Approved Immune Checkpoint Inhibitors in China: PD-1, PD-L1, CTLA-4 and Bispecific Antibodies

Immune checkpoint inhibitors (ICIs) restore T-cell–mediated antitumor immunity by blocking key regulatory pathways such as PD-1/PD-L1 and CTLA-4, and have become a cornerstone of modern oncology treatment.

As one of the world’s most important markets for oncology innovation, China has established a comprehensive development landscape covering both monoclonal antibodies and bispecific antibodies.

As of April 2026:

• Globally approved ICIs: 31
• Approved immune checkpoint inhibitors in China: 26

✨ These therapies are widely used in multiple tumor types, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), gastric cancer, esophageal cancer, and cervical cancer, with indications continuing to expand.

Against the backdrop of the accelerating global adoption of immuno-oncology therapies, Chinese pharmaceutical distributor DengYueMed is playing an increasingly important role in connecting approved immune checkpoint inhibitors in China with international markets.

Approved Immune Checkpoint Inhibitors in China (26 Total)

Target/Type	Number	Representative Drugs
PD-1 inhibitors	12	Nivolumab, Pembrolizumab, Toripalimab, Sintilimab, Camrelizumab, Tislelizumab, Penpulimab, Zimberelimab, Serplulimab, Pucotenlimab, Enlonstobart, Finotonlimab
PD-L1 inhibitors	8	Durvalumab, Atezolizumab, Envafolimab, Sugemalimab, Adebrelimab, Socazolimab, Benmelstobart, Tagitolimab
CTLA-4 inhibitor	2	Ipilimumab, Ipilimumab N01
PD-1/CTLA-4 bispecific	2	Cadonilimab, Iparomlimab
PD-1/VEGF bispecific	1	Ivonescimab
PD-L1/TGF-βRII bispecific	1	Retlirafusp-α injection

I. PD-1 Inhibitors (12)

PD-1 inhibitors block the PD-1 receptor on T cells, reversing tumor-induced immune suppression. This class represents the most widely used and indication-rich category among approved immune checkpoint inhibitors in China, covering the majority of solid tumors.

1. Nivolumab

First approval: June 2018
Indications (14 total, 7 first-line):

• NSCLC (EGFR/ALK-negative, post-platinum progression)
• Head and neck squamous cell carcinoma (PD-L1 positive, second-line)
• Gastric/gastroesophageal junction adenocarcinoma (third-line+)
• Malignant pleural mesothelioma (first-line, with ipilimumab)
• Gastric/esophageal adenocarcinoma (first-line)
• Adjuvant esophageal cancer
• Esophageal squamous cell carcinoma (first-line, with chemotherapy)
• Neoadjuvant NSCLC
• Adjuvant urothelial carcinoma
• MSI-H/dMMR colorectal cancer (first-line, with CTLA-4 inhibitor)
• First-line urothelial carcinoma (with chemotherapy)
• First-line HCC (with CTLA-4 inhibitor)
• Perioperative NSCLC
• First-line NSCLC (PD-L1 ≥1%, with CTLA-4 inhibitor)

2. Pembrolizumab

First approval: July 2018
Indications (19 total, 12 first-line):

• Melanoma (second-line and first-line)
• Non-squamous NSCLC (first-line, with pemetrexed + platinum)
• Squamous NSCLC (first-line, with chemotherapy)
• NSCLC monotherapy (PD-L1 TPS ≥1%)
• Esophageal squamous cell carcinoma (second-line, CPS ≥10)
• Esophageal cancer (first-line, with chemotherapy)
• Head and neck squamous cell carcinoma (first-line, CPS ≥20)
• MSI-H/dMMR colorectal cancer (first-line)
• MSI-H/dMMR solid tumors (tumor-agnostic)
• Gastric/GEJ adenocarcinoma (first-line)
• Biliary tract cancer (first-line)
• HER2-positive gastric cancer (with trastuzumab)
• HCC (second-line)
• HCC (with TACE + targeted therapy)
• Triple-negative breast cancer (perioperative)
• Perioperative NSCLC
• Cervical cancer (with chemoradiotherapy)
• Urothelial carcinoma (first-line)

3. Toripalimab

First approval: December 2018
Indications (12 total, 8 first-line):

• Melanoma (second-line and first-line)
• Nasopharyngeal carcinoma (second-line and first-line)
• Esophageal squamous cell carcinoma (first-line, with chemotherapy)
• Non-squamous NSCLC (first-line, with chemotherapy)
• Perioperative NSCLC
• Renal cell carcinoma (first-line, with apatinib)
• Small cell lung cancer (first-line)
• Triple-negative breast cancer (first-line)
• Hepatocellular carcinoma (first-line)
• Urothelial carcinoma (second-line)

4. Sintilimab

First approval: December 2018
Indications (8 total, 5 first-line):

• Relapsed/refractory Hodgkin lymphoma
• Non-squamous NSCLC (first-line)
• Squamous NSCLC (first-line)
• HCC (first-line, with bevacizumab)
• Esophageal squamous cell carcinoma (first-line)
• Gastric cancer (first-line)
• EGFR-mutant NSCLC (post-TKI combination therapy)
• Endometrial cancer

5. Camrelizumab

First approval: June 2019
Indications (10 total, 5 first-line):

• Hodgkin lymphoma
• HCC (second-line)
• Non-squamous NSCLC (first-line)
• Esophageal squamous cell carcinoma (second-line)
• Nasopharyngeal carcinoma (second-line and first-line)
• Squamous NSCLC (first-line)
• Esophageal squamous cell carcinoma (first-line)
• HCC (first-line, with apatinib)
• Cervical cancer

6. Tislelizumab

First approval: December 2019
Indications (14 total, 7 first-line):

• Hodgkin lymphoma
• Urothelial carcinoma
• Squamous and non-squamous NSCLC (first-line)
• HCC
• Second-line NSCLC
• MSI-H/dMMR solid tumors
• Esophageal squamous cell carcinoma (second-line and first-line)
• Nasopharyngeal carcinoma (first-line)
• Gastric cancer (first-line)
• HCC (first-line)
• Small cell lung cancer (first-line)
• Perioperative NSCLC

7. Penpulimab

First approval: August 2021
Indications (4 total, 2 first-line):

• Hodgkin lymphoma
• Squamous NSCLC (first-line)
• Nasopharyngeal carcinoma (second-line and first-line)

8. Zimberelimab

First approval: August 2021
Indications (2):

• Hodgkin lymphoma
• Cervical cancer

9. Serplulimab

First approval: March 2022
Indications (5 total, 4 first-line):

• MSI-H solid tumors
• Squamous NSCLC (first-line)
• Small cell lung cancer (first-line)
• Esophageal squamous cell carcinoma (first-line)
• Non-squamous NSCLC (first-line)

10. Pucotenlimab

First approval: July 2022
Indications (2):

• MSI-H/dMMR solid tumors
• Melanoma

11. Enlonstobart

First approval: June 2024
Indication:

• PD-L1 positive recurrent/metastatic cervical cancer

12. Finotonlimab

First approval: February 2025
Indication:

• First-line recurrent/metastatic head and neck squamous cell carcinoma (with cisplatin + 5-FU)

II. PD-L1 Inhibitors (8)

PD-L1 inhibitors block the ligand on tumor cells, indirectly restoring T-cell activity. Within the landscape of approved immune checkpoint inhibitors in China, they play a key role in consolidation and biomarker-selected populations.

1. Durvalumab

First approval: December 2019
Indications (5 total, 4 first-line):

• Stage III unresectable NSCLC (post-chemoradiotherapy consolidation)
• Small cell lung cancer (first-line)
• Biliary tract cancer (first-line)
• Perioperative NSCLC
• Limited-stage SCLC

2. Atezolizumab

First approval: February 2020
Indications (5 total, 4 first-line):

• SCLC (first-line)
• HCC (first-line, with bevacizumab)
• NSCLC (first-line monotherapy and combination)
• Adjuvant NSCLC

3. Envafolimab

First approval: November 2021
Indication:

• MSI-H/dMMR solid tumors

4. Sugemalimab

First approval: December 2021
Indications (5 total, 5 first-line):

• Non-squamous and squamous NSCLC (first-line)
• NSCLC consolidation
• Esophageal squamous cell carcinoma (first-line)
• Gastric cancer (first-line)

5. Adebrelimab

First approval: March 2023
Indication:

• SCLC (first-line)

6. Socazolimab

First approval: December 2023
Indication:

• Cervical cancer

7. Benmelstobart

First approval: May 2024
Indications (3 total, 2 first-line):

• SCLC (first-line)
• Endometrial cancer
• Renal cell carcinoma (first-line)

8. Tagitanlimab

First approval: December 2024
Indications (2 total, 1 first-line):

• Nasopharyngeal carcinoma (second-line and first-line)

III. CTLA-4 Inhibitor (2)

CTLA-4 inhibitors act at the early stage of T-cell activation and are commonly used in combination regimens within approved immune checkpoint inhibitors in China.

Ipilimumab

First approval: June 2021
Indications (4 total, 4 first-line):

• Malignant pleural mesothelioma (first-line, with PD-1 inhibitor)
• MSI-H/dMMR colorectal cancer (first-line)
• HCC (first-line)
• NSCLC (first-line)

Ipilimumab N01

First approval: December 2025
Indication:

• Neoadjuvant treatment of resectable stage IIB–III microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer, in combination with Sintilimab.

IV. PD-1/CTLA-4 Bispecific Antibodies (2)

These agents simultaneously block two key immune checkpoints, enhancing antitumor immunity and representing an important innovation direction among approved immune checkpoint inhibitors in China.

1. Cadonilimab

First approval: June 2022
Indications (3 total, 2 first-line):

• Cervical cancer (second-line and first-line)
• Gastric cancer (first-line)

2. Iparomlimab

First approval: September 2024
Indication:

• Cervical cancer

V. PD-1/VEGF Bispecific Antibody (1)

PD-1/VEGF bispecific antibodies simultaneously regulate immune suppression and tumor angiogenesis, enabling a dual mechanism of action combining immunotherapy with anti-angiogenic effects.

This strategy is considered a key innovative approach to overcoming the efficacy limitations of traditional immunotherapy.

Ivonescimab

First approval: May 2024
Indications (2 total, 1 first-line):

• EGFR-mutant NSCLC (post-TKI progression)
• First-line NSCLC (PD-L1 positive)

VI. PD-L1/TGF-βRII Bispecific Antibody (1)

PD-L1/TGF-β bispecific antibodies simultaneously block immune checkpoints and immunosuppressive cytokine pathways, thereby improving the tumor microenvironment.

This class improves the tumor microenvironment and shows promise in “cold tumors,” further expanding the scope of approved immune checkpoint inhibitors in China.

Retlirafusp-α Injection

First approval: January 2026
Indication:

• First-line gastric/GEJ adenocarcinoma (PD-L1 positive, with chemotherapy)

Industry Trends and Future Outlook

The market for approved immune checkpoint inhibitors in China has entered a phase characterized by both intense competition and rapid innovation:

1️⃣ Increasing Homogeneity
Rapid growth in PD-1/PD-L1 products with overlapping indications intensifies pricing and channel competition.

2️⃣ Combination Therapy as Standard
ICIs combined with chemotherapy, anti-angiogenic agents (e.g., VEGF inhibitors), radiotherapy, and targeted therapies continue to expand efficacy boundaries.

3️⃣ Rise of Bispecific Antibodies
PD-1/VEGF and PD-L1/TGF-β bispecifics are emerging as key differentiation strategies.

4️⃣ Earlier Treatment Settings
Expansion from late-stage to neoadjuvant and adjuvant settings significantly improves long-term survival.

5️⃣ Precision Medicine Integration
Biomarkers such as PD-L1 expression and MSI-H/dMMR are becoming central to treatment decision-making.

About DengYueMed — Enabling Healthier Lives for More People

The DengYueMed team is driven by professionalism and responsibility, committed to improving global patient access to innovative oncology therapies.

🐱‍🏍 We focus on unmet medical needs in oncology, integrating high-quality innovative drug resources from China and efficiently connecting advanced therapies—including immune checkpoint inhibitors—to international markets, creating greater value for global partners.

In our development, we uphold innovation with integrity, strictly complying with international regulations and industry standards to ensure the quality, stability, and reliability of pharmaceutical supply, while building a safe, transparent, and sustainable partnership ecosystem.

As China continues to make breakthroughs in immuno-oncology—particularly in the large-scale deployment of PD-1 therapies and rapid advancements in bispecific antibodies—DengYueMed is strengthening its role as a key bridge within the global supply chain, accelerating the global reach of China’s innovative medicines.

Our ultimate goal is to help people live healthier lives. 💖

Conclusion

As outlined above, approved immune checkpoint inhibitors in China have rapidly expanded to 26 therapies across PD-1, PD-L1, CTLA-4, and emerging bispecific antibody formats, with broad applications across major tumor types and continuously evolving indications.

Driven by advances in novel targets, combination strategies, and precision medicine, China is transitioning from a fast follower to a global leader in immuno-oncology innovation.

In this context, china pharmaceutical wholesaler DengYueMed is helping bridge approved immune checkpoint inhibitors in China to global markets, enabling efficient and compliant access to innovative cancer therapies.

FAQ about Approved Immune Checkpoint Inhibitors in China