A Global, Multicenter, Randomized, Dose-Optimization Phase II Study of Trastuzumab Rezetecan (SHR-A1811) in Combination With mFOLFOX6 (-1) and Bevacizumab as First-Line Treatment in Patients With HER2-Positive Advanced Colorectal Cancer (HORIZON-CRC221)

This global study is being conducted to evaluate the safety and determine the recommended phase 3 dose of trastuzumab rezetecan in combination with mFOLFOX6 chemotherapy (dose level -1) and bevacizumab as first-line treatment in participants with advanced colorectal cancer that expresses HER2, including but not limited to HER2 immunohistochemistry (IHC) 2+ "equivocal" or 3+ "positive" based on gastric cancer criteria, focused on the Western population. Encouraging data in efficacy and safety with trastuzumab rezetecan in a similar setting in China (NCT06015048) were presented at 2026 American Society of Clinical Oncology annual meeting.

开始日期2026-11-01

申办/合作机构

江苏恒瑞医药股份有限公司

NCT07669610

/ Not yet recruiting临床3期IIT

A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab as First- to Third-Line Treatment for Basal-like Immune-suppressed Triple-Negative Breast Cancer

This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the BLIS subtype. A total of 140 patients are planned to be enrolled.

开始日期2026-10-01

申办/合作机构

复旦大学

NCT07760844

/ Not yet recruiting临床3期IIT

A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus as First- to Third-Line Treatment for Luminal Androgen Receptor Subtype of Triple-Negative Breast Cancer

This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the LAR subtype. A total of 180 patients are planned to be enrolled.

开始日期2026-10-01

申办/合作机构

复旦大学

100 项与瑞康曲妥珠单抗相关的临床结果

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100 项与瑞康曲妥珠单抗相关的专利（医药）

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项与瑞康曲妥珠单抗相关的文献（医药）

2026-08-01·LANCET ONCOLOGY

Trastuzumab rezetecan versus pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer (HORIZON-Breast01): interim analysis of a multicentre, open-label, randomised, controlled, phase 3 trial

Article

作者: Zhou, Shoubing ; Fu, Fangmeng ; Niu, Zhaofeng ; Yan, Min ; Yan, Xi ; Zhu, Zhengqiu ; Gao, Jinnan ; Wang, Biyun ; Xie, Weimin ; Li, Wenfeng ; Sun, Tao ; Wang, Shusen ; Yuan, Peng ; Sun, Zhengkui ; Ouyang, Quchang ; Nie, Jianyun ; Yao, Herui ; Zhao, Bing ; Zhang, Ying ; Geng, Cuizhi ; Cheng, Jing ; Cheng, Lin ; Li, Wei ; Sheng, Zhen ; Yin, Yongmei ; Wu, Jingna ; Wang, Xinshuai ; Song, Erwei ; Zhu, Xiaoyu ; Wu, Zhiyong ; Tong, Zhongsheng ; Yi, Tienan ; Zhang, Qingyuan ; Yang, Yaping ; Wang, Xiaojia ; Wei, Wei ; Gan, Lu ; Han, Xinghua ; Zhao, Jianli ; Li, Huiping ; Wang, Yongsheng

BACKGROUND:

Trastuzumab rezetecan has shown antitumour activity in a phase 1 trial. Pyrotinib plus capecitabine is the current standard treatment for patients with HER2-positive advanced or metastatic breast cancer after trastuzumab and chemotherapy (taxane or anthracycline). We aimed to evaluate the efficacy and safety of trastuzumab rezetecan versus pyrotinib plus capecitabine in this patient population.

METHODS:

This interim analysis of a multicentre, open-label, randomised, controlled, phase 3 trial was conducted at 50 hospitals in China. Eligible patients were aged 18-75 years with histologically confirmed HER2-positive unresectable or metastatic breast cancer; previously received a taxane and trastuzumab at the advanced stage or had disease progression within 12 months after (neo)adjuvant treatment with an anti-HER2 monoclonal antibody and taxane-based regimen; had measurable lesions; and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1; stratified by hormone receptor status and previous lines of chemotherapy for metastatic disease), using permuted blocks to intravenous trastuzumab rezetecan (4·8 mg/kg) on day 1 of each 21-day cycle or oral pyrotinib 400 mg once per day continuously plus oral capecitabine 1000 mg/m² twice per day on days 1-14 of each 21-day cycle. Protocol amendments led to a temporary modification (between Nov 29, 2022, and July 12, 2023) of trastuzumab rezetecan dose to 6·4 mg/kg; primary evaluation focuses on the 4·8 mg/kg group. The primary endpoint was progression-free survival per blinded independent central review in the modified intention-to-treat population 1 (defined as all patients randomly assigned to the trastuzumab rezetecan 4·8 mg/kg or control groups). Results presented here are from a prespecified interim analysis. This study was registered with ClinicalTrials.gov, NCT05424835 (active, not recruiting).

FINDINGS:

From Aug 4, 2022, to Aug 9, 2024, 414 patients with HER2-positive metastatic breast cancer were assessed for eligibility, 127 were ineligible and 287 were randomly assigned to trastuzumab rezetecan (n=142) or pyrotinib plus capecitabine (control group; n=145) in the modified intention-to-treat population 1. All 287 patients were female and the median age was 55·0 years (IQR 49·0-60·0). 268 (93%) patients self-reported as Han Chinese and 19 (7%) as other Chinese ethnicity. At data cutoff of the interim analysis on June 30, 2025, after a median follow-up of 15·0 months (IQR 12·9-18·5) for the trastuzumab rezetecan group versus 13·9 months (11·4-17·8) for the control group, 124 progression-free survival events had occurred (37 [26%] vs 87 [60%]). The median progression-free survival was 30·6 months (95% CI 16·8-not reached [NR]) with trastuzumab rezetecan and 8·3 months (6·9-11·0) with pyrotinib plus capecitabine (HR 0·22 [0·15-0·34]; p<0·0001). The 12-month progression-free survival rate was 84·7% (77·0-90·0) in the trastuzumab rezetecan group versus 35·5% (26·8-44·2) in the control group. The most common (grade ≥3) treatment-related adverse events were decreased neutrophil count (77 [54%] with trastuzumab rezetecan vs 13 [9%] with the control), decreased white blood cell count (29 [20%] vs four [3%]), and decreased platelet count (15 [11%] vs two [1%]); whereas treatment-related serious adverse events occurred in 19 (13%) versus 17 (12%). Two adverse events led to death (one [1%] septic shock unrelated to trastuzumab rezetecan treatment and one [1%] unknown reason related to pyrotinib plus capecitabine treatment). Interstitial lung disease occurred in four (3%) patients in the trastuzumab rezetecan group.

INTERPRETATION:

Trastuzumab rezetecan improved progression-free survival versus pyrotinib plus capecitabine and showed a distinct safety profile in patients with HER2-positive breast cancer, presenting as a potential new treatment option.

FUNDING:

Jiangsu Hengrui Pharmaceuticals.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

2026-05-01·CPT-Pharmacometrics & Systems Pharmacology

Population Pharmacokinetics of Trastuzumab Rezetecan in Patients With HER2 ‐Expressing or Mutated Advanced Solid Tumors

Article

作者: Zhang, Yanyan ; Zhao, Jun ; Zhao, Chen ; Zhao, Kaijing ; Gao, Xuehu ; Djebli, Nassim ; Zhao, Yanyong

ABSTRACT:

Trastuzumab Rezetecan (SHR‐A1811) is an antibody‐drug conjugate (ADC) targeting the human epidermal growth factor receptor 2 (HER2). It features a novel enzyme‐cleavable linker and delivers the topoisomerase I inhibitor payload, rezetecan, with a drug‐to‐antibody ratio of approximately 6.0. Its population pharmacokinetics (PopPK) were characterized using a nonlinear mixed‐effects model based on data from 645 patients with HER2‐expressing or HER2‐mutated advanced solid tumors with 18,671 samples across three phase 1 trials. A two‐analyte PopPK model was developed to describe the intact ADC and released payload. The intact ADC followed a two‐compartment model with linear elimination, while the payload rezetecan was best described by a one‐compartment model with first‐order release and linear elimination. Stepwise covariate modeling identified several baseline factors—body weight, tumor size, albumin, aspartate aminotransferase, age, and cancer type—as statistically significant parameters‐covariates' relationships. However, their effects on the AUC of both intact ADC and payload were limited (< 20% change). No clinically relevant impacts were observed for race, sex, formulation, or renal/hepatic function on ADC or payload exposure. In conclusion, the developed PopPK model adequately characterizes the pharmacokinetics of Trastuzumab Rezetecan and its released payload. Based on the covariate analysis, no dose adjustments are warranted for the studied patient population. This model can further support dose selection in future clinical trials through exposure–response analyses.

2026-01-01·DRUGS

Trastuzumab Rezetecan: First Approval

Review

作者: Hoy, Sheridan M.

Trastuzumab rezetecan (Avida ^®) is a human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate being developed by Jiangsu HengRui Medicine Co., Ltd. for the treatment of various solid tumours, including breast cancer, colorectal cancer, gastric cancer, gastroesophageal junction adenocarcinoma and lung cancer. In May 2025, it was approved by the National Medical Products Administration of China for the treatment of adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have human epidermal growth factor receptor 2 (HER2) [ERBB2]-activating mutations and have received ≥ 1 previous systemic treatment. This article summarizes the milestones in the development of trastuzumab rezetecan leading to this first approval.

3,362

项与瑞康曲妥珠单抗相关的新闻（医药）

2026-09-13

·AI临研工具箱

医药研发热点周报-9月第2周

2026年9月7日 · 星期一｜9月第1周（8.31-9.7） 1今日焦点事件重磅·评分最高TQB2102 治疗 HER2 低表达复发/转移性乳腺癌的 III 期临床研究成功企业：正大天晴领域：TQB2102 / HER2双表位双抗ADC阶段：III期中国生物制药旗下正大天晴自主研发的HER2双表位双抗ADC TQB2102，治疗HER2低表达复发/转移性乳腺癌的III期研究成功达到主要终点，PFS显著改善。这是全球首个在该人群取得成功的HER2双抗ADC III期研究，已获CDE同意近期递交上市申请。 2国内药企动态企业名称事件类型药物/靶点阶段来源康方生物 III期临床阳性依沃西单抗 / PD-1×VEGF双抗III期OS阳性头条百济神州 III期启动 BG-C9074 / B7-H4 ADCIII期启动腾讯信达生物 NDA受理 IBI343 / CLDN18.2 ADCNDA优先审评头条恒瑞医药 III期达终点瑞康曲妥珠单抗 / HER2 ADCIII期达终点头条恒瑞医药 NDA受理 HRS-7535 / GLP-1R激动剂NDA受理头条百利天恒 III期首例入组宜泽康 / EGFR×HER3双抗ADCIII期入组头条中国生物制药 III期成功 TQB2102 / HER2双表位双抗ADCIII期成功头条科济药业医保申报舒瑞基奥仑赛 / CAR-T申报医保 DoNews 华东医药国家重大专项 HDM2005 / ROR1 ADCIII期推进头条诺诚健华临床获批 ICP-B381 / PSMA×STEAP1双抗ADCI期临床头条 3跨国药企动态企业名称事件类型药物/靶点阶段来源拜耳 FDA加速批准 Sevabertinib / HER2FDA一线获批头条默沙东/科伦博泰 III期双终点阳性 Sac-TMT / TROP2 ADCIII期OS+PFS 头条礼来行业排名 GLP-1减重管线全球前三头条阿斯利康管线调整 AZD4360/AZD959 / ADC终止开发头条 GSK/和黄医药 BD授权 HMPL-A830 / KRAS-EGFR ATTC13亿美元头条罗氏/先声药业 BD授权 TCE分子15.3亿美元头条辉瑞/信达生物 BD合作创新药管线105亿美元头条强生 III期注册 Ramantamig / GPRC5D/BCMA/CD3三抗III期临床头条 4新进入临床药物清单药物名企业靶点/类型适应症阶段/登记号 BG-C9074 百济神州 B7-H4 ADC 卵巢癌一线维持治疗III期启动 / GOG-3144 TQB2102 中国生物制药/正大天晴 HER2双表位双抗ADC HER2低表达乳腺癌III期成功，即将NDA 宜泽康（BL-B01D1）百利天恒 EGFR×HER3双抗ADC EGFR突变NSCLC维持治疗III期首例入组瑞康曲妥珠单抗恒瑞医药 HER2 ADC HER2阳性乳腺癌III期达主要终点 IBI363 信达生物 PD-1/IL-2α双抗融合蛋白晚期结直肠癌III期首例给药 CM512 康诺亚 TSLP×IL-13双抗慢性鼻窦炎伴鼻息肉III期启动 Sac-TMT 默沙东/科伦博泰 TROP2 ADC 子宫内膜癌III期双终点阳性 / TroFuse-005 ICP-B381 诺诚健华 PSMA×STEAP1双抗ADC 前列腺癌等实体瘤I期 / CDE临床批件 APL-2501 亚虹医药 CLDN6/CLDN9 ADC 晚期实体瘤I期 / NMPA临床许可 [²²⁵Ac]Ac-FL-261 辐联科技 c-MET RDC 非鳞状NSCLCI期 / FDA IND批准 HDM2005 华东医药 ROR1 ADC 血液瘤/实体瘤I/Ib-II/III期同步推进 AP308 礼邦医药 IgA蛋白酶 IgA肾病I期 / FDA IND批准 5广东省板块🏢 康方生物（总部中山）依沃西单抗（PD-1/VEGF双抗）头对头K药III期OS期中分析阳性，为全球首个双抗击败PD-1单抗的OS阳性结果。📈 股市表现：消息公布后两个交易日累计上涨超15%，总市值约836亿港元。9月1日单日卖空4.68亿港元。🏢 信达生物（总部苏州） IBI343（CLDN18.2 ADC）NDA获受理并纳入优先审评；IBI363（PD-1/IL-2α双抗）结直肠癌III期完成首例给药。📊 业绩：2026年上半年总营收86.1亿元，利润超2025年全年。🏥 医保国谈：9月6日参与2026国家医保目录肿瘤药现场谈判。🏛️ 产业政策与大会 2026中国医药工业发展大会将于9月14-16日在中山举办，由工信部中小企业发展促进中心、广东省工信厅、中山市人民政府共同主办。📍 中山市已集聚8个1类新药、超650家生物医药企业，为大会重要产业支撑。💊 2026医保国谈（9月5-11日）广东多家药企参与，政策方向从普涨红利转向精准扶持创新药。 6热门靶点与研发趋势 🧪 ADC耐药新方向诺华11亿美元收购Myricx布局NMT抑制剂payload平台；真实生物ZSSW-136（非喜树碱类TOPO1抑制剂）对伊立替康耐药类器官抑制效果为伊立替康的400倍。☢️ RDC最新进展辐联科技[²²⁵Ac]Ac-FL-261（c-MET RDC）获FDA I期IND批准；纳安科技探索RDC+ADC协同策略应对HER2 ADC耐药；思路迪PSMA靶向RDC公布临床前数据。 7AI医药领域Top 3热点 1 英矽智能Rentosertib登《自然·生物技术》，展示"生物年龄逆转" 英矽智能AI设计的Rentosertib在42名特发性肺纤维化（IPF）患者的12周临床试验中，六套独立蛋白质组衰老时钟一致指向生物年龄逆转，最显著组逆转近6年。60mg QD组患者FVC平均改善+98.4 mL。9月8日股价盘中一度涨9.9%，市值约294.84亿港元。2026上半年营收1.063亿美元，上市以来首次半年度盈利。 2 AI制药进入"临床验证元年"，9款AI药物进入III期全球AI驱动新药临床管线已增至179个，其中9个进入III期。英矽智能Rentosertib、德睿智药MDR-001等成为代表性品种。艾普司韦（AI辅助研发新冠口服药）从分子发现到获批仅用时三年半。2026年全球AI制药市场规模预计达29.94亿美元，AIDD渗透率约6%。 3 AI+CRO/CMO模式分化，晶泰科技vs英矽智能路径差异英矽智能以AI发现靶点+AI设计分子+BD授权为核心，上半年药物研发收入占比97%，经营现金流转正；晶泰科技则侧重物理AI+机器人实验+智算平台，研发投入同比加码66%。花旗维持英矽智能"买入"评级，目标价85港元。7家AI制药企业总市值约1300亿港元。 8政策与监管📋 2026国家医保目录谈判启动（9月5-11日）医保+商保双目录同步协商机制首次落地；预申报机制落地，新药完成药监技术审评即可参与评估；续约规则优化，专利期内创新药豁免集采。默沙东、阿斯利康、罗氏、恒瑞、信达、百利天恒等国内外药企参与谈判。💊 CDE发布参比制剂目录（第110批） 9月7日NMPA发布《化学仿制药参比制剂目录（第一百一十批）（征求意见稿）》：新增品规8个，修订品规44个，未通过审议品规4个。☢️ 放射性药品审评审批改革征求意见国家药监局发布《关于改革完善放射性药品审评审批管理的意见（征求意见稿）》，提出优先审评审批、沟通交流优先处理、优化注册检验和核查机制等措施，利好RDC赛道。📑 双抗ADC临床应用专家共识发布《中华肿瘤杂志》发布业内首部双抗ADC临床应用专家共识，百利天恒伦康依隆妥单抗（EGFR×HER3双抗ADC）为核心品种，为临床规范化应用提供指导。 9大盘与资本市场 🏥 礼来排名跃升靠减肥药大卖，礼来挤掉默沙东成为全球第三大药企。财富500强排名224位，营收651.79亿美元，利润206.40亿美元。股价一度突破1208美元创历史新高。📊 行业基本面 2026年上半年医药行业营业收入同比增长2.8%，归母净利润同比增长8.8%，扣非归母净利润同比增长17.4%，创新药企业盈利质量持续改善。 📰 信息来源康方生物依沃西单抗头对头K药OS期中分析阳性. 今日头条百济神州首款ADC BG-C9074启动III期临床. 腾讯新闻信达生物IBI343 NDA获受理并纳入优先审评. 今日头条恒瑞医药瑞康曲妥珠单抗III期达到主要终点. 今日头条恒瑞医药HRS-7535 NDA获CDE受理. 今日头条百利天恒宜泽康III期首例受试者入组. 今日头条中国生物制药TQB2102 III期研究成功. 今日头条科济药业舒瑞基奥仑赛申报2026国家医保目录. DoNews 华东医药HDM2005入选国家科技重大专项. 今日头条诺诚健华ICP-B381双抗ADC获批临床. 今日头条拜耳sevabertinib获FDA加速批准一线HER2突变NSCLC. 今日头条默沙东/科伦博泰sac-TMT III期双终点阳性. 今日头条 2026医保国谈第二日跨国药企阵容扩容. 财联社阿斯利康终止2款ADC及1款RDC开发. 今日头条和黄医药与GSK达成KRAS-EGFR ATTC授权. 今日头条先声药业与罗氏达成15.3亿美元授权合作. 今日头条多发性骨髓瘤GPRC5D靶点爆发. 今日头条 ADC载荷同质化与交叉耐药问题. 今日头条真实生物非喜树碱类TOPO1抑制剂亮相. 今日头条辐联科技[²²⁵Ac]Ac-FL-261获FDA IND批准. 搜狐英矽智能Rentosertib数据登《自然·生物技术》. 新浪财经 AI制药临床验证元年，179个AI药物进入临床. 新华日报 2026中国医药工业发展大会将在中山举办. 今日头条 CDE发布化学仿制药参比制剂目录第110批. 腾讯新闻恒瑞医药与BMS 152亿美元战略合作. 今日头条中国生物制药44.8亿元收购正大天晴5%股权. 今日头条 © 2026 医药研发热点日报 |本日报基于公开信息整理，仅供行业研究参考，不构成投资建议。数据截至2026年9月13日，覆盖周期为2026年9月8日至9月13日。

临床3期抗体药物偶联物优先审批申请上市临床2期

2026-09-13

·PRNewswire

Phase III ARTEMIS-008 Trial Shows Risvutatug Rezetecan Significantly Improves Overall Survival in Relapsed Small-Cell Lung Cancer

B7-H3-directed antibody-drug conjugate reduced the risk of death by 54% compared with topotecan and improved progression-free survival and response rates SEOUL, South Korea, Sept. 13, 2026 /PRNewswire/ -- Results from the randomized Phase III ARTEMIS-008 trial show that risvutatug rezetecan (Ris-Rez), a B7-H3-directed antibody-drug conjugate, significantly improved overall survival compared with topotecan in patients with relapsed small-cell lung cancer (SCLC) whose disease progressed on or after platinum-based chemotherapy. The findings were presented today at the IASLC 2026 World Conference on Lung Cancer (WCLC). Continue Reading Jie Wang, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences Peking Union Medical College, Beijing, China ARTEMIS-008 (NCT06498479) is a multicenter, open-label, randomized Phase III study. A total of 461 patients in China were randomized 1:1 to receive Ris-Rez 8.0 mg/kg every three weeks or topotecan 1.2 mg/m² on days 1 through 5 every three weeks. More than 80% of patients had previously received PD-(L)1 inhibitors. The primary endpoint was overall survival, with progression-free survival, objective response rate, disease control rate and safety among the key secondary endpoints. At the June 6, 2026 data cutoff, after a median follow-up of 12.2 months, median overall survival was 18.5 months with Ris-Rez compared with 10.3 months with topotecan. Ris-Rez reduced the risk of death by 54% (HR 0.46; 95% CI, 0.35–0.62; P<0.0001), with consistent overall survival benefits across relevant subgroups. Blinded independent central review also favored Ris-Rez across key secondary efficacy measures. Median progression-free survival was 7.2 months with Ris-Rez versus 3.0 months with topotecan (HR 0.33; 95% CI, 0.25–0.42). The objective response rate was 58.3% versus 12.6%, respectively, and the disease control rate was 90.4% versus 60.2%. Investigator-assessed outcomes were consistent with the central review findings. Grade 3 or higher treatment-related adverse events occurred less frequently with Ris-Rez than with topotecan, at 60.9% versus 78.2%. The most common grade 3 or higher treatment-related adverse events were hematologic toxicities, including decreased neutrophil count, decreased white blood cell count, anemia, decreased lymphocyte count and decreased platelet count. "Ris-Rez demonstrated a statistically significant and clinically meaningful overall survival benefit over topotecan in patients with SCLC that progressed after platinum-based therapy, with a favorable safety profile," said Professor Jie Wang, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences Peking Union Medical College, Beijing, China. "These results suggest the potential of Ris-Rez to define a new standard of care in relapsed SCLC." About the IASLC The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit for more information. About the WCLC The WCLC is the world's largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,000 researchers, physicians, and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit . Contact: Chris Martin, IASLC Media Relations, [email protected] SOURCE International Association for the Study of Lung Cancer 21% more press release views with Request a Demo

临床结果临床3期AACR会议

2026-09-11

·有驾

恒瑞医药股价波动，9月11日表现亮眼，看看下周走势预测

9月11日恒瑞医药股价收盘价为42.67元，在当天跌幅0.61%。整个交易时间段内股价上下波动区间在41.89元到42.76元之间。成交额33.94亿元，换手率1.26%，量比为1.24。从盘面来看表面数字只是下跌了6毛，但是这里面实际所透露的信息远远不止涨跌幅那么简单。从9月7日的46.26元到9月11日的42.67元，短短四天就回撤了7.76%。“5日跌幅约在-3%-3%”，而“20个交易日累计跌幅约为-8%-8%，年初至今更是下跌了28.13%。”总市值为2832亿元、TTM市盈率高达36.65倍的创新药龙头企业，没有业绩“大地雷”、中报也保持创新药双位数增长的情况下竟然出现了这么一波连续下跌，其实不能全怪在大盘情绪身上。这轮下挫背后牵扯出量价表现、中报质量、管线进展、医保动态和短期市场预期等多个层面。今天我们就拆开谈一下恒瑞现在的几个主要因素，仅供参考研究不涉及具体投资建议。一、9月11日盘面释放的信号 9月11日早盘恒瑞小幅低开，开盘价42.65元，昨天收在42.93元，最高冲到42.76元，在此期间没有翻红。午后最低点跌至41.89元，尾盘有所回拉。K线的影子很短、下影较长，“低位有资金接盘”、“上方卖压未被完全消化”。全天成交量只有80多万手、额33.94亿，相比9月10日的104万手、44.89亿，是明显缩量的，量比为1.24，换手率为1.26%。盘面组合有两种解读方式：第一种是杀跌动能枯竭、底部换手机开始酝酿；第二种则是下跌途中休整，在之前跌下来的中阴线还没被收复。把近五天拉一条线更直观点。 9月7日收在46.26元，之后分别是9月8日45.71元跌了1.19%；9日，又跌2.19%至44.71元；10日更狠，收42.93元跌3.98%；11日42.67元跌0.61%。9月十日内放量破位就是情绪集中宣泄，而九月十一日内缩量探底又拉回来一点，但还不是趋势逆转的信号。同天医药生物板块整体跌了1.94%，化学制药下跌1.9%，上证指数跌1.18%，深成指跌1.08%。恒瑞最近相比整个医药板块还算抗跌，但是看一下自己在9月初站在46元上方的位置，现在已经明显下行小通道了。纯技术上来说，41.89元就是本周短线第一道支撑位。如果下周再放量跌破的话，则41元到40.5元左右将成为下一次的观察点。以上三重压力分别对应的是最近一个收盘价为42.93、9月9日收盘价为44.71以及近期7天前收市价为46.26元。不能放量站稳了，就只能视为弱势震荡的修复阶段；如果能够连续两天都守住上个交易日的水平即不破，那么市场也可能会考虑重新修复九月十日那波阴线下跌所造成的局面。但是要说情绪全面转强，则还得重新站回44.71元的位置，并且最好有成交量配合。有很多投资者看恒瑞的中报只是关注净利润44.65亿元，同比只增加0.34%，认为增速几乎停滞，并且再加上最近股价下跌，则很容易就得出公司基本面已经坏掉的结论。但是只从净利润上来看并不能说明问题。2026年上半年恒瑞营业收入为154.56亿元，产品销售收入为139.48亿元，同比增长率为1.87%。仅看创新药销售收入达88.09亿元，同比上升了16.38%，在药品收入中占比达到了63.2%，而去年同期还只占了一半。可以看出公司的主营业务正逐步向创新药方向倾斜，并且速度比人们想象的要快得多。关于抗肿瘤药物内部结构的研究，有文章提到抗肿瘤药物收入达到62.65亿元，同比增长了2.58%，占到创新药整体的71.11%；非肿瘤类产品销售收入为25.45亿元，同比激增了73.97%。可以看出非肿瘤领域的增速成了新亮点。之前市场给恒瑞的估值偏向于肿瘤领域，即ADC、PD-1、CDK4/6等大单品。但是如果未来非肿瘤持续高速增长的话，则恒瑞的形象会由原来的“单一肿瘤龙头”变为“全领域创新药平台”。在目前的回调中被忽视的是对于未来的估值锚变化的影响。再来看费用端。研发这块上半年投入46.05亿元，同比增长18.96%，占营收比重29.8%。其中费用化研发34.93亿元，增长8.21%。把三成的营业收入都投向研发，在A股药企中算是非常拼了。结果是管线储备厚起来但是利润短期被压制了。2026年二季度单季净利润预计为21.83亿元左右，相比去年同期下降了15.25%。“利润高速增长、估值低”的消费股打法其实并不适用，真正要看的还是创新药收入能否保持增长，毛利率、现金流以及后续药物研发的持续性。整体毛利率约为86%，销售净利率接近30%，该份中报的盈利质量还算可以。但是现金流量表上没有净利润那么多，上半年销售现金比率只有16.41%，净利润现金含量也达到了54.99%。经营现金流不能和利润同步增长，之后的研发投入以及市场推广压力会更大。对于药企来说，当利润不是问题的时候经营现金流才是安全垫。三、管线催化点集中在9月底后目前市场对恒瑞事件节奏的关注较少。9月7日公司公告显示HRS-6209胶囊、HRS-4508片、SHR-1179注射液、HRS-1597片等四款新药获批临床，肿瘤新靶点和体重管理领域都有。其中，HRS-6209定位CDK4抑制剂，用于实体瘤；SHR-1179是体重管理的创新生物制剂，国内外同类产品不多，未来可能有更高的市场想象空间。9月10日海曲泊帕乙醇胺片新适应症获批针对实体瘤化疗相关血小板减少和儿童慢性免疫血小板减少症，并且今年3月拓展了重型再障适应症，产品进入多适应症新阶段，给中长期销售提供更大的空间。真正值得期待的窗口会在9月底欧洲糖尿病大会(EASD)上。公司公告指出本次EASD年会将是在9月28日到10月2日期间进行的，并且会有大量的管线有重要的临床数据公布。口服小分子GLP-1 HRS-7535做了两项III期试验，基础胰岛素周制剂SHR-3167有两个II期试验，GLP-1/GIP双靶点瑞普泊肽肥胖及多囊卵巢数据、GLP-1/GIP/GCG三靶点已经进入I期。这些创新药管线分布广，数据披露如果亮眼，则很可能会重新为恒瑞的代谢板块带来估值重估的机会。如果数据差强人意，则短期股价承压的风险也存在，因此该节点对于市场判断来说是非常重要的。 ADC和双抗药物不能忽略。瑞康曲妥珠单抗等大分子的HER2新适应症仍在拓展，今明两年将陆续覆盖新瘤种。达尔西利在乳腺癌的纵深发展也在强化管线厚度。对恒瑞这样的创新药平台型公司而言，单一药物的爆发已经不再是全部，持续的产品线拓展才是保持增长的关键。四、医保谈判和集采更多的是一种结构性的变局 2026年医保国谈和创新药商业保险目录还会同步进行，目前政策偏向逐渐有利于创新药。但是要认识的是，新药专利期与协议期的产品大都不会被包含在常规集采当中，医保政策正逐步地鼓励真创新而不是一味压价。商业保险目录也会给价格敏感并且临床价值突出的新产品开辟出一条第二条销售途径。预申报和续约制度也在减少产品放量的时间滞后。长期来看这些举措对恒瑞这样的管线丰富的新药企是利好，尤其是多个创新药处在医保谈判或者续约阶段。但是短线并不是全是红利。医保国谈期间，一有风吹草动就会对股价产生冲击。成熟大品种即便有销售基础，在下次续约的时候也会面临“卖得好就要主动降价腾出空间”的思路。创新药虽然暂时不集采，但是公司部分仿制药和过专利期药物还是会受到一定的影响。“政策层面的影响其实更加细分，比如创新药、非肿瘤品种、出海授权业务受益最大，而老品种生存压力无解。” 五、下周怎么走？三种思路做准备将盘面、事件和技术因素结合起来，下周主要有三种演变思路，各自的信号也不难把握。一种是缩量止跌，弱势修复。9月11日已经出现了反拉，在41.89元之上出现支撑位；如果在接下来的一周之内没有跌破42.36元的关口，则成交额将会维持在25亿到35亿之间，股价就在41.9元至42.93元之间横盘，大概率等到9月底EASD新药数据公布的那一刻。假如是这样的情形之下，则无需追高回踩不破41.90元的水平线，或者有放量重返到42.93元之上，在此期间可以小幅度偏多为方向，并且把目标定位于44.71元的压力位。第二种情况为放量突破，假如下周哪一天成交量猛增，价格重新站上42.93元或者冲过44.71元，并且公告面或者医保政策有新的利好，则短线情绪会转强。属于业绩与产品管线共振的强修复行情。但是前提必须是成交量有较大的提升，否则就是假突破。第三种为破位再探底，如果恒瑞在41.89元被放量击穿时，短期还会寻找新的支撑区间的范围在40.5元到41元之间。区间能否企稳还要看市场整体资金面、板块情绪以及EASD前夕市场是否愿意为创新药板块买单。如果连40.5元也不稳，那可能还得考验资金耐心了。持有人目前真正要关注的并不是明天能不能涨，而是想清楚自己关注的是哪一部分的投资逻辑。如果看重的是创新药升级，则需要观察未来几个月内非肿瘤板块是否能保持高速增长；如果关心的是EASD数据，则要在9月底前做好应对方案，数据亮眼或者平平的时候，持仓策略应该提前确定好；短线只需要盯住41.89元和42.93元两个点就可以了。六、市场普遍容易混淆的几点第一是把今年以来28%的下跌当成绝对便宜。别忘了恒瑞市盈率还有36倍多，在一票创新药里只能说中等偏上。如果未来利润端继续受压，估值不能说毫无风险，归根结底还要看创新药和出海业务能不能加速。第二是误把个别季度利润波动当作基本面出问题。其实恒瑞的创新药和非肿瘤业务还处在正轨上，结构性提升才更值得单季度利润下滑未必就是坏信号。第三是对于医保国谈利好的过度假设及利空的过分放大。“恒瑞产品多、管线多”，谈判结果对每款药物影响不一样，“部分品种压力加大、部分新药获得新机会”的局面也出现不到。如果未来出海和授权能继续兑现，那么恒瑞的长期估值逻辑会逐渐向全球创新药公司靠拢。这个变化节奏很慢，但是方向是值得关注的。短期影响最大的还是A股资金面、基金调仓和监管政策；中期比拼非肿瘤新管线、代谢板块的成长性；长期才是真正看ADC、双抗、GLP-1系列和国际化业务落地。不区分周期就会高点追，低点慌。七，简单说后市节奏 9月11日恒瑞缩量探底回拉，目前属于下跌之后的观察期，并没有开始扭转趋势。中报显示创新药、非肿瘤业务的趋势向好，但是利润端仍然受到费用和降价的压力影响。如果下周守住41.89元并且有成交量重新冲上42.93元，则可以上看44.71元甚至更高。反之，守不住的话就要关注到在区间内有没有被承接的区域。“真正的中期转强信号”还需要等到9月底EASD临床数据公布之后，再看ADC、双抗新适应症落地情况以及医保谈判和创新药收入接力表现。所有分析基于公开资料进行交流与讨论。投资有风险，入市需谨慎。

IPO

100 项与瑞康曲妥珠单抗相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HER2阳性结直肠癌	中国	苏州盛迪亚生物医药有限公司	2026-08-04
HER2阳性乳腺癌	中国	苏州盛迪亚生物医药有限公司	2026-03-17
HER2突变型非小细胞肺癌	中国	苏州盛迪亚生物医药有限公司	2025-05-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HER2低表达乳腺癌	申请上市	中国	江苏恒瑞医药股份有限公司	2026-06-29
卵巢上皮癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-09-04
晚期结直肠腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-08-28
大肠腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2026-08-05
PD-L1阳性三阴性乳腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-08-20
转移性胃食管结合部腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-08-18
铂耐药上皮性卵巢癌	临床3期	中国	江苏恒瑞医药股份有限公司	2025-03-13
铂耐药性输卵管癌	临床3期	中国	江苏恒瑞医药股份有限公司	2025-03-13
铂类耐药性原发性腹膜癌	临床3期	中国	江苏恒瑞医药股份有限公司	2025-03-13
RAS 野生型结直肠癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2024-03-01

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临床结果

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分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05424835 (HORIZON-Breast01, Pubmed \| Lancet Oncol)	临床3期	HER2阳性转移性乳腺癌 HER2-positive	287	Trastuzumab rezetecan	窪憲遞壓觸遞蓋繭觸獵(鑰獵膚夢觸獵鏇膚遞廠) = decreased neutrophil count (77 [54%] with trastuzumab rezetecan vs 13 [9%] with the control), decreased white blood cell count (29 [20%] vs four [3%]), and decreased platelet count (15 [11%] vs two [1%]); 鹹醖蓋鹽蓋壓艱遞夢選 (醖獵觸鬱夢遞繭鹹鑰蓋 )	积极	2026-08-01
				Pyrotinib plus capecitabine
NCT07307287 (ASCO2026)	临床2期	HR阳性/HER2阳性乳腺癌新辅助 HR-positive \| HER2-positive	44	SHR-A1811 plus pertuzumab	鏇鏇製鬱網艱蓋糧壓繭(築壓築製網遞襯鑰餘鏇) = 壓襯膚襯顧顧網繭簾繭構膚簾膚壓鬱獵淵築鏇 (憲窪窪網鹹鑰糧膚製積 )	积极	2026-05-29
NCT04446260 (HORIZON-X, Signal Transduct Target Ther) 人工标引	临床1期	HER2阳性实体瘤 HER2-expressing \| HER2 mutated	396	SHR-A1811	淵夢鏇衊獵鬱蓋顧鏇膚(淵膚鹽選構鏇廠憲糧願) = 襯鏇鬱鏇構範廠襯遞鬱繭壓觸廠獵壓蓋鹽蓋築 (築選選齋鏇構製蓋遞廠 ) 更多	积极	2026-03-19
				SHR-A1811 (patients with HER2-positive breast cancer)	鹹壓鏇獵蓋鹹構鬱餘遞(壓膚顧遞鬱願觸鏇窪製) = 鹽繭鹽獵願蓋衊窪憲窪顧製窪築蓋廠築網積衊 (觸選淵淵觸蓋遞襯艱襯, 17.2 ~ 33.6)
NCT05424835 (SHR-A1811-Ⅲ-301 \| HORIZON-Breast01, NEWS) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	287	SHR-A1811	蓋淵窪鑰鑰蓋膚顧鏇廠(鹽醖獵願齋築繭廠積繭) = 繭鏇壓鏇窪窪願網醖壓繭鹹壓製鹽構蓋構壓鏇 (觸築糧餘蓋願廠糧網窪, 16.8 ~ NR) 达到更多	积极	2025-10-22
				Pyrotinib+Capecitabine	蓋淵窪鑰鑰蓋膚顧鏇廠(鹽醖獵願齋築繭廠積繭) = 廠鏇壓製鏇淵膚餘憲夢繭鹹壓製鹽構蓋構壓鏇 (觸築糧餘蓋願廠糧網窪, 6.9 ~ 11.0) 达到更多
NCT05353361 (ESMO2025)	临床1/2期	HER2阳性转移性乳腺癌 HER2+	75	SHR-A1811 3.2 mg/kg	襯觸蓋窪醖淵齋顧艱衊(遞網鏇積壓願遞衊憲構) = Not observed in phase 1b cohorts 獵構艱壓繭願願壓齋齋 (艱築醖蓋憲廠蓋鏇網壓 ) 更多	积极	2025-10-17
				SHR-A1811 4.8 mg/kg
NCT06411457 (ESMO2025)	临床2期	HR阴性/HER2低表达乳腺癌 HER2-low \| HR- or low HR expression	24	SHR-A1811Adebrelimab + SHR-A1811Adebrelimab (HR-negative/HR-low, HER2-low metastatic breast cancer)	獵衊獵窪襯簾鏇憲艱簾(遞繭鏇選繭壓衊膚艱蓋) = 窪壓鑰窪遞選膚醖衊襯壓膚顧獵鹹艱顧憲簾鬱 (積壓鬱簾觸蓋簾願餘鬱 ) 更多	积极	2025-10-17
NCT05424835 (HORIZON-Breast01, ESMO2025)	临床3期	晚期 HER2 阳性乳腺癌二线 HER2+	287	SHR-A1811	襯顧範窪鹹積齋廠築積(選衊獵鑰鏇簾鏇艱淵糧) = 築窪顧網夢憲鹽艱繭範願築選願鹹襯淵廠觸糧 (鬱範遞構齋觸膚壓願製 ) 更多	积极	2025-10-17
				CapecitabinePyrotinib + CapecitabinePyrotinibine	襯顧範窪鹹積齋廠築積(選衊獵鑰鏇簾鏇艱淵糧) = 鹽膚遞構淵艱鑰積夢積願築選願鹹襯淵廠觸糧 (鬱範遞構齋觸膚壓願製 ) 更多
NCT05635487 (MUKDEN 07, ESMO2025)	临床2期	HER2阳性乳腺癌新辅助 HER2-positive	64	SHR-A1811 monotherapy	齋齋窪淵繭鬱選簾鹹鏇(構鬱衊糧網構簾醖鏇範) = 網蓋壓鹽鬱壓選餘願艱夢鹽鹹衊築艱願築獵膚 (積齋願繭鏇餘選鏇糧網 ) 更多	积极	2025-10-17
				SHR-A1811 plus pyrotinib combination therapy	齋齋窪淵繭鬱選簾鹹鏇(構鬱衊糧網構簾醖鏇範) = 觸鹽齋淵衊積選壓鹽鬱夢鹽鹹衊築艱願築獵膚 (積齋願繭鏇餘選鏇糧網 ) 更多
NCT05424835 (SHR-A1811-Ⅲ-301, Corporate Publications) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	325	SHR-A1811 + 吡咯替尼 + 卡培他滨	簾簾艱選製廠製壓觸鏇(壓製艱鹹膚觸膚鑰獵鏇) = 达到预设的优效标准鹽衊壓夢顧鏇壓夢憲窪 (廠糧壓範壓憲廠夢衊築 ) 达到更多	积极	2025-09-17
NCT05769010 (REIN, ASCO2025 \| NEWS) 人工标引	临床2期	HER2阳性转移性乳腺癌 HER2 Positive	58	SHR-A1811 6.4 mg/kg	鑰壓廠蓋觸糧憲選簾獵(範築廠蓋蓋夢願艱窪醖) = 鹽簾鹽鏇膚壓膚構衊製構築遞餘鏇願範範獵蓋 (衊選壓鬱窪蓋觸餘鹽鑰 ) 更多	积极	2025-05-30
				SHR-A1811 4.8 mg/kg + Bevacizumab 15 mg/kg	鑰壓廠蓋觸糧憲選簾獵(範築廠蓋蓋夢願艱窪醖) = 鑰鬱醖築鹽衊膚積觸鏇構築遞餘鏇願範範獵蓋 (衊選壓鬱窪蓋觸餘鹽鑰 ) 更多