Group 1 - The core viewpoint of the report is that Guangfa Securities is optimistic about the differentiated biopharmaceutical platform of CStone Pharmaceuticals-B (09966) and the development potential of its ADC drugs, which have shown preliminary clinical efficacy [1] - The company was established in 2015 and focuses on the development, production, and commercialization of innovative anti-tumor biologics, with a highly differentiated internal pipeline covering anti-tumor drugs at various research stages [1] - The first product, KN035 (Envafolimab injection), was launched in November 2021, marking the company's entry into the commercialization phase [1] Group 2 - CStone Pharmaceuticals has developed several globally leading biopharmaceutical technology platforms, including glycoengineered conjugation platform, linker payload platform, bispecific antibody platform, and subcutaneous high-concentration formulation platform, which have differentiated therapeutic advantages [1] - The glycoengineered conjugation platform reduces the production cost of ADC drugs while effectively minimizing toxin release in the circulatory system, enhancing drug safety [1] - Products developed based on this platform, JSKN003 and JSKN016, have entered clinical stages, and the company has upgraded the dual payload technology platform with corresponding products expected to enter clinical trials [1] Group 3 - The HER2 bispecific antibody KN026 is undergoing registration clinical studies for second-line gastric cancer, first-line breast cancer, and neoadjuvant therapy, with a promising path to market [2] - The HER2 bispecific ADC JSKN003 is in phase III clinical trials for breast cancer and platinum-resistant ovarian cancer, demonstrating competitive efficacy in early clinical studies [2] - The HER3/TROP2 bispecific ADC JSKN016 has initiated clinical trials for lung cancer and breast cancer, indicating a broad potential market, while new generation ADCs like JSKN021 (dual payload) and JSKN022 are expected to advance to clinical stages quickly [2]

证券研究报告·公司深度研究·化学制药 华东医药（000963） 白马药企转型创新，开启发展新阶段 2025 年 06 月 09 日 买入（维持） | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 40,624 | 41,906 | 45,915 | 49,414 | 52,228 | | 同比（%） | 7.71 | 3.16 | 9.57 | 7.62 | 5.69 | | 归母净利润（百万元） | 2,839 | 3,512 | 4,032 | 4,555 | 5,154 | | 同比（%） | 13.59 | 23.72 | 14.81 | 12.96 | 13.17 | | EPS-最新摊薄（元/股） | 1.62 | 2.00 | 2.30 | 2.60 | 2.94 | | P/E（现价&最新摊薄） | 27.06 | 21.88 | 19.05 | 16.87 | 14.91 | [Table_Tag] [Tabl ...

研究报告 Research Report 9 Jun 2025 [Table_Info] 首次覆盖优于大市 Initiate with OUTPERFORM 评级 优于大市 OUTPERFORM 现价 HK$214.40 目标价 HK$269.70 HTI ESG 4.8-4.8-4.5 E-S-G: 0-5, (Please refer to the Appendix for ESG comments) 市值 HK$18.87bn / US$2.41bn 日交易额 (3 个月均值) US$21.04mn 发行股票数目 88.04mn 自由流通股 (%) 74% 1 年股价最高最低值 HK$225.00-HK$176.50 注：现价 HK$209.00 为 2025 年 06 月 05 日收盘价 资料来源： Factset 1mth 3mth 12mth 绝对值 0.8% 绝对值（美元） -0.4% 相对 MSCI China -0.4% [Table_Profit] Rmb mn Dec-23A Dec-24E Dec-25E Dec-26E Revenue 1,787 1,949 975 1,170 Re ...

三生PD-1/VEGF 双抗（707） 12.5 亿美金首付款授权辉瑞，创新能力得到验证 三生双抗成功授权辉瑞，首付款创新高。5 月20 日，三生制药宣布将PD-1/VEGF 双抗SSGJ-707 的全球 （不包含中国内地）开发、生产、商业化权利授予辉瑞，总交易金额最高可达60.5 亿美元（含12.5 亿首 付款，总额最多为48 亿美元的潜在付款，创国产创新药出海首付纪录），以及根据授权地区产品销售 额计算得到的两位数百分比的梯度销售分成，辉瑞同时1 亿美元战略入股。未来辉瑞可能重点扩展非小 细胞肺癌及结直肠癌领域。 机构：中信建投证券 研究员：贺菊颖/袁清慧/魏佳奥 核心观点 三生制药在创新药国际化合作与临床进展上双获突破：5 月20 日与辉瑞达成 PD-1/VEGF 双抗 SSGJ-707 海外权益授权，总金额最高达 61.5 亿美元（含 1 亿美元战略入股），创本土双抗出海重磅纪录；6 月1 日 ASCO 公布该药单药治疗晚期 NSCLC 的 II期数据，鳞癌/非鳞癌客观缓解率分别达75%/64 %，疾病 控制率97%，且 3 级以上治疗相关不良反应仅24.1%。此次合作充分体现公司双抗平台的临床价值， ...

Core Insights - The article discusses significant licensing agreements in the biopharmaceutical industry, particularly focusing on the collaboration between Bristol-Myers Squibb (BMS) and BioNTech for the development of BNT327, a bispecific antibody targeting PD-L1 and VEGF-A, with a total potential payment of up to $11.1 billion [1][2][6]. Group 1: Licensing Agreements - BMS will pay BioNTech an upfront fee of $1.5 billion and up to $2 billion in annual payments before 2028, along with milestone payments that could total $7.6 billion [1][2]. - The agreement allows for shared global profits and losses between BMS and BioNTech, marking a shift from traditional licensing models [2][6]. Group 2: Market Dynamics - The PD-(L)1 market is projected to reach $52.5 billion by 2024, with a compound annual growth rate (CAGR) of 16% from 2021 to 2024, and the PD-1/VEGF bispecific antibodies are expected to become a cornerstone in a market potentially exceeding $100 billion by 2028 [3][4]. - The ADC (Antibody-Drug Conjugate) market is also growing rapidly, with a projected size of $14.5 billion by 2024 and a CAGR of 40% from 2021 to 2024 [4][5]. Group 3: Innovation and Collaboration - The article highlights a trend where multinational corporations are increasingly partnering with Chinese biotech firms to enhance their pipelines, driven by the need to overcome patent cliffs and the high cost of drug development in the U.S. [6][7]. - Chinese innovative drug companies are becoming more competitive, with significant increases in business development (BD) transactions, from $9.2 billion in 2020 to an expected $52.3 billion in 2024 [7][8]. Group 4: Clinical Development and Future Prospects - BioNTech's BNT327 has shown promising clinical trial results for treating locally advanced or metastatic triple-negative breast cancer, indicating its potential in a high-demand therapeutic area [2][5]. - The article emphasizes the importance of clinical trial execution quality and innovative drug characteristics in negotiating favorable terms in BD transactions [8][10].

有分析数据表明，EGFR突变在亚洲患者群体中更为普遍。据估计，亚洲非小细胞肺癌患者的EGFR突 变率为40%至50%，而欧美人群的这一比例仅为10%至15%。 两家公司去年称，依沃西在中国的一项头对头试验中的结果甚至与默沙东目前的PD-1销量冠军"帕博利 珠单抗"Keytruda（K药）表现相当。 中国本土创新药企的研发成果正在越来越多地吸引跨国制药巨头的关注。2024年大型跨国药企引进的创 新药候选分子大约有31%来自中国，而2019年这一数字还为零。 在芝加哥召开的美国临床肿瘤学会（ASCO）年会上，来自中国的创新药企集中亮相，超过70项研究入 选口头报告，其中双抗药和ADC药物研究进展备受关注。 康方生物与合作伙伴Summit Therapeutics在ASCO期间发布了PD-1/VEGF 双特异性抗体依沃西 （ivonescimab）的首个全球3期临床试验结果。数据显示，该药物可将既往接受过治疗的表皮生长因子 受体（EGFR）突变非鳞状非小细胞肺癌 (NSCLC) 患者的疾病进展或死亡风险降低48%。根据此前的一 项中国3期临床数据，该药物将患者的疾病进展或死亡风险降低了54%。 其他亮相ASCO的中 ...

医药 本周医药板块上涨 1.27%，百济 BTK PROTAC 启动头对头 3 期临 床 证券研究报告 | 行业周报 2025 年 05 月 19 日 | 股票 | 股票 | 投资 | EPS （元） | | PE | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 评级 | 2025E | 2026E | 2025E | 2026E | | 002755.SZ | 奥赛康 | 买入 | 0.2 | 0.28 | 87.7 | 62.64 | | 01952.HK | 云顶新耀 | 买入 | -0.94 | 0.58 | - | - | | 600079.SH | 人福医药 | 增持 | 1.59 | 1.86 | 12.83 | 10.97 | | 688192.SH | 迪哲医药 | 增持 | -1.33 | -0.08 | - | - | | 688315.SH | 诺禾致源 | 买入 | 0.53 | 0.62 | 26.51 | 22.66 | | 688321.SH | 微芯生物 | 增持 | 0.05 | 0.23 | 349. ...

2025 年 05 月 12 日 行业走势图 投资评级：看好（维持） 数据来源：聚源 -36% -24% -12% 0% 12% 24% 2024-05 2024-09 2025-01 生物制品 沪深300 相关研究报告 生物制品 《重症肌无力：生物制剂打开治疗新 格局，AAN2025 泰它西普重磅 III 期 数 据 即 将 读 出 — 行 业 深 度 报 告 》 -2025.4.1 《DLL3：SCLC 高表达明星靶点，多 款国产新药未来可期 —行业深度报 告》-2024.12.30 《双抗&CAR-T：新一代 BCDT 疗法 新星，进军千亿自免蓝海市场—行业 深度报告》-2024.12.7 小细胞肺癌：中国管线全球领先，研发聚焦三大新领域 ——行业深度报告 | 余汝意（分析师） | 余克清（分析师） | 汪晋（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | wangjin3@kysec.cn | | 证书编号：S0790523070002 | 证书编号：S0790525010002 | 证书编号：S0790123050 ...

编号：2025-001 投资者关系活 动类别 √特定对象调研 □分析师会议 □媒体采访 □业绩说明会 □新闻发布会 □路演活动 □现场参观 √其他 （电话会议） 参与单位名称 及人员姓名 招商基金、泓德基金、中融基金、大家资产、东吴证券、招商证券、西部证 券、国盛证券等 75 家机构 93 名参与人员 时间 2025 年 4 月 30 日—2025 年 5 月 8 日 地点 北京 公司会议室 上市公司 接待人员 董事长、总经理 陈宜顶 副总经理、董事会秘书、财务负责人 林涛 证券事务代表 李鹏君 投资者关系活 动主要内容介 绍 问：公司 2024 年度业绩？ 2024 年，公司聚焦生物医药与细胞免疫治疗，集中优势资源推动核心业 务发展，并坚定不移地推进全球化战略。公司秉持"市场导向、客户至上、 创新驱动"的研发理念，持续加强重点与热点产品的研发力度，推出一系列 高质量且契合市场需求的产品，有效满足市场对重组蛋白等生物试剂不断增 长需求。在内部管理方面，公司进行全面优化，建立健全营销网络体系，全 方位提升综合竞争力与盈利能力。得益于全体员工的共同努力，2024 年度， 公司实现营业收入 64,502.19 万元 ...

Core Viewpoint - Lepu Biopharma-B (02157) has regained market attention due to significant progress in its ADC pipeline, leading to a stock price increase of nearly 78% year-to-date, despite a previous decline since its IPO in 2022 [1][18]. Group 1: Company Overview - Lepu Biopharma was established in 2018 and has built its pipeline through acquisitions and partnerships, including PD-1 antibodies and ADC drugs [1]. - The company focuses on integrating PD-1 as a cornerstone for cancer treatment while developing ADCs and other therapies for enhanced clinical outcomes [1][12]. Group 2: Financial Performance - In 2024, Lepu Biopharma is projected to achieve revenue of 368 million RMB, a year-on-year increase of 63.21%, driven by the commercialization of PD-1 [4]. - Despite revenue growth, the company reported a loss of 424 million RMB in the same year, with cash reserves remaining stable at 401 million RMB [4]. Group 3: Pipeline Development - The core drug in Lepu's pipeline is MRG003, an EGFR-targeting ADC, which has shown promising results in clinical trials for nasopharyngeal carcinoma (NPC) and head and neck squamous cell carcinoma (HNSCC) [4][10]. - MRG003 has received breakthrough therapy designation from both the CDE and FDA, indicating its potential in treating difficult-to-manage cancers [10]. Group 4: Competitive Landscape - The global market for EGFR-targeting ADCs is competitive, with several companies, including Rakuten Medical and Systimmune, also developing similar therapies [6][7]. - Lepu's MRG003 has demonstrated superior efficacy compared to existing treatments, with an overall response rate (ORR) of 47.4% in NPC patients, significantly higher than the typical 20-30% ORR for second-line therapies [7][10]. Group 5: Future Prospects - The company is actively exploring combination therapies, such as MRG003 with PD-1, which has shown an ORR of 66.7% in early trials [12]. - Lepu is also advancing its CG0070 oncolytic virus therapy, which has shown promising results in treating non-muscle invasive bladder cancer (NMIBC) and has received breakthrough therapy designation from the FDA [14][15]. Group 6: Challenges Ahead - Despite the positive developments, Lepu Biopharma's reliance on external acquisitions for its pipeline raises questions about its internal R&D capabilities [18]. - The company faces challenges related to ongoing losses and the need for substantial funding to support its numerous clinical trials [18].