immunotherapy has fundamentally reshaped the treatment landscape for lung cancer, with new therapies like antibody-drug conjugates (ADC), bispecific antibodies, T-cell engagers (TCE), and tumor vaccines emerging rapidly [1] - The global incidence of lung cancer remains the highest among malignant tumors, with the company having launched 9 products that benefit over 900,000 patients worldwide, including the first approved PD-1 monoclonal antibody for first-line treatment of SCLC [1] Group 2 - The company's R&D strategy focuses on antibodies and their derivatives, including monoclonal antibodies, bispecific antibodies, multi-specific antibodies, and ADCs, supported by three core technology engines [2] - High-value projects such as HLX3901 and HLX48 are prioritized for future development, while the company continues to build a robust pipeline [2] - Local innovative enterprises have made significant progress over the past decade, providing effective "Chinese solutions" for clinical challenges, emphasizing the need for international collaboration and continuous innovation in tackling lung cancer [2]

Core Viewpoint - The "International Lung Cancer Frontier and Innovation Forum" held in Shanghai highlighted the advancements in lung cancer treatment and provided a platform for Chinese innovative pharmaceutical companies to showcase their R&D capabilities, with a focus on the promising PD-L1 antibody-drug conjugate (ADC) HLX43 from Fuhong Hanlin [1][2]. Group 1: Company Overview - Fuhong Hanlin has successfully launched nine products, benefiting over 900,000 patients globally, and is recognized as a pioneer in the lung cancer treatment field [2]. - The company aims to leverage its innovative pipeline, particularly HLX43, to achieve breakthroughs in lung cancer treatment and expand its global presence [3][4]. Group 2: Product Highlights - HLX43 demonstrated broad efficacy without dependence on biomarkers, making it a potential "best-in-class" product for various lung cancer patients, regardless of their EGFR mutation status or PD-L1 expression levels [5][7]. - In clinical trials, HLX43 showed an objective response rate (ORR) of 48.6% in non-squamous NSCLC and 33.3% in squamous NSCLC, indicating its effectiveness in hard-to-treat patient populations [6][7]. - The drug also exhibited a high disease control rate (DCR) of 90.0% in patients with brain metastases, showcasing its ability to penetrate the blood-brain barrier [7][8]. Group 3: Market Potential and Strategic Positioning - The positive data from HLX43 has attracted attention from top investment institutions, with Goldman Sachs issuing a "buy" rating and setting a target price of HKD 100.70, indicating strong upside potential for the company [9][10]. - The company is positioned to transition from a biosimilar pioneer to a global innovative pharmaceutical player, with HLX43 as a key driver of its global pipeline [10][11]. Group 4: Future Outlook - The successful forum and HLX43 data release mark a milestone for Fuhong Hanlin, indicating that its "innovation-driven" strategy is yielding results and establishing its capability to produce globally competitive drugs [11]. - The anticipated expansion of HLX43's indications and continued clinical advancements are expected to solidify its role as a core growth driver for the company's future performance [11].