> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/serplulimab-6abb7125-5518-4ea5-9f58-b233f74f26e8
> Record changed: 2026-10-13

# Serplulimab

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594550)

Drug type

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594550)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594550)

## Names and chemistry

**Drug type**

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594550)

**Drug name**

Serplulimab

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594550)

### Other names (19)

- 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

## Identifiers

**ATC classification codes**

- L01FF12

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594550)

**CAS registry numbers**

- 2231029-82-4

**ChEMBL ID**

CHEMBL4594550

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594550)

**FDA ingredient codes (UNII)**

- S3GQZ2K36V

## Regulatory information

### European Union

**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

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/hetronifly)

### Other regulatory facts

**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

### Drug classification

**Pharmacology name**

serplulimab

**Type**

Antibody

**Drug name stem**

\-mab

**Approval recorded by Guide to Pharmacology**

Yes

### Mechanisms of action (3)

- **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

### Investigated indications (22)

- **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

### Open Targets indications (54)

- **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.

### Reported adverse events (66)

- **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.

### Trial references (58)

- NCT03468751  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03468751)
- NCT03757936  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03757936)
- NCT05400265  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05400265)
- NCT05442996  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05442996)
- NCT05483530  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05483530)
- NCT06302062  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06302062)
- NCT03952403  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03952403)
- NCT04033354  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04033354)
- NCT04976647  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04976647)
- NCT05766800  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05766800)
- NCT05787613  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05787613)
- NCT05882513  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882513)
- NCT06195683  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06195683)
- NCT06334757  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06334757)
- NCT03958890  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03958890)
- NCT06422858  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06422858)
- NCT03973112  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03973112)
- NCT04465734  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04465734)
- NCT05290220  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05290220)
- NCT06349980  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06349980)
- NCT04063163  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04063163)
- NCT05353257  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353257)
- NCT05354700  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05354700)
- NCT05468489  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05468489)
- NCT05765825  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05765825)

And 33 more, listed on the interactive page.

## Chemical properties

**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](https://trialight.com/data/trial/a-phase-i-study-to-evaluate-the-safety-tolerability-and-pk-27e0e6b6-4ce4-4d22-8157-ab038d8ab47e.md)
- 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](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 3
- Carcinoma of esophagus Phase 3
- [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) Phase 3
- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 2
- [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) Phase 2
- [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) Phase 3
- [Gastric adenocarcinoma](https://trialight.com/data/condition/gastric-adenocarcinoma-6bb74a55-7ba6-53e3-a113-22296a84d6ae.md) Phase 3
- [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 3
- [Gastroesophageal junction adenocarcinoma](https://trialight.com/data/condition/gastroesophageal-junction-adenocarcinoma-de7e280e-cbd1-5266-a5dd-dda00261a706.md) Phase 2
- [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) Phase 2
- [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Phase 3
- [Lung adenocarcinoma](https://trialight.com/data/condition/lung-adenocarcinoma-1cff3624-1dd5-5076-89a7-1f8a28c087a6.md) Phase 2
- [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 2
- Malignant colon neoplasm Phase 2
- [Malignant pancreatic neoplasm](https://trialight.com/data/condition/malignant-pancreatic-neoplasm-5dd0b53e-5962-50ea-a2e5-cf2444bd0485.md) Phase 2
- [Nasopharyngeal neoplasm](https://trialight.com/data/condition/nasopharyngeal-neoplasm-48691b20-fad8-5218-b6aa-4dd6c49469e4.md) Phase 2
- Neoplasm Phase 3
- [Neuroendocrine carcinoma](https://trialight.com/data/condition/neuroendocrine-carcinoma-66cf52f3-045d-597f-80d3-d7a422d5ef1c.md) Phase 1
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 3

### Other linked conditions (1)

- Rectal cancer

### Targets (1)

- [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) Programmed cell death protein 1 antagonist

---

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