里昂证券 中信里昂发布研报称，维持康方生物(81,6.00,8.00%)(09926)目标价112.6港元及"跑赢大市"评级。报 告指，康方生物及其合作夥伴SummitTherapeutics上周五发布了Ivonescimab用于治疗二线EGFR+非小细胞肺癌 (NSCLC)的全球III期临床试验数据。该数据与去年在内地的临床试验数据一致，该公司计划提交生物制品许可 申请(BLA)，未来与美国食品药物管理局(FDA)的谘询将是值得关注的关键。 康方生物-B(09926):维持目标价112.6港元,评级"跑赢大市" ...

智通财经记者 | 李科文 智通财经编辑 | 许悦 据河南广电集团《大象新闻》6月2日报道，宫颈癌患者李某美经重庆大学附属肿瘤医院医生李某推荐， 使用卡度尼利单抗注射液后出现肺炎不良反应。此后，患者发现，其花79320元从医药代表手上购买的 卡度尼利单抗注射液为"仅供临床研究使用"。 卡度尼利单抗注射液在2022年6月获得国家药品监督管理局批准上市，用于治疗复发或转移性宫颈癌， 该适应症于2025年1月1日纳入国家医保目录；2024年10月，卡度尼利单抗获批用于一线胃癌治疗；目前 卡度尼利单抗也在针对其他适应症开展多项III期临床研究。 6月4日，康方生物向智通财经记者回应，不存在患者"花钱购买了临床研究用药"的情况。对于患者李某 美使用的临床研究药物，公司从未向患者李某美收取任何费用，公司经办销售人员亦未收取患者李某美 的任何费用。 康方生物表示，患者李某美所免费获得的药物，系严格按照国家GMP标准生产的药物，与公司商业销 售产品执行同样严格的药品质量管理要求；公司始终严格遵守国家相关法律法规，进行药品临床研究、 生产和销售。 李某美表示，正规包装的卡度尼利单抗注射液其共用了11支。但关键在于，其之后拿到手的 ...

近日，"流入市场的临床试验抗癌药"引发行业关注，涉及到的药物正是康方生物的卡度尼利单抗。6月4 日，康方生物向记者提供的《关于重庆某宫颈癌患者使用公司药物相关新闻报道的声明》称，经调查核 实：对于患者李某美使用的临床研究药物，公司从未向患者李某美收取任何费用，公司经办销售人员亦 未收取患者李某美的任何费用。即不存在患者"花钱购买了临床研究用药"的情况。声明提到，公司重庆 销售人员通过伪造研究立项文件及医院伦理批件等材料，以研究者发起的药品上市后临床研究的名义， 从公司骗取了若干药物，并无偿给予患者李某美使用。据销售人员所述：多次无偿提供该药物给李某美 使用，主要系其考虑李某美支付能力十分有限，且使用卡度尼利单抗注射液以来疗效较好。康方生物强 调，患者李某美所免费获得的药物，系严格按照国家GMP标准生产的药物，与公司商业销售产品执行 同样严格的药品质量管理要求。(智通财经) ...

Core Insights - Bristol-Myers Squibb (BMS) announced a collaboration with BioNTech to develop and commercialize a dual-specific antibody drug, BNT327, targeting PD-L1 and VEGF-A, with a potential investment of up to $11.1 billion [1][2] - The partnership highlights the growing influence of Chinese companies in the global PD-(L)1/VEGF dual antibody drug development space, with multiple recent high-value collaborations [2][3] Company Developments - BMS will pay an upfront fee of $1.5 billion, with additional payments totaling $2 billion by 2028, and up to $7.6 billion in milestone payments, sharing global development and manufacturing costs as well as profits or losses [2] - BNT327 has undergone clinical trials involving over 1,000 patients for various cancers, including non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC), with a global Phase III trial for TNBC set to start by the end of 2025 [2] Industry Trends - The collaboration between BMS and BioNTech follows a recent $1.25 billion deal between Pfizer and 3SBio for a PD-1/VEGF dual antibody, indicating a trend of increasing valuations for Chinese innovative drugs in the global market [2][3] - The success of Chinese companies in this sector is underscored by the approval of the first PD-(L)1/VEGF dual antibody, developed by Kangfang Biopharma, and the subsequent international interest in similar products [3] Market Reactions - Summit's stock price fell over 30% following disappointing results from a Phase III trial for its PD-(L)1/VEGF dual antibody, highlighting the volatility and competitive pressures in the market [5][6] - Despite the challenges, Kangfang Biopharma's stock showed resilience, rebounding after initial declines, indicating ongoing investor confidence in the company's prospects [7]

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 ...

Core Insights - Bristol-Myers Squibb (BMS) acquired BioNTech's PD-L1/VEGF dual antibody BNT327 for $9 billion, highlighting the increasing interest in Chinese biotech firms and their innovative drug pipelines [1][2] - The rapid financial success of BioNTech, which earned over $8 billion from the initial $55 million licensing deal with Chinese firm Pumice Biologics, raises questions about the pricing strategies of Chinese pharmaceutical companies in the global market [1][2][3] - The trend of multinational corporations (MNCs) aggressively acquiring Chinese dual antibodies is reshaping the global landscape of innovative drugs, with significant deals such as the $6.05 billion agreement between 3SBio and Pfizer [1][4] Group 1: Major Transactions - BMS's deal with BioNTech includes a $1.5 billion upfront payment, a record for oncology licensing agreements, along with additional milestone payments totaling $76 billion [2] - 3SBio's licensing of its PD-1/VEGF dual antibody SSGJ-707 to Pfizer for $6.05 billion, with an upfront payment of $1.25 billion, sets a new record for domestic innovative drug licensing [4][5] - Other notable transactions include Merck's $3.3 billion investment in LianBio and the anticipated $5 billion deal involving Shijiazhuang Yiling Pharmaceutical [5][6] Group 2: Market Dynamics - The surge in MNCs acquiring Chinese dual antibodies is driven by the expiration of patents for existing blockbuster drugs and the need for new products [6][7] - Chinese innovative drug companies benefit from lower development costs and a large patient pool, making them attractive targets for MNCs seeking to enhance their product pipelines [6][7] - The total value of outbound licensing deals for Chinese innovative drugs reached $45.5 billion since early 2025, with 42% of high-value projects coming from China [5][6] Group 3: Future Outlook - The ongoing trend of MNCs partnering with Chinese biotech firms is expected to bolster the confidence of domestic companies in pursuing research and development [7][8] - The ability of Chinese innovative drug companies to negotiate higher prices in licensing deals will depend on their negotiation skills and market positioning [8] - The need for a "pricing power revolution" in the Chinese pharmaceutical industry is emphasized, as companies face challenges from rising R&D costs and stringent domestic pricing policies [9]

Core Insights - The technology sector in Hong Kong is experiencing a strong upward trend, with the CSI Hong Kong Stock Connect Technology Index rising by 1.21% as of June 3, 2025 [1] - Key stocks such as Kangfang Biotech, Li Auto, and Kingsoft Biotech have shown significant gains, with Li Auto reporting a 16.7% year-on-year increase in vehicle deliveries for May [1] - The Hong Kong Technology ETF has seen a cumulative increase of 24.87% over the past six months, reflecting positive market sentiment [1] Company Performance - Kangfang Biotech rebounded by over 6% after a previous drop of 10% due to OS data concerns [1] - Li Auto delivered 40,856 vehicles in May, marking a 20.38% month-on-month increase [1] - The top ten weighted stocks in the CSI Hong Kong Stock Connect Technology Index account for 71.48% of the index, with major players including Xiaomi, BYD, Alibaba, Tencent, and Meituan [2] Market Dynamics - Competition among major e-commerce platforms like Alibaba, JD.com, and Meituan in the food delivery and instant retail sectors continues, potentially impacting short-term profits [1] - The ongoing "618" promotional event is expected to benefit platforms like Alibaba and JD.com, particularly in the health supplement category [1] - The strategic adjustments within leading companies such as Tencent, NetEase, JD.com, and Meituan are seen as valuable for long-term performance [2]

创新药旗手：炸裂！BMS和BioNTech（其从中国购买）PDL1xVEGF双抗达成重大合作，首付款15亿美金，总包 111亿美金；康方生物HARMONi研究结果发布，国内临床数据海外成功复现，助于创新药出海加速，持续重点推 荐创新药板块。 建议关注：新增千红制药（翻倍空间）、三生制药、康方生物、恒瑞医药、百利天恒、百济神州H股、信达生物 等！【东吴医药朱国广团队】 事件1： 6月2日，百时美施贵宝和 创新药旗手：炸裂！BMS和BioNTech（其从中国购买）PDL1xVEGF双抗达成重大合作，首付款15亿美金，总包 111亿美金；康方生物HARMONi研究结果发布，国内临床数据海外成功复现，助于创新药出海加速，持续重点推 荐创新药板块。 建议关注：新增千红制药（翻倍空间）、三生制药、康方生物、恒瑞医药、百利天恒、百济神州H股、信达生物 等！【东吴医药朱国广团队】 事件1： 6月2日，百时美施贵宝和BioNTech宣布双方已达成协议，将在全球范围内共同开发和商业化BioNTech的双特异性 抗体候选药物BNT327（PM8002，收购自普米斯），用于多种实体瘤类型。 点评： 国内临床数据海外成功复现，国产创新 ...

弘则研究：ADC payload 特征及 pd1vegf 竞争格局调 研反馈 20250530 摘要 ADC 药物的 payload 类型显著影响其在不同癌种中的疗效和不良反应。 拓扑异构酶抑制剂在乳腺癌、卵巢癌和非小细胞肺癌中表现较好，而微 管抑制剂（如 MAEIL）在结直肠癌中可能更具优势。不同 payload 与特 定不良反应相关，如口腔黏膜炎与拓扑异构酶相关，间质性肺炎与 linker 代谢相关。 双抗产品主要分为 TCE、PD-1 加其他靶点以及双靶点组合。TCE 应用 于血液系统疾病，PD-1 组合旨在替代 PD-1 单抗，解决冷肿瘤响应率低 和耐药问题，双靶点组合旨在拓宽适应症。PD-1/VEGF 组合因其较高确 定性和潜力，被认为是迭代 PD-1 品类的方向。 康方生物的 AK122 在 PD-1/VEGF 双抗领域领先，其临床进展对市场布 局至关重要。其他公司如三生制药和科利斯，通过改进贝伐珠单抗结构， 提高 VEGF 亲和力或降低 ADCC/CDC 效应，以增强疗效。 益芯科和华海制药通过绑定 VGFR1 和 D2 结构，增强了产品对 VEGF 的亲和力，并采用 IgG1 结构以增强 AD ...

Core Insights - The ASCO conference has witnessed the rise of Chinese innovative drugs, with a significant increase in the number of oral presentations and Late-Breaking Abstracts from Chinese researchers over the past decade [1][2][4] - Chinese biopharmaceutical companies are now recognized for their quality research, with many studies presenting groundbreaking results that have global implications [4][5] - The "ASCO effect" has begun to influence stock prices of Chinese pharmaceutical companies, reflecting the growing importance of their research in the global market [5][6] Company Highlights - China Biologic Products set a record with 12 oral presentations at ASCO 2025, including 4 Late-Breaking Abstracts, totaling over 40 studies presented [4] - Innovative studies such as the DIAMOND trial by Junshi Biosciences have demonstrated significant advancements in treatment protocols, marking a shift from merely participating to leading in global research [4] - Companies like Innovent Biologics and Hengrui Medicine are at the forefront of ADC and bispecific antibody development, with numerous studies presented at ASCO [8][12] Industry Trends - The ADC sector is dominated by Chinese companies, with 89 out of 184 ADC-related studies presented at ASCO coming from China, representing approximately 48.4% of the total [8][10] - The bispecific antibody (bispecific) pipeline from China accounts for nearly 50% of the global total, with significant clinical advancements reported at ASCO [12][14] - The trend of increasing license-out transactions and upfront payments for Chinese innovative drugs indicates a shift in the global pharmaceutical landscape, with a notable rise in the use of the NewCo model for collaborations [18][24] Market Impact - The stock prices of companies like China Biologic Products and Innovent Biologics have seen significant increases following the ASCO conference, indicating a positive market response to their research presentations [6] - The total value of license-out transactions for Chinese pharmaceutical companies has surged, with a notable increase in upfront payments, reflecting enhanced negotiation power [20][24] - The emergence of new treatment modalities and innovative drug pipelines positions Chinese companies as key players in the global biopharmaceutical market [16][18]