Drugs / Candonilimab
Candonilimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed gastroesophageal adenocarcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | gastroesophageal adenocarcinoma | 2024-01-01 | “2024年1月，基于AK104-302研究结果，康方生物关于卡度尼利联合XELOX用于一线治疗不可手术切除的局部晚期复发或转移性G/GEJ腺癌的新药上市许可申请（NDA）已被成功受理” akesobio.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | China (NMPA) | — | recurrent or metastatic cervical cancer | 2021-09-24 | “国家药品监督管理局（NMPA）已经正式受理公司全球首创的PD-1/CTLA-4双特异性抗体开坦尼单抗（Cadonilimab，研发代号：AK104）用于治疗复发或转移性宫颈癌的上市申请” akesobio.com ↗ “2021年9月，国家药品监督管理局已经受理卡度尼利单抗治疗经含铂化疗失败的复发或转移性宫颈癌的上市申请” akesobio.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06587425 | Jul 2024 → Jul 2025 overdue | adenocarcinoma | Shanghai Zhongshan Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06455254 | Jul 2024 → Dec 2025 overdue | — | Jin-hong Chen | Recruiting | No outcome recorded |
| Phase 2 | NCT06487702 | Jul 2024 → Jun 2026 overdue | esophageal squamous cell carcinoma | Rui-hua Xu, MD, PhD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05978609 | Jul 2023 → Jul 2025 | cholangiocarcinoma | West China Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05760599 | Feb 2023 → Jan 2024 | hepatocellular carcinoma | Shi Ming | Unknown | No outcome recorded |
| Phase 2 | NCT05886257 | Dec 2022 → Mar 2023 | hepatocellular carcinoma | Shi Ming | Withdrawn | No outcome recorded |
| Phase 2 | NCT06728631 | Jun 2020 → Dec 2023 overdue | oral cavity cancer, preneoplastic lesion | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-11-20 | Akeso | Results ESMO Asia 2023丨康方生物PD-1/CTLA-4双抗3项研究成果将发布 akesobio.com ↗
结果显示，卡度尼利联合FOLFOX-HAIC新辅助治疗肝癌具有较好的疗效及安全性. |
| 2023-10-12 | Akeso | Results 登刊Lancet Oncology！全球首创PD-1/CTLA-4双抗卡度尼利治疗晚期实体瘤研究成果重磅发表 akesobio.com ↗
中位随访时间为14.6个月时，由独立影像评估委员会（IRRC）评估的卡度尼利单药治疗既往含铂化疗治疗失败的晚期CC患者，客观缓解率（ORR）为32.3%，14.1%（14例）达完全缓解（CR），18.2%（18例）达部分缓解（PR），中位OS尚未达到，18个月的OS率为51.2%. |
| 2022-06-29 | Akeso | Regulatory 全球首个肿瘤双免疫检查点抑制剂双抗——康方生物开坦尼®（PD-1/CTLA-4双抗，卡度尼利单抗注射液）治疗宫颈癌获批上市 akesobio.com ↗
康方生物（9926.HK）宣布其自主研发的全球首创肿瘤免疫治疗新药PD-1/CTLA-4双特异性抗体（商品名：开坦尼®，通用化学名：卡度尼利单抗注射液）正式获得国家药品监督管理局的批准，用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌（recurrent or metastatic cervical cancer，R/M CC）患者的治疗. |
| 2022-03-16 | Akeso | Results 卡度尼利（PD-1/CTLA-4双抗）治疗R/M宫颈癌II期临床数据将在SGO 2022口头报告 akesobio.com ↗
该项研究结果表明了卡度尼利单抗单药治疗经含铂化疗失败的复发或转移性宫颈不仅在PD-L1阳性人群中获得较高的响应率，在PD-L1阴性人群中也看到了良好的效果，无进展生存期也有显著提升，生存期也有显著延长，有潜力为中国晚期宫颈癌患者带来更好的治疗手段. |
| 2021-09-24 | Akeso | Regulatory 国家药品监督管理局受理开坦尼（PD-1/CTLA-4双特异性抗体）用于治疗复发或转移性宫颈癌患者的适应症上市申请 akesobio.com ↗
2021年9月24日,康方生物（9926.HK）宣布，国家药品监督管理局（NMPA）已经正式受理公司全球首创的PD-1/CTLA-4双特异性抗体开坦尼单抗（Cadonilimab，研发代号：AK104）用于治疗复发或转移性宫颈癌的上市申请，并获优先审评. |
| 2021-08-24 | Akeso | Regulatory 康方生物PD-1/CTLA-4双抗获CDE同意递交上市申请并获优先审评资格 akesobio.com ↗
目前，国家药品监督管理局（NMPA）药品审评中心（CDE）已经同意公司递交Cadonilimab治疗复发或转移性宫颈癌的新药上市申请，并给予优先审评资格. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-11-20 | Akeso | ESMO Asia 2023丨康方生物PD-1/CTLA-4双抗3项研究成果将发布 akesobio.com ↗ |
| 2023-10-12 | Akeso | 登刊Lancet Oncology！全球首创PD-1/CTLA-4双抗卡度尼利治疗晚期实体瘤研究成果重磅发表 akesobio.com ↗ |
| 2022-06-29 | Akeso | 全球首个肿瘤双免疫检查点抑制剂双抗——康方生物开坦尼®（PD-1/CTLA-4双抗，卡度尼利单抗注射液）治疗宫颈癌获批上市 akesobio.com ↗ |
| 2022-03-16 | Akeso | 卡度尼利（PD-1/CTLA-4双抗）治疗R/M宫颈癌II期临床数据将在SGO 2022口头报告 akesobio.com ↗ |
| 2021-09-24 | Akeso | 国家药品监督管理局受理开坦尼（PD-1/CTLA-4双特异性抗体）用于治疗复发或转移性宫颈癌患者的适应症上市申请 akesobio.com ↗ |
| 2021-08-24 | Akeso | 康方生物PD-1/CTLA-4双抗获CDE同意递交上市申请并获优先审评资格 akesobio.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Candonilimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05760599 ↗ |
| Known as | AK104 | “Candonilimab (AK104) is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.” NCT06455254 ↗1“Candonilimab (AK104) is a PD-1/CTLA-4 Bispecific Antibody.” NCT06487702 ↗ |
| Known as | cadonilimab | “cadonilimab (a bispecific antibody targeting PD-1 and CTLA-4)” NCT06587425 ↗ |
| Modality | Monoclonal antibody | “Candonilimab is a humanized bisspecific monoclonal antibody against PD-1/ CTLA-4 IgG1.” NCT05760599 ↗ |
| Route | Intravenous | “iv.drip” NCT05760599 ↗ |