Drugs / Serplulimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Hetronifly | — | 2025-02-03 | europa.eu ↗ |
Trials 145 · started per year
today
EU approved 2025
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2018201920202021202220232024202520262027
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07647094 | Nov 2025 → Oct 2026 expected | non-small cell lung carcinoma | People's Hospital of Quzhou | Recruiting | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT07231445 | Apr 2026 → Dec 2028 expected | small cell lung carcinoma | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT06302062 | Jun 2023 → Dec 2025 overdue | neoplasm | Guangzhou FineImmune Biotechnology Co., LTD. | Recruiting | No outcome recorded |
| Phase 1 | NCT05442996 | Jan 2023 → Apr 2024 | cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 1 | NCT05483530 | Dec 2022 → Dec 2024 | — | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 1 | NCT05400265 | Jul 2022 → Aug 2023 | — | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 1 | NCT03757936 | Nov 2018 → Sep 2019 | neoplasm | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 1 | NCT03468751 | Feb 2018 → Jun 2020 | cancer | Henlix, Inc | Unknown | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT07708285 | Jul 2026 → Dec 2028 expected | NF2-related schwannomatosis, acoustic neuroma, meningioma | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07358585 | Jan 2026 → Jul 2027 expected | colon adenocarcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07141771 | Dec 2025 → Jun 2030 expected | small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07182565 | Nov 2025 → Aug 2029 expected | gastroesophageal junction adenocarcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07175389 | Oct 2025 → Sep 2027 expected | pancreatic ductal adenocarcinoma | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06848699 | Feb 2025 → Oct 2026 expected | non-small cell lung carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05747729 | Jun 2023 → Oct 2026 expected | neuroendocrine carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05882630 | Jun 2023 → Jun 2025 | small cell lung carcinoma | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT05641493 | Feb 2023 → Mar 2025 | non-small cell lung carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 1/2 | NCT05501340 | Sep → Dec 2022 | peritoneal neoplasm | Second Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 296 trials | ||||||
| Phase 2 | NCT07713745 | Jul 2026 → Jun 2036 expected | NF2-related schwannomatosis, acoustic neuroma, ependymoma, meningioma | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07699939 | Jul 2026 → Nov 2028 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | National Cancer Center, Japan | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07621484 | Jul 2026 → May 2028 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07691632 | Jun 2026 → Dec 2027 expected | colorectal adenocarcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07622550 | Jun 2026 → Dec 2027 expected | colorectal cancer | Jiangsu Cancer Institute & Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07527520 | Jun 2026 → Jul 2028 expected | rectal cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07596121 | May 2026 overdue | non-small cell lung carcinoma | Tang-Du Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07604909 | May 2026 → Sep 2027 expected | colorectal cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07543848 | May 2026 → Dec 2028 expected | rectum adenocarcinoma | Chongqing University Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07487519 | Apr 2026 → May 2027 expected | triple-negative breast carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07507916 | Apr 2026 → Dec 2029 expected | gastric cancer, gastroesophageal junction adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07466303 | Mar 2026 → Feb 2028 expected | female breast carcinoma, progesterone-receptor negative breast cancer | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07457528 | Mar 2026 → Jun 2027 expected | esophageal squamous cell carcinoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07283692 | Mar → Dec 2026 expected | triple-negative breast carcinoma | RenJi Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07403435 | Feb 2026 → May 2027 expected | esophageal squamous cell carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07398937 | Feb 2026 → Dec 2027 expected | — | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07381400 | Feb 2026 → Feb 2028 expected | rectal cancer | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07418866 | Feb 2026 → Feb 2028 expected | non-small cell lung carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07269782 | Jan → Jul 2026 overdue | non-small cell lung carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT07340489 | Dec 2025 → Nov 2027 expected | cervical cancer | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07347951 | Dec 2025 → Dec 2027 expected | rectal cancer | First Affiliated Hospital of Wenzhou Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07538180 | Oct 2025 → Dec 2027 expected | diffuse large B-cell lymphoma | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07064876 | Oct 2025 → Oct 2026 expected | lung carcinoma | Xi Junjie | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07155122 | Sep 2025 → Sep 2027 expected | esophageal small cell neuroendocrine carcinoma | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07150949 | Aug 2025 → Aug 2027 expected | — | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07488533 | Aug 2025 → Dec 2027 expected | nonpapillary renal cell carcinoma | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07506057 | Jul 2025 → Jul 2027 expected | biliary tract cancer, urothelial carcinoma | Xiujuan Qu | Recruiting | No outcome recorded |
| Phase 2 | NCT06812260 | Jun 2025 → Oct 2026 expected | small cell lung carcinoma | Shanghai Henlius Biotech | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06857279 | Apr 2025 → Dec 2027 expected | head and neck carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06850103 | Apr 2025 → Dec 2027 expected | colorectal carcinoma | First Affiliated Hospital of Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT07101679 | Apr 2025 → Apr 2027 expected | pancreatic ductal adenocarcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06860529 | Apr 2025 → Mar 2028 expected | hormone receptor-positive breast cancer | Henan Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06521866 | Mar 2025 → Aug 2026 overdue | colorectal carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07257575 | Jan 2025 → Jan 2027 expected | gastric cancer | Guangdong Provincial People's Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06692491 | Jan 2025 → Dec 2027 expected | — | Peking University Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06727617 | Nov 2024 → Dec 2025 overdue | cervical cancer | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06576921 | Nov 2024 → May 2026 overdue | gastric neoplasm | Xijing Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06554535 | Oct 2024 → Oct 2026 expected | small cell lung carcinoma | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06599827 | Sep 2024 → Sep 2026 expected | rectal cancer | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06531291 | Aug 2024 → Aug 2027 expected | biliary tract cancer, esophageal squamous cell carcinoma, gastric cancer, malignant pancreatic neoplasm | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06349980 | Aug 2024 → Feb 2027 expected | hepatocellular carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06542588 | Jul 2024 → Dec 2025 overdue | rectal cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT06439550 | Jul 2024 → Dec 2026 expected | — | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06601309 | Jul 2024 → Jul 2026 overdue | esophageal squamous cell carcinoma | Fujian Medical University Union Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06491355 | Jul 2024 → Jun 2025 | colorectal cancer | Sir Run Run Shaw Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06461910 | Jun 2024 → Jan 2026 overdue | gastric cancer, gastroesophageal junction adenocarcinoma | Zekuan Xu | Recruiting | No outcome recorded |
| Phase 2 | NCT06911606 | May 2024 → Jun 2026 overdue | small cell lung carcinoma | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06422858 | May 2024 → Dec 2025 | esophageal squamous cell carcinoma | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06419673 | May 2024 → May 2025 overdue | cervical cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06368141 | May 2024 → Feb 2026 overdue | colon carcinoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06394661 | Apr 2024 → Dec 2025 overdue | breast cancer | Henan Cancer Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06295926 | Apr 2024 → Jan 2027 expected | small cell lung carcinoma | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05872685 | Dec 2023 → Apr 2026 overdue | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Yu jiren | Recruiting | No outcome recorded |
| Phase 2 | NCT06433869 | Dec 2023 → Dec 2026 expected | peritoneal neoplasm | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06354218 | Dec 2023 → Dec 2025 overdue | carcinoma of esophagus | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06195683 | Dec 2023 → Dec 2024 | non-small cell lung carcinoma | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06099951 | Nov 2023 → Sep 2024 overdue | colorectal cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05988372 | Oct 2023 overdue | pancreatic exocrine neoplasm | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06350162 | Oct 2023 → Dec 2024 | small cell lung carcinoma | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05954429 | Jul 2023 → Dec 2026 expected | colorectal cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05787613 | Jul 2023 → Feb 2026 overdue | non-small cell lung carcinoma | Shanghai Henlius Biotech | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05957510 | Jul 2023 → Jun 2026 overdue | small cell lung carcinoma | Guangdong Association of Clinical Trials | Recruiting | No outcome recorded |
| Phase 2 | NCT05584137 | Jun → Dec 2023 | colorectal carcinoma | Shanghai Henlius Biotech | Terminated | No outcome recorded |
| Phase 2 | NCT05894837 | Jun 2023 → Jun 2024 | metastasis from malignant tumor of colon | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 2 | NCT06496789 | May 2023 → Dec 2024 | gastric adenocarcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05882513 | May 2023 → Dec 2025 overdue | non-small cell lung carcinoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06334757 | May 2023 → Aug 2024 | non-small cell lung carcinoma | Henan Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05831891 | May 2023 → Jul 2026 overdue | renal cell carcinoma | RenJi Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06370065 | Apr 2023 → Jun 2024 | hepatocellular carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05354700 | Mar 2023 → Mar 2024 | small cell lung carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05775796 | Mar 2023 → May 2024 | non-small cell lung carcinoma | Fudan University | Completed | No outcome recorded |
| Phase 2 | NCT05765825 | Mar 2023 → Jul 2024 overdue | small cell lung carcinoma | Sichuan University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05585580 | Mar 2023 → Apr 2026 overdue | gastroesophageal adenocarcinoma | Qilu Hospital of Shandong University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05732493 | Mar → Dec 2023 | colorectal cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05769725 | Mar 2023 → Mar 2025 | — | RenJi Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05742425 | Mar 2023 → Mar 2028 expected | metastasis from malignant tumor of colon | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT05731726 | Feb 2023 → Dec 2026 expected | rectal carcinoma | Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT05918419 | Feb 2023 → Jun 2024 | gastroesophageal junction adenocarcinoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06455072 | Feb 2023 → Jan 2025 | cervical cancer | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05675033 | Jan 2023 | lung adenocarcinoma | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05975749 | Jan 2023 → Jan 2026 overdue | gastric cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT05942573 | Dec 2022 → Oct 2023 | gastroesophageal cancer | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05659251 | Dec 2022 → Oct 2024 overdue | esophageal squamous cell carcinoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05444374 | Oct 2022 → Sep 2024 | cervical cancer | Sichuan Cancer Hospital and Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT05443646 | Sep 2022 → Jun 2024 | small cell lung carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT05221658 | Aug 2022 → Jun 2024 | digestive system carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05290220 | Aug 2022 → Dec 2023 | hepatocellular carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05239650 | Jul 2022 → Oct 2025 overdue | — | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05311189 | Apr 2022 → Dec 2023 | carcinoma | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05246982 | Mar 2022 → Dec 2023 | gastric cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT04947826 | Aug 2021 → Jul 2024 | hepatocellular carcinoma | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04297995 | Jul 2020 → May 2024 | head and neck squamous cell carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT04150575 | Mar 2020 → Jun 2022 | cervical cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT04133259 | Dec 2019 → Apr 2022 | chronic hepatitis B virus infection | Henlix, Inc | Unknown | No outcome recorded |
| Phase 2 | NCT03973112 | Sep 2019 → Jun 2022 | hepatocellular carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT03941574 | Jul 2019 → May 2024 | high grade malignant neoplasm | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2/35 trials | ||||||
| Phase 2/3 | NCT07318883 | Mar 2026 → Jan 2031 expected | non-small cell squamous lung carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07134218 | Oct 2025 → Oct 2027 expected | rectal cancer | Changhai Hospital | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06280495 | Feb 2024 → Dec 2026 expected | metastasis from malignant tumor of colon | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05807893 | May 2023 → Mar 2024 | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 2/3 | NCT04547166 | Mar 2021 → Sep 2025 overdue | colorectal cancer | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 318 trials | ||||||
| Phase 3 | NCT07113275 | May 2026 → Jan 2028 expected | rectal carcinoma | Tao Zhang | Recruiting | No outcome recorded |
| Phase 3 | NCT07551479 | May 2026 → Dec 2032 expected | rectal cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07336953 | Feb 2026 → Jul 2027 expected | pancreatic ductal adenocarcinoma | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07277842 | Dec 2025 → Dec 2028 expected | rectum adenocarcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07235930 | Nov 2025 → Jul 2029 expected | exocrine pancreatic carcinoma | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT07177443 | Sep 2025 → Dec 2031 expected | nasopharyngeal carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07020247 | Nov 2024 → Jul 2027 expected | rectal cancer | West China Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05173272 | Jul 2023 → Dec 2027 expected | cervical cancer | Sichuan Cancer Hospital and Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05468489 | Nov 2022 → Feb 2026 overdue | small cell lung carcinoma | Shanghai Henlius Biotech | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04465734 | Nov 2022 → Oct 2023 | hepatocellular carcinoma | Shanghai Henlius Biotech | Withdrawn | No outcome recorded |
| Phase 3 | NCT04806945 | Sep 2022 → Feb 2024 | cervical cancer | Shanghai Henlius Biotech | Withdrawn | No outcome recorded |
| Phase 3 | NCT05353257 | May 2022 → Jun 2026 overdue | small cell lung carcinoma | Shanghai Henlius Biotech | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04301739 | Apr 2020 → Sep 2022 overdue | triple-negative breast carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04139135 | Dec 2019 → Oct 2023 | gastric cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 3 | NCT03952403 | Dec 2019 → Oct 2023 | non-small cell lung carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 3 | NCT04063163 | Sep 2019 → May 2024 | small cell lung carcinoma | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 3 | NCT04033354 | Aug 2019 → Dec 2023 | non-small cell squamous lung carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 3 | NCT03958890 | Jun 2019 → Apr 2023 | esophageal squamous cell carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07446465 | Mar 2026 → Jan 2027 expected | colorectal cancer | Ye Xu | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06388135 | May 2024 → May 2026 overdue | esophageal squamous cell carcinoma | Yang Jianjun, PhD | Not yet recruiting | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07674342 | Jun 2026 → Jun 2028 expected | adenocarcinoma | Tongji Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06688786 | Nov 2024 → Jul 2025 overdue | rectal cancer | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Active not recruiting | No outcome recorded |
| — | NCT06580665 | Sep 2024 → Sep 2028 expected | non-small cell lung carcinoma | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06335147 | Apr 2024 → Jan 2026 | metastasis from malignant tumor of colon | Henan Cancer Hospital | Unknown | No outcome recorded |
| — | NCT06364046 | Apr → Dec 2024 | small cell lung carcinoma | The Central Hospital of Lishui City | Unknown | No outcome recorded |
| — | NCT06156332 | Jan 2024 → Jan 2025 overdue | neuroendocrine neoplasm | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 17 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06716619 Background | Feb 2025 → Dec 2026 expected | neoplasm | Guangzhou FineImmune Biotechnology Co., LTD. | Recruiting | No outcome recorded |
| Phase 1 | NCT06394414 Background | Apr 2024 → Apr 2027 expected | neoplasm | MediLink Therapeutics (Suzhou) Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06115642 Background | Nov 2023 → Jun 2026 overdue | metastatic malignant neoplasm | Shanghai Henlius Biotech | Enrolling by invitation | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT07391826 Background | Feb → Dec 2026 expected | gastric carcinoma | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07172412 Background | Nov 2025 → Dec 2027 expected | small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07134101 Background | Sep 2025 → Aug 2028 expected | colorectal cancer | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07154316 Background | Aug 2025 → Aug 2028 expected | colorectal cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06497530 Background | Dec 2024 → Dec 2026 expected | small cell lung carcinoma | Guangzhou Institute of Respiratory Disease | Recruiting | No outcome recorded |
| Phase 2 | NCT07583511 Background | Feb 2024 → May 2027 expected | small cell lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06084897 Background | Oct 2023 → Apr 2026 overdue | esophageal cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT06393166 Background | May 2023 → May 2025 | exocrine pancreatic carcinoma | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05766800 Background | Mar 2023 → Apr 2025 overdue | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| Phase 2 | NCT05513573 Background | Dec 2022 → Sep 2024 overdue | nasopharyngeal carcinoma | Shanghai Henlius Biotech | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04976647 Comparator | Jan 2022 → Jan 2023 | non-small cell squamous lung carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06128252 Background | Sep 2024 → Jun 2027 expected | gastric cancer | Tang-Du Hospital | Recruiting | No outcome recorded |
| — | NCT06462105 Background | Jul 2024 → Jun 2027 expected | small cell lung carcinoma | Zhou Chengzhi | Not yet recruiting | No outcome recorded |
| — | NCT06702566 Background | Jul 2024 → Jul 2026 overdue | acute leukemia, cancer | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 164 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Serplulimab | “YL201 (High dose, medium dose and low dose; Q3W) in Combination with Serplulimab (4.5mg/kg; Q3W) with or without Platinum(70 mg/m2; Q3W)-based Chemotherapy.” NCT06394414 ↗123“Serplulimab will be administered concurrently with chemotherapy at a fixed dose of 300 mg via intravenous infusion on Day 1 of each 3-week cycle.” NCT07182565 ↗ “OBJECTIVE: We report the efficacy and safety of serplulimab, a novel humanized anti-programmed death-1 antibody, plus nanoparticle albumin-bound” PMID 37153587 ↗ Apr 2023 “iTNT group receives short-course radiotherapy (25Gy/5Fx) followed by 6 cycles of Serplulimab combined with CAPOX.” NCT07551479 ↗ “PD-1 inhibitor includes pembrolizumab，Nivolumab，Sintilimab，tislelizumab，Triplimab，Camrelizumab, Serplulimab.” NCT06702566 ↗ “Nivolumab or Pembrolizumab or Tislelizumab or Serplulimab or Toripalimab or Sintilimab or Camrelizumab” NCT06084897 ↗ “Preoperative treatment with 4-6 cycles of mFOLFOX6 regimen combined with serplulimab” NCT06688786 ↗ “Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody)” NCT05513573 ↗ “Serplulimab 300 mg IV infusion on day 1 every 21 days.” NCT06599827 ↗ “combined with serplulimab (200mg ivgtt Q3W)” NCT07101679 ↗ “Serplulimab: IV 3 mg/kg on Day 1, q2w” NCT06521866 ↗ “PD-1 inhibitor (serplulimab)” NCT07154316 ↗ “Serplulimab 300mg IV day 2” NCT07538180 ↗ “serplulimab 300mg d1 q21” NCT05173272 ↗ |
| Known as | HLX10 | “Perioperative HLX10 (Serplulimab) With S-1+Oxaliplatin (SOX) in Locally Advanced and PD-L1-Positive Gastric or Esophagogastric Junction Adenocarcinoma” NCT07699939 ↗41“HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.” NCT04150575 ↗ “HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04）” NCT06370065 ↗ “Treatment of CHB patient with HLX10” NCT04133259 ↗ |
| Known as | Serplulimab+SOX | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06496789 ↗ |
| Known as | Serplulimab, mFOLFOX6 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06335147 ↗ |
| Known as | Srulimab | “patients can eventually be enrolled and receive PD-1 monoclonal antibody (Serplulimab, Srulimab) combined with mFOLFOX6 (oxaliplatin, fluorouracil) regimen, 2 weeks for 1 cycle.” NCT06335147 ↗ |
| Action | Inhibit | “Functional programmed death 1 blockade was observed across dose levels.” PMID 38194016 ↗ Jan 2024 |
| Modality | Monoclonal antibody | “HLX10 is a new monoclonal antibody targeting PD1 on T cells” NCT03468751 ↗ |
| Route | Intravenous | “HLX10, at three dose levels (1, 3, 10 mg/kg), to be intravenously injected once every two weeks” NCT03757936 ↗ |
| Target | PDCD1 | “HLX10 is a new monoclonal antibody targeting PD1 on T cells” NCT03468751 ↗ |