Drugs / PIMURUTAMAB
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05360368 | Mar → Dec 2023 | cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 1 | NCT02648490 | Sep 2016 → Jun 2019 | cancer | Henlix, Inc | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07358585 | Jan 2026 → Jul 2027 expected | colon adenocarcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT03577704 | Aug 2018 → Sep 2022 | cancer | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT06857279 | Apr 2025 → Dec 2027 expected | head and neck 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 | NCT05354700 | Mar 2023 → Mar 2024 | small cell lung carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05215925 | Feb → Jul 2023 | neoplastic disease or syndrome | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05513573 | Dec 2022 → Sep 2024 overdue | nasopharyngeal carcinoma | Shanghai Henlius Biotech | Active not recruiting | 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 | NCT05238363 | Jun 2022 → May 2023 | skin squamous cell carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05246982 | Mar 2022 → Dec 2023 | gastric cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT04976647 | Jan 2022 → Jan 2023 | non-small cell squamous lung carcinoma | Shanghai Henlius Biotech | 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 2/32 trials | ||||||
| Phase 2/3 | NCT07459751 | May 2026 → Jan 2030 expected | non-small cell squamous lung carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07318883 | Mar 2026 → Jan 2031 expected | non-small cell squamous lung carcinoma | Shanghai Henlius Biotech | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-09-11 | Shanghai Henlius Biotech | Results Results from Phase 2 Study of Pimurutamab (HLX07) in Advanced Cutaneous Squamous Cell Carcinoma Published in Therapeutic Advances in Medical Oncology henlius.com ↗
HLX07 monotherapy has demonstrated promising efficacy and a favorable safety profile in treating advanced CSCC (aCSCC), warranting further investigation in larger populations. |
| 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 ↗ |
| 2026-01-27 | 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 ↗ |
| 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. |
| 2025-09-30 | Shanghai Henlius Biotech | Regulatory Henlius Receives the NMPA IND Approval for Its PD-L1-Targeting ADC HLX43 in Combination with Novel Anti-EGFR mAb HLX07 henlius.com ↗
has been approved by the China National Medical Products Administration (NMPA) |
| 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. |
| 2025-06-01 | Shanghai Henlius Biotech | Results Latest Results of Serplulimab in Lung and Gastrointestinal Cancer Released at ASCO 2025 henlius.com ↗
Additionally, updated data from a phase 2 study of HLX07 plus serplulimab as first-line treatment for sqNSCLC led by Professor Yi-Long Wu from Guangdong Provincial People’s Hospital was released. |
| 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. |
| 2024-11-20 | Shanghai Henlius Biotech | Results Cancer Communications Published the Results of HLX07-ESCC201: HLX07 as monotherapy or combination therapy in ESCC henlius.com ↗ |
| 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. |
| 2023-06-06 | Shanghai Henlius Biotech | Results Results From the Phase 2 Clinical Trial of HLX07 for the Treatment of ESCC Released at 2023 ASCO henlius.com ↗ |
| 2023-05-26 | Shanghai Henlius Biotech | Results 2023 ASCO Annual Meeting Released Clinical Data of Two Henlius Trials henlius.com ↗
HLX07 was safe and well tolerated when combined with chemotherapy in patients with advance solid tumors. |
| 2023-02-02 | Shanghai Henlius Biotech | Results Henlius completed the phase 1b/2 clinical trial of HLX07 for the treatment of advanced solid tumours henlius.com ↗
The results showed that no DLT related to HLX07 occurred during the study, and the MTD of HLX07 was not reached when combined with different chemotherapy regimens. |
| 2022-09-29 | Shanghai Henlius Biotech | Regulatory Henlius Received IND Approval from US FDA for HLX07 in CSCC patients henlius.com ↗
Shanghai, China, September 29th, 2022 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for its HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). |
| 2022-09-08 | Shanghai Henlius Biotech | Regulatory 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 ↗
An investigational new drug application for a phase 2 trial of serplulimab in combination with HLX04 and HLX07 (innovative anti-EGFR mAb) for the first-line treatment of unresectable or metastatic HCC has been approved by the National Medical Products Administration (NMPA). |
| 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). |
| 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. |
| 2021-12-09 | Shanghai Henlius Biotech | Results Pre-clinical and preliminary Phase 1 clinical results of Henlius HLX07, a novel anti-EGFR mAb, published in well-known journal EXPERT OPIN BIOL TH henlius.com ↗
The pre-clinical and preliminary Phase 1 clinical data suggested a potential superior antitumour efficacy and better safety profile of HLX07. |
| 2020-03-31 | Shanghai Henlius Biotech | Results Henlius Novel Anti-EGFR Monoclonal Antibody Demonstrated Favorable Safety and Tolerability Profile in Its Phase 1 Clinical Study henlius.com ↗
Shanghai, China, March, 31, 2020 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that HLX07, a recombinant anti-epidermal growth factor receptor (EGFR) humanised monoclonal antibody (mAb) injection, demonstrated favorable safety and tolerability profile in a prospective, open-label, dose-escalation Phase 1 clinical study (HLX07FIH, NCT02648490) for the treatment of advanced solid tumours. |
| 2019-12-13 | Shanghai Henlius Biotech | Regulatory First Patient Dosed in Phase 3 Clinical Trial of Anti-PD-1 mAb HLX10 in Combination with Bevacizumab Biosimilar HLX04 in Patients with Metastatic nsNSCLC henlius.com ↗
Henlius also received IND approval to initiate clinical trials in China evaluating HLX10 in combination with HLX07 (an anti-EGFR antibody) for the treatment of head and neck squamous cell carcinoma. |
| 2019-12-13 | Shanghai Henlius Biotech | Regulatory First Patient Dosed in Phase 3 Study of Anti-PD-1 mAb in Combination with Chemotherapy in Neo-/Adjuvant Treatment for Patients with Gastric Cancer henlius.com ↗
Henlius also received IND approval to initiate clinical trials in China evaluating HLX10 in combination with HLX07 (an anti-EGFR antibody) for the treatment of head and neck squamous cell carcinoma. |
| 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-EGFR Antibody HLX07 for Potential Treatment of Squamous Cell Carcinoma of the Head and Neck henlius.com ↗
Among 17 evaluable patients, one patient in the 600mg cohort achieved a partial response (PR) and five patients across all cohorts had reached stable disease (SD). |
| 2019-08-20 | Shanghai Henlius Biotech | Regulatory Monoclonal Antibody HLX10 in Patients with Metastatic MSI-H/dMMR Solid Tumors henlius.com ↗
The investigational new drug (IND) of HLX10 in combination with HLX07, an innovative anti-EGFR mAb, has been accepted to review by NMPA. |
| 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 ↗
The clinical trial application of HLX10 in combination with HLX07, a fully humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody, has been submitted to the National Medical Product Administration (NMPA) for review. |
| 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. |
| 2016-10-14 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma Biosimilar Innovation Breakthrough Approval for Clinical Trials on Bio-better of Henlius Biotech in Mainland China, Taiwan and San Francisco fosunpharma.com ↗
Currently, registration applications of HLX07 of Henlius Biotech have been approved for clinical trials in mainland China, Taiwan and USA. |
| 2016-06-20 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory New drug for Cancer Treatment by Fosun Pharma Approved for Clinical Trials in Taiwan fosunpharma.com ↗ |
All press releases naming this drug 30 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PIMURUTAMAB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594549 ↗ |
| Known as | HLX07 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05354700 ↗ |
| Action | Inhibit | “Anti-EGFR” NCT05215925 ↗ |
| Modality | Monoclonal antibody | “HLX07 is an improved version of anti-EGFR monoclonal antibody.” NCT02648490 ↗ |
| Route | Intravenous | “HLX07 was administered weekly by 2-h intravenous infusion at doses ranging from 50 to 800 mg.” PMID 33713216 ↗ Mar 2021 |
| Target | EGFR | “recombinant human anti-EGFR monoclonal antibody against cancers” NCT02648490 ↗ |