Ivonescimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | non-small cell lung carcinoma | 2024-07-29 | “依沃西一线治疗PD-L1表达阳性NSCLC的新药上市申请(sNDA)也已获CDE受理” akesobio.com ↗ “7月29日,依沃西该项适应症的新药上市申请(sNDA)获得了CDE的受理.” akesobio.com ↗ |
| Filed | China (NMPA) | — | non-small cell lung carcinoma | 2023-08-18 | “值得关注的是,AK112除了有1项适应症的上市申请在国内被CDE受理” akesobio.com ↗ “依沃西已经有1项新药上市申请获得中国国家药品监督管理局受理并优先审评” akesobio.com ↗ “目前依沃西在国内已经有1项新药上市申请获得国家药品监督管理局受理” akesobio.com ↗ “2023年8月,依沃西新药上市申请获得国家药品监督管理局受理” akesobio.com ↗ “目前依沃西一项适应症的上市申请(NDA)已被CDE受理” akesobio.com ↗ “依沃西除了1项新药上市申请成功获得NMPA受理” akesobio.com ↗ “AK112-301研究:NDA已被CDE受理” akesobio.com ↗ |
Trials 163 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT07363408 | Dec 2026 → Jul 2027 expected | colorectal carcinoma | City of Hope Medical Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07650825 | Aug 2026 → Jan 2027 expected | cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07619339 | May 2026 → May 2029 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07340476 | Dec 2025 → Apr 2026 overdue | — | Akeso | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06913218 | Jul 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06990620 | Jun 2025 → Jun 2027 expected | hepatocellular carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06868732 | Apr 2025 → Jun 2028 expected | non-small cell lung carcinoma | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT06424626 | May 2024 → Dec 2027 expected | metastatic melanoma, mucosal melanoma | Peking University Cancer Hospital & Institute | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT05116007 | Mar 2021 → Dec 2023 | small cell lung carcinoma | Akeso | Completed | No outcome recorded |
| Phase 1 | NCT04047290 | Sep 2019 → Feb 2024 | cancer | Akeso Biopharma, Inc. | Completed | No outcome recorded |
| Phase 1/231 trials | ||||||
| Phase 1/2 | NCT07602855 | Sep 2026 → Jun 2029 expected | lung neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07590531 | Jun 2026 → May 2027 expected | non-small cell lung carcinoma | Multitude Therapeutics Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07623356 | Jun 2026 → Jun 2028 expected | non-small cell lung carcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07560124 | Jun 2026 → Jun 2028 expected | breast cancer | Akeso | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07594522 | May 2026 → May 2028 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07535463 | Apr 2026 → Apr 2028 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07535437 | Apr 2026 → Apr 2028 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07357220 | Mar 2026 → Feb 2027 expected | metastasis from malignant tumor of colon | Akeso | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07339839 | Mar 2026 → Sep 2027 expected | non-small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07397338 | Jan 2026 → May 2029 expected | colorectal cancer, metastatic neoplasm, non-small cell lung carcinoma | Revolution Medicines, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07385001 | Jan 2026 → Jan 2027 expected | esophageal squamous cell carcinoma | Tang-Du Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07208773 | Oct 2025 → Jan 2027 expected | non-small cell lung carcinoma, small cell lung carcinoma | MediLink Therapeutics (Suzhou) Co., Ltd. | 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 | NCT06938321 | Apr 2025 → May 2027 expected | biliary tract cancer | Akeso | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06809517 | Mar 2025 → Mar 2026 overdue | neoplastic meningitis | Guangzhou Medical University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06844422 | Feb 2025 → Feb 2028 expected | malignant pancreatic neoplasm | Shandong Cancer Hospital and Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06672575 | Jan 2025 → Jan 2028 expected | glioblastoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06646055 | Jan 2025 → Dec 2026 expected | pancreatic ductal adenocarcinoma | Akeso | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06196814 | Oct 2024 → Mar 2026 overdue | — | Hunan Province Tumor Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06530251 | Sep 2024 → Jun 2026 overdue | hepatocellular carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06472895 | Jul 2024 → Dec 2025 overdue | renal cell carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05951608 | Oct 2023 → May 2026 overdue | cancer | Akeso | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05904379 | Jul 2023 → Jun 2026 overdue | non-small cell lung carcinoma | Akeso | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05846867 | May 2023 → May 2026 overdue | colorectal cancer | Akeso | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05689853 | Apr 2023 → Dec 2026 expected | cancer | Akeso | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05636267 | Feb 2023 → Feb 2025 | non-small cell lung carcinoma | Akeso | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05229497 | May 2022 → Dec 2026 expected | cancer | Akeso | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05214482 | Jan 2022 → Nov 2025 | cancer | Akeso | Completed | No outcome recorded |
| Phase 1/2 | NCT04999605 | Jun 2021 → Jun 2022 | ovarian carcinoma | Akeso | Terminated | No outcome recorded |
| Phase 1/2 | NCT04900363 | May 2021 → Jun 2024 | non-small cell lung carcinoma | Akeso | Completed | No outcome recorded |
| Phase 1/2 | NCT04597541 | Oct 2020 → Mar 2022 | cancer | Akeso | Completed | No outcome recorded |
| Phase 2103 trials | ||||||
| Phase 2 | NCT07743138 | Feb 2027 → May 2028 expected | adrenal cortex carcinoma, paraganglioma, pheochromocytoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07655570 | Nov 2026 → May 2027 expected | skin angiosarcoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07819591 | Oct 2026 → Dec 2028 expected | small cell lung carcinoma | Shaodong Hong | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07854600 | Oct 2026 → Oct 2028 expected | biliary tract cancer | Haitao Zhao, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT07359456 | Aug 2026 → Aug 2029 expected | colorectal cancer | UNICANCER | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07809893 | Aug 2026 → Dec 2027 expected | colorectal cancer | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07393555 | Aug 2026 → Nov 2028 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07712094 | Aug 2026 → Feb 2029 expected | neuroendocrine neoplasm | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07064902 | Aug 2026 overdue | nasopharyngeal carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07650838 | Aug 2026 → Dec 2027 expected | soft tissue sarcoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07381075 | Jul 2026 → Dec 2028 expected | head and neck squamous cell carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07669779 | Jul 2026 → Aug 2027 expected | non-small cell lung carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT07630077 | Jul 2026 → Jul 2027 expected | non-small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07158489 | Jul 2026 → Jul 2028 expected | non-small cell lung carcinoma | Swiss Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07603791 | Jun 2026 → Dec 2027 expected | non-small cell lung carcinoma | Shanghai Allink Biotherapeutics Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07636772 | Jun 2026 → Aug 2028 expected | urothelial carcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07226544 | Jun 2026 → Sep 2027 expected | clear cell renal carcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07244978 | Jun 2026 → Dec 2027 expected | esophageal squamous cell carcinoma | Second Affiliated Hospital, Zhejiang University, School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07591090 | Jun 2026 → Sep 2027 expected | female breast carcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07412262 | May 2026 → Mar 2028 expected | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07405190 | May 2026 → Mar 2028 expected | disease of genetic or genomic mechanism, non-small cell lung carcinoma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07565389 | May 2026 → May 2031 expected | nasopharyngeal carcinoma | National University Hospital, Singapore | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07489703 | Apr 2026 → Dec 2027 expected | non-small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07647016 | Apr 2026 → Dec 2027 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07516925 | Apr 2026 → Apr 2029 expected | leiomyosarcoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07057791 | Mar 2026 → Dec 2027 expected | small cell lung carcinoma | PrECOG, LLC. | Recruiting | No outcome recorded |
| Phase 2 | NCT07472478 | Mar 2026 → Dec 2027 expected | non-small cell lung carcinoma | Guangdong Provincial People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06951646 | Mar 2026 → Jul 2028 expected | non-small cell lung carcinoma | Second Xiangya Hospital of Central South University | Recruiting | No outcome recorded |
| Phase 2 | NCT07374250 | Feb 2026 → Dec 2027 expected | gastric cancer | Sichuan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07669051 | Jan 2026 → Jan 2028 expected | non-small cell lung carcinoma | Shandong Cancer Hospital and Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07394218 | Dec 2025 → Mar 2028 expected | Her2-receptor negative breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07244965 | Dec 2025 → Jul 2027 expected | cervical carcinoma | Women's Hospital School Of Medicine Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07241819 | Nov 2025 → Nov 2027 expected | non-small cell lung carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06846346 | Nov 2025 → Sep 2027 expected | esophageal adenocarcinoma, gastric adenocarcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT07094685 | Nov 2025 → Aug 2027 expected | head and neck squamous cell carcinoma | University of Michigan Rogel Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07229417 | Oct 2025 → Sep 2027 expected | invasive lobular breast carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07070466 | Oct 2025 → Dec 2026 expected | esophageal cancer, gastric cancer | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06529718 | Oct 2025 → Aug 2027 expected | biliary tract cancer | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT07204548 | Oct 2025 → Oct 2027 expected | non-small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07114315 | Sep 2025 → Aug 2027 expected | malignant pancreatic neoplasm | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT06848842 | Sep 2025 → Jun 2027 expected | metastasis from malignant tumor of colon | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT07103447 | Sep 2025 → Dec 2027 expected | female breast carcinoma | Shuangyue Liu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07158840 | Sep 2025 → Sep 2028 expected | non-small cell lung carcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07162714 | Sep 2025 → Jun 2026 overdue | rectal cancer | Zhejiang Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06904300 | Aug 2025 → Apr 2028 expected | gastric cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07130240 | Aug 2025 → Aug 2028 expected | cervical cancer | Obstetrics & Gynecology Hospital of Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07021950 | Aug 2025 → Oct 2027 expected | colorectal cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07095803 | Aug 2025 → Feb 2026 overdue | multiple polyglandular tumor | Sheng Zhang | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07086326 | Jul 2025 → Dec 2026 expected | non-small cell lung carcinoma | Yang Fan, MD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06959550 | Jul 2025 → Jul 2028 expected | colorectal cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07038915 | Jul 2025 | squamous cell lung carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT07017673 | Jul 2025 → Dec 2027 expected | triple-negative breast carcinoma | Cedars-Sinai Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07091227 | Jul 2025 → Jul 2026 overdue | gastroesophageal adenocarcinoma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07052253 | Jul 2025 → May 2027 expected | hepatocellular carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT06980077 | Jul 2025 → Jun 2027 expected | thymic carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06940518 | Jul 2025 → Jan 2028 expected | clear cell renal carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07188103 | Jul 2025 → Jun 2027 expected | esophageal squamous cell carcinoma | Anhui Provincial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06840834 | Jun 2025 → Mar 2026 overdue | pleural mesothelioma | French Cooperative Thoracic Intergroup | Recruiting | No outcome recorded |
| Phase 2 | NCT07070479 | Jun 2025 → Jan 2027 expected | nasopharyngeal carcinoma | Ming-Yuan Chen | Recruiting | No outcome recorded |
| Phase 2 | NCT06991491 | Jun 2025 → Jun 2026 overdue | malignant pancreatic neoplasm | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07009925 | Jun 2025 → May 2027 expected | squamous cell lung carcinoma | Jiangsu Cancer Institute & Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06977542 | Jun 2025 → Jan 2029 expected | triple-negative breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06993025 | May 2025 → Apr 2026 overdue | biliary tract cancer | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06936644 | Apr 2025 → Apr 2027 expected | respiratory system cancer | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06790212 | Apr 2025 → Aug 2027 expected | colon carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06925724 | Apr 2025 → Apr 2027 expected | cervical cancer, endometrial cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06944106 | Mar 2025 → Apr 2026 overdue | malignant pancreatic neoplasm | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06875076 | Mar 2025 → Jan 2028 expected | malignant pleural mesothelioma | The First Hospital of Jilin University | Recruiting | No outcome recorded |
| Phase 2 | NCT06814158 | Mar 2025 → Jul 2026 overdue | esophageal squamous cell carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06820762 | Feb 2025 → Dec 2026 expected | small cell lung carcinoma | The Second Affiliated Hospital of Dalian Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06805617 | Feb 2025 → Jul 2026 overdue | salivary gland adenoid cystic carcinoma | Glenn J. Hanna | Recruiting | No outcome recorded |
| Phase 2 | NCT06686030 | Feb 2025 → Oct 2027 expected | carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT06814067 | Feb 2025 → Feb 2029 expected | head and neck squamous cell carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06718543 | Feb 2025 → Oct 2026 expected | rectal cancer | fan li | Recruiting | No outcome recorded |
| Phase 2 | NCT06769971 | Feb 2025 → Dec 2026 expected | small cell lung carcinoma | Sichuan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06769295 | Feb 2025 → Dec 2026 expected | non-small cell lung carcinoma | Sichuan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06760520 | Jan 2025 → Dec 2027 expected | — | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06750952 | Dec 2024 → Dec 2026 expected | thymus cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06793332 | Dec 2024 → Jan 2026 overdue | metastatic malignant neoplasm in the brain, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06567314 | Dec 2024 → Sep 2028 expected | skin squamous cell carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06402435 | Nov 2024 → Aug 2026 overdue | breast cancer | Hubei Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06489197 | Nov 2024 → Oct 2026 expected | esophageal squamous cell carcinoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06560112 | Nov 2024 → May 2026 overdue | ovarian cancer | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT06684873 | Nov 2024 → Dec 2027 expected | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06802666 | Oct 2024 → Sep 2026 overdue | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT06478043 | Oct 2024 | small cell lung carcinoma | Zhejiang Cancer Hospital | Completed | No outcome recorded |
| Phase 2 | NCT06620796 | Sep 2024 → Sep 2026 overdue | small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06537011 | Aug 2024 → Jul 2027 expected | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06637007 | Aug → Dec 2024 overdue | bone sarcoma, soft tissue sarcoma | Shanxi Province Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06491472 | Jul 2024 → Jul 2026 overdue | malignant pancreatic neoplasm | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT06791148 | Jul 2024 → Jul 2027 expected | gastric cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Phase 2 | NCT06444009 | Jul 2024 → Dec 2025 overdue | head and neck squamous cell carcinoma | Lei Liu | Recruiting | No outcome recorded |
| Phase 2 | NCT06375486 | Mar 2024 → Mar 2025 | hepatocellular carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06196775 | Jan 2024 → Jan 2026 overdue | hepatocellular carcinoma | Harbin Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05582499 | Nov 2022 → Dec 2027 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05432492 | Aug 2022 → Apr 2025 | hepatocellular carcinoma | Akeso | Completed | No outcome recorded |
| Phase 2 | NCT05382442 | Jun 2022 → May 2026 overdue | colorectal cancer | Akeso | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05227664 | Mar 2022 → Dec 2026 expected | triple-negative breast carcinoma | Akeso | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05247684 | Feb 2022 → Aug 2025 overdue | non-small cell lung carcinoma | Akeso | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04870177 | Apr 2021 → May 2024 | endometrium neoplasm, female reproductive organ cancer, metastatic malignant neoplasm, ovarian neoplasm +1 | Akeso | Completed | No outcome recorded |
| Phase 2 | NCT04736823 | Feb 2021 → Jul 2026 overdue | non-small cell lung carcinoma | Akeso | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07815665 | Sep 2026 → Oct 2030 expected | urothelial carcinoma | Summit Therapeutics | Recruiting | No outcome recorded |
| Phase 315 trials · 3 met primary | ||||||
| Phase 3 | NCT07264075 | May 2026 → May 2030 expected | head and neck squamous cell carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | Recruiting | No outcome recorded |
| Phase 3 | NCT07228832 | Nov 2025 → May 2028 expected | colorectal cancer | Summit Therapeutics | Recruiting | No outcome recorded |
| Phase 3 | NCT06928389 | Jul 2025 → May 2027 expected | non-small cell lung carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT07010263 | Jun 2025 → Dec 2028 expected | small cell lung carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT06953999 | Jun 2025 → May 2027 expected | malignant pancreatic neoplasm | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT06951503 | May 2025 → Jan 2027 expected | colorectal adenocarcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT06767514 | Feb 2025 → Apr 2028 expected | non-small cell lung carcinoma | Summit Therapeutics | Recruiting | No outcome recorded |
| Phase 3 | NCT06767527 | Feb 2025 → Dec 2026 expected | triple-negative breast carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT06601335 | Oct 2024 → Jan 2027 expected | head and neck squamous cell carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT06591520 | Oct 2024 → Oct 2026 expected | biliary tract cancer | Akeso | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05899608 | Oct 2023 → Dec 2028 expected | non-small cell lung carcinoma | Summit Therapeutics | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05840016 | Aug 2023 → Feb 2025 overdue | non-small cell squamous lung carcinoma | Akeso | Active not recruiting | Met primary |
| Phase 3 | NCT06396065 | May 2023 → Apr 2025 overdue | non-small cell lung carcinoma | Summit Therapeutics | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05499390 | Nov 2022 → Jan 2024 overdue | non-small cell lung carcinoma | Akeso | Active not recruiting | Met primary |
| Phase 3 | NCT05184712 | Jan 2022 → Mar 2023 overdue | non-small cell lung carcinoma | Akeso | Active not recruiting | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06930573 | Dec 2024 → May 2026 overdue | hepatocellular carcinoma | The First Affiliated Hospital of Zhengzhou University | Recruiting | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06936488 | Mar 2025 → Oct 2026 expected | colorectal adenocarcinoma | Huai'an First People's Hospital | Enrolling by invitation | No outcome recorded |
| — | NCT06766591 | Jan → Oct 2025 overdue | neoplastic meningitis, non-small cell lung carcinoma | Jiangsu Province Nanjing Brain Hospital | Not yet recruiting | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT07614646 Background | Nov 2026 → Jul 2028 expected | non-small cell squamous lung carcinoma | Everest Medicines (Beijing) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07857135 Comparator | Oct 2026 → Feb 2029 expected | — | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06877650 Background | Apr 2025 → Mar 2028 expected | cancer | Shanghai JMT-Bio Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07234877 Background | Nov 2026 → Jan 2032 expected | non-small cell lung carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07245446 Background | Oct 2025 → Dec 2027 expected | small cell lung carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT06196697 Background | Apr 2024 → Jan 2027 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Harbin Medical University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07076693 Background | Jun 2025 → May 2028 expected | non-small cell lung carcinoma | Shanghai Chest Hospital | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 56
| Date | Issuer | Release |
|---|---|---|
| 2026-09-22 | Akeso | Results 依沃西1L胆道癌III期OS数据入选LBA,康方生物近30项研究闪耀ESMO 2026! akesobio.com ↗
其中,依沃西联合化疗对比度伐利尤联合化疗一线治疗晚期胆管癌Ⅲ期的OS阳性数据(HARMONi-GI1)入选主席论坛,将以LBA形式重磅口头报告; |
| 2026-09-15 | Akeso | Results 口头报告|依沃西对比帕博利珠单抗一线治疗PD-L1阳性NSCLC的OS统计学显著阳性结果在WCLC 2026重磅发布(HARMONi-2研究) akesobio.com ↗
研究结果显示:较帕博利珠单抗,依沃西一线治疗PD-L1阳性晚期NSCLC显著延长患者总生存期(OS),达到预设统计学显著性并具有明确临床获益;预设亚组分析总体上呈现一致的OS获益趋势,其中PD-L1高表达人群尤为突出. |
| 2026-09-03 | Akeso | Results 对比帕博利珠单抗获OS显著阳性结果!依沃西HARMONi-2研究期中分析达到OS关键次要终点,一线治疗PD-L1表达阳性NSCLC akesobio.com ↗
经独立数据监察委员会(IDMC)评估的预先设定的总生存期(OS)期中分析显示:研究达到总生存期(OS)关键次要终点,取得具有统计学显著性和临床获益的阳性结果. |
| 2026-08-26 | Akeso | Results 对比国际金标准取得OS显著阳性结果!依沃西联合化疗一线治疗胆道癌III期达到主要终点 akesobio.com ↗
研究达到总生存期(OS)主要研究终点,取得具有统计学显著性和重大临床获益的阳性结果;研究也达到无进展生存期(PFS)与客观缓解率(ORR)的所有关键次要终点. |
| 2026-08-18 | Akeso | Results 荣登Nature Medicine!依沃西联合化疗一线治疗TNBC II期研究结果发表,III期注册性研究高效推进 akesobio.com ↗
近日,康方生物全球首创的肿瘤免疫2.0基石药物依达方®(通用名:依沃西单抗注射液)联合化疗,用于一线治疗局部晚期不可切除或转移性三阴性乳腺癌(TNBC)的II期临床研究结果,全文发表于国际顶级医学期刊《自然·医学》(Nature Medicine). |
| 2026-08-12 | Akeso | Regulatory 依沃西联合化疗治疗一线sq-NSCLC重磅获批上市,HARMONi-6重塑肺癌治疗金标准 akesobio.com ↗
2026年8月12日,康方生物(9926.HK)欣喜宣布,公司全球首创的肿瘤免疫2.0基石药物依达方®(通用名:依沃西单抗注射液)联合化疗一线治疗晚期鳞状非小细胞肺癌(sq-NSCLC)的新药上市申请(sNDA),已获得国家药品监督管理局(NMPA)批准上市. |
| 2026-07-29 | Shanghai Allink Biotherapeutics Co., Ltd. | Regulatory Allink Biotherapeutics and Akeso Announce Clinical Collaboration to Evaluate FGFR2b ADC Plus Ivonescimab for Squamous Cell Lung Cancer allinkbio.com ↗
The IND application for this combination study was recently approved by the NMPA in China. |
| 2026-06-09 | Akeso | Results 四靶点协同抗肿瘤!康方首创TIGIT/TGF-β双靶点抗体融合蛋白联合依沃西后线治疗胆道癌优异数据发布|ASCO2026 akesobio.com ↗
45mg/kg Q3W(推荐的II期研究剂量,RP2D)组ORR为25.0%,DCR为68.8%;且获得疾病控制的患者中,85.7%观察到肿瘤明显退缩; |
| 2026-05-31 | Akeso | Results OS显著阳性,HR=0.66!依沃西联合化疗战胜PD-1联合化疗OS结果在ASCO盛大发布,一线治疗sq-NSCLC akesobio.com ↗
研究结果显示,相比替雷利珠单抗联合化疗,依沃西联合化疗可显著延长患者OS. |
| 2026-04-08 | Akeso | Results 强效脑保护!依沃西实现NSCLC脑转移“治疗+预防”双重获益|2026ELCC akesobio.com ↗
本次ELCC公布的结果显示,无论基线是否存在脑转移,联合依沃西均可带来更长的颅内PFS获益,且颅内脑转移累积发生率更低. |
| 2026-02-06 | Akeso | Regulatory 依沃西获得第五个突破性疗法认定,一线治疗胆道癌! akesobio.com ↗
近日,据国家药品监督管理局药品审评中心(CDE)官网公示结果,康方生物自主研发的全球首创双特异性抗体新药依沃西(PD-1/VEGF双抗)联合疗法用于一线治疗晚期胆道恶性肿瘤(BTC)已被纳入突破性治疗药物(BTD)名单. |
| 2025-12-11 | Akeso | Results 长期随访疗效突破性愈发凸显!依沃西方案一线治疗TNBC优异更新数据在ESMO IO 2025发布 akesobio.com ↗ |
| 2025-12-09 | Akeso | Results 依沃西联合疗法患者生存和生活双重获益!HARMONi-6 更新数据发布| 2025 ESMO Asia akesobio.com ↗
结果显示,与接受替雷利珠单抗方案治疗相比,接受依沃西方案治疗在帮助患者显著延长无进展生存期(PFS)的同时,让患者拥有了更好的耐受性和治疗依从性,能更长时间地保持更好的总体健康状况和生活质量. |
| 2025-11-03 | Akeso | Regulatory 四获BTD!一线治疗三阴性乳腺癌,依沃西获得第四个突破性疗法认定 akesobio.com ↗
近日,据国家药品监督管理局药品审评中心(CDE)官网公示结果,康方生物自主研发的全球首创双特异性抗体新药依沃西(PD-1/VEGF双抗)联合疗法用于一线治疗三阴性乳腺癌(TNBC)已被纳入突破性治疗药物(BTD)名单. |
| 2025-10-30 | Akeso | Results 全球首个PFS和OS双阳性免疫疗法!依沃西HARMONi-A最终分析入选SITC 2025 LBA并作重磅口头报告 akesobio.com ↗
HARMONi-A研究是EGFR-TKI耐药EGFR突变nsq-NSCLC领域,全球首个在无进展生存期(PFS)与总生存期(OS)同时取得具有临床意义和统计学显著性获益的免疫疗法III期临床试验. |
| 2025-10-20 | Akeso | Results 依沃西+化疗一线治疗肺鳞癌mPFS=11.14m(HR=0.6,p<0.0001)!HARMONi-6在柳叶刀&ESMO重磅发布 akesobio.com ↗
试验组依沃西联合化疗一线治疗sq-NSCLC的mPFS长达11.14个月,对照组替雷利珠单抗联合化疗的mPFS为6.90个月 |
| 2025-07-28 | Akeso | Regulatory 依沃西联合化疗1L治疗sq-NSCLC的上市申请获NMPA受理 akesobio.com ↗
联合化疗一线治疗晚期鳞状非小细胞肺癌(sq-NSCLC)的新药上市许可申请(sNDA)已被受理. |
| 2025-04-26 | Akeso | Regulatory 依沃西一线治疗NSCLC获批上市,基于全球首个对比帕博利珠单抗获显著阳性结果的III期研究|全球肿瘤免疫迭代性突破 akesobio.com ↗
一线治疗PD-L1阳性NSCLC是依沃西获批上市的第二个适应症,这让中国患者“率先用上全球最优治疗方案”成为现实. |
| 2025-04-23 | Akeso | Results 战胜PD-1联合化疗!依沃西联合化疗一线治疗sq-NSCLC(vs替雷利珠单抗疗法)获显著阳性结果 akesobio.com ↗
相较对照组,依沃西组在PD-L1阳性及PD-L1阴性人群中,均显示出具有临床意义的PFS显著获益; |
| 2025-03-07 | Akeso | Results 荣登The Lancet!依沃西头对头帕博利珠单抗Ⅲ期临床研究结果全文发表 akesobio.com ↗ |
| 2024-12-31 | Akeso | Results 宋勇教授点评:依沃西单抗结合“夹心饼”模式,肺癌围术期治疗焕发新机 akesobio.com ↗
联合化疗组的pCR率超过50%,这是非常高的,MPR率亦超过了70%;单药组的pCR和MPR也分别达到了30%和60%,均优于既往的同类研究. |
| 2024-12-27 | Akeso | Results 李高峰教授:免疫2.0时代推动围术期治疗创新,双抗安全性与疗效共赢 akesobio.com ↗ |
| 2024-12-24 | Akeso | Results 赵晓亮教授解读:肺癌围术期免疫治疗新纪元,依沃西单抗突破pCR率瓶颈 akesobio.com ↗ |
| 2024-12-20 | Akeso | Results 陈椿教授专访:肺癌一线及围术期免疫治疗迎来迭代,双抗新药依沃西未来可期 akesobio.com ↗ |
| 2024-12-13 | Akeso | Results HARMONi-A研究依沃西方案颅内PFS优异疗效数据发表于ESMO IO 2024 akesobio.com ↗ |
| 2024-12-05 | Akeso | Results 龙浩教授专访:WCLC大会现场的双重震撼!双特异性抗体开拓肺癌免疫治疗新时代 akesobio.com ↗
依沃西单抗单药治疗组MPR率高达60%,pCR率达到30%,依沃西联合化疗组的pCR率达到52.7%,MPR率提升至72.7% |
| 2024-11-07 | Akeso | Results 赵军教授专访:肺癌脑转移规范化诊疗迎来新篇章,依沃西单抗为难治人群带来显著获益 akesobio.com ↗ |
| 2024-10-14 | Akeso | Results 2024 WCLC | 王长利教授:依沃西单抗pCR率勇攀新高,围术期免疫治疗迈入新纪元 akesobio.com ↗
最终得到了非常亮眼的结果——依沃西单抗在围术期NSCLC中的疗效得到了验证,并且数据更是超越了以往的记录,再次创造了历史. |
| 2024-10-10 | Akeso | Results CSCO2024 | 双特异性抗体闪耀CSCO!肿瘤免疫治疗迎来重大创新 akesobio.com ↗
结果显示,接受依沃西单抗单药治疗的患者的中位无进展生存期(mPFS)高达11.14个月,接受帕博利珠单抗单药治疗的患者的中位无进展生存期(mPFS)则为5.82个月; |
| 2024-09-29 | Akeso | Results CSCO 2024 | 依沃西HARMONi-A研究重磅亮相 :共启肺癌免疫治疗2.0时代 akesobio.com ↗
中位随访7.9个月时,依沃西方案治疗组和对照组的中位PFS分别为7.1个月 vs 4.8个月,HR 0.46,P<0.001;研究各亚组的获益趋势一致;依沃西方案治疗组OS获益趋势明显. |
| 2024-09-09 | Akeso | Results WCLC 2024 | 再获Oral报告!依沃西围手术期治疗NSCLC II期优异结果发表 akesobio.com ↗ |
| 2024-09-08 | Akeso | Results WCLC 2024 | 全球首个对比帕博利珠单抗取得显著阳性结果的随机对照大III期研究——依沃西HARMONi-2重磅研究成果发表 akesobio.com ↗ |
| 2024-09-06 | Akeso | Results ESMO 2024 | 多项Oral发布:康方生物卡度尼利、依沃西、莱法利等13项重磅研究成果发表 akesobio.com ↗
本研究初步数据显示,针对快速缩瘤需求特别高的HNSCC,依沃西疗法展现了优异的ORR和PFS数据,依沃西联合莱法利单抗后,ORR和PFS数据均获得进一步大幅提升. |
| 2024-08-15 | Akeso | Regulatory 再获优先审评!继被纳入突破性治疗品种名单后,依沃西一线治疗NSCLC“去化疗”方案获优先审评 akesobio.com ↗
8月14日,国家药品监督管理局药品审评中心(NMPA CDE)官网公示显示,康方生物(9926. HK)全球首创新药依达方®(通用名:依沃西单抗注射液)(PD-1/VEGF双抗,AK112)被纳入优先审评品种名单. |
| 2024-07-29 | Akeso | Regulatory 肺癌一线将迎“去化疗”新标准方案!康方生物依沃西1L治疗PD-L1阳性NSCLC的sNDA获NMPA受理 akesobio.com ↗
7月29日,康方生物(9926.HK)欣喜地宣布,公司独立自主研发的全球首创PD-1/VEGF双特异性抗体新药依达方®(通用名:依沃西单抗注射液)单药一线治疗PD-L1表达阳性(PD-L1 TPS≥1%)的局部晚期或转移性非小细胞肺癌(NSCLC)的新药上市申请(sNDA),已经获得中国国家药品监督管理局(NMPA)受理. |
| 2024-07-24 | Akeso | Results JAMA丨张力团队为肺癌患者带来免疫治疗新方案 akesobio.com ↗
依沃西单抗联合化疗对比化疗组的客观缓解率(ORR)为50.6%(95% CI 42.6-58.6)和35.4%(95% CI 28.0-43.3). |
| 2024-06-01 | Akeso | Results ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布,依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准 akesobio.com ↗
依达方®治疗EGFR-TKI进展EGFR突变nsq-NSCLC相较于对照组显著延长患者无进展生存期(PFS),并具有总生存期(OS)获益趋势,安全性可控. |
| 2024-05-31 | Akeso | Results 史无前例!康方依沃西单药对比帕博利珠1L治疗PD-L1阳性NSCLC的III期临床获决定性胜出阳性结果 akesobio.com ↗
HARMONi-2(AK112-303)研究数据表明,在意向治疗人群(ITT)中,依沃西组相较于帕博利珠组显著延长了患者无进展生存期(PFS),风险比(HR)显著优于预期. |
| 2024-05-24 | Akeso | Regulatory 康方生物PD-1/VEGF双抗新药依达方®获批上市 akesobio.com ↗ |
| 2024-04-25 | Akeso | Results PD-1/VEGF双抗治疗nsq-NSCLC的III期研究结果将口头报告重磅发布丨ASCO 2024预告 akesobio.com ↗
本次数据发表是该研究首次数据发表,研究结果显示,依沃西联合化疗治疗EGFR -TKI治疗后进展的局部晚期或转移性nsq-NSCLC患者的疗效优异,安全性良好,有望成为该类疾病治疗全新高效的免疫治疗方案. |
| 2024-04-23 | Akeso | Results 依沃西治疗晚期实体瘤临床研究结果重磅发表于《癌症免疫治疗杂志》 akesobio.com ↗ |
| 2024-03-28 | Akeso | Results ELCC2024 | PD-1/VEGF双抗依沃西联合化疗一线治疗NSCLC更新数据发布于欧洲肺癌大会 akesobio.com ↗
在备受瞩目的2024年欧洲肺癌大会(ELCC)上,康方生物与合作伙伴Summit Therapeutics(Summit)联合发布了PD-1/VEGF双抗依沃西(AK112/SMT112)联合化疗一线治疗晚期非小细胞肺癌(NSCLC)II期临床研究(AK112-201)的队列1(EGFR/ALK野生型)的更新数据. |
| 2024-03-25 | Akeso | Results PD-1/VEGF双抗依沃西治疗脑转移NSCLC研究数据首次发布于ELCC 2024 akesobio.com ↗
依沃西联合化疗方案的颅内缓解率达39%,完全缓解(CR)率达25%;依沃西单药治疗方案的颅内缓解率达14%,CR率为14%. |
| 2024-01-15 | Akeso | Regulatory 康方PD-1/VEGF双抗依沃西联合卡度尼利/AK130/AK127治疗肝细胞癌Ⅰb/Ⅱ期临床研究获批 akesobio.com ↗ |
| 2023-10-30 | Akeso | Results 重磅登刊JTO!康方PD-1/VEGF双抗依沃西单药一/二线治疗IO初治NSCLC akesobio.com ↗
结果显示,无论治疗剂量、既往治疗史和PD-L1表达如何,晚期或转移性NSCLC都可受益于依沃西单药治疗,临床前景广阔且耐受性良好. |
| 2023-08-25 | Akeso | Regulatory 拟获优先审评资格,康方生物依沃西上市进程提速 akesobio.com ↗
2023年8月24日,国家药品监督管理局药品审评中心(NMPA CDE)官网公示显示,康方生物(9926. HK)全球首创的依沃西单抗(PD-1/VEGF双抗,AK112)被纳入拟优先审评品种公示名单. |
| 2023-08-06 | Akeso | Results 张力教授团队PD-1/VEGF双抗(AK112)治疗肺癌最新临床研究结果在《柳叶刀》子刊发布 akesobio.com ↗
张力教授牵头的这项开放标签、多中心、Ⅱ期临床研究,初步验证了AK112联合化疗治疗晚期NSCLC具有良好的疗效和耐受性. |
| 2023-05-02 | Akeso | Regulatory 依沃西联合化疗对比PD-1抑制剂联合化疗一线治疗鳞状NSCLC的Ⅲ期临床获批开展 akesobio.com ↗
依沃西(PD-1/VEGF双抗,AK112)联合含铂化疗对比PD-1抑制剂联合含铂化疗一线治疗鳞状非小细胞肺癌(NSCLC)的Ⅲ期临床,已经获得国家药品监督管理局药品评审中心(CDE)批准开展. |
| 2022-11-14 | Akeso | Regulatory 三获BTD!治疗PD-1/L1耐药的NSCLC,康方PD-1/VEGF双抗获得第三个突破性疗法认定 akesobio.com ↗
近日,国家药品监督管理局药品审评中心(CDE)官网显示,康方生物自主研发的全球首创双特异性抗体新药依沃西(PD-1/VEGF双抗,AK112),被CDE拟被纳入突破性治疗品种名单,用于联合多西他赛治疗既往PD-1/L1抑制剂和含铂化疗治疗耐药的局部晚期或转移性非小细胞肺癌(NSCLC). |
| 2022-10-31 | Akeso | Results ACLC Oral | 康方生物PD-1/VEGF双抗一线治疗ES-SCLC数据 akesobio.com ↗
研究结果显示:在ES-SCLC的一线治疗中,依沃西联合化疗展现了优秀的抗肿瘤疗效和生存获益,安全性良好. |
| 2022-10-21 | Akeso | Regulatory 再获突破性疗法认定!康方PD-1/VEGF双抗治疗EGFR-TKI耐药的nsq-NSCLC akesobio.com ↗
2022年10月20日,国家药品监督管理局药品审评中心(CDE)网站公示,由康方生物完全独立自主研发的全球首创双特异性抗体新药依沃西(PD-1/VEGF双抗,AK112),拟被纳入突破性治疗品种名单,用于联合化疗治疗经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗耐药的EGFR突变的局部晚期或转移性非鳞非小细胞肺癌(nsq-NSCLC). |
| 2022-09-02 | Akeso | Regulatory 康方生物依沃西(PD-1/VEGF双抗,AK112)一线治疗PD-L1表达阳性的NSCLC拟被CDE纳入突破性治疗品种 akesobio.com ↗
近日,国家药品监督管理局药品审评中心(CDE)网站公示,由康方生物完全独立自主研发的全球首创双特异性抗体新药依沃西(PD-1/VEGF双抗,AK112),拟被纳入突破性治疗品种名单,用于一线治疗PD-L1表达阳性(TPS≥1%)的局部晚期或转移性非小细胞肺癌(NSCLC). |
| 2022-01-10 | Akeso | Regulatory CD47单抗(AK117)联合PD-1/VEGF双抗(AK112)联合或不联合化疗治疗恶性肿瘤的Ib/II临床研究获批开展 akesobio.com ↗
已经获得国家药品监督管理局药品审评中心(CDE)批准,开展联合或不联合化疗治疗晚期恶性肿瘤的Ib/II期临床研究 |
| 2021-11-15 | Akeso | Results 康方生物PD-1/VEGF双抗(AK112)治疗耐铂上皮卵巢癌的I期临床研究成果SITC 2021上发布 akesobio.com ↗
研究结果显示,AK112在铂耐药/难治性上皮性卵巢癌患者中获得了令人鼓舞的抗肿瘤活性和良好的安全性. |
| 2021-09-26 | Akeso | Results PD-1/VEGF双抗(AK112)联合化疗一线治疗晚期NSCLC的II期临床研究成果在2021 CSCO发布 akesobio.com ↗ |
| 2021-09-23 | Akeso | Results 2021CSCO|康方生物PD-1/VEGF双抗(AK112)两项肺癌和卵巢癌的II期临床研究成果发布 akesobio.com ↗
至数据截止日期,37例初治NSCLC受试者接受AK112联合化疗治疗,显示出了良好的安全性和良好的抗肿瘤活性. |
All press releases naming this drug 63 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 173 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ivonescimab | “As the world's first PD-1/VEGF bispecific antibody, ivonescimab ((AK112) has shown superior systemic efficacy compared to conventional VEGF targeted therapy combined with...” NCT06809517 ↗117“This is an open-label, single arm , Ib/II phase trial to evaluate the efficacy and safety of AK112(ivonescimab)monotherapy as first-line treatment for favourable risk...” NCT06472895 ↗ “A Prospective, Parallel, Double-cohort, Multicenter Phase II Clinical Study of Ivonescimab (AK112) Combined With IP Chemotherapy ± TACE for First-line Treatment of Metastatic...” NCT07712094 ↗ “A Phase 1b Study of Ivonescimab, a Programmed Cell Death Protein-1 and Vascular Endothelial Growth Factor Bispecific Antibody, as First- or Second-Line Therapy for Advanced or...” PMID 37879536 ↗ Oct 2023 “A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined with Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced...” NCT07385001 ↗ “The advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation will receive the combination of fulzerasib (IBI351) with ivonescimab (AK-112) in...” NCT06936644 ↗ “Patients with squamous cell carcinoma received docetaxel administered in 3-week cycles, and patients with adenocarcinoma received pemetrexed, patinum and one of sintilimab or...” NCT07076693 ↗ “Ivonescimab (AK112) is a first-in-class bispecific antibody that simultaneously targets programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF) with cooperative binding.” PMID 40114411 ↗ Mar 2025 “The immunotherapy drug used is Ivonescimab (AK112) (20mg/kg) , administered every 3 weeks concurrently with chemotherapy for 8 cycles.” NCT06402435 ↗ “Ivonescimab is a humanized IgG1 bispecific anti-programmed cell death protein 1/vascular endothelial growth factor antibody.” PMID 39490738 ↗ Oct 2024 “Ivonescimab is a novel humanized tetrameric IgG-scFv bispecific antibody targeting PD-1 and VEGF.” NCT07130240 ↗ |
| Known as | AK112 | “A Prospective, Single Arm, Open Label, Phase II Clinical Study on the Efficacy and Safety of Ivonescimab (AK112) Combined With TAS-102 in the Treatment of Refractory MSS/pMMR...” NCT06936488 ↗76“The advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation will receive the combination of fulzerasib (IBI351) with ivonescimab (AK-112) in...” NCT06936644 ↗ “All enrolled subjects will receive Ivonescimab(AK112,a PD-1/VEGF bispecific antibody,20mg/kg Q3W) in combination with HAIC (utilizing the FOLFOX chemotherapy regimen)” NCT06375486 ↗ “Ivonescimab (AK112) is a novel PD-1/VEGF bispecific antibody designed to simultaneously block PD-1-mediated immune evasion and inhibit VEGF-driven angiogenesis.” NCT07064902 ↗ “Ivonescimab (AK112/SMT112) is a bispecific antibody targeting PD-1 and VEGF, designed to simultaneously modulate immune and angiogenic pathways.” NCT07158489 ↗ “This study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.” NCT07208773 ↗ “Subjects will receive Ivonescimab (SMT112 or AK112) Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles.” NCT05184712 ↗ “Ivonescimab(AK112) combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma (ESCC).” NCT06489197 ↗ “Trastuzumab Rezetecan (SHR-A1811) combined with ivonescimab (AK112)” NCT07630077 ↗ “Ivonescimab(AK112,a PD-1/VEGF bispecific antibody,20mg/kg Q3W)” NCT06944106 ↗ “Ivonescimab (AK112) + platinum-based doublet chemotherapy” NCT07086326 ↗ |
| Known as | Envafolimab | “combined with AK112 (Envafolimab) with or without chemotherapy” NCT06718543 ↗ |
| Known as | Ivonescimab Injection | “Drug: Ivonescimab Injection” NCT07228832 ↗ |
| Known as | ivosidan | “The purpose of this study is to evaluate the safety and efficacy of AMT-116 in combination with ivosidan (AK112) in patients with advanced non-small cell lung cancer (NSCLC).” NCT07590531 ↗ |
| Known as | Ivosimab | “An Open-label, Multicenter Phase Ib/II Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMT116 in Combination With Ivosimab (AK112) in Patients With...” NCT07590531 ↗ |
| Known as | SMT112 | “Ivonescimab (AK112/SMT112) is a bispecific antibody targeting PD-1 and VEGF, designed to simultaneously modulate immune and angiogenic pathways.” NCT07158489 ↗5“Subjects will receive Ivonescimab (SMT112 or AK112) Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles.” NCT05184712 ↗ “Ivonescimab (SMT112 /AK112) Plus Pemetrexed and Carboplatin” NCT06396065 ↗ “Ivonescimab (SMT112 or AK112) Injection” NCT06913218 ↗ “Ivonescimab (SMT112 or AK112) Injection” NCT06760520 ↗ “ivonescimab (AK112/SMT112)” PMID 38642937 ↗ Apr 2024 |
| Action | Inhibit | “Serum VEGF level was rapidly down-regulated after each administration.” PMID 40114411 ↗ Mar 2025 |
| Modality | Monoclonal antibody | “humanized IgG1 bispecific antibody” PMID 37593227 ↗ Aug 2023 |
| Route | Intravenous | “20 mg/kg IV Q3W monotherapy” NCT01042379 ↗ |