格隆汇5月28日丨科济药业-B(02171.HK)宣布，舒瑞基奥仑赛注射液(产品编号：CT041，一款靶向 Claudin18.2蛋白的自体CAR-T细胞治疗候选产品)已被国家药品监督管理局药品审评中心纳入优先审 评，用于治疗Claudin18.2表达阳性、至少二线治疗失败的晚期胃╱食管胃结合部腺癌的患者。 舒瑞基奥仑赛注射液是一款潜在全球同类首创的、靶向Claudin18.2蛋白的自体CAR-T细胞治疗候选产 品，用于治疗Claudin18.2阳性实体瘤，主要治疗胃╱食管胃结合部腺癌及胰腺癌。已开展的试验包括在 中国开展的研究者发起的临床试验(CT041-CG4006, NCT03874897)，在中国开展的针对晚期胃╱食管胃 结合部腺癌的确证性II期临床试验(CT041-ST-01, NCT04581473)，在中国开展的针对胰腺癌辅助治疗的 Ib期临床试验(CT041-ST-05, NCT05911217)，在中国开展的用于胃╱食管胃结合部腺癌患者术後辅助治 疗後巩固治疗的研究者发起的临床试验(CT041-CG4010，NCT06857786)以及在北美开展的针对晚期胃 癌或胰腺癌的1b/2期临床试验( ...

科济药业 20250523 摘要 科济药业 CT041 针对 CLDN18.2 阳性晚期胃癌三线治疗的 II 期临床试 验取得阳性结果，计划 2025 年 6 月提交上市申请，预计 2026 年获批。 数据显示，CT041 显著降低疾病进展或死亡风险达 63%，中位 PFS 从 1.84 个月延长至 4.37 个月，总生存期延长约 2.5 个月，且安全性良好。 GPRC5D CAR-T CT071 项目针对新诊断多发性骨髓瘤的一期临床试验 显示，客观缓解率达 100%，完全缓解率约 70%，且未发现 3 级以上 CRS，安全性良好。GPRC5D 是继 BCMA 之后的重要靶点，尤其适合 BCMA 阴性或 BCMA 靶向治疗失败的患者。 研究发现，肿瘤微环境中特殊的 T 细胞能够增强 CAR-T 细胞的敏感性， 而表达 IQGAP3 的癌细胞会形成免疫抑制微环境，导致 CAR-T 细胞耐 药。这些发现为后续筛选患者和开展 CAR-T 细胞治疗提供了方向。 与单臂研究相比，随机对照试验（RCT）设计对 CAR-T 疗效评价带来挑 战，因为肿瘤控制难度增加。对照组 PFS 约一个月，仅 4%的病人有客 观缓解，影响 ...

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [3]. Core Insights - Significant transactions have occurred, enhancing the value of Best in Class (BIC) new drugs, particularly with the licensing agreement of SSGJ-707 between Sanofi and Pfizer, which includes a $1.25 billion upfront payment and potential milestone payments totaling $4.8 billion [5]. - The approval of the world's first influenza RNA polymerase PB2 protein inhibitor, Anladiwei tablets, provides a new treatment option for influenza resistance [6]. - The gout and hyperuricemia market presents substantial growth potential, with an expected increase in patients from 1.7 billion in 2020 to 2.4 billion by 2030 in China [8]. - The oral weight loss drug sector is seeing increased activity, with Novo Nordisk's collaboration with Septerna to develop oral small molecule drugs for obesity and type 2 diabetes, reflecting competitive pressures in the market [10]. - Chinese innovative drug companies are leading breakthroughs in CAR-T technology, with significant advancements expected in 2025 [12]. Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical sector outperformed the CSI 300 index by 1.96% over the past week, with a weekly increase of 1.78% [27]. - Over the past month, the pharmaceutical sector also outperformed the CSI 300 index by 1.74%, with a monthly increase of 4.26% [31]. 2. Pharmaceutical Sector Trends and Valuation - The current PE (TTM) for the pharmaceutical sector is 33.25, slightly above the five-year historical average of 32.64 [46]. 3. Recent Research Achievements - The report highlights various recent research achievements, including deep reports on the blood products industry and the impact of policies on inhalation preparations [49]. 4. Recent Industry Policies and News - Recent policy changes include a reduction in tariffs on U.S. imports, which may impact the pharmaceutical sector positively [52]. - Notable news includes the approval of several innovative drugs, such as Anladiwei tablets and the KRAS G12C inhibitor by Ailis, indicating a vibrant drug approval landscape [53][55]. 5. Key Company Recommendations - The report recommends several companies based on their market potential, including: - **Zhongsheng Pharmaceutical** for its innovative drug pipeline [15]. - **Yifang Biotechnology** for its technology platform [15]. - **Kejia Pharmaceutical** for its CAR-T technology advancements [15].

证 券 研 究 报 告 行业周报 重磅交易落地，BIC价值提升 医药行业周报 | 投资评级： | 推荐 （ 维持 ） | | --- | --- | | 报告日期： | 2025年05月25日 | 分析师：胡博新 SAC编号：S1050522120002 分析师：吴景欢 SAC编号：S1050523070004 医 药 行 业 观 点 1. 重磅交易落地，带动Best in class 新药价值提升 2025年5月20日，三生制药发布公告，将PD-1/VEGF双抗（SSGJ-707）的中国外全球权益授权给辉瑞，根据协议，辉瑞 支付12.50亿美元预付款，48亿美元里程碑付款，以及双位数百分比的销售分成。对比近年来国内授权的双抗和ADC， SSGJ-707的首付款创历史记录，总额仅次于百利天恒的EGFR/HER3 ADC。SSGJ-707能获得高估值的重要基础不仅在于 非小细胞肺癌的患者人群基数，更重要是SSGJ-707采用了CLF共同轻链-Fab双抗技术平台构建，在二期临床中取得了积极 的临床数据，并启动了单药治疗头对头对比Keytruda的临床研究，具备Best in Class 的潜力。SSGJ-707的 ...

智通财经APP获悉，截止5月22日收盘，有88只股票创52周新高，其中名仕快相(08483)、茂盛控股 (00022)、帝王实业控股(01950)创高率位于前3位，分别为67.60%、46.55%、45.71%。 | 南方东英越南３０ | 6.690 | 6.690 | 0.22% | | --- | --- | --- | --- | | (03004) | | | | | 诺诚健华(09969) | 10.960 | 11.320 | 0.18% | | 港灯－ＳＳ(02638) | 5.680 | 5.680 | 0.18% | | ESR(01821) | 12.860 | 12.860 | 0.16% | | 招商局港口(00144) | 14.320 | 14.460 | 0.14% | | 紫金矿业(02899) | 18.580 | 18.980 | 0.12% | | Ａ博时人民币－Ｒ | 1,059.000 | 1,059 | 0.05% | | (83192) | | | | | 工银南方国债(03199) | 115.400 | 115.400 | 0.04% | | Ａ博时港元(03 ...

| 健倍苗苗(02161) | 2.380 | 2.380 | 0.42% | | --- | --- | --- | --- | | 中视金桥(00623) | 2.710 | 2.750 | 0.36% | | 古茗(01364) | 26.600 | 27.550 | 0.36% | | ＴＣＬ电子(01070) | 11.000 | 11.220 | 0.36% | | 建设银行(00939) | 6.970 | 7.000 | 0.29% | | 中国移动(00941) | 88.100 | 88.450 | 0.23% | | ＧＸ日本全球领导 | 70.160 | 70.160 | 0.20% | | (03150) | | | | | ＧＸ０３月债(03440) | 55.360 | 55.360 | 0.18% | | 港灯－ＳＳ(02638) | 5.650 | 5.670 | 0.18% | | 安硕亚洲除日(03010) | 59.880 | 60.100 | 0.17% | | ESR(01821) | 12.840 | 12.840 | 0.16% | | ＧＸＡＩ基础设施 | 5 ...

Key Points - As of May 20, 91 stocks reached their 52-week highs, with the top three being Sanofi Pharmaceutical (01530), TEAMWAY INTL GP (01239), and China Carbon Neutral (01372) [1] - Sanofi Pharmaceutical achieved a closing price of 19.180, with a peak price of 22.000, marking a high rate of 49.25% [1] - TEAMWAY INTL GP closed at 0.229, reaching a high of 0.248, reflecting a high rate of 30.53% [1] - China Carbon Neutral closed at 1.600, with a peak of 1.640, resulting in a high rate of 17.14% [1] - Other notable stocks include Songjing Technology (01079) with a high rate of 16.47% and H&H International Holdings (01112) at 16.28% [1] - The report also lists several stocks with lower high rates, indicating a broader market trend [1][2][3]

分析师：胡博新 SAC编号：S1050522120002 分析师：吴景欢 SAC编号：S1050523070004 医 药 行 业 观 点 证 券 研 究 报 告 行业周报 关税短期冲击减弱，出海仍是主要趋势 医药行业周报 | 投资评级： | 推荐 （ 维持 ） | | --- | --- | | 报告日期： | 2025年05月19日 | 1. 出海仍是主要趋势，关税短期冲击减弱 根据医保商会统计，2025年Q1，医药出口额为266.32亿美元，同比增长4.39%，其中对美出口46.39亿美元，同比增长 9.6%，美国仍为中国出口的第一大单体市场，占比17.4%。医药虽然有部分被豁免，但仍非豁免品种受到关税的冲击，5月 12日之后，美国订单有望显著恢复。医药交易方面，根据医药魔方数据，2025年Q1，中国医药交易数量同比增加34%，交 易总金额同比增加222%。美国制药企业也是全球医药交易的主要受让方，美国市场是全球最大的创新药市场，未来增长可 能受到政策的干扰，但考虑美国商业保险模式占据主导，而且医疗体制改革需要长周期布局，创新药高度市场化定价机制 仍将维持。近年来，中国创新药的研发效率和质量得到迅速提升 ...

S1130518080002 yuan_wei gjzq.com.cn S1130514100001 zhaohc gjzq.com.cn S1130523080002 heguanzhou gjzq.com.cn 投资逻辑 本周医药行情演绎较为缓和，整体温和上行但涨幅弱于其他大部分一级行业。年报一季报落幕，医药板块仍在寻找和 调整方向进程中，预计交易调整完成后新一轮行情即将展开。我们在前期年报一季报复盘报告中指出，医药政策端、 基本面、市场面的压制因素已经基本出清，同时 2024 年医药业绩基数前高后低，基数压力逐季度下降，我们非常看 好 2025 年下半年医药板块成功实现景气度反转，业绩端增速止跌回升，回到增长趋势。 药品：本周，科济药业发布了通用型 CAR-T 的临床数据，海思科的镇痛新药安瑞克芬获批上市。全球生物医药创新 正随着基础科学发现的不断新突破和新技术手段的应用而得到加速发展，包括中国在内的创新药企也将会有更多里程 碑式突破的新分子或治疗手段得到商业化应用。本土创新药企正在日益崭露出国际领先的创新实力，在营收业绩、对 外授权合作以及国际权威会议与期刊上发布的优异临床数据方面都展现出靓丽成果。我 ...

Group 1 - The article highlights significant trading volume increases for various companies, indicating potential investment opportunities [1][2][3] - Notable companies with high trading volumes include卓越教育集团 (Zhuoyue Education Group) with a volume ratio of 2.45 and成交额 (transaction amount) of 27.16 million, and中国太保 (China Pacific Insurance) with a volume ratio of 2.29 and成交额 of 947.61 million [2][3] - Other companies showing substantial trading activity include维亚生物 (Viya Bio) with a volume ratio of 2.20 and成交额 of 16.22 million, and天津发展 (Tianjin Development) with a volume ratio of 2.17 and成交额 of 1.64 million [2][3] Group 2 - The data indicates that卓越教育集团 (Zhuoyue Education Group) and中国太保 (China Pacific Insurance) have both experienced a single day of increased trading volume, suggesting a potential trend [2][3] - Companies like弘业期货 (Hongye Futures) and招商证券 (China Merchants Securities) have shown consistent trading volume increases over multiple days, with弘业期货 recording a volume ratio of 1.50 and成交额 of 116.44 million, and招商证券 with a volume ratio of 1.70 and成交额 of 28.22 million [2][3] - The report also lists other companies with varying degrees of trading volume increases, such as顺丰同城 (SF Intra-city) and吉利汽车 (Geely Auto), indicating a broader market trend [2][3]