证券研究报告 | 2025年06月03日 康方生物（09926.HK） HARMONi 临床达到 PFS 主要终点，国内外患者展现出一致的获益 |  | 公司研究·海外公司快评 | |  医药生物·生物制品 |  投资评级：优于大市（维持） | | --- | --- | --- | --- | --- | | 证券分析师： | 陈曦炳 | 0755-81982939 | chenxibing@guosen.com.cn | 执证编码：S0980521120001 | | 证券分析师： | 彭思宇 | 0755-81982723 | pengsiyu@guosen.com.cn | 执证编码：S0980521060003 | | 证券分析师： | 陈益凌 | 021-60933167 | chenyiling@guosen.com.cn | 执证编码：S0980519010002 | 事项： 公司合作伙伴 Summit 公告 HARMONi 临床达到 PFS 主要临床终点。 国信医药观点：1）HARMONi 是依沃西联合含铂双药化疗治疗 EGFR-TKI 治疗进展的 EGFRm NSCLC 的全球多 中 ...

截至6月3日收盘，细胞免疫治疗概念上涨3.87%，位居概念板块涨幅第2，板块内，51股上涨，舒泰 神、冠昊生物等20%涨停，海南海药、ST中珠等涨停，睿智医药、佐力药业、荣昌生物等涨幅居前，分 别上涨13.15%、10.66%、9.90%。跌幅居前的有雪榕生物、*ST生物、复星医药等，分别下跌1.76%、 1.14%、0.39%。 今日涨跌幅居前的概念板块 | 概念 | 今日涨跌幅（%） | 概念 | 今日涨跌幅（%） | | --- | --- | --- | --- | | 中韩自贸区 | 4.23 | 特钢概念 | -0.93 | | 细胞免疫治疗 | 3.87 | 医疗废物处理 | -0.51 | | 重组蛋白 | 3.64 | 果指数 | -0.41 | | 足球概念 | 3.56 | 无线充电 | -0.39 | | 毛发医疗 | 3.51 | 光热发电 | -0.33 | | CRO概念 | 3.41 | 深圳国企改革 | -0.24 | | 创新药 | 3.38 | F5G概念 | -0.23 | | 培育钻石 | 3.11 | 租售同权 | -0.22 | | 仿制药一致性评价 | 3.08 ...

| 概念 | 今日涨跌幅（%） | 概念 | 今日涨跌幅（%） | | --- | --- | --- | --- | | 中韩自贸区 | 4.23 | 特钢概念 | -0.93 | | 细胞免疫治疗 | 3.87 | 医疗废物处理 | -0.51 | | 重组蛋白 | 3.64 | 果指数 | -0.41 | | 足球概念 | 3.56 | 无线充电 | -0.39 | | 毛发医疗 | 3.51 | 光热发电 | -0.33 | | CRO概念 | 3.41 | 深圳国企改革 | -0.24 | | 创新药 | 3.38 | F5G概念 | -0.23 | | 培育钻石 | 3.11 | 租售同权 | -0.22 | | 仿制药一致性评价 | 3.08 | 一体化压铸 | -0.21 | | 眼科医疗 | 3.08 | 硅能源 | -0.18 | 资金面上看，今日足球概念板块获主力资金净流入662.48万元，其中，14股获主力资金净流入，8股主 力资金净流入超千万元，净流入资金居首的是粤传媒，今日主力资金净流入9298.90万元，净流入资金 居前的还有蒙草生态、金陵体育、中体产业等，主力资金分别净流入56 ...

Financial Data and Key Metrics Changes - The company has achieved significant growth, reaching over 3.4 million patients treated globally with its oncology medicines, supported by strong commercial execution [56] - Keytruda is approved in 56 indications in the US, 44 in the EU, and 41 in Japan, showcasing its leadership in immuno-oncology [56][59] Business Line Data and Key Metrics Changes - The oncology portfolio has yielded 35 phase three trials with statistically significant overall survival and 56 FDA approved indications [7] - The development of subcutaneous pembrolizumab with barahyaluronidase alfa has shown comparability to IV Keytruda, with a median injection time of two minutes [17][19] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in earlier stage diseases, particularly in head and neck cancer, where there is a significant unmet medical need [60] - The anticipated peak uptake of subcutaneous pembrolizumab in the US is expected to reach between 30-40% within 18 to 24 months [62] Company Strategy and Development Direction - The company aims to diversify its oncology portfolio beyond Keytruda, focusing on additional therapeutic areas such as HIV vaccines, immunology, cardiovascular, and ophthalmology [6] - The strategy includes leveraging the proven track record of Keytruda to sustain leadership in oncology beyond its loss of exclusivity in 2028 [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing development of innovative therapies and the potential for significant impact on cancer care through a diversified pipeline [55] - The company is committed to maximizing patient access and improving outcomes through its robust commercial engine and innovative product offerings [63] Other Important Information - The company has a strong focus on biomarker development, which is crucial for patient selection and optimizing treatment outcomes [36] - There are ongoing phase III studies for various agents, including MK1084 and Sac TMT, which are expected to read out in the near future [53][64] Q&A Session Summary Question: What is the company's perspective on the evolving market for PD-1, PD-L1, and VEGF bispecifics? - Management highlighted the consistent improvements in progression-free survival across multiple indications and expressed optimism about the ongoing trials in China, with plans to expand to the US [75][78] Question: How does the company view the market opportunity for head and neck cancer treatments? - Management clarified that patients receiving preoperative Keytruda did not lose the opportunity for surgery, and emphasized the safety and efficacy of the treatment [79]

Core Viewpoint - The announcement highlights the clinical data and latest progress of ZG006 and ZG005, which will be presented at the 2025 ASCO annual meeting, indicating the company's ongoing commitment to advancing its innovative oncology therapies [1]. Group 1: ZG006 Overview - ZG006, also known as Alveltamig, is a trispecific antibody drug developed by the company and its subsidiary, Gensun Biopharma Inc., targeting DLL3 and CD3, and has received orphan drug designation from the FDA [1][2]. - ZG006 is the first-in-class molecule targeting DLL3, showing potential to be a best-in-class therapy [1]. Group 2: ZG006 Clinical Data - In the ZG006-002 study, 48 patients with refractory advanced small cell lung cancer were randomized to receive either 10 mg or 30 mg Q2W treatment, with objective response rates (ORR) of 62.5% and 58.3%, respectively [2][3]. - The disease control rates (DCR) were 70.8% for the 10 mg group and 66.7% for the 30 mg group, with safety profiles showing no treatment-related adverse events leading to permanent discontinuation [3]. - In the ZG006-001 study, 47 patients received varying doses of ZG006, with confirmed ORR of 75.0% for 10 mg, 53.8% for 30 mg, and 58.3% for 60 mg, indicating strong anti-tumor activity [4][5]. Group 3: ZG005 Overview - ZG005, known as Nilvanstomig, is a recombinant humanized bispecific antibody targeting PD-1 and TIGIT, positioned as an innovative immunotherapy for various solid tumors [6][7]. - ZG005 is among the first of its kind to enter clinical research globally, with no similar mechanism drugs approved yet [6]. Group 4: ZG005 Clinical Data - In the ZG005-001 study, 55 patients with advanced cervical cancer were treated, showing an ORR of 40.9% and DCR of 68.2% in the 20 mg/kg group [7]. - The safety profile was favorable, with 83.6% of patients experiencing treatment-related adverse events (TRAE), predominantly grade 1-2 [7]. - In the ZG005-003 study, 60 patients with first-line cervical cancer were treated, with the 20 mg/kg group showing an ORR of 82.1% and DCR of 96.4% [8][9]. Group 5: ZGGS15 Overview - ZGGS15 is a recombinant humanized bispecific antibody targeting LAG-3 and TIGIT, representing a novel approach in tumor immunotherapy [10][11]. - It is the first of its kind to enter clinical research globally, with no similar mechanism drugs approved yet [10]. Group 6: ZGGS15 Clinical Data - In the ZGGS15-001 study, 22 patients were enrolled, with a DCR of 35.3% among evaluable patients [12]. - The safety profile showed that 90.1% of patients experienced TRAE, with no dose-limiting toxicities observed [12][13].

每经记者｜金喆 每经编辑｜魏官红 美东时间5月30日，全球肿瘤学领域规模最大的学术盛会之一的2025年美国临床肿瘤学会（简称"ASCO 2025"）如期而至。中山大学肿瘤防治中心马骏院士在大会口头报告环节解读DIAMOND研究的临床数 据。 长期以来，顺铂联合同期放化疗一直是鼻咽癌治疗的标准基石方案。DIAMOND研究旨在验证"全疗程 免疫、同期去顺铂"能否在疗效上达到与免疫联合含顺铂同期放化疗方案（即CONTINUUM研究试验 组）相媲美的水平，同时显著降低患者呕吐等毒副作用。研究结果显示：采用PD-1抗体特瑞普利单抗 进行全程治疗，并在同期治疗阶段去除顺铂后，成功实现了减毒不减效的目标。 基石疗法毒副作用大，影响治疗依从性 DIAMOND研究为治疗困境提供了全新思路 《每日经济新闻》记者了解到，DIAMOND研究严格筛选532例无远处转移的T3-4N1-2或N2-3期局部区 域晚期患者，采用1∶1随机化原则分配至试验组（特瑞普利单抗+吉西他滨-顺铂诱导化疗后，特瑞普利 单抗+放疗，及特瑞普利单抗辅助治疗，全程17个疗程）与对照组（在试验组基础上增加2疗程顺铂同 期放化疗），疗效终点以FFS和所有分级呕吐发 ...

从二线单药治疗到一线联合化疗的临床数据连番释放，本质上亦映射出中国创新药企在双抗领域从"技术可行性验证"到"临床价值深挖"的进阶能力。 在全球创新药投资逻辑向"真创新、高壁垒"切换的背景下，中国创新药企在双抗等前沿领域持续突破，开始在国际顶级学术舞台展露锋芒。 继去年美国临床肿瘤学会（ASCO）年会以单药疗法惊艳亮相后，维立志博研发的抗PD-L1/4-1BB双抗LBL-024在2025年ASCO舞台再获突破性验证。 那么站在投资者的视角而言，应当如何来看待这一最新临床数据的表现？该数据对于维立志博又有何意义？ 潜在全球首创，真正源头创新锚定临床价值 不同于传统单抗疗法的线性突破逻辑，LBL-024通过PD-L1靶向锁定肿瘤微环境、4-1BB共刺激激活T细胞的"双引擎"设计，实现肿瘤微环境里的条件激活T 细胞，开创性地解决了4-1BB靶点系统性激活引发肝毒性的痛点。这种肿瘤微环境精准调控机制，使其成为全球首个有望实现4-1BB靶点商业化突破的免疫 疗法。 2024 ASCO大会，LBL-024单药在针对二线治疗、三线及以上治疗肺外神经内分泌癌（EP-NEC）的患者中，展现出良好的安全性和强有力的有效信号。 数据 ...

截至5月30日收盘，细胞免疫治疗概念上涨1.25%，位居概念板块涨幅第6，板块内，29股上涨，睿智医 药20%涨停，海南海药涨停，舒泰神、冠昊生物、复星医药等涨幅居前，分别上涨15.02%、8.88%、 5.23%。跌幅居前的有雪榕生物、赛福天、近岸蛋白等，分别下跌4.23%、2.74%、2.61%。 | 代码 | 简称 | 今日涨跌幅 | 今日换手率 | 主力资金流量（万 | 主力资金净流入比率 | | --- | --- | --- | --- | --- | --- | | | | （%） | （%） | 元） | （%） | | 000566 | 海南海 药 | 10.07 | 5.72 | 14366.28 | 35.56 | | 600196 | 复星医 药 | 5.23 | 2.82 | 5452.19 | 3.62 | | 300149 | 睿智医 药 | 19.98 | 33.35 | 3478.32 | 2.12 | | 603127 | 昭衍新 药 | 5.12 | 11.88 | 3186.12 | 2.27 | | 300558 | 贝达药 业 | 1.84 | 3.00 | 244 ...

细胞免疫治疗板块短线拉升，舒泰神（300204）涨超10%，雪榕生物（300511）、荣昌生物、金域医学 （603882）、莱美药业（300006）、和元生物等跟涨。 暗盘资金正涌入这些股票，点击速看>>> ...

本次sBLA是基于一项将倍诺达®用于一线治疗失败后不适合自体干细胞移植的成人r/rLBCL的单臂、多 中心、关键性临床研究的结果。这项在中国开展的2期单臂开放研究纳入了接受过靶向CD20抗体和蒽环 类一线系统治疗失败的且不适合ASCT的r/r LBCL患者。患者在清淋化疗后接受了100×106CAR+T细 胞。截至2025年1月21日，已完成49例患者的回输并完成了至少3个月的随访；基于48例可进行疗效评估 的患者，瑞基奥仑赛展现了显着的临床疗效和良好的安全性，最佳客观缓解率(ORR)为81.3%，最佳完 全缓解率(CRR)为54.2%，重度(≥3级)的细胞因数释放综合征(CRS)发生率为4.1%，无重度神经毒性(NT) 发生。 格隆汇5月28日丨药明巨诺-B(02126.HK)宣布中国国家药品监督管理局("NMPA")已受理其细胞免疫治疗 产品倍诺达®(瑞基奥仑赛注射液)用于二线治疗复发或难治成人大B细胞淋巴瘤("r/r LBCL")患者的新适 应症上市许可申请("sBLA")。这是药明巨诺针对倍诺达®递交的第四项上市许可申请。于2025年1月， 倍诺达®被NMPA授予二线治疗r/r LBCL的突破性治疗药 ...