Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed esophageal squamous cell carcinoma 1 milestone | |||||
| Filed | China (NMPA) | HANSIZHUANG | esophageal squamous cell carcinoma | 2022-12-02 | “the new drug application (NDA) of serplulimab for the treatment of ESCC has been accepted by the National Medical Products Administration (NMPA).” henlius.com ↗ “The NDA of Serplulimab for the treatment of ESCC has been accepted by the National Medical Products Administration (NMPA).” henlius.com ↗ |
| Filed gastroesophageal adenocarcinoma 1 milestone | |||||
| Filed | China (NMPA) | HANSIZHUANG | gastroesophageal adenocarcinoma | 2025-12-12 | “has been accepted by the National Medical Products Administration (NMPA) and granted Priority Review.” henlius.com ↗ |
| Filed non-small cell squamous lung carcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | non-small cell squamous lung carcinoma | 2021-09-17 | “the NDA of serplulimab for first-line treatment of locally advanced or metastatic sqNSCLC has been accepted by the NMPA” henlius.com ↗ |
| Filed small cell lung carcinoma 2 milestones | |||||
| Filed | EU (EMA) | HANSIZHUANG | small cell lung carcinoma | 2023-03-23 | “the European Medicines Agency (EMA) has validated the application for its self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab)” henlius.com ↗ “Its Marketing Authorisation Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA)” henlius.com ↗ “In March 2023, EMA validated the marketing authorisation application (MAA) of HANSIZHUANG for ES-SCLC.” henlius.com ↗ “Its marketing application has been validated by the European Medicines Agency (EMA) in March 2023” henlius.com ↗ “1 marketing applications is under review in EU” henlius.com ↗ |
| Filed | US (FDA) | HANSIZHUANG | small cell lung carcinoma | — | “Based on the positive feedback from the US Food and Drug Administration (FDA) Biologics License Application (BLA) submission for HANSIZHUANG for the treatment of ES-SCLC” henlius.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Hetronifly | — | 2025-02-03 | europa.eu ↗ |
Trials 148 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 299 trials | ||||||
| Phase 2 | NCT07779694 | Oct 2026 → Dec 2028 expected | rectal carcinoma | Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07819604 | Sep 2026 → Sep 2027 expected | colorectal cancer | Xijing Hospital | Not yet recruiting | No outcome recorded |
| 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 | NCT07647094 | Nov 2025 → Oct 2026 expected | non-small cell lung carcinoma | People's Hospital of Quzhou | 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 → Aug 2026 overdue | gastric neoplasm | Xijing Hospital | Active not 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 overdue | 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 | NCT06195683 | Dec 2023 → Dec 2024 | non-small cell lung carcinoma | Zhejiang Cancer Hospital | Unknown | 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 | 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 Stop: Enrollment |
| 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 → Oct 2027 expected | renal cell adenocarcinoma | 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 | NCT05769725 | Mar 2023 → Mar 2025 | — | RenJi Hospital | Unknown | 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 | 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 · 1 missed | ||||||
| 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 | Missed primary |
| Phase 318 trials · 5 met primary | ||||||
| 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 2035 expected | nasopharyngeal carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 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 | Met primary |
| Phase 3 | NCT03952403 | Dec 2019 → Oct 2023 | non-small cell lung carcinoma | Shanghai Henlius Biotech | Unknown | Met primary |
| Phase 3 | NCT04063163 | Sep 2019 → May 2024 | small cell lung carcinoma | Shanghai Henlius Biotech | Completed | Met primary |
| Phase 3 | NCT04033354 | Aug 2019 → Dec 2023 | non-small cell squamous lung carcinoma | Shanghai Henlius Biotech | Unknown | Met primary |
| Phase 3 | NCT03958890 | Jun 2019 → Apr 2023 | esophageal squamous cell carcinoma | Shanghai Henlius Biotech | Unknown | Met primary |
| 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 applicable7 trials | ||||||
| — | NCT07854964 | Oct 2026 → May 2030 expected | — | Tang-Du Hospital | Not yet recruiting | No outcome recorded |
| — | 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 |
| Comparator or background therapy18 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 2 | NCT07854977 Background | Nov 2026 → May 2029 expected | pancreatic ductal adenocarcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 105
| Date | Issuer | Release |
|---|---|---|
| 2026-08-20 | Shanghai Henlius Biotech | Results Comprehensive First-Line Coverage Across Advanced Lung Cancer, Henlius’ Serplulimab to Feature in Seven Studies at WCLC 2026 henlius.com ↗
Serplulimab combined with chemotherapy demonstrated encouraging clinical activity and acceptable safety as a first-line treatment for LCNEC in this ongoing trial, supporting further exploration in this rare and aggressive malignancy. |
| 2026-07-06 | Shanghai Henlius Biotech | Results Henlius’ Serplulimab Final Analysis in nsqNSCLC Published in Cancer Communications, Reinforcing Durable Survival Benefit henlius.com ↗
The study showed that serplulimab plus chemotherapy achieved a median overall survival (mOS) of 26.8 months. |
| 2026-07-03 | Shanghai Henlius Biotech | Regulatory Lotus Pharmaceutical and Henlius Announce MFDS Approval of SERPLUMA® (serplulimab) for First-Line Treatment of ES-SCLC henlius.com ↗
The MFDS approval was supported by results from the global phase 3 ASTRUM-005 study, a randomized, double-blind trial involving 585 treatment-naïve patients with ES-SCLC. |
| 2026-07-02 | Shanghai Henlius Biotech | Regulatory HETRONIFLY® (SERPLULIMAB) FORMALLY ENTERS ROUTINE USE IN THE NHS FOLLOWING NICE RECOMMENDATION, BECOMING THE FIRST ANTI-PD-1 IMMUNOTHERAPY FOR EXTENSIVE-STAGE SMALL CELL LUNG CANCER IN ENGLAND and WALES henlius.com ↗
Accord Healthcare UK (Accord) and Shanghai Henlius Biotech, Inc. (2696.HK) recently announced that HETRONIFLY® (serplulimab) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine use within the National Health Service (NHS) in England and Wales. |
| 2026-06-26 | Shanghai Henlius Biotech | Regulatory Henlius’ Serplulimab Receives European Approval for a Fourth Indication, Expanding Its First-Line Treatment Footprint in Major High-Burden Cancers henlius.com ↗
The European Commission (EC) has approved a new indication for serplulimab (trade name: Hetronifly® in Europe) for squamous non-small cell lung cancer (sqNSCLC) |
| 2026-06-23 | Shanghai Henlius Biotech | Results Henlius’ Serplulimab Marks Third Publication in a Leading International Journal, with Small Cell Lung Cancer Long-Term Survival Data Published in JAMA Oncology and a 4-Year OS Rate of 21.9% henlius.com ↗
The final analysis confirmed that serplulimab delivers durable and clinically meaningful survival benefits for patients with ES-SCLC, accompanied by a contemporaneous editor’s note that highly recognized the durable clinical benefit this study brings to patients with ES-SCLC. |
| 2026-06-17 | Shanghai Henlius Biotech | Regulatory Exploring Earlier-Stage Treatment Potential: Henlius’ Phase 2 Clinical Trial of HLX43 in Combination with Serplulimab for Neoadjuvant Treatment of NSCLC Approved for Clinical Trial in Australia henlius.com ↗ |
| 2026-06-09 | Shanghai Henlius Biotech | Regulatory Henlius’ Serplulimab Approved for Perioperative Gastric Cancer, Pioneering a Chemotherapy-Sparring Adjuvant Approach henlius.com ↗
With this approval, serplulimab becomes the first and only* anti-PD-1 mAb in the world approved for perioperative treatment of gastric cancer, filling a long-standing clinical gap in this setting. |
| 2026-06-02 | Shanghai Henlius Biotech | Results Featured in Both The Lancet and ASCO: Henlius’ Serplulimab Pioneers a New Perioperative Chemotherapy-Sparring Regimen for Gastric Cancer henlius.com ↗
Median EFS by BICR was also significantly prolonged in the serplulimab group (NR vs. 52.0 months; HR=0.67), translating into a 33% reduction in recurrence risk. |
| 2026-05-23 | Shanghai Henlius Biotech | Regulatory Henlius' Serplulimab Receives Positive CHMP Opinion for the Treatment of sqNSCLC henlius.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a new indication for serplulimab (trade name: Hetronifly® in Europe) for squamous non-small cell lung cancer (sqNSCLC) |
| 2026-05-22 | Shanghai Henlius Biotech | Results ASCO 2026: Henlius’ Serplulimab Unveils 8 Major Studies, Highlighted by the Global Debut of Perioperative Gastric Cancer Data with Significant Improvement in EFS and pCR Rate of 21.6% henlius.com ↗
pCR was achieved in 30.0% (9/30), and MPR in 56.7% (17/30). |
| 2026-05-19 | Shanghai Henlius Biotech | Results ESTRO 2026 | Henlius' Serplulimab Achieves 42.5% pCR Rate in Neoadjuvant Colon Cancer; Study Results Presented Orally henlius.com ↗
The results showed that radiochemotherapy combined with serplulimab demonstrated favorable efficacy, with the pathological complete response (pCR) rate significantly increased to 42.5%, representing more than a four-fold improvement over the control group. |
| 2026-05-10 | Shanghai Henlius Biotech | Regulatory Henlius' Serplulimab Secures EC Approval for Two New Indications, Further Deepening Global Commercialisation Footprint henlius.com ↗
The European Commission (EC) has formally approved two new indications for serplulimab for the first-line treatment of non-squamous non-small cell lung carcinoma (nsqNSCLC) and esophageal squamous cell carcinoma (ESCC) |
| 2026-04-24 | Shanghai Henlius Biotech | Regulatory Henlius' Phase 2/3 Trial of Pimurutamab (HLX07) in Combination with Serplulimab for Advanced sqNSCLC Completes CTN in Australia henlius.com ↗ |
| 2026-03-30 | Shanghai Henlius Biotech | Regulatory Henlius Receives Two Positive CHMP Opinions for Serplulimab, Advancing Global Regulatory Progress henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly®), has received two positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). |
| 2026-03-27 | Shanghai Henlius Biotech | Results Latest Results from Studies of Henlius’Serplulimab in Lung Cancer Released at ELCC 2026 henlius.com ↗
At the congress, Henlius announced several research findings for its innovative anti-PD-1 monoclonal antibody (mAb), HANSIZHUANG (serplulimab, trade name in Europe: Hetronifly®) via poster presentations. |
| 2026-01-27 | Shanghai Henlius Biotech | Regulatory Henlius Receives an IND Approval for Its PD-L1-Targeting ADC HLX43 in Combination with Anti-PD-1 mAb Serplulimab and Novel Anti-EGFR mAb HLX07 henlius.com ↗ |
| 2026-01-11 | Shanghai Henlius Biotech | Results Results from Neoadjuvant studies of Henlius' serplulimab in colon/rectal cancer released at ASCO GI 2026 henlius.com ↗
The pCR was achieved in 42.9% (12/28) of pts, and MPR in 67.9% (19/28). |
| 2025-12-16 | Shanghai Henlius Biotech | Results Real-World Data of Serplulimab in Small-cell Lung Cancer Patients with Brain Metastases Presented at ESMO IO 2025 henlius.com ↗
The preliminary results suggest that serplulimab-based therapy may offer potential therapeutic benefits for previously untreated SCLC patients with brain metastases. |
| 2025-12-12 | Shanghai Henlius Biotech | Regulatory China NMPA Accepts NDA and Grants Priority Review to Serplulimab for Neo-/Adjuvant Treatment of Gastric Cancer henlius.com ↗
The NDA acceptance and priority review of serplulimab marks its formal entry onto a fast regulatory track for perioperative gastric cancer. |
| 2025-12-08 | Shanghai Henlius Biotech | Results Henlius Unveils Multi-Disciplinary Research on Serplulimab at ESMO Asia, Demonstrating Broad Clinical Value henlius.com ↗
Conclusion: Serplulimab demonstrated significant efficacy and a manageable safety profile in patients with advanced, recurrent, or metastatic cervical cancer. |
| 2025-11-21 | Shanghai Henlius Biotech | Regulatory Henlius' Serplulimab (anti-PD-1 mAb) Granted Breakthrough Therapy Designation by China NMPA for Neo-/Adjuvant Treatment for Gastric Cancer henlius.com ↗
This marks the first gastric cancer perioperative drug to receive the CDE’s BTD. |
| 2025-11-14 | Shanghai Henlius Biotech | Regulatory Serplulimab Approved in Peru, Expanding into LATAM henlius.com ↗
Serplulimab’s approval in Peru becomes Henlius’ fourth product to be approved in the Latin America market |
| 2025-11-03 | Shanghai Henlius Biotech | Results Henlius Announces Updated Follow-up Results of Anti-EGFR MAb HLX07 Combined with Serplulimab in First-Line Treatment of EGFR-High Squamous NSCLC henlius.com ↗
The newly updated analysis, at a median follow-up of 23.5 months, showed that the combination maintained consistent efficacy and safety outcomes, further confirming its durable clinical-benefit potential in EGFR-high sqNSCLC. |
| 2025-10-21 | Shanghai Henlius Biotech | Results mOS in nsqNSCLC Exceeds Two Years! Henlius Announces Latest Results for Serplulimab at ESMO 2025 henlius.com ↗
The final analysis results showed that the median overall survival (mOS) for the serplulimab plus chemotherapy group reached 26.8 months, successfully surpassing the two-year mark. |
| 2025-10-09 | Shanghai Henlius Biotech | Results Phase 3 Clinical Trial of HANSIZHUANG Plus Chemotherapy Meets Primary Endpoint in Neoadjuvant/Adjuvant Gastric Cancer, Greenlighting Early NDA Submission henlius.com ↗
The phase 3 clinical trial of HANSIZHUANG for perioperative gastric cancer treatment met its EFS primary endpoint, supporting an early New Drug Application (NDA) submission |
| 2025-09-12 | Shanghai Henlius Biotech | Results A New First-Line Option for EGFR Overexpression Patients: Henlius Presents Updated Phase 2 Data of HLX07 Combination Therapy in sqNSCLC henlius.com ↗
The positive dose-finding phase 2 signals support the feasibility of combining EGFR-targeted therapy with immunotherapy and lay the groundwork for larger-scale studies in the EGFR overexpression sqNSCLC population. |
| 2025-09-08 | Shanghai Henlius Biotech | Results Henlius Showcased 9 Study Findings on Serplulimab at 2025 WCLC with 3 Oral Presentations henlius.com ↗
These findings indicated that a dose-reduced bevacizumab regimen combined with serplulimab and platinum-based doublet chemotherapy exhibited promising efficacy and manageable safety for patients with EGFR-TKI-resistant nsq-NSCLC. |
| 2025-06-24 | Shanghai Henlius Biotech | Regulatory Serplulimab Approved in the UK and India for the First-Line Treatment of Extensive-Stage Small Cell Lung Cancer henlius.com ↗
Henlius (2696.HK) announced that its self-developed anti-PD-1 monoclonal antibody (mAb) serplulimab (trade name in Europe: Hetronifly®) has been approved in both the United Kingdom and India for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). |
| 2025-06-13 | Shanghai Henlius Biotech | Regulatory Expanding Southeast Asian Presence: Serplulimab Approved in Singapore and Malaysia henlius.com ↗
This marks another significant expansion in Southeast Asia following earlier approvals in Indonesia, Cambodia, and Thailand. |
| 2025-06-04 | Shanghai Henlius Biotech | Results Updated results and biomarker analysis from the Pivotal Clinical Trial ASTRUM-005 of Serplulimab Published on Cancer Communications henlius.com ↗
At the recent 2025 ASCO Annual Meeting, the ASTRUM-005 study released 42.4 months of median follow-up data, disclosing a four-year overall survival (OS) rate of 21.9%. |
| 2025-06-01 | Shanghai Henlius Biotech | Results Latest Results of Serplulimab in Lung and Gastrointestinal Cancer Released at ASCO 2025 henlius.com ↗
Shanghai, China, June 1, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the latest results from over ten studies on lung and gastrointestinal cancer of Henlius’ self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe) were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2025-03-27 | Shanghai Henlius Biotech | Results Latest RWS Results of Serplulimab for SCLC Released at 2025 ELCC henlius.com ↗
The study confirms the real-world efficacy and favorable safety of serplulimab in ES-SCLC, corroborating the results of the ASTRUM-005 study and providing strong supporting evidence for the use of serplulimab in combination with chemotherapy as a first-line treatment for ES-SCLC. |
| 2025-02-05 | Shanghai Henlius Biotech | Regulatory Serplulimab Approved in the EU for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) henlius.com ↗
This approval establishes serplulimab as the first and only anti-PD-1 mAb approved in the EU for the treatment of ES-SCLC. |
| 2025-01-26 | Shanghai Henlius Biotech | Results Results from Clinical Trials of Two Henlius’ Innovative Products Released at ASCO GI 2025 henlius.com ↗ |
| 2025-01-24 | Shanghai Henlius Biotech | Results Serplulimab plus HLX04 for HCC: Phase 2 Results Published in Cancer Immunology, Immunotherapy henlius.com ↗
The study demonstrated that the combination therapy of serplulimab with HLX04 showed a manageable safety profile and promising anti-tumor efficacy in previously untreated patients with advanced HCC. |
| 2025-01-06 | Shanghai Henlius Biotech | Regulatory Henlius Receives the NMPA IND Approval for Its PD-L1-Targeting ADC HLX43 in Combination with Novel Anti-PD-1 mAb Serplulimab henlius.com ↗ |
| 2024-12-16 | Shanghai Henlius Biotech | Results Latest Results of Serplulimab in The Neoadjuvant Treatment of ESCC Released In 2024 ESMO IO henlius.com ↗
Complete pCR in both primary tumor and lymph nodes was achieved in 14 patients (31.1%). |
| 2024-12-09 | Shanghai Henlius Biotech | Results Latest Results of 5 Clinical Trials Released at ESMO Asia 2024 henlius.com ↗
Recently, results from five clinical trials of Henlius' self-developed products, including novel anti-PD-1 mAb HANSIZHUANG (serplulimab), anti-EGFR mAb HLX07 and daratumumab biosimilar candidate HLX15, were released at European Society for Medical Oncology Asia (ESMO Asia) Congress 2024. |
| 2024-12-03 | Shanghai Henlius Biotech | Regulatory Henlius’ Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Receives NMPA Approval for the Treatment of nsNSCLC henlius.com ↗
The approval of a new indication for HANSIZHUANG in the treatment of lung cancer signifies a broadened therapeutic application, directly benefiting a large number of patients with advanced non-small cell lung cancer. |
| 2024-11-05 | Shanghai Henlius Biotech | Results Latest Research into the Differentiated Mechanisms of Action of Serplulimab Published in mAbs Journal henlius.com ↗
The study revealed insights into the possible mechanisms underlying the excellent efficacy of serplulimab. |
| 2024-09-21 | Shanghai Henlius Biotech | Regulatory Henlius Receives Positive CHMP Opinion for HANSIZHUANG as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer henlius.com ↗ |
| 2024-09-18 | Shanghai Henlius Biotech | Results Latest Results of HANSIZHUANG and HANQUYOU Released at 2024 ESMO henlius.com ↗
The exploratory biomarker analysis suggests improved clinical benefit with the addition of serplulimab to chemo regardless of genetic mutation status. |
| 2024-09-09 | Shanghai Henlius Biotech | Results Latest Results of Serplulimab in the Field of SCLC Released at 2024 WCLC henlius.com ↗
the latest results of the company’s self-developed innovative anti-PD-1 monoclonal antibody (mAb), HANSIZHUANG (serplulimab) were released as poster presentations at 2024 World Conference on Lung Cancer (“WCLC 2024”) in the field of small cell lung cancer (SCLC). |
| 2024-07-02 | Shanghai Henlius Biotech | Regulatory Henlius Receives Approval in Japan for Phase 3 MRCT of Anti-PD-1 mAb Serplulimab Combo on First-Line mCRC henlius.com ↗
HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. |
| 2024-06-17 | Shanghai Henlius Biotech | Results Advances in Immunotherapy for mCRC: Serplulimab Combo Published in MED henlius.com ↗
The results have shown that serplulimab plus HLX04 (bevacizumab, trade name in China: HANBEITAI) and chemotherapy exhibits promising efficacy and is safe and tolerable in patients with treatment-naïve metastatic colorectal cancer (mCRC). |
| 2024-06-04 | Shanghai Henlius Biotech | Results Latest Results of Serplulimab Released at 2024 ASCO henlius.com ↗
Shanghai, China, June 4, 2024 –Shanghai Henlius Biotech, Inc. (2696.HK) announced that the updated results of the company’s self-developed innovative anti-PD-1 mAb, HANSIZHUANG (serplulimab) were released by 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2024-04-10 | Shanghai Henlius Biotech | Results Results of Exploratory Biomarker Analysis of Pivotal Clinical Trial ASTRUM-005 of Serplulimab Initially Released at AACR 2024 henlius.com ↗ |
| 2024-03-13 | Shanghai Henlius Biotech | Regulatory Henlius Awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for Serplulimab in ES-SCLC henlius.com ↗
This designation marks serplulimab’s entry into the U.K.’s Innovative Licensing and Access Pathway (ILAP) and is expected to promote the presence of serplulimab in the U.K., benefiting more local SCLC patients. |
| 2024-01-17 | Shanghai Henlius Biotech | Results Results from Clinical Trials of Two Henlius’ Novel Products Released at ASCO GI 2024 henlius.com ↗ |
| 2024-01-05 | Shanghai Henlius Biotech | Results Cancer Cell Published the Results of ASTRUM-004: HANSIZHUANG Combined with Chemotherapy for the First-line Treatment of sqNSCLC henlius.com ↗
The ASTRUM-004 study validated in the final analysis that serplulimab in combination with chemotherapy significantly improved survival with a manageable safety profile in previously untreated locally advanced or metastatic sqNSCLC patients. |
| 2023-12-28 | Shanghai Henlius Biotech | Regulatory HANSIZHUANG Sets Sail in Indonesia Market henlius.com ↗
This is the first time HANSIZHUANG has been successfully approved for marketing in an overseas market, and it has become the first China anti-PD-1 mAb successfully approved for marketing in Southeast Asia. |
| 2023-12-12 | Shanghai Henlius Biotech | Regulatory The NDA for New Indication of Henlius Anti-PD-1 mAb Serplulimab in Combination with Chemotherapy for the First-line Treatment of non-squamous NSCLC Accepted by the NMPA henlius.com ↗
has been accepted by the National Medical Products Administration (NMPA) |
| 2023-12-04 | Shanghai Henlius Biotech | Results Results from Four Phase 1/2 Clinical Trials of Henlius’ Innovative Products Released at 2023 ESMO Asia henlius.com ↗
were released as poster presentations at European Society for Medical Oncology Asia (ESMO Asia) Congress 2023. |
| 2023-12-04 | Shanghai Henlius Biotech | Results Results of the Asian Subgroup in Phase 3 Clinical Study of Novel Anti-PD-1 mAb HANSIZHUANG for the First-Line Treatment of sqNSCLC Released at ESMO Asia 2023 henlius.com ↗ |
| 2023-10-31 | Shanghai Henlius Biotech | Results Phase 3 Clinical Study of HANSIZHUANG in Combination with Chemotherapy for Treatment on Patients with non-squamous NSCLC Met Primary Endpoint henlius.com ↗
Based on the results, HANSIZHUANG in combination with chemotherapy significantly prolonged PFS compared with placebo plus chemotherapy, which met the pre-specified efficacy criteria, with a manageable safety profile with no new safety signal identified. |
| 2023-10-11 | Shanghai Henlius Biotech | Regulatory Henlius Xuhui Facility Passes GMP Inspection for HANSIZHUANG by PIC/S Member BPOM henlius.com ↗
It is the first time that the production lines for HANSIZHUANG have passed GMP inspection conducted by overseas authorities. |
| 2023-09-22 | Shanghai Henlius Biotech | Regulatory Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ESCC henlius.com ↗ |
| 2023-09-11 | Shanghai Henlius Biotech | Results The Phase 3 Clinical Study Results of a Novel Anti-PD-1 mAb HANSIZHUANG for the First-Line Treatment of sqNSCLC Released at WCLC 2023 henlius.com ↗
Current data showed that serplulimab significantly improved survival with a manageable safety profile in previously untreated locally advanced or metastatic sqNSCLC patients. |
| 2023-08-17 | Shanghai Henlius Biotech | Results Henlius Announces Upcoming Oral Presentation at WCLC 2023 Featuring Results for HANSIZHUANG from a Phase 3 MRCT in sqNSCLC henlius.com ↗
Current data showed that serplulimab significantly improved survival with a manageable safety profile in previously untreated locally advanced or metastatic sqNSCLC patients. |
| 2023-05-26 | Shanghai Henlius Biotech | Regulatory 2023 ASCO Annual Meeting Released Clinical Data of Two Henlius Trials henlius.com ↗
Meanwhile, the investigational new drug application (IND) for a phase 2 clinical trial of serplulimab in combination with HLX26 for the first-line treatment of advanced non-small cell lung cancer (NSCLC) has been approved by the National Medical Products Administration (NMPA). |
| 2023-05-26 | Shanghai Henlius Biotech | Results Results from the Phase 3 Clinical Study of Novel Anti-PD-1 mAb Serplulimab for the First-line Treatment of ESCC Released at 2023 ASCO Annual Meeting henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the updated results of the phase 3 clinical study (ASTRUM-007) of company’s self-developed innovative anti-PD-1 mAb, HANSIZHUANG (serplulimab), targeting the first-line treatment of esophageal squamous cell carcinoma (ESCC), were released as online abstract by 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2023-05-10 | Shanghai Henlius Biotech | Results Frontiers in Immunology has Published Results from the Phase 2 Clinical Study of HANSIZHUANG Plus Chemotherapy for the Treatment of Advanced Cervical Cancer henlius.com ↗
IRRC-assessed ORR was 57.1% (95% confidence interval [CI] 34.0–78.2%); 3 patients achieved complete response and 9 partial response. |
| 2023-05-05 | Shanghai Henlius Biotech | Regulatory IND application of phase 2 clinical trial of HANSIZHUANG in combination with novel anti-LAG-3 mAb and chemotherapy for the first-line treatment of advanced non-small cell lung cancer patients was approved by NMPA henlius.com ↗ |
| 2023-03-23 | Shanghai Henlius Biotech | Regulatory EMA Validates Marketing Authorization Application for Henlius' HANSIZHUANG (Serplulimab) henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Medicines Agency (EMA) has validated the application for its self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), in combination with chemotherapy (carboplatin and etoposide), for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). |
| 2023-02-03 | Shanghai Henlius Biotech | Results Nature Medicine Published the Results of ASTRUM-007: HANSIZHUANG Combined with Chemotherapy for the First-line Treatment of Esophageal Squamous Cell Carcinoma henlius.com ↗
Serplulimab plus chemotherapy significantly improved PFS and OS in patients with previously untreated, PD-L1–positive, advanced ESCC, with a manageable safety profile. |
| 2023-01-17 | Shanghai Henlius Biotech | Regulatory Henlius’ Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Approved for the Treatment of ES-SCLC henlius.com ↗
This is the second approval HANSIZHUANG has received in the first-line treatment of lung cancer, after approval of sqNSCLC, demonstrating its great potential in lung cancer treatment. |
| 2022-12-15 | Shanghai Henlius Biotech | Regulatory HANSIZHUANG Granted Orphan Drug Designation in the European Union for Small Cell Lung Cancer henlius.com ↗
Shanghai, China, December 15th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Commission (EC) has granted Orphan Drug Designation (ODD) for HANSIZHUANG (serplulimab) for the treatment of small cell lung cancer (SCLC). |
| 2022-12-02 | Shanghai Henlius Biotech | Results The Phase 3 Clinical Study Results of Novel Anti-PD-1 mAb Serplulimab for the First-Line Treatment of ESCC Released at ESMO Asia Congress 2022 henlius.com ↗ |
| 2022-12-02 | Shanghai Henlius Biotech | Results The Updated Results of Phase 3 Clinical Study of Novel Anti-PD-1 mAb Serplulimab for the First-Line Treatment of ES-SCLC Released at ESMO Asia Congress 2022 henlius.com ↗ |
| 2022-12-02 | Shanghai Henlius Biotech | Regulatory First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Novel Anti-GARP mAb HLX60 henlius.com ↗
Recently, the phase 1 clinical trial application of HLX60 in combination with HANSIZHUANG for the treatment of advanced or metastatic solid tumours has been approved in Australia. |
| 2022-11-18 | Shanghai Henlius Biotech | Regulatory The CTA of Anti-PD-1 mAb Serplulimab for MRCT Phase 3 Studies on First-Line LS-SCLC Patients Approved in EU henlius.com ↗
has been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). |
| 2022-11-11 | Shanghai Henlius Biotech | Regulatory The IND Application of Phase 1b/2 Clinical Trial of BARF V600E Inhibitor HLX208 in Combination with HANSIZHUANG for the Treatment of BARF V600 Mutation-Positive Solid Tumours was Approved by the NMPA henlius.com ↗
for the treatment of BRAF V600E or BRAF V600 mutation-positive advanced solid tumours was approved by the National Medical Products Administration (NMPA). |
| 2022-11-01 | Shanghai Henlius Biotech | Regulatory Henlius' Novel Anti-PD-1 mAb HANSIZHUANG (Serplulimab) Receives NMPA Approval for the Treatment of sqNSCLC henlius.com ↗ |
| 2022-10-28 | Shanghai Henlius Biotech | Regulatory The Phase 2 IND Application of Henlius’ Novel Anti-HER2 mAb HLX22 Combined with Anti-PD-1 mAb HANSIZHUANG and HANQUYOU for the Treatment of HER2+ Gastric Cancer Approved by NMPA henlius.com ↗ |
| 2022-10-27 | Shanghai Henlius Biotech | Results Phase 2 Study of the PD-1 Inhibitor Serplulimab in Patients with MSI-H Solid Tumours Published in British Journal of Cancer henlius.com ↗
Serplulimab demonstrated a durable anti-tumour effect and a manageable safety profile in patients with previously treated MSI-H solid tumours. |
| 2022-10-25 | Shanghai Henlius Biotech | Regulatory Henlius Anti-PD-1 mAb Serplulimab Combined with Chemotherapy and Concurrent Radiotherapy MRCT Phase 3 Study on First-Line LS-SCLC Patients Received Clinical Trial Approved in Australia henlius.com ↗ |
| 2022-10-17 | Shanghai Henlius Biotech | Regulatory The IND Application of Henlius’ Novel Anti-GARP mAb HLX60 Approved by NMPA henlius.com ↗
Recently, the phase 1 clinical trial application of HLX60 in combination with HANSIZHUANG for the treatment of advanced or metastatic solid tumours has been approved in Australia. |
| 2022-09-28 | Shanghai Henlius Biotech | Results ASTRUM-005: The first immunotherapy clinical study of SCLC published in JAMA, one of the top medical journals in the world henlius.com ↗
Compared with chemotherapy, the treatment prolonged median OS by 4.5 months and had the lowest HR of 0.63. |
| 2022-09-08 | Shanghai Henlius Biotech | Results Phase 2 Study of the PD-1 Inhibitor Serplulimab Plus the Bevacizumab Biosimilar HANBEITAI in Patients with Advanced Hepatocellular Carcinoma Published in Liver Cancer henlius.com ↗
As of April 8, 2021, results from both groups (group A, n=20; group B, n=21) demonstrated that serplulimab plus HLX04 was safe and well-tolerated. |
| 2022-08-26 | Shanghai Henlius Biotech | Regulatory Henlius Novel Anti-GARP and Anti-PD-1 Dual mAb Therapy Received Clinical Trial Approval in Australia henlius.com ↗
Clinical Trial Notification (CTN) has been acknowledged by the Therapeutic Goods Administration (TGA), Australia. |
| 2022-08-26 | Shanghai Henlius Biotech | Regulatory The NDA for New Indication of Henlius Anti-PD-1 mAb Serplulimab in Combination with Chemotherapy for the First-line Treatment of Patients with Esophageal Squamous Cell Carcinoma Accepted by the NMPA henlius.com ↗
ESCC is the fourth indication for HANSIZHUANG has been accepted by NMPA. |
| 2022-05-18 | Shanghai Henlius Biotech | Results Phase 3 Clinical Study of Henlius Anti-PD-1 mAb, Serplulimab, in Combination with Chemotherapy for Treatment on Patients with Esophageal Squamous Cell Carcinoma Met Primary Endpoints henlius.com ↗
met the co-primary endpoints of progression-free survival (PFS) and overall survival (OS) in a planned interim analysis, evaluated by the Independent Data Monitoring Committee (IDMC). |
| 2022-04-29 | Shanghai Henlius Biotech | Regulatory IND Application of Phase I Clinical Trial of HANSIZHUANG in combination with Innovative Anti-LAG-3 mAb for the Treatment of Advanced/Metastatic Solid Tumours or Lymphomas Patients was Approved by NMPA henlius.com ↗ |
| 2022-04-20 | Shanghai Henlius Biotech | Regulatory IND Application for Phase 2 Clinical Trial of Serplulimab in Combination with Bevacizumab and Anti-EGFR mAb for the First-Line Treatment of HCC was Approved by The NMPA henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for a phase 2 clinical trial of HANSIZHUANG (serplulimab), an innovative anti-PD-1 monoclonal antibody (mAb) independently developed by the Company, in combination with HANBEITAI (bevacizumab biosimilar) and HLX07 (innovative anti-EGFR mAb) for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA). |
| 2022-04-11 | Shanghai Henlius Biotech | Regulatory The NDA of Henlius Novel Anti-PD-1 mAb Serplulimab for the First-Line Treatment of Small Cell Lung Cancer Accepted by NMPA henlius.com ↗ |
| 2022-04-07 | Shanghai Henlius Biotech | Regulatory HANSIZHUANG Granted Orphan-Drug Designation in the United States for Small Cell Lung Cancer henlius.com ↗
Shanghai, China, April 7th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG (serplulimab) for the treatment of small cell lung cancer (SCLC). |
| 2022-03-31 | Shanghai Henlius Biotech | Regulatory Henlius Anti-PD-1 mAb Serplulimab IND for MRCT Phase 3 Studies on First-Line LS-SCLC Patients Approved by NMPA henlius.com ↗ |
| 2022-03-25 | Shanghai Henlius Biotech | Regulatory Henlius Receives NMPA Approval for its First Innovative Monoclonal Antibody HANSIZHUANG henlius.com ↗
I'm very glad to see the first indication of HANSIZHUANG was approved in China. |
| 2022-03-21 | Shanghai Henlius Biotech | Results Henlius Published Phase 2 Study Results of Novel anti-PD-1 mAb Serplulimab for the treatment of advanced cervical cancer patients at SGO 2022 henlius.com ↗
Professor Jusheng An from National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, presented the results of HLX10-011-CC201 online, which demonstrated encouraging efficacy and a manageable safety profile of serplulimab in advanced cervical cancer patients. |
| 2022-01-20 | Shanghai Henlius Biotech | Results The preclinical and structural analysis results of Henlius’ innovative anti-PD-1 mAb serplulimab, published in an international journal PLOS ONE henlius.com ↗
The results showed that compared to nivolumab and pembrolizumab, serplulimab showed similar or better bioactivity in vitro and in vivo and anti-tumor activity in several tumour models. |
| 2021-12-21 | Shanghai Henlius Biotech | Regulatory The Phase 2 IND application of innovative PD-1 inhibitor serplulimab in combination with innovative anti-EGFR mAb HLX07 for the treatment of solid tumours was granted by the NMPA henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Phase 2 IND application of innovative PD-1 inhibitor serplulimab in combination with innovative anti-EGFR mAb HLX07 for the treatment of solid tumours was granted by the NMPA. |
| 2021-12-17 | Shanghai Henlius Biotech | Results Henlius' anti-PD-1 mAb MRCT achieved 15.38 months OS in first-line treatment of SCLC, reducing the risk of death by 38% of the overall population henlius.com ↗
The 2-year OS rate (OSR) in the two treatment groups were 43.2% and 8.0%, respectively. |
| 2021-12-07 | Shanghai Henlius Biotech | Results Henlius’ Phase 3 clinical study of novel PD-1 inhibitor serplulimab for the treatment of first-line extensive-stage small cell lung cancer (ES-SCLC) meets primary study endpoint henlius.com ↗
I’m very excited to see that the Phase 3 study of serplulimab in ES-SCLC has met its primary endpoint OS, and its efficacy and safety have been fully validated. |
| 2021-09-26 | Shanghai Henlius Biotech | Results Henlius Presents Results from Phase 2 Clinical Study of Its Novel anti-PD-1 mAb Serplulimab in Patients with Advanced Cervical Cancer at 2021 CSCO henlius.com ↗
In this meeting, Henlius releases phase 2 study results of serplulimab (HLX10, novel anti-PD-1 antibody), in patients with advanced cervical cancer in an oral presentation. |
| 2021-09-17 | Shanghai Henlius Biotech | Regulatory The NDA of Henlius Novel Anti-PD-1 mAb Serplulimab for First-Line Treatment of sqNSCLC Accepted by China's NMPA, Phase 3 MRCT Met its Primary Endpoint henlius.com ↗ |
| 2021-04-22 | Shanghai Henlius Biotech | Regulatory The NDA of the Novel Anti-PD-1 mAb Serplulimab of Henlius Accepted by NMPA and Proposed to be Granted Priority Review henlius.com ↗ |
| 2020-03-31 | Shanghai Henlius Biotech | Regulatory Henlius Novel Anti-EGFR Monoclonal Antibody Demonstrated Favorable Safety and Tolerability Profile in Its Phase 1 Clinical Study henlius.com ↗
Clinical trial applications for this combination therapy have been approved by the National Medical Products Administration (NMPA). |
| 2019-12-09 | Shanghai Henlius Biotech | Regulatory The Anti-PD-1 mAb Combined with Anti-EGFR mAb Therapy of Henlius Received Approvals to Conduct Clinical Trials by NMPA henlius.com ↗
This is the first domestic dual mAbs combination therapy that has received IND approval in China. |
| 2019-11-27 | Shanghai Henlius Biotech | Results A Novel Anti-PD-1 Antibody HLX10 Study Led to the Initiation of Combination Immunotherapy henlius.com ↗ |
| 2019-07-12 | Shanghai Henlius Biotech | Regulatory Henlius Novel Anti-PD-1 Antibody HLX10 Received Clinical Trial Approval in Taiwan for the Treatment of Hepatitis B henlius.com ↗
Henlius has recently received a clinical approval from the Taiwan Food and Drug Administration (TFDA) for its HLX10, a recombinant humanized anti-programmed death-1 (PD-1) monoclonal antibody, for the treatment of chronic hepatitis B infection. |
| 2019-03-19 | Shanghai Henlius Biotech | Regulatory The 2nd Combination Immunotherapy of Henlius Received Notification of Acceptance henlius.com ↗
Henlius recently has received notification of acceptance from the China National Medical Products Administration (NMPA) for its investigational new drug (IND) application of HLX10, a recombinant humanized anti-PD-1 monoclonal antibody (mAb) injection, in combination with HLX07, a Recombinant Humanized Anti-EGFR mAb Injection, for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck. |
| 2018-09-10 | Shanghai Henlius Biotech | Regulatory Important News! Henlius Combination Therapy Received Approval to Conduct Clinical Trials in China henlius.com ↗
Recently, Henlius has received an approval from National Medical Products Administration (NMPA) for its combination therapy with HLX10 (recombinant humanized anti-PD-1 monoclonal antibody injection) and HLX04 (recombinant anti-VEGF humanized monoclonal antibody injection) to treat advanced solid tumors. |
| 2017-12-22 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Henlius Biotech’s Anti-PD-1 Antibody Receives Approval for Taiwan Clinical Trials fosunpharma.com ↗
Recently, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (referred to “Fosun Pharma”) announced that HLX10-Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection (the “New Drug”) received the approval letter from “Taiwan Food and Drug Administration, Ministry of Health and Welfare” (“TFDA”) for clinical trials of solid tumors treatment, which was researched by Henlix Biotech Inc. ("Henlix Biotech"), a holding subsidiary of Shanghai Henlius Biotech., Inc. ("Henlius Biotech"), the biologics platform of Fosun Pharma. |
| 2017-09-30 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Henlius, Biologics Platform of Fosun Pharma receives FDA approval for Drug Clinical Test again fosunpharma.com ↗
Henlius, the biologics platform of Fosun Pharma, announced recently that it has received FDA approval for drug clinical test for HLX10 - Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection (the “New Drug”), a new drug independently developed by its subsidiary Taiwan Henlius. |
All press releases naming this drug 152 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 152 releases opens the full record — a long page | ||
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 168 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 ↗127“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 ↗ “Serplulimab 3mg/kg day IV for every three weeks” NCT07854977 ↗ “combined with serplulimab (200mg ivgtt Q3W)” NCT07101679 ↗ |
| 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 ↗ |