An Open-label, Single-center, Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of RC48-ADC Combined With Pyrotinib in Local Advanced or Metastasis NSCLC With HER2 Mutation

This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.

开始日期2027-12-01

申办/合作机构

荣昌生物制药（烟台）股份有限公司

NCT07783815

/ Not yet recruiting临床1期IIT

An Open-Label, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Intravesical Instillation of Disitamab Vedotin Combined With Toripalimab in Patients With HER2-Positive High-Risk Non-Muscle Invasive Bladder Cancer Who Are BCG-Naïve or Have BCG Failure

This study is an open-label, single-arm investigator-initiated clinical trial, aiming to evaluate the efficacy and safety of vicedetinib bladder instillation combined with teprotumumab in the treatment of patients with HER2-expressing, previously untreated, or BCG-resistant high-risk non-muscle-invasive bladder cancer (NMIBC). The subjects to be included in the study must have undergone standard TURBT within 3 weeks before enrollment, removed all visible lesions, and had a clear pathological diagnosis of NMIBC, with their risk classification according to the "Chinese Bladder Cancer Diagnosis and Treatment Guidelines (2022)" falling into the high-risk group (including extremely high-risk group). All surgical tumor specimens of the included subjects underwent HER2 testing, indicating HER2 expression, defined as immunohistochemistry (IHC) 1+, 2+ or 3+, with FISH verification for amplification if IHC 2+ is present. The subjects were divided into two groups based on whether they had received BCG treatment in the past: one group was high-risk NMIBC patients who had not received BCG treatment, including one of the following situations: ① refused BCG treatment, ② had contraindications to BCG use, ③ BCG was inaccessible; the other group was high-risk NMIBC patients who had no response to BCG, meeting any of the following criteria: ① had persistent/recurrent high-risk NMIBC within 12 months (±1 month) after adequate BCG treatment, ② had high-grade T1 disease during the first assessment after induction BCG treatment. Adequate BCG treatment was defined as completing at least 5 BCG bladder instillations within 2 months, and then at least 2 BCG bladder instillations for 6 consecutive weeks within the next 10 months, meaning at least "5+2" BCG bladder instillations within approximately 12 months. Eligible subjects received vicedetinib bladder instillation combined with teprotumumab treatment; vicedetinib was administered once weekly at 180mg for 8 times. For patients receiving treatment, if there was no occurrence of persistent/recurrent NMIBC, disease progression, or intolerable toxicity, they would receive maintenance bladder instillation with vicedetinib for one year, with the maintenance regimen being: once every 4 weeks for 10 times. Teprotumumab: 240mg per dose, intravenous, once every 3 weeks for 1 year. Patients were required to collect urine samples before the first treatment and after the last treatment. Safety during the study was evaluated according to the NCI-CTCAE V5.0 standard, and the observation indicators included vital signs, physical examination, laboratory tests, electrocardiogram and echocardiogram examinations, adverse events and serious adverse events.

开始日期2026-09-01

申办/合作机构

中南大学湘雅医院

ChiCTR2600130765

/ SuspendedN/AIIT

A Multicenter, Single-Arm, Exploratory Study of Ipaloritol Vorlimab Combined with Disitamab Vedotin and S-1 in the Neoadjuvant Treatment of Locally Advanced HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

开始日期2026-09-01

申办/合作机构

福建省立医院

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100 项与维迪西妥单抗相关的临床结果

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100 项与维迪西妥单抗相关的转化医学

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100 项与维迪西妥单抗相关的专利（医药）

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612

项与维迪西妥单抗相关的文献（医药）

2026-11-01·BIOCHEMICAL PHARMACOLOGY

Antibody-drug conjugates in colorectal cancer: advances, challenges, and prospectives

Review

作者: Zeng, Lili ; Zhu, Yuanlin ; Ding, Jie ; Liu, Bin ; Zhang, Ke

Antibody-drug conjugates (ADCs) represent an emerging class of targeted therapeutics with considerable potential in the management of colorectal cancer (CRC). By delivering highly potent cytotoxic agents to cancer cells via specific antibodies, ADCs enable precise tumor targeting while minimizing off-target toxicity. Recent advancements have identified several promising targets for ADC development in CRC, including human epidermal growth factor receptor 2 (HER2), carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5), mesenchymal-epithelial transition factor (c-MET), epidermal growth factor receptor (EGFR), cadherin-17 (CDH17), and trophoblast cell surface antigen 2 (Trop-2). Clinical trials have demonstrated encouraging objective response rates and survival benefits with ADCs such as trastuzumab deruxtecan (T-DXd) and disitamab vedotin in patients with advanced CRC. Nonetheless, the clinical application of ADCs faces several challenges, including tumor heterogeneity leading to variable target expression, the emergence of diverse resistance mechanisms that limit long-term efficacy, and manageable but significant safety concerns. Future research should prioritize tumor-selective linker design, novel payload development, bispecific and dual-payload ADC platforms, and rational combination strategies to overcome resistance and further improve the therapeutic index of ADCs in CRC.

2026-08-01·EUROPEAN UROLOGY

Efficacy and Safety of Disitamab Vedotin Combined with Gemcitabine as Neoadjuvant Therapy in Muscle-invasive Bladder Cancer: An Open-label, Multicenter, Single-arm, Phase 2 Trial

Article

作者: Huang, Haijun ; Liu, Bo ; Zhang, Yucong ; Yang, Chunguang ; Wan, Jie ; Zhou, Gaofeng ; Zeng, Xing ; Dai, Haitao ; Ma, Wei ; Hu, Zhiquan

There are barriers to the clinical use of cisplatin-based neoadjuvant regimens in muscle-invasive bladder cancer (MIBC), especially for patients with renal dysfunction, hearing loss, heart diseases, or other severe comorbidities. Favorable efficacy and safety of disitamab vedotin (DV), an antibody-drug conjugate targeting HER2, have recently been demonstrated in urothelial carcinoma. We explored neoadjuvant gemcitabine combined with RC48 in the MIBC setting. Initially, 26 patients with clinical stage T2-4a Nx M0 MIBC and a HER2 immunohistochemical expression score of 2+/3+ were enrolled. The neoadjuvant regime comprised DV (2 mg/kg intravenous infusion, day 1) and gemcitabine (1000 mg/m² intravenous infusion, day 2) in a 14-d cycle. Thirteen patients received three cycles, and the other 13 patients received four cycles, in a nonrandomized manner. Subsequently, 22 patients underwent radical cystectomy (RC). Postoperative pathology revealed a pathological complete response (pCR) rate of 59% (13/22) among RC patients, 40% (4/10) of whom had received three cycles and 75% (9/12), four cycles. Intention-to-treat analysis revealed pCR rates of 50% (13/26) overall, 31% (4/13) for the three-cycle group, and 69% (9/13) for the four-cycle group. At median follow-up of 16.9 mo, 25 patients remained event-free. Treatment-related adverse events primarily included aspartate aminotransferase elevation (35%), alanine aminotransferase elevation (38%), a decrease in appetite (23%), alopecia (23%), and sensory neuropathy (23%). Validation of the long-term efficacy of this regimen is required.

2026-07-15·BIOCONJUGATE CHEMISTRY

Rapid and Efficient Antibody–Drug Conjugate Design Using Mechanistic Bottom-Up Modeling from In Vitro to Human

Article

作者: Sweeney-Lasch, Stanley ; Kolmar, Harald ; Kahl, Jan-Philip ; Hecht, Stefan ; Lindroos, Tatu ; Anderl, Jan ; Stein, Judith ; Kaempffe, Anna ; Krug, Michael

Antibody-drug conjugates (ADCs) are complex molecules, and many fail clinically despite promising preclinical data. Here, a modular, bottom-up modeling strategy employing mechanistic PK-PD models was developed to translate ADC efficacy and toxicity from bench to bedside and to guide ADC design. The models handle various antigens, payloads, and ADCs, validated using six ADCs (Enhertu, Kadcyla, Trodelvy, RC48, RN927C, and Datroway). Using determined cellular distribution of payloads/ADCs, payload killing parameters, and systemic parameters (assay volume, cell doubling time), ADC in vitro potency was predicted with 94.64% accuracy within a 2-fold range. Incorporating ADC and payload pharmacokinetic parameters enables prediction of in vivo efficacy comparable to cell line- and patient-derived xenograft data from the literature. Scaling parameters from mouse to human (PK, tumor volume, and tumor doubling time) led to the reproduction of clinical efficacy trends. Beyond efficacy, the approach predicts key hematologic toxicities such as neutropenia and thrombocytopenia, demonstrated for Kadcyla and Enhertu. Application to the clinically failed RN927C demonstrated how our modeling approach could have flagged issues and enabled suggestions for design modifications to widen the therapeutic window and prevent the clinical failure. In conclusion, our presented modeling strategy delivers accurate efficacy and toxicity translation from in vitro to humans utilizing easily accessible parameters as the foundation and deepens understanding of ADCs and their individual components, thereby supporting ADC design and candidate and patient selection and accelerating ADC development.

5,818

项与维迪西妥单抗相关的新闻（医药）

2026-09-23

·丁香园 Insight 数据库

ESMO LBA 摘要揭晓！近 30 项中国研究入选，全体大会研究独占 4 席

2026 年欧洲肿瘤内科学会（ESMO）年会将于 10 月 23 日至 27 日在西班牙马德里举行。作为全球肿瘤学领域最具影响力的综合性学术会议之一，ESMO 每年汇聚来自世界各地的肿瘤领域顶尖专家学者与临床医生，覆盖从基础研究、机制探索到临床试验与诊疗实践的全链条，是全球肿瘤治疗格局和研究方向的重要学术窗口。当前，ESMO 官网已正式公布了超 90 项 Late-Breaking Abstract（LBA，突破性摘要）标题，其中 12 项最具突破意义及最能改变临床实践的 LBA 研究将在 ESMO 全体大会环节汇报。值得关注的是，近年来中国肿瘤研究的国际影响力持续攀升，越来越多由中国学者牵头或深度参与的研究登上 ESMO 等国际顶级学术会议的重要报告舞台。今年 ESMO 大会上，共有 28 项中国 LBA 研究入选，其中 4 项进入全体大会环节，占比达三分之一。从创新治疗探索到关键临床研究，中国研究者正持续为全球肿瘤学循证证据贡献「中国数据」。一、Presidential Symposium（主席研讨会）摘要号：LBA6 中文标题：奥希替尼联合赛沃替尼对比含铂培美曲塞方案治疗 EGFR 突变伴 MET 过表达和 / 或扩增的奥希替尼进展后晚期 NSCLC：SAFFRON III 期主要结果英文标题：Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase (Ph) 3 primary results 讲者：上海交通大学医学院附属胸科医院陆舜摘要号：LBA7 中文标题：CLARITY-Gastric 01（CG-01）：一项 sonesitatug vedotin（Sone-Ve）用于二线及以上治疗 CLDN18.2 阳性晚期或转移性胃食管腺癌（GEC） III 期研究英文标题：CLARITY-Gastric 01 (CG-01): a Phase 3 study of sonesitatug vedotin (Sone-Ve) in second or later-line (2L+) advanced or metastatic Claudin 18.2 (CLDN18.2) positive gastroesophageal carcinoma (GEC) 讲者：中山大学肿瘤防治中心徐瑞华摘要号：LBA8 中文标题：依沃西单抗联合化疗对比度伐利尤单抗联合化疗一线治疗晚期胆道癌：一项随机、对照、双盲 III 期研究（HARMONi-GI1）英文标题：Ivonescimab plus chemotherapy versus durvalumab plus chemotheray as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double- blinded, phase 3 trial (HARMONi-GI1) 讲者：复旦大学附属中山医院周俭摘要号：LBA9 中文标题：Risvutatug Rezetecan（Ris-Rez）对比吉西他滨联合多西他赛治疗重度经治的复发 / 难治骨肉瘤：III 期 ARTEMIS-011 研究主要结果英文标题：Risvutatug Rezetecan (Ris-Rez) versus Gemcitabine and Docetaxel (GD) in Heavily Pretreated Patients (pts) with Relapsed or Refractory (R/R) Osteosarcoma: Primary Results from the Phase 3 ARTEMIS-011 Study 讲者：北京大学人民医院谢璐二、优选论文专场（Proffered paper session） 01 乳腺癌摘要号：LBA13 中文标题：瑞康曲妥珠单抗（SHR-A1811）治疗 HER2 低表达晚期乳腺癌：一项随机 III 期研究（HORIZON-Breast06）英文标题：Trastuzumab rezetecan (SHR-A1811) in HER2-low advanced breast cancer (BC): a randomized, phase 3 study (HORIZON-Breast06) 讲者：中国医学科学院肿瘤医院樊英摘要号：LBA50 中文标题：PANKU-Breast01：伦康依隆妥单抗（iza-bren）治疗既往经治的不可切除局部晚期或转移性 HR+/HER2− 乳腺癌的随机 III 期研究英文标题：PANKU-Breast01: Randomized Phase III Study of Izalontamab Brengitecan (iza-bren) in Previously Treated Unresectable Locally Advanced or Metastatic (LA/M) Hormone Receptor-Positive/HER2-negative (HR+/HER2-) Breast Cancer (BC) 讲者：中国医学科学院肿瘤医院兰波摘要号：LBA15 中文标题：Anbenitamab 联合白蛋白结合型多西他赛治疗 HER2 阳性晚期乳腺癌：一项随机 III 期研究英文标题：Anbenitamab plus albumin-bound docetaxel in patients (pts) with HER2-positive advanced breast cancer (BC): A randomized phase III study 讲者：中国医学科学院肿瘤医院徐兵河 02 肺癌摘要号：LBA66 中文标题：芦康沙妥珠单抗（sac-TMT）联合帕博利珠单抗 vs 化疗联合帕博利珠单抗一线治疗 PD-L1 阴性晚期非鳞 NSCLC：随机 III 期 OptiTROP-Lung06 研究英文标题：Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: randomized phase 3 OptiTROP-Lung06 study 讲者：同济大学附属东方医院周彩存摘要号：LBA67 中文标题：芦康沙妥珠单抗对比含铂化疗治疗 EGFR-TKI 进展后 EGFR 突变 NSCLC 的最终总生存分析：III 期 OptiTROP-Lung04 研究英文标题：Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: phase III OptiTROP-Lung04 study 讲者：中山大学肿瘤防治中心张力摘要号：LBA69 中文标题：赛沃替尼或安慰剂联合奥希替尼一线治疗伴 MET 过表达的 EGFR 突变晚期 NSCLC：III 期 SANOVO 研究结果英文标题：Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase 3 SANOVO Study 讲者：广东省人民医院吴一龙摘要号：LBA71 中文标题：PANKU-Lung01：伦康依隆妥单抗（iza-bren）治疗三代 EGFR-TKI 进展后 EGFR 突变非鳞 NSCLC 的随机 III 期研究英文标题：PANKU-Lung01: Randomized Phase III Study of Izalontamab Brengitecan (iza-bren) in EGFR-Mutant Non-squamous Non‑Small Cell Lung Cancer (NSCLC) After Progression on a Third Generation EGFR TKI 讲者：中山大学肿瘤防治中心张力摘要号：LBA72 中文标题：Ruzaltatug rezetecan（HER3 靶向 ADC）vs 含铂化疗治疗 EGFR-TKI 进展后 EGFR 突变晚期 NSCLC：III 期 HERON-Lung01 研究中期分析英文标题：Ruzaltatug rezetecan, a HER3-directed ADC, vs platinum-based chemotherapy (PBC) in EGFR-mutated advanced NSCLC progressing after EGFR-TKI: interim analyses (IA) from the phase 3 HERON-Lung01 trial 讲者：广东省人民医院吴一龙摘要号：LBA64 中文标题：特瑞普利单抗联合化疗用于可切除 II 或 III 期 NSCLC 围手术期治疗：III 期 Neotorch 研究最终分析英文标题：Toripalimab plus chemotherapy as perioperative treatment for resectable stage II or III non-small cell lung cancer (NSCLC): Final analysis of the Phase 3 Neotorch study 讲者：上海交通大学医学院附属胸科医院陆舜 03 黑色素瘤摘要号：LBA55 中文标题：自体肿瘤浸润淋巴细胞（GC101 TIL）治疗晚期黑色素瘤：一项随机、开放标签、关键 II 期试验的延长随访英文标题：TAutologous Tumor-Infiltrating Lymphocytes (GC101 TIL) in Advanced Melanoma: Extended Follow‑up of a Randomized, Open-Label, Pivotal Phase II Trial 讲者：北京大学肿瘤医院斯璐 04 头颈癌摘要号：LBA43 中文标题：Tam-Peli vs 化疗治疗重度经治复发 / 转移性鼻咽癌：多中心、随机、开放标签 III 期研究（TAISHAN-301）英文标题：Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomized, open-label, phase 3 study (TAISHAN-301) 讲者：中山大学肿瘤防治中心洪少东 05 神经内分泌肿瘤摘要号：LBA57 中文标题：Opamtistomig（LBL-024）单药治疗既往 ≥2 线治疗后的晚期肺外神经内分泌癌：新型 PD-L1×4-1BB 双抗的关键注册 IIb 期研究结果英文标题：Opamtistomig (LBL-024) monotherapy in advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC) after ≥2 prior lines of therapies: results from a pivotal, registrational phase IIb study of a novel PD-L1×4-1BB bispecific antibody 讲者：北京大学肿瘤医院陆明三、快速口头报告专场（Rapid oral session） 01 消化道肿瘤摘要号：LBA80 中文标题：Anbenitamab 联合化疗治疗既往经治的 HER2 阳性胃癌或胃食管结合部癌：KC-WISE 研究总生存（OS）更新分析英文标题：Anbenitamab plus chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Updated overall survival (OS) analysis of KC-WISE 讲者：解放军总医院徐建明摘要号：LBA81 中文标题：LOMAC 随机试验：II–IIIB 期胃癌患者辅助 XELOX 治疗 4 个月与 6 个月疗程的比较英文标题：Four Months of Adjuvant XELOX versus Six Months in Stage II–IIIB Gastric Cancer — The LOMAC Randomized Trial 讲者：复旦大学附属肿瘤医院徐大志摘要号：LBA85 中文标题：HRS-4642 联合化疗 ± 阿得贝利单抗用于 KRAS G12D 突变胰腺癌围手术期治疗：一项 II 期研究初步结果英文标题：HRS-4642 Plus Chemotherapy ± Adebrelimab as Perioperative Therapy in KRAS G12D-Mutant Pancreatic Cancer: Preliminary Results of a Phase 2 Study 讲者：上海交通大学医学院附属瑞金医院沈柏用 02 乳腺癌摘要号：LBA17 中文标题：HER2-PET 成像预测德曲妥珠单抗（T-DXd）在晚期乳腺癌中的疗效：II 期 PREDICT-HER 试验英文标题：HER2-PET imaging to predict trastuzumab deruxtecan (T-DXd) efficacy in advanced breast cancer: The phase II PREDICT-HER trial 讲者：复旦大学附属肿瘤医院金娟摘要号：LBA27 中文标题：APEX-Breast01：TQB2102 vs 化疗治疗 HER2 低表达复发或转移性乳腺癌的随机 III 期研究结果英文标题：APEX-Breast01: TQB2102 versus chemotherapy in HER2-low recurrent or metastatic breast cancer (r/m BC) : Results from a randomized phase 3 study 讲者：中山大学肿瘤防治中心王树森 03 肺癌摘要号：LBA75 中文标题：Deulorlatinib（TGRX-326）vs 克唑替尼治疗 TKI 初治晚期 ALK 阳性 NSCLC：一项 III 期研究英文标题：Deulorlatinib (TGRX‑326) vs crizotinib in TKI-naive advanced ALK+ NSCLC: a phase 3 study 讲者：中山大学肿瘤防治中心张力摘要号：LBA65 中文标题：诱导免疫联合化疗在潜在可切除或不可切除Ⅲ期非小细胞肺癌中的手术转化与生存结局：前瞻性 II 期研究（CTONG 1804 Part 3）的初步结果英文标题：Surgical Conversion and Survival Outcomes After Induction Chemoimmunotherapy in Potentially Resectable or Unresectable Stage III NSCLC: Preliminary Results from the Prospective Phase II Study (CTONG 1804 Part 3) 讲者：广东省人民医院潘燚 04 黑色素瘤摘要号：LBA61 中文标题：维迪西妥单抗治疗 HER2 高表达、局部晚期或转移性乳房外 Paget 病：前瞻性单臂 II 期研究（Formula-10）英文标题：Disitamab Vedotin in locally advanced or metastatic extramammary Paget’s disease with HER2 high expression: a prospective, single-arm phase II trials (Formula-10) 讲者：中山大学肿瘤防治中心谭星亮 05 头颈癌摘要号：LBA47 中文标题：围手术期替雷利珠单抗联合化疗治疗局部晚期可切除口腔鳞癌的前瞻性随机 II 期研究（OPTIMAL 研究）英文标题：A Prospective, Randomized, Phase II Study of Perioperative Tislelizumab with Chemotherapy in Patients with Locally Advanced Resectable Oral Squamous Cell Carcinoma(OPTIMAL study) 讲者：上海交通大学医学院附属第九人民医院何悦 06 探索性免疫疗法摘要号：LBA52 中文标题：个体化新抗原疫苗联合精准关键病灶放疗（CLERT）治疗晚期实体瘤：iNATURE II 期试验更新结果英文标题：Personalized Neoantigen Vaccine Combined with Precision Critical Lesion Radiotherapy (CLERT) in Advanced Solid Tumors: Updated Results from the iNATURE Phase II Trial 讲者：中国香港大学孔凤鸣 07 新兴疗法摘要号：LBA33 中文标题：GFH276 单药治疗既往经治 RAS 突变晚期实体瘤的安全性与疗效英文标题：Safety and efficacy of GFH276 monotherapy in previously treated RAS-mutated advanced solid tumors 讲者：中山大学肿瘤防治中心马翔宇摘要号：LBA34 中文标题：MRG007（ARR-217），一种靶向 CDH17 的依喜替康抗体偶联药物在局部晚期或转移性实体瘤患者中的首次人体研究英文标题：First-in-human study of MRG007 (ARR-217), a CDH17-directed exatecan ADC, in patients with locally advanced or metastatic solid tumors 讲者：北京大学肿瘤医院李健

2026-09-22

·J先泩

医药、创新药为什么如此强势？？

A股医药‑创新药板块强势分析风险提示：仅产业逻辑客观梳理，不构成投资建议。创新药行业存在临床失败、出海不及预期、医保降价、一次性BD收入不可持续、靶点内卷等风险。一、本轮创新药强势的五大核心驱动逻辑1、政策端：全链条制度红利落地，从研发到支付闭环打通1）顶层规划：“十五五”医药工业规划，将生物医药确立为国家新兴支柱产业，提出创新药产业年均增速目标20%以上，重点支持ADC、CGT、mRNA、双抗、AI制药等前沿方向。2）研发端：药监局加速审评，CGT纳入30日快速审评通道；科创板第五套上市标准持续支持未盈利Biotech，允许研发型企业登陆资本市场融资。2026上半年国产1类创新药获批31款，占全部新药80%。3）支付端：医保+商保双目录并行，新增预申报机制，创新药上市进入医保周期前置约1年；商保目录承接高价前沿新药，缓解医保压力，拓宽商业化路径，改变过去“只有降价进医保一条路”的局面。2、产业基本面：出海License‑Out进入大规模兑现期，中国创新药全球议价能力抬升过去国内创新药以me‑too为主；当前ADC、双抗、多特异性抗体、自免靶点管线质量大幅提升，跨国药企主动来采购中国管线。• 2026上半年国内创新药对外授权BD总规模超1000亿美元，多笔十亿、百亿美元级合作落地，首付款、里程碑直接增厚利润，部分Biotech依靠BD实现扭亏为盈。• 变化：不再仅仅输出早期临床前资产，临床Ⅰ/Ⅱ期优质管线即可获得大额首付款，部分项目走向共同开发、全球分成模式，不再单纯低价卖海外权益。• 行业拐点：从“国内内卷价格战”转向“国内商业化+全球权益变现”双收益模式。3、业绩拐点：板块盈利从集体亏损走向大面积兑现1）Big‑Pharma（大型药企）：创新药收入占比持续走高，非肿瘤管线（代谢、自免、心血管）成为第二增长曲线，摆脱单一肿瘤依赖。2）Biotech：一部分依靠BD里程碑实现报表扭亏；一部分自研产品国内获批放量；科创板创新药板块整体由亏转盈。3）CXO/CDMO：全球生物医药研发需求回暖，ADC、双抗、多肽订单爆发，产能利用率修复，营收利润回暖，作为卖铲子环节同步走强。4、估值与资金：前期深度调整，高低切换带来增量资金入场1）过去2‑3年板块持续回调，大量创新药、Biotech估值处于历史分位低位，具备估值修复基础。2）上半年AI算力、半导体科技主线高位震荡，资金向景气度改善、位置更低的成长板块做高低切换；医药ETF持续大额净流入，机构仓位回补创新药赛道。5、技术迭代：ADC、双抗、GLP‑1、CGT、AI制药多技术平台集体成熟• ADC：本轮行情最强主线，国内已经形成完整的Linker‑Payload‑抗体全链条平台，多项临床数据在国际大会读出，疗效数据对标海外一流产品。• 双抗/多抗：实体瘤、血液瘤临床数据持续超预期。• GLP‑1代谢赛道：国内多家企业跟进，从减重拓展至肾病、NASH等适应症。• AI制药：缩短药物分子发现周期，降低临床前研发成本，头部药企已经将AI嵌入完整研发流程。二、细分赛道景气排序1. ADC抗体偶联药物：景气度最高，BD交易最活跃，临床数据持续输出；2. 双抗/多特异性抗体：肿瘤、自免方向管线密集读出；3. 自免与代谢（GLP‑1、TYK2等）：摆脱肿瘤内卷，市场空间大；4. CGT细胞基因治疗、小核酸siRNA：政策支持，尚处在早期；5. CXO‑CDMO：创新药上游卖铲子，ADC订单驱动；6. 传统小分子创新药：相对稳健，内卷较为严重。三、代表A股强势标的，分三类拆解逻辑（仅产业业务梳理，非推荐）第一类：Big Pharma，自研商业化+出海双轮驱动1. 恒瑞医药国内创新药龙头，创新药收入占比超63%；肿瘤管线丰富，同时大力布局代谢、自免等第二增长曲线；频繁开展全球BD合作，输出多条管线，海外价值打开。2. 百济神州（科创板）泽布替尼实现全球销售；多条自研大品种海内外获批，2026上半年利润大幅改善；海外商业化能力是国内第一梯队。3. 信达生物PD‑1商业化基础扎实；双抗、ADC管线储备丰厚；与辉瑞等跨国药企深度合作，共同开发全球市场，海外授权持续落地。第二类：Biotech，核心看点：ADC、双抗、出海License‑Out（科创板U股为主）1. 荣昌生物核心管线维迪西妥单抗（ADC）国内商业化；RC148与艾伯维达成大额全球授权，带来大额报表收益，ADC平台完整，持续推进新管线临床。2. 百利天恒双抗/ADC技术平台，BL‑B01D1与BMS达成巨额全球合作，近期触发里程碑付款，平台持续输出新项目。3. 迪哲医药‑U舒沃替尼授权阿斯利康，拿到6亿美金首付款，里程碑丰厚；小分子肿瘤创新平台，BD变现能力突出。4. 诺诚健华‑UBTK抑制剂奥布替尼海内外销售；自免管线进入临床后期，海外授权推进；血液瘤+实体瘤双线布局。5. 科伦博泰ADC管线储备庞大，多次与默沙东开展海外授权合作；国内ADC管线布局最丰富的Biotech之一。第三类：CXO/CDMO，创新药上游卖铲子，受益ADC浪潮1. 药明康德全球综合CXO龙头，ADC、大分子订单回暖，一体化平台，业绩弹性来自全球创新药研发投入复苏。2. 凯莱英小分子CDMO龙头，ADC的Payload、连接子代工业务高速增长，多个ADC项目走向商业化阶段。3. 博腾股份ADC CDMO产能建设，承接海外Biotech偶联药物工艺开发与生产，受益全球ADC浪潮。4. 康龙化成药物发现+CDMO一体化，ADC早期到后期订单持续提升。四、行业核心风险点（必须重视）1. BD收入很多是一次性非经常性收益：首付款、里程碑计入当期利润，但不代表持续性经营性现金流，要区分“授权收益”和“产品销售利润”。2. 临床风险：创新药高度依赖临床数据读出，即使前期BD金额巨大，Ⅲ期临床依然存在失败风险。3. 靶点内卷风险：ADC、Claudin18.2等热门赛道大量企业扎堆，未来会出现同质化竞争，临床数据不占优品种价值会大幅缩水。4. 出海地缘风险：海外监管、GMP核查、国际关系变化会影响授权与海外临床推进。5. 医保谈判降价压力：国内创新药进入医保依然面临价格压力。风险提示：仅产业逻辑客观梳理，不构成投资建议。

2026-09-22

·今日头条

医疗成果转化与产业融合创新发展论坛专家团走进荣昌生物

REMEGEN 9月19日，“智聚烟台·科创赋能”医疗成果转化与产业融合创新发展论坛在烟台举行。论坛由四川大学华西医院管理研究所主办，烟台毓璜顶医院协办，荣昌生物公益支持，十余家国内三级公立医院的院领导及科技创新、科研管理、成果转化等相关负责人参加。上午论坛在烟台毓璜顶医院举行，下午与会嘉宾走进荣昌生物，实地参观K座生产车间和烟台国际生物药谷展示中心，并围绕生物医药领域医疗成果转化与产业融合展开深入对话。四川大学华西医院管理研究所特聘专家袁淑兰指出，医院是医疗成果的重要策源地，也是成果转化的关键环节。她结合华西医院实践经验，强调要打通从临床需求到产业应用的通道。她表示，“十五五”规划进一步强化企业科技创新主体地位，为医院与企业深化产学研协同、共同推动成果转化提供了政策支持。医院管理研究所正在探索从走进医院到走进企业的交流形式，此次参访有助于各方了解企业研发与产业化实践，拓展合作思路。她对荣昌生物为此次交流提供的支持表示感谢。荣昌生物董事长王威东对各位院长、专家的到来表示热烈欢迎，对大家长期以来给予荣昌生物大力支持表示衷心感谢。他指出，健康中国建设在“十五五”时期迈入更加注重创新驱动、协同发展的新阶段，加快医疗成果转化是健康中国建设的重要举措。“十三五”“十四五”以来，我国在创新药领域积累了大量的科研成果，现在正是实现成果转化的关键时刻。王威东表示，与医院建立高水平战略合作关系，是荣昌生物发展战略的重要组成部分，也是公司发展的重要支点。创新成果最终要在临床上得到验证，离不开医院及专家的参与，一方面要加强临床研究与创新合作，我国临床研究水平不断提升，已达到国际同等水平，并在细分领域实现了领跑，为成果转化和共同开发奠定了基础；另一方面要加强科研成果转化合作，推动创新药的临床应用，让患者得到有效治疗、满足临床需求，并最终转化为商业成果。公司发展与医院高水平合作密不可分，希望以此次论坛为契机，让各位专家了解荣昌生物的发展现状与未来规划，找到契合点，为成果转化贡献新的力量。荣昌生物首席执行官房健民博士表示，临床医生在发现未被满足的临床需求、开展药物临床评价和推动创新成果应用中发挥着关键作用。创新成果转化需要技术创新与专业管理的共同支撑，泰它西普和维迪西妥单抗的研发与上市为公司积累了实践经验。荣昌生物希望加强与医院的联系，关注源头创新项目，在临床试验和适应症拓展等方面深化合作，并持续关注药物上市后的有效性和安全性，推动更多创新成果惠及患者。在当天上午的论坛开幕式上，荣昌集团总裁王荔强分享了三点体会：一是以临床需求明确创新方向，使成果转化从起点就贴近临床实践；二是促进医院研究优势与企业开发能力对接，为有潜力的成果创造更充分的转化条件；三是贯通研发、生产与临床应用，推动成果转化形成从临床需求到患者获益的完整链条。王荔强表示，荣昌愿以开放务实的态度，与各家医院和科研机构加强联系，围绕临床研究、成果转化和人才交流探讨更多合作机会。在下午的交流中，山东大学齐鲁医院副院长韩辉围绕医院科技平台建设、成果转化机制等分享实践经验，荣昌生物首席医学官石明博士介绍了公司研发管线与成果亮点。主题沙龙讨论环节，与会专家介绍了各自医院的优势学科与科研情况，并围绕联合创新平台建设、复合型人才培养和临床需求导向的成果转化等方向交流意见，探讨进一步合作的可能路径。此次参访为医疗机构与生物医药企业增进了解、对接创新需求提供了交流机会。荣昌生物表示，将继续与医疗机构、高校和科研院所加强沟通，围绕临床研究与成果转化探索务实合作，推动有价值的创新成果更好服务临床、惠及患者。文字 | 危颖影像 | 春媛编辑 | 春媛荣昌生物科创板上市 | 港交所上市挺进医保 | License out 泰它西普 | 维迪西妥单抗 RC28 | RC118 | RC148 | RC278 | RC288

100 项与维迪西妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12989	-	L01X	-

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低表达乳腺癌	中国	荣昌生物制药（烟台）股份有限公司	2026-03-17
乳腺癌肝脏转移	中国	荣昌生物制药（烟台）股份有限公司	2025-04-30
HER2阳性转移性乳腺癌	中国	荣昌生物制药（烟台）股份有限公司	2025-04-30
HER2阳性尿路上皮癌	中国	荣昌生物制药（烟台）股份有限公司	2021-12-31
HER2阳性胃癌	中国	荣昌生物制药（烟台）股份有限公司	2021-06-08

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
晚期胃食管交界处腺癌	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2026-01-12
HER2阳性胃腺癌	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2026-01-12
HER2表达胃食管交界处腺癌	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2026-01-12
HER2低表达胃食管交界处癌	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2025-05-15
HER2阳性胃食管结合部腺癌	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2025-04-25
胃食管交界处腺癌	临床3期	中国	荣昌生物制药（烟台）股份有限公司	2024-02-22
转移性尿路上皮癌	临床3期	美国	Seagen, Inc.	2023-09-22
转移性尿路上皮癌	临床3期	日本	Seagen, Inc.	2023-09-22
转移性尿路上皮癌	临床3期	阿根廷	Seagen, Inc.	2023-09-22
转移性尿路上皮癌	临床3期	澳大利亚	Seagen, Inc.	2023-09-22

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临床结果

适应症

分期

评价

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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


ASCO2026	N/A	肾盂和输尿管尿路上皮癌辅助	105	Disitamab vedotin + PD-1 inhibitors	淵繭遞構襯構願繭襯築(鹽願遞憲選鬱網網壓膚) = 簾簾夢壓製壓糧簾願鏇淵壓襯遞網壓製繭顧觸 (齋觸積窪憲艱鑰獵鹹繭, 66.8 ~ 100.0) 更多	积极	2026-05-29
ASCO2026	N/A	肾盂和输尿管尿路上皮癌辅助	105	Gemcitabine-platinum	淵繭遞構襯構願繭襯築(鹽願遞憲選鬱網網壓膚) = 簾鏇構餘糧願膚觸繭築淵壓襯遞網壓製繭顧觸 (齋觸積窪憲艱鑰獵鹹繭, 54.3 ~ 77.7) 更多	积极	2026-05-29
NCT05996952 (ASCO2026)	临床2期	HER2表达非肌层浸润性膀胱肿瘤辅助 HER2 overexpression	28	Disitamab vedotin (Cohort A (adjuvant therapy))	蓋齋鹹憲鑰鏇鹹積餘鹹(選膚廠觸構夢積願簾範) = 鬱網鹽鬱選夢鏇選蓋餘襯醖網簾襯製鏇鏇選範 (餘築憲繭鏇鑰糧淵衊鬱 ) 更多	积极	2026-05-29
NCT05996952 (ASCO2026)	临床2期	HER2表达非肌层浸润性膀胱肿瘤辅助 HER2 overexpression	28	Disitamab vedotin (Cohort B (rescue therapy))	蓋齋鹹憲鑰鏇鹹積餘鹹(選膚廠觸構夢積願簾範) = 衊齋糧襯膚淵願餘糧繭襯醖網簾襯製鏇鏇選範 (餘築憲繭鏇鑰糧淵衊鬱 ) 更多	积极	2026-05-29
NCT06227117 (ASCO2026)	临床2期	HR阴性/HER2低表达乳腺癌新辅助 HR-negative \| HER2-low	68	DV + Tor + carboplatin	願餘構餘鹹餘範構鏇憲(膚製衊醖構獵鹹糧壓鹹) = 觸顧蓋淵窪願顧觸繭遞齋襯壓鑰製醖鬱築蓋願 (膚淵齋鹽醖範醖獵衊齋, 79.6 ~ 98.4) 更多	积极	2026-05-29
NCT06227117 (ASCO2026)	临床2期	HR阴性/HER2低表达乳腺癌新辅助 HR-negative \| HER2-low	68	DV + Tor followed by epirubicin + cyclophosphamide + Tor	願餘構餘鹹餘範構鏇憲(膚製衊醖構獵鹹糧壓鹹) = 鏇觸衊願壓艱繭築構餘齋襯壓鑰製醖鬱築蓋願 (膚淵齋鹽醖範醖獵衊齋, 55.1 ~ 89.3) 更多	积极	2026-05-29
ChiCTR2400086605 (SAVE, ASCO2026)	临床2期	阴茎肿瘤	8	Disitamab vedotin + Toripalimab	顧鏇醖範鑰鑰餘願膚餘(選膚壓範夢淵鏇蓋遞淵) = 齋積範襯窪衊構觸壓餘衊積獵網鹽簾壓鏇襯膚 (鏇鬱獵糧齋鏇蓋憲鑰窪 ) 更多	积极	2026-05-29
NCT06354231 (ASCO2026)	临床2期	肾盂和输尿管尿路上皮癌 HER2 1+ \| HER2 2+ \| HER2	9	Disitamab Vedotin + Toripalimab	網窪餘範壓遞構夢醖艱(遞範廠獵簾襯繭觸衊壓) = 範築膚齋淵憲糧衊淵壓餘獵選鹽襯膚願糧構簾 (簾淵鬱衊醖範糧構糧築 ) 更多	积极	2026-05-29
ChiCTR2400081555 (ASCO2026)	临床2期	HER2阳性尿路上皮癌 HER2 expression ≥ 2+	21	Toripalimab (3mg/kg, Q2W) combined with Disitamab Vedotin (2mg/kg, Q2W) (Pelvic lymph node dissection (PLND))	選選鏇願艱範醖鑰糧醖(壓鑰淵網醖憲蓋窪蓋憲) = 遞憲遞襯襯範顧構鹹鏇築襯願鬱獵獵簾顧醖簾 (壓餘積選選製構獵積願 ) 更多	积极	2026-05-29
ASCO2026	N/A	转移性尿路上皮癌 HER2-expressing	880	Disitamab vedotin 2.0 mg/kg IV every 2 weeks (HER2-expressing locally advanced or metastatic urothelial carcinoma)	膚蓋蓋衊衊窪糧鑰觸鹽(鬱網夢壓築觸齋鹹淵顧) = 衊簾衊鬱鹽積鹹遞餘淵鬱醖齋觸窪積鹽觸積遞 (網顧鬱壓範獵選窪構網, 80 ~ 88) 更多	积极	2026-05-29
NCT06574763 (ASCO2026)	临床2期	卵巢癌新辅助 HER2-expressing	24	Disitamab vedotin plus carboplatin	觸憲壓遞淵廠繭簾淵憲(糧網願構憲夢廠餘廠餘) = 鏇鬱積壓鹽窪鹹網繭糧網鹹網衊簾鹽襯膚襯憲 (範鬱窪網夢糧壓餘簾獵 ) 更多	积极	2026-05-29
ChiCTR2400093839 (PUNCH03, ASCO2026)	临床2期	HER2阳性浸润性膀胱癌 HER2 positive	24	Disitamab vedotin + Tislelizumab + BCG	願鹹餘鏇鏇糧醖窪窪憲(築鏇蓋蓋艱窪艱簾鹹簾) = 築鏇鬱衊鹽選衊鏇齋夢遞窪願選齋壓夢簾蓋鑰 (夢範壓獵淵膚鹹構憲觸, 90.7 ~ 100)	积极	2026-05-29
NCT07315750 (RC48-C040, ASCO2026)	临床3期	HER2表达胃食管交界处腺癌一线 HER2-high	555	Disitamab vedotin + Trastuzumab + Tislelizumab	淵鏇選艱願願醖築製觸(餘憲製壓窪鹽蓋範鑰糧) = 繭遞艱艱憲網壓壓選餘餘繭艱顧願獵艱鬱願構 (繭窪願願構選鏇構顧夢 ) 更多	积极	2026-05-29
NCT07315750 (RC48-C040, ASCO2026)	临床3期	HER2表达胃食管交界处腺癌一线 HER2-high	555	Chemotherapy + Trastuzumab ± Pembrolizumab	淵鏇選艱願願醖築製觸(餘憲製壓窪鹽蓋範鑰糧) = 醖夢鹹鏇廠襯壓淵築鑰餘繭艱顧願獵艱鬱願構 (繭窪願願構選鏇構顧夢 )	积极	2026-05-29