Serplulimab
Highest phase reached
Phase 3
Drug type
Antibody
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Antibody
- Drug name
- Serplulimab
- drug serplulimab
- Drug: Serplulimab
- hlx 10
- HLX-10
- hlx10
- Hlx10
- HLX10
- HLX10 (PD-1 antibody)
- Immunoglobulin G4 [228-proline], anti-(human programmed cell death protein 1) (human-Mus musculus monoclonal HLX10 γ4-chain), disulfide with human-Mus musculus monoclonal HLX10 κ-chain, dimer
- immunoglobulin g4 228 proline anti human programmed cell death protein 1 human mus musculus monoclonal hlx10 γ4 chain disulfide with human mus musculus monoclonal hlx10 κ chain dimer
- serplulimab
- Serplulimab
- serplulimab [INN]
- SERPLULIMAB [USAN]
- Serplulimab [WHO-DD]
- Serplulimab Injection
- serplulimab inn
- serplulimab usan
- serplulimab who dd
- ATC classification codes
- L01FF12
Sources for recorded values
- CAS registry numbers
- 2231029-82-4
- ChEMBL ID
- CHEMBL4594550
- FDA ingredient codes (UNII)
- S3GQZ2K36V
- Status
- Authorised
- Status date
- 3 Feb 2025
- Authorisation date
- 3 Feb 2025
- Approved indications
- Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC). Non-small cell lung carcinoma (NSCLC) Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have: locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC. Oesophageal squamous cell carcinoma (OSCC) Hetronifly in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.
- Product number
- EMEA/H/C/006170
- Authorisation holder
- Accord Healthcare S.L.U.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Carcinoma, Non-Small-Cell Lung
- Esophageal Squamous Cell Carcinoma
- Small Cell Lung Carcinoma
European medicines record
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Pharmacology name
- serplulimab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
- Action
- Antagonist
- Action type
- Antagonist
- Target
- programmed cell death 1 (CD279)
- Gene symbol
- PDCD1
- Protein identifier
- Q15116
- Median affinity
- 8.36
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Programmed cell death protein 1 antagonist
- Action type
- Antagonist
- Target
- Programmed cell death protein 1
- Protein identifier
- Q15116
- Action
- Binding
- Action type
- Binding
- Target
- programmed cell death 1 (CD279)
- Gene symbol
- PDCD1
- Protein identifier
- Q15116
- Median affinity
- 8.62
- Affinity units
- pKd
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- Programmed cell death protein 1 antagonist
- Action type
- Antagonist
- Target
- Programmed cell death protein 1
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Adenocarcinoma of Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000571
- Subject identifier
- D000077192
- Condition
- Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002916
- Subject identifier
- D004938
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Nasopharyngeal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004252
- Subject identifier
- D009303
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005922
- Subject identifier
- D004938
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000359
- Subject identifier
- D010190
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001951
- Subject identifier
- D015179
- Condition
- Ascites
- Highest recorded phase
- 2
- Condition identifier
- HP:0001541
- Subject identifier
- D001201
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0001056
- Subject identifier
- D013274
- Condition
- Carcinoma, Neuroendocrine
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0002120
- Subject identifier
- D018278
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0002974
- Subject identifier
- D002583
- Condition
- Adenocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0003219
- Subject identifier
- D000230
- Condition
- Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005575
- Subject identifier
- D015179
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Colonic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0021063
- Subject identifier
- D003110
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000702
- Condition identifier
- EFO_0002916
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004252
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005922
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000657
- Condition identifier
- HP_0001541
- Highest recorded phase
- 2
- Condition identifier
- HP_0004326
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002120
- Condition identifier
- MONDO_0002120
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002169
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002974
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0003060
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003210
- Condition identifier
- MONDO_0003219
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003550
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004116
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004950
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005008
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005036
- Highest recorded phase
- 2
And 29 more, listed on the interactive page.
- Event
- abdominal infection
- Reports
- 3
- Reporting signal score
- 12.4904
- Event
- abdominal pain
- Reports
- 10
- Reporting signal score
- 8.4174
- Event
- adrenal insufficiency
- Reports
- 6
- Reporting signal score
- 17.9849
- Event
- alanine aminotransferase increased
- Reports
- 14
- Reporting signal score
- 27.6619
- Event
- anaemia
- Reports
- 30
- Reporting signal score
- 56.0752
- Event
- aspartate aminotransferase increased
- Reports
- 14
- Reporting signal score
- 29.233
- Event
- bile acids increased
- Reports
- 1
- Reporting signal score
- 7.12499
- Event
- blood alkaline phosphatase increased
- Reports
- 4
- Reporting signal score
- 6.56192
- Event
- blood bilirubin increased
- Reports
- 5
- Reporting signal score
- 9.26022
- Event
- cardiotoxicity
- Reports
- 3
- Reporting signal score
- 7.67059
- Event
- cerebral radiation injury
- Reports
- 1
- Reporting signal score
- 8.13641
- Event
- constipation
- Reports
- 8
- Reporting signal score
- 7.30718
- Event
- cytokine increased
- Reports
- 1
- Reporting signal score
- 9.52262
- Event
- cytopenia
- Reports
- 4
- Reporting signal score
- 10.6557
- Event
- decreased appetite
- Reports
- 18
- Reporting signal score
- 30.3532
- Event
- dermatitis
- Reports
- 4
- Reporting signal score
- 9.59219
- Event
- diarrhoea
- Reports
- 27
- Reporting signal score
- 26.5642
- Event
- endocrine toxicity
- Reports
- 1
- Reporting signal score
- 6.75043
- Event
- fatigue
- Reports
- 20
- Reporting signal score
- 13.3168
- Event
- gastrointestinal toxicity
- Reports
- 2
- Reporting signal score
- 8.13355
- Event
- granulocyte count decreased
- Reports
- 2
- Reporting signal score
- 8.03489
- Event
- haematotoxicity
- Reports
- 5
- Reporting signal score
- 14.426
- Event
- hepatic function abnormal
- Reports
- 10
- Reporting signal score
- 23.162
- Event
- hepatitis
- Reports
- 7
- Reporting signal score
- 15.5028
- Event
- hyperbilirubinaemia
- Reports
- 8
- Reporting signal score
- 25.912
And 41 more, listed on the interactive page.
- NCT03468751
- NCT03757936
- NCT05400265
- NCT05442996
- NCT05483530
- NCT06302062
- NCT03952403
- NCT04033354
- NCT04976647
- NCT05766800
- NCT05787613
- NCT05882513
- NCT06195683
- NCT06334757
- NCT03958890
- NCT06422858
- NCT03973112
- NCT04465734
- NCT05290220
- NCT06349980
- NCT04063163
- NCT05353257
- NCT05354700
- NCT05468489
- NCT05765825
And 33 more, listed on the interactive page.
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Related records
Trials (149)
- 16-Hour Fasting Plus Serplulimab and CAPEOX as Neoadjuvant Therapy in pMMR/MSS Advanced Mid-to-Low Rectal Cancer
- A Clinical Study Evaluating the Use of HLX10 in Combination With HLX04 for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients
- A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer
- A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC
- A Clinical Study to Evaluate Efficacy and Safety of HLX10 Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy
- A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)
- A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy
- A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer
- A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients
- A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
- A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer
- A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Anti-PD-1 Antibody (HLX10) in Combination With Avastin Biosimilar (HLX04) in Patients With Advanced Solid Tumors
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of HLX35 in Combination With HLX10 in Patients With Advanced or Metastatic Solid Tumors
- A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors
- A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors
- A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors
- A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E Mutation
- A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer
- A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC
In development for (22)
- Breast cancer Phase 3
- Cancer Phase 3
- Carcinoma of esophagus Phase 3
- Cervical cancer Phase 3
- Colorectal cancer Phase 2
- Colorectal carcinoma Phase 2
- Esophageal squamous cell carcinoma Phase 3
- Gastric adenocarcinoma Phase 3
- Gastric cancer Phase 3
- Gastroesophageal junction adenocarcinoma Phase 2
- Head and neck squamous cell carcinoma Phase 2
- Hepatocellular carcinoma Phase 3
- Lung adenocarcinoma Phase 2
- Lung cancer Phase 2
- Malignant colon neoplasm Phase 2
- Malignant pancreatic neoplasm Phase 2
- Nasopharyngeal neoplasm Phase 2
- Neoplasm Phase 3
- Neuroendocrine carcinoma Phase 1
- Non-small cell lung carcinoma Phase 3
Other linked conditions (1)
- Rectal cancer
Targets (1)
- PDCD1 Programmed cell death protein 1 antagonist