Drugs / Disitamab Vedotin
Disitamab Vedotin
also known as
RC48-ADC · RC48 · Vidiximab · Disitamab Vedotin （RC48-ADC) · trastuzumab vedotin · vedixizumab
Monoclonal antibody targets ERBB2
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed urothelial carcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | urothelial carcinoma | 2025-08-08 | “NMPA）已于近日受理公司自主研发的抗PD-1单抗药物特瑞普利单抗（商品名：拓益 ® ）联合荣昌生物自主研发的抗体偶联（ADC）药物维迪西妥单抗用于HER2表达（HER2表达定义为HER2免疫组织化学检查结果为1+、2+或3+）的局部晚期或转移性尿路上皮癌患者治疗的新适应症上市申请。” junshipharma.com ↗ “In July 2021 the National Medical Products Administration (NMPA) of China also accepted a New Drug Application for disitamab vedotin in mUC.” remegen.com ↗ “submitted a New Drug Application (NDA) in China in July of this year for the new indication of disitamab vedotin combined with toripalimab” remegen.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | China (NMPA) | — | HER2-positive advanced breast cancer with liver metastasis | 2024-10-15 | “NMPA accepted the BLA submission of Telitacicept for MG and Disitamab Vedotin for HER2-positive breast cancer with liver metastasis.” remegen.com ↗ “officially accepted and granted priority review for its Biologics License Application (BLA) of Disitamab Vedotin” remegen.com ↗ |
Trials 131 · started per year
today
1
2
1
2
2
4
6
19
36
27
18
11
2
20162017201820192020202120222023202420252026202720282029
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06660511 | Oct 2024 → Sep 2025 overdue | ovarian carcinoma | Second Xiangya Hospital of Central South University | Recruiting | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT07853053 | Jan 2027 → Dec 2029 expected | urinary bladder cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05940896 | Jun 2023 → Nov 2024 overdue | cancer | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06078982 | Jun 2023 → Aug 2025 | gastric cancer | Shanghai East Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05514158 | Sep 2022 → May 2024 | gastric cancer | RemeGen Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04280341 | Jun 2020 → Dec 2024 | — | Peking University | Unknown | No outcome recorded |
| Phase 1 | NCT02881138 | Mar 2016 → Apr 2020 | cancer | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02881190 | Dec 2015 → Jun 2019 | cancer | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT05745740 | Dec 2027 expected | non-small cell lung carcinoma | RemeGen Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06966453 | Jun 2025 → Oct 2027 expected | breast cancer | Pfizer | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06957561 | Apr 2025 → May 2026 overdue | urinary bladder carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06650332 | Jul 2024 → Aug 2026 overdue | gastroesophageal cancer | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06341400 | Jun 2024 → May 2028 expected | infiltrating bladder urothelial carcinoma | Zhujiang Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06378242 | Jun 2024 → Mar 2029 expected | non-invasive bladder urothelial carcinoma | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05982834 | May 2023 → May 2025 | carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05403242 | Sep 2022 → Sep 2025 overdue | gastroesophageal adenocarcinoma | Chinese PLA General Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04264936 | Feb 2020 → Jan 2021 | urothelial carcinoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 1/2 | NCT03052634 | Dec 2016 → Jul 2022 | breast cancer | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 290 trials | ||||||
| Phase 2 | NCT07602140 | Aug 2026 → Aug 2028 expected | gastric cancer | Shandong Provincial Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07690878 | Jul 2026 → Oct 2027 expected | urinary bladder cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07591805 | May 2026 → Jan 2027 expected | renal pelvis/ureter urothelial carcinoma | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07509424 | Apr 2026 → Apr 2029 expected | rectal cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07507526 | Apr 2026 → Apr 2028 expected | gastric adenocarcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07474064 | Mar 2026 → Mar 2031 expected | urinary bladder carcinoma | chenxu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07311577 | Jan 2026 → Dec 2027 expected | ovarian cancer | Jiangsu Cancer Institute & Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07279597 | Dec 2025 → Dec 2027 expected | infiltrating bladder urothelial carcinoma | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07201675 | Dec 2025 → Dec 2027 expected | urinary bladder carcinoma | Qilu Hospital of Shandong University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07172217 | Oct 2025 → Feb 2027 expected | — | Qilu Hospital of Shandong University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07194005 | Sep 2025 → Sep 2028 expected | gastric cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07142200 | Sep 2025 → Jun 2026 overdue | bladder transitional cell carcinoma | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07100184 | Sep 2025 → May 2028 expected | — | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07151560 | Aug 2025 → Aug 2027 expected | — | Renmin Hospital of Wuhan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07159217 | Aug 2025 → May 2027 expected | biliary tract cancer | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07117851 | Aug 2025 → Dec 2027 expected | extramammary Paget disease, scrotal disorder | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07093866 | Jul 2025 → Dec 2026 expected | castration-resistant prostate carcinoma | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Phase 2 | NCT06992362 | May 2025 → Dec 2026 expected | hepatoid adenocarcinoma | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06642545 | Feb 2025 → Oct 2026 expected | breast cancer | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07285941 | Jan 2025 → Jan 2027 expected | ovarian cancer | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06791070 | Jan 2025 → Jan 2027 expected | scrotum Paget disease | Fujian Medical University Union Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06105008 | Dec 2024 → Dec 2025 | breast neoplasm | RemeGen Co., Ltd. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06649331 | Oct 2024 → Sep 2026 overdue | triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06730373 | Oct 2024 → Dec 2026 expected | gastric carcinoma | Qilu Hospital of Shandong University | Recruiting | No outcome recorded |
| Phase 2 | NCT06630871 | Oct 2024 → Oct 2026 expected | non-invasive bladder urothelial carcinoma | Fujian Medical University Union Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06540729 | Sep 2024 → Aug 2028 expected | ovarian cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06560528 | Sep 2024 → Sep 2027 expected | gastric cancer, gastroesophageal junction adenocarcinoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06561555 | Aug 2024 → Aug 2025 overdue | Paget disease | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06492317 | Jul 2024 → Jul 2026 overdue | — | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06734182 | Jun 2024 → Jun 2027 expected | non-small cell lung carcinoma | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06157892 | May 2024 → Jul 2029 expected | HER2 positive breast carcinoma, gastric cancer, gastroesophageal junction adenocarcinoma, triple-negative breast carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06487429 | May 2024 → May 2026 overdue | gastric cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT06233864 | Apr 2024 → Apr 2025 | malignant pancreatic neoplasm | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT06227156 | Apr 2024 → Dec 2025 | castration-resistant prostate carcinoma | RemeGen Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT07646145 | Apr 2024 → Apr 2027 expected | urinary bladder carcinoma | Shanxi Province Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06210490 | Feb 2024 → May 2028 expected | renal pelvis/ureter urothelial carcinoma | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06749860 | Feb 2024 → Jun 2026 overdue | lung cancer | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06185400 | Feb 2024 → Jul 2025 overdue | non-small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06227325 | Feb → Dec 2024 | gastric cancer | Henan Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06155396 | Jan 2024 → Jun 2027 expected | cervical cancer | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07065435 | Jan 2024 → Dec 2025 overdue | HER2 positive breast carcinoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07446452 | Jan 2024 → Dec 2026 expected | breast carcinoma by gene expression profile | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06187506 | Dec 2023 → Sep 2026 overdue | urinary bladder cancer | Fudan University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06178159 | Nov 2023 → Jun 2026 overdue | breast cancer | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06155383 | Nov 2023 → Jan 2025 overdue | gastric cancer, gastroesophageal junction adenocarcinoma | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06003231 | Nov 2023 → Mar 2026 overdue | endometrium neoplasm, head and neck neoplasm, non-small cell lung carcinoma, ovarian neoplasm | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06112041 | Oct 2023 → Oct 2026 expected | carcinoma | Second Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06074484 | Sep 2023 → Aug 2024 | infiltrating bladder urothelial carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT05785325 | Aug → Dec 2023 | colorectal cancer | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT06000033 | Aug 2023 → Dec 2024 | breast cancer | Qilu Hospital of Shandong University | Unknown | No outcome recorded |
| Phase 2 | NCT06178601 | Aug 2023 → Sep 2024 | urothelial carcinoma | Shanxi Province Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05955209 | Aug 2023 → Aug 2024 | castration-resistant prostate carcinoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 2 | NCT05979740 | Aug → Dec 2023 | urinary bladder carcinoma | RenJi Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05996952 | Aug 2023 → Aug 2025 overdue | urinary bladder carcinoma | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06227117 | Jul 2023 → Dec 2025 overdue | breast cancer | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06354231 | Jul 2023 → Dec 2026 expected | impaired renal function disease, renal pelvis/ureter urothelial carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05578287 | Jul 2023 → Dec 2024 | colorectal cancer | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05928897 | Jul 2023 → Jul 2025 | gastric cancer | Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| Phase 2 | NCT05912205 | Jul 2023 → Jul 2025 | urothelial carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 2 | NCT05943379 | Jun 2023 → Dec 2025 overdue | urinary bladder cancer | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06383533 | May 2023 → May 2025 | bile duct adenocarcinoma | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05847764 | May 2023 → Oct 2024 | non-small cell lung carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05720533 | Mar 2023 → Mar 2024 | gastric cancer | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05726175 | Mar 2023 → Jul 2024 | breast cancer | West China Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05586061 | Feb 2023 → Dec 2024 overdue | — | Qilu Hospital of Shandong University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05627414 | Jan 2023 → Jun 2024 | gastric cancer | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05837806 | Dec 2022 → Dec 2026 expected | — | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05917158 | Nov 2022 → Dec 2027 expected | renal pelvis/ureter urothelial carcinoma | Jinling Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT05493683 | Aug 2022 → Jul 2025 | colorectal cancer | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05417230 | Aug 2022 → Aug 2024 | biliary tract cancer | Jiangsu Cancer Institute & Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05333809 | Jul 2022 → Jul 2024 | colorectal neoplasm | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05350917 | Jun 2022 → Jun 2025 | colorectal cancer | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| Phase 2 | NCT05297552 | May 2022 → Jun 2024 | infiltrating bladder urothelial carcinoma | RemeGen Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05313906 | May 2022 → Apr 2024 | gastric carcinoma | Henan Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04879329 | May 2022 → Dec 2026 expected | urothelial carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 2 | NCT05356351 | May 2022 → Jul 2023 overdue | urinary bladder cancer | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05135715 | Apr 2022 → Dec 2024 | melanoma | RemeGen Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05331326 | Apr 2022 → Dec 2023 | breast cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT05601401 | Mar 2022 → Mar 2023 | tumor of salivary gland | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04965519 | Dec 2021 → Oct 2024 | female reproductive organ cancer | RemeGen Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05113459 | Dec 2021 → Dec 2023 | gastric cancer | Guoxin Li | Unknown | No outcome recorded |
| Phase 2 | NCT05134519 | Nov 2021 → Sep 2024 | HER2 positive breast carcinoma | Xijing Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05016973 | Oct 2021 → Sep 2024 | urinary bladder cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Unknown | No outcome recorded |
| Phase 2 | NCT05495724 | Jul 2021 → Feb 2025 | bladder transitional cell carcinoma | Tianjin Medical University Second Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04329429 | Aug 2020 → Nov 2023 | biliary tract cancer | RemeGen Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04073602 | Aug 2019 → Sep 2022 | urothelial carcinoma | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03809013 | Jan 2019 → Mar 2021 | urothelial carcinoma | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03556345 | Jul 2018 → Jun 2020 | gastric carcinoma | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03507166 | Dec 2017 → Oct 2018 | urothelial carcinoma | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 2/35 trials · 1 met primary | ||||||
| Phase 2/3 | NCT07608224 | Jun 2026 → Jun 2030 expected | urinary bladder cancer | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07366840 | Jan 2026 → Jan 2028 expected | HER2 positive breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06221748 | Feb 2024 → Dec 2026 expected | gastric cancer, gastroesophageal junction adenocarcinoma | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05980481 | Aug 2023 → Jul 2025 overdue | gastric cancer | RemeGen Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03500380 | Apr 2018 → Jul 2024 | HER2 positive breast carcinoma | RemeGen Co., Ltd. | Unknown | Met primary |
| Phase 310 trials · 1 met primary | ||||||
| Phase 3 | NCT07498907 | May 2026 → May 2029 expected | renal pelvis/ureter urothelial carcinoma | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT07315750 | Jan 2026 → Jun 2029 expected | gastric carcinoma | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07207824 | Dec 2025 → Jun 2030 expected | non-invasive bladder urothelial carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06944496 | May 2025 → May 2028 expected | gastric carcinoma | RemeGen Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05911295 | Sep 2023 → Jan 2027 expected | urothelial carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06278870 | Sep 2023 → Jun 2031 expected | HER2 positive breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT05904964 | Jul 2023 → Mar 2028 expected | hormone receptor-positive breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT05302284 | Jun 2022 → Dec 2026 expected | urothelial carcinoma | RemeGen Co., Ltd. | Recruiting | Met primary |
| Phase 3 | NCT04714190 | Mar 2021 → Dec 2024 | gastric cancer | RemeGen Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04400695 | Sep 2020 → Dec 2027 expected | breast cancer | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05861635 | Feb 2023 → Feb 2025 | breast cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 4 | NCT05661357 | Jan 2023 → Jan 2025 | colorectal cancer | Zhongnan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05723991 | Sep 2022 → Sep 2024 | urinary bladder cancer, urothelial carcinoma | Chunguang yang (101937) | Unknown | No outcome recorded |
| Phase 4 | NCT05488353 | Sep 2022 → Apr 2026 | urinary bladder cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT06558682 | Oct 2024 → Oct 2026 expected | cervical cancer | Qilu Hospital of Shandong University | Recruiting | No outcome recorded |
| — | NCT06015113 | Sep 2023 → Apr 2026 overdue | breast cancer | Xi'an International Medical Center Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05831878 | May 2023 → Dec 2026 expected | female breast carcinoma | RenJi Hospital | Recruiting | No outcome recorded |
| — | NCT05540483 | Aug 2022 → Aug 2024 | bile duct carcinoma | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1/2 | NCT06572319 Background | Sep 2024 → Aug 2026 overdue | gastroesophageal junction adenocarcinoma | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07662863 Comparator | Jul 2026 → Dec 2028 expected | peripheral neuropathy, urinary bladder cancer, urothelial carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06904573 Background | Jan 2025 → Jan 2027 expected | urothelial carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05115500 Background | Nov 2021 → Oct 2024 | carcinoma | Second Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 3 | NCT07693959 Background | Jul 2026 → Jul 2028 expected | — | Zhiquan Hu | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2026-06-28 | RemeGen Co., Ltd. | Results The Journal of Clinical Oncology (JCO) Publishes Full Results of Disitamab Vedotin in a "Triple-Drug Combination" (RCTS) Regimen for First-Line Gastric Cancer Therapy remegen.com ↗
Its efficacy data achieved remarkable milestones: an objective response rate (ORR) of 89.5%, a median progression-free survival (PFS) of 13.8 months, and a median overall survival (OS) of 31.9 months. |
| 2026-05-21 | Shanghai Junshi Bioscience Co., Ltd. | Regulatory 君实生物宣布特瑞普利单抗一线治疗HER2表达尿路上皮癌成功获批 junshipharma.com ↗
本次新适应症的获批主要基于RC48-C016研究（NCT05302284）的研究数据。 |
| 2026-04-17 | RemeGen Co., Ltd. | Results 2026 EAU | Original Research Findings on Disitamab Vedotin Unveiled: Showcasing Breakthroughs in Urothelial Carcinoma Care remegen.com ↗
In the real-world multicenter study led by Professor Cuijian Zhang from Peking University First Hospital, DV alone or combined with PD-1 inhibitor demonstrated favorable efficacy and manageable safety profile in patients with HER2-expressing HR-NMIBC. |
| 2026-02-28 | RemeGen Co., Ltd. | Results 2026 ASCO-GU | RC48-C017 study update: Disitamab vedotin plus immunotherapy as neoadjuvant treatment delivers lasting survival gains in bladder cancer. remegen.com ↗
The results showed that this combination therapy demonstrated durable disease control and survival benefits during the neoadjuvant phase, with good safety, providing important reference for future clinical practice. |
| 2025-10-20 | RemeGen Co., Ltd. | Results ESMO Congress 2025 Presidential Symposium Oral Presentation | Disitamab Vedotin Achieves Major Breakthrough as First-Line Treatment for Urothelial Carcinoma remegen.com ↗
The results showed that the RC48-C016 study met the dual primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS). |
| 2025-08-08 | Shanghai Junshi Bioscience Co., Ltd. | Regulatory 君实生物宣布特瑞普利单抗一线治疗HER2表达尿路上皮癌新适应症上市申请获受理 junshipharma.com ↗
国家药品监督管理局（NMPA）已于近日受理公司自主研发的抗PD-1单抗药物特瑞普利单抗（商品名：拓益 ® ）联合荣昌生物自主研发的抗体偶联（ADC）药物维迪西妥单抗用于HER2表达（HER2表达定义为HER2免疫组织化学检查结果为1+、2+或3+）的局部晚期或转移性尿路上皮癌患者治疗的新适应症上市申请。 |
| 2025-06-03 | RemeGen Co., Ltd. | Results 2025 ASCO ｜ Selected in Rapid Oral Abstract Presentation: Disitamab Vedotin as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Gastric Cancer Achieves Efficacy Breakthrough remegen.com ↗
Comparing to the placebo group who received standard-of-care therapy, the DV combination therapy demonstrated clinically meaningful efficacy improvement with a potential to extend beneficial population to prior targeted treatment non-response patients. |
| 2025-05-12 | RemeGen Co., Ltd. | Results Poised to Reshape Treatment Landscape: A Phase 3 Clinical Trial on Disitamab Vedotin as a First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma Reached its Primary Endpoints of PFS and OS remegen.com ↗
The primary subgroup analysis showed that DV combined with toripalimab significantly improved PFS and OS compared with the standard chemotherapy of la/mUC, irrespective of cisplatin eligibility or HER2 expression level. |
| 2025-05-09 | RemeGen Co., Ltd. | Regulatory RemeGen’s Disitamab Vedotin Gains Approval in China for its Third Indication Making it the First ADC Approved for HER2-Positive Advanced Breast Cancer with Liver Metastasis Globally remegen.com ↗
With the third indication approved in China, disitamab vedotin now is the first ADC clinically available for patients with HER2-positive advanced breast cancer with liver metastasis globally |
| 2025-02-14 | RemeGen Co., Ltd. | Results ASCO GU｜RemeGen Announced Highly Encouraging Data from the Phase II Clinical Trial Evaluating Disitamab Vedotin plus Immunotherapy as Perioperative Regimen for Bladder Cancer remegen.com ↗
The recently updated data indicated clinically meaningful benefits of this therapeutic approach. |
| 2025-01-28 | Pfizer | Results Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium pfizer.com ↗
Updated efficacy and safety data from an ongoing Phase 2 study (sponsored by Remegen) evaluating the HER2-targeting ADC disitamab vedotin plus toripalimab show encouraging results as a perioperative regimen in HER2-expressing muscle-invasive bladder cancer (MIBC). |
| 2025-01-07 | RemeGen Co., Ltd. | Results Published in Annals of Oncology: Disitamab Vedotin Combined with PD-1 Inhibitor is a Promising Treatment Option for Locally Advanced or Metastatic Urothelial Carcinoma remegen.com ↗
The nearly-three-year follow-up revealed an objective response rate (ORR) of 73.2% and median overall survival (OS) of 33.1 months, superior to any prospective clinical study on ADC plus PD-1 inhibitor therapy for la/mUC with data published. |
| 2024-12-13 | RemeGen Co., Ltd. | Results 2024 SABCS｜Results Unveiled for the Phase III Study of Disitamab Vedotin in Treating HER2-Positive Advanced Breast Cancer with Liver Metastasis remegen.com ↗
This is the first prospective randomized phase III study globally on a HER2-targeting ADC that demonstrated significant efficacy in patients with HER2-positive advanced BCLM. |
| 2024-10-17 | RemeGen Co., Ltd. | Results IGCS 2024 | Results of Disitamab Vedotin Combined with Cadonilimab for Cervical Cancer First Announced with ORR up to 50% remegen.com ↗
At the meeting, the result of a phase 2 clinical study on Disitamab Vedotin combined with Cadonilimab to treat recurrent or metastatic cervical cancer (AK001) was published for the first time, drawing much attention. |
| 2024-10-15 | RemeGen Co., Ltd. | Regulatory BLA Accepted and Priority Review Granted to Disitamab Vedotin for Its Third Indication of HER2-Positive Advanced Breast Cancer with Liver Metastasis remegen.com ↗ |
| 2024-09-27 | RemeGen Co., Ltd. | Results 2024 CSCO｜Disitamab Vedotin Combined with Camrelizumab and S-1 as Perioperative Therapy for Gastric Cancer Showed Promising Efficacy with a pCR Rate of 30% remegen.com ↗ |
| 2024-09-15 | RemeGen Co., Ltd. | Results 2024 ESMO | Disitamab Vedotin Achieves 33 Months OS as First-Line Treatment of Advanced Urothelial Carcinoma remegen.com ↗
The median overall survival (OS) of this study was 33.1 months, 20 months longer than that (13 months) of the first-line platinum-containing chemotherapy. |
| 2024-06-28 | RemeGen Co., Ltd. | Results The Data of Disitamab Vedotin for Treatment of Breast Cancer Published in Cancer Communications remegen.com ↗
The published article reported the efficacy and safety of Disitamab Vedotin in the treatment of patients with HER2-overexpressing and HER2-low advanced breast cancer (ABC). |
| 2023-11-22 | RemeGen Co., Ltd. | Results JCO, a Top Oncology Journal, Published Research Results of Disitamab Vedotin of RemeGen in the Treatment of Urothelial Cancer remegen.com ↗
Study results showed an objective response rate of 50.5% (95% CI, 40.6-60.3) as assessed by the Blinded Independent Review Committee. |
| 2023-10-13 | Guangzhou Gloria Biosciences Co., Ltd. | Regulatory 誉衡生物与荣昌生物PD-1与HER2 ADC联合用药临床研究正式获批 gloriabio.com ↗
开展联合用药临床研究的申请正式获得中国国家药品监督管理局（NMPA）批准。 |
| 2023-02-16 | RemeGen Co., Ltd. | Regulatory RemeGen Disitamab Vedotin in Combination with Pyrotinib Maleate Tablets in the Treatment of Non-Small Cell Lung Cancer Approved for Clinical Trials remegen.com ↗ |
| 2022-06-04 | RemeGen Co., Ltd. | Results Disitamab Vedotin appeared on ASCO 2022 meeting and brought exciting clinical data on urothelial carcinoma remegen.com ↗
At ASCO meeting this year, RemeGen announced the results of three clinical studies on Disitamab Vedotin in the form of poster discussion, once again demonstrating its advantages in urothelial carcinoma. |
| 2022-02-18 | RemeGen Co., Ltd. | Results RC48-ADC appeared on ASCO-GU 2022 meeting and the ORR of HER2(3+) patients reached 100% remegen.com ↗
What was particularly surprising was that the objective response rate (ORR) in HER2(3+) patients is as high as 100%. |
| 2021-06-10 | RemeGen Co., Ltd. | Regulatory Disitamab Vedotin has become the first ADC drug created and developed by a China biopharma to receive marketing approval! remegen.com ↗ |
| 2021-06-05 | RemeGen Co., Ltd. | Results RC48-ADC appeared on ASCO 2021 meeting again and brought exciting clinical data remegen.com ↗
This study showed that Disitamab Vedotin has prominent curative effect and survival benefit for patients who has received second-line or above systemic chemotherapy. |
| 2020-09-21 | RemeGen Co., Ltd. | Regulatory RemeGen Announces US FDA Has Granted Breakthrough Therapy Designation for Disitamab Vedotin (RC48) in Urothelial Cancer remegen.com ↗ |
All press releases naming this drug 30 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 139 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Disitamab Vedotin | “This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and...” NCT06630871 ↗101“Based on the PTC results, each participant will receive an individualized neoadjuvant regimen selected from gemcitabine plus cisplatin, disitamab vedotin (RC48), enfortumab...” NCT07690878 ↗ “A Prospective, Open-label, Single-arm, Clinical Study of Disitamab Vedotin Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or...” NCT06354231 ↗ “Disitamab Vedotin Combined With Platinum and Bevacizumab as First-Line and Maintenance Therapy for HER2-Expressing, HRD-Negative High-Risk Ovarian Cancer: A Multicenter,...” NCT07311577 ↗ “using Disitamab Vedotin（RC48） combined with Tislelizumab or third-generation EGFR-TKI Furmonertinib, in the aim of providing new treatment strategies for lung cancer patients...” NCT05847764 ↗ “Drug: Disitamab vedotin(RC48) •An antibody-drug conjugates (ADCs) targeting HER2, has been approved in China for chemotherapy-refractory advanced UC with HER2-expression.” NCT07207824 ↗ “Disitamab Vedotin (2mg/kg, q2w), Tislelizumab (2mg/kg, q2w) combined with low-dose capecitabine 0.5g bid chemotherapy and the COX2 inhibitor celecoxib 200mg bid” NCT05578287 ↗ “Disitamab Vedotin Plus Toripalimab for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer: A Phase II, Open-Label, Randomized Clinical Trial” NCT07151560 ↗ “disitamab vedotin (DV, RC48-ADC), a novel humanized anti-human epidermal growth factor receptor 2 (HER2) antibody conjugated with monomethyl auristatin E” PMID 37988648 ↗ Nov 2023 “The emergence of novel antibody-drug conjugates (ADCs) has brought new hope for anti-HER2 therapy in ovarian cancer, such as Disitamab Vedotin (RC48).” NCT07285941 ↗ “Disitamab Vedotin (RC48) : 2.5 mg/kg, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle” NCT07172217 ↗ |
| Known as | Disitamab Vedotin （RC48-ADC) | “Disitamab Vedotin （RC48-ADC)” NCT06155396 ↗ |
| Known as | RC48 | “The purpose of the trial is evaluated Disitamab Vedotin (RC48) plus Cadonilimab (AK104) as first-line therapy for HER2-overexpressing advanced stomach carcinoma, and also check...” NCT06492317 ↗26“Disitamab vedotin (RC48) plus toripalimab with cetirizine and mecobalamin in patients with locally advanced unresectable or metastatic bladder cancer who have not received...” NCT07853053 ↗ “using Disitamab Vedotin（RC48） combined with Tislelizumab or third-generation EGFR-TKI Furmonertinib, in the aim of providing new treatment strategies for lung cancer patients...” NCT05847764 ↗ “Efficacy and safety of a novel anti-HER2 therapeutic antibody RC48 in patients with HER2-overexpressing, locally advanced or metastatic gastric or gastroesophageal junction cancer” PMID 34665942 ↗ Oct 2021 “This multicenter, Phase II study (RADIANT-BC01) evaluates the efficacy and safety of Disitamab Vedotin (RC48) in combination with either bevacizumab or pyrotinib in adult patients” NCT07065435 ↗ “Disitamab Vedotin（RC-48 ）Combined With Zimberelizumab（GLS-010） in HER2-overexpressed Patients With Previously Treated Unresectable Biliary Tract Cancer” NCT05540483 ↗ “The emergence of novel antibody-drug conjugates (ADCs) has brought new hope for anti-HER2 therapy in ovarian cancer, such as Disitamab Vedotin (RC48).” NCT07285941 ↗ “Disitamab Vedotin (RC48) contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker” NCT06000033 ↗ “Disitamab Vedotin (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90 min); Gemcitabine is 1000mg/m2, once every two weeks.” NCT05723991 ↗ “Disitamab Vedotin (RC48) : 2.5 mg/kg, administered once every 3 weeks (Q3w), via intravenous infusion on Day 1 of each treatment cycle” NCT07172217 ↗ “Patients enrolled will receive 3 cycles of tislelizumab 200 mg in combination with disitamab-vedotin (RC48) 2.0mg/kg intravenously.” NCT05837806 ↗ |
| Known as | RC48-ADC | “To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous...” NCT05831878 ↗37“Disitamab vedotin (DV, RC48-ADC) is an antibody-drug conjugate comprising a human epidermal growth factor receptor 2 (HER2)-directed antibody, linker and monomethyl auristatin E.” PMID 38940019 ↗ Jun 2024 “Disitamab vedotin (RC48-ADC) is a novel humanized anti-human epidermal growth factor receptor 2 (HER2) antibody conjugated with monomethyl auristatin E via a cleavable linker.” NCT06210490 ↗ “disitamab vedotin (DV, RC48-ADC), a novel humanized anti-human epidermal growth factor receptor 2 (HER2) antibody conjugated with monomethyl auristatin E” PMID 37988648 ↗ Nov 2023 “RC48-ADC combined with hypofractionated radiotherapy, PD-L1 inhibitor sequential GM- CSF and Thymopentin” NCT06112041 ↗ “RC48-ADC combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2” NCT05115500 ↗ “Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate (RC48-ADC)” NCT04280341 ↗ “RC48-ADC 2.0 mg/kg D1,Triplizumab 3mg/kg D2，Q2W” NCT05356351 ↗ |
| Known as | trastuzumab vedotin | “ADC drugs have shown some efficacy in brain metastasis patients, and as a domestically developed ADC drug, trastuzumab vedotin has demonstrated good anti-tumor effects.” NCT06015113 ↗ |
| Known as | vedixizumab | “Patients with myometrial invasive bladder cancer expressing HER2 and not suitable for cisplatin chemotherapy were treated with vedixizumab (RC48) 2.0mg/kg, once every two...” NCT05723991 ↗ |
| Known as | Vidiximab | “Vidiximab contains a new humanized anti HER2 antibody Disitamab, which is coupled to monomethylolestatin E (MMAE) through a cleavable linker.” NCT05661357 ↗1“Vidiximab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90 min); Gemcitabine is 1000mg/m2, once every 2 weeks” NCT05723991 ↗ |
| Action | Inhibit | “inhibiting downstream signal pathways activated by HER2” NCT05016973 ↗ |
| Modality | Monoclonal antibody | “recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate RC48-ADC” PMID 33945049 ↗ May 2021 |
| Route | Intravenous | “RC48-ADC administered intravenously” NCT02881190 ↗ |
| Target | ERBB2 | “anti-HER2” NCT03500380 ↗ |