Drugs / Penpulimab
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Penpulimab

Monoclonal antibody targets PDCD1

Developed for
hepatocellular carcinoma · non-small cell lung carcinoma · nasopharyngeal carcinoma · colorectal cancer · gastric cancer · head and neck squamous cell carcinoma · cancer of unknown primary site · classic Hodgkin lymphoma
+32 more · diffuse large B-cell lymphoma · esophageal squamous cell carcinoma · breast cancer · gastroesophageal adenocarcinoma · pancreatic neoplasm · soft tissue sarcoma · cancer · cervical cancer · female reproductive organ cancer · gastric carcinoma · gastroesophageal cancer · glioblastoma · head and neck cancer · high grade malignant neoplasm · Hodgkins lymphoma · lung cancer · lung carcinoma · lung neoplasm · lymphoma · malignant pancreatic neoplasm · melanoma · metastatic malignant neoplasm · osteosarcoma · pancreatic adenocarcinoma · paraganglioma · pheochromocytoma · primary central nervous system lymphoma · rectal cancer · small cell lung carcinoma · squamous cell lung carcinoma · thyroid cancer · urinary bladder cancer
Investigated by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Akeso · The First Affiliated Hospital with Nanjing Medical University · Akeso Tiancheng, Inc · Peking Union Medical College Hospital · Sun Yat-sen University
+39 more · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The First Affiliated Hospital of Zhengzhou University · West China Hospital · Henan Cancer Hospital · Hunan Cancer Hospital · Nanfang Hospital, Southern Medical University · Ruijin Hospital · Tianjin Medical University Cancer Institute and Hospital · Xijing Hospital · Akeso Biopharma, Inc. · Anshan Tumor Hospital · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Chaoyang Central Hospital · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Degan Lu · Eye & ENT Hospital of Fudan University · Fudan University · Fukuang General Hospital of Liaoning health industry group · Fuzhou Pulmonary Hospital of Fujian · Hubei Cancer Hospital · Huludao central hospital · Lei Liu · Liaoning Cancer Hospital & Institute · Peking University Cancer Hospital & Institute · Peking University Third Hospital · Rongchang Biopharmaceutical · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai Zhongshan Hospital · Sichuan Cancer Hospital and Research Institute · Southern Medical University, China · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Tang-Du Hospital · The Central Hospital of Lishui City · The Third Affiliated Hospital of Southern Medical University · Third Affiliated Hospital, Sun Yat-Sen University · Wu Jieping Medical Foundation · Zhengda Tianqing Pharmaceutical Group Co., Ltd. · Zhongda Hospital

Trials 77 · started per year

today
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2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06853769 Sep 2024 → Aug 2026 overdue colorectal cancer The First Affiliated Hospital with Nanjing Medical University Active not recruiting No outcome recorded
Phase 18 trials
Phase 1 NCT06649656 Nov 2024 → Nov 2026 expected high grade malignant neoplasm Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT06320080 May 2024 → Nov 2025 hepatocellular carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Terminated No outcome recorded
Phase 1 NCT06297642 May → Jul 2024 cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Terminated No outcome recorded
Phase 1 NCT06010901 Jan 2024 → Mar 2025 colorectal cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1 NCT05975645 Aug 2023 → Jun 2025 hepatocellular carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Terminated No outcome recorded
Phase 1 NCT05894421 Jun 2023 → Jan 2025 cancer of unknown primary site Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1 NCT05333276 Jul 2022 → Dec 2023 cancer of unknown primary site Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03352531 Jan 2018 → Nov 2020 cancer of unknown primary site Akeso Biopharma, Inc. Completed No outcome recorded
Phase 1/26 trials
Phase 1/2 NCT07075419 Aug 2025 → Jul 2027 expected hepatocellular carcinoma West China Hospital Not yet recruiting No outcome recorded
Phase 1/2 NCT06821503 Apr 2025 → Dec 2027 expected malignant pancreatic neoplasm Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT05400876 Jun 2022 → May 2023 lymphoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT04803851 May 2021 → Feb 2024 pancreatic neoplasm Peking Union Medical College Hospital Unknown No outcome recorded
Phase 1/2 NCT04172506 Sep 2019 → Dec 2021 hepatocellular carcinoma, lung neoplasm Akeso Completed No outcome recorded
Phase 1/2 NCT03722147 Aug 2018 → Jan 2020 classic Hodgkin lymphoma Akeso Completed No outcome recorded
Phase 246 trials
Phase 2 NCT07612098 Jul 2026 → Dec 2031 expected soft tissue sarcoma Cancer Institute and Hospital, Chinese Academy of Medical Sciences Not yet recruiting No outcome recorded
Phase 2 NCT07392320 Feb 2026 → Feb 2031 expected nasopharyngeal carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT07381075 Feb 2026 → Oct 2028 expected head and neck squamous cell carcinoma West China Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06767800 Nov 2024 → Sep 2026 expected gastroesophageal adenocarcinoma Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT06516978 Oct 2024 → Oct 2028 expected diffuse large B-cell lymphoma The First Affiliated Hospital with Nanjing Medical University Not yet recruiting No outcome recorded
Phase 2 NCT06444009 Jul 2024 → Dec 2025 overdue head and neck squamous cell carcinoma Lei Liu Recruiting No outcome recorded
Phase 2 NCT06500091 Jul 2024 → Jun 2026 overdue melanoma, soft tissue sarcoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT06032052 Feb 2024 → Sep 2026 expected lung carcinoma Hubei Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT06341530 Jan → Dec 2024 non-small cell lung carcinoma The First Affiliated Hospital of Zhengzhou University Unknown No outcome recorded
Phase 2 NCT06081673 Oct 2023 → Dec 2024 overdue head and neck squamous cell carcinoma Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05344924 Oct 2022 → Mar 2023 hepatocellular carcinoma Zhongda Hospital Unknown No outcome recorded
Phase 38 trials
Phase 3 NCT06048315 Sep 2023 → Jun 2026 overdue lung cancer Degan Lu Not yet recruiting No outcome recorded
Phase 3 NCT05862337 May 2023 → Aug 2024 overdue hepatocellular carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT05244642 Feb 2022 → Dec 2025 Hodgkins lymphoma Akeso Unknown No outcome recorded
Phase 3 NCT04974398 Aug 2021 → Feb 2026 overdue nasopharyngeal carcinoma Akeso Active not recruiting No outcome recorded
Phase 3 NCT04344158 Aug 2020 → Dec 2026 expected hepatocellular carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Active not recruiting No outcome recorded
Phase 3 NCT04385550 May 2020 → Oct 2023 gastroesophageal adenocarcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 3 NCT03866993 Dec 2018 → Oct 2020 non-small cell lung carcinoma, squamous cell lung carcinoma Akeso Completed No outcome recorded
Phase 3 NCT03866980 Nov 2018 → Jun 2023 non-small cell lung carcinoma Akeso Terminated No outcome recorded
Phase 42 trials
Phase 4 NCT05488353 Sep 2022 → Apr 2026 urinary bladder cancer Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Unknown No outcome recorded
Phase 4 NCT05387109 Jun 2022 → Apr 2023 non-small cell lung carcinoma Tang-Du Hospital Unknown No outcome recorded
Phase not applicable5 trials
NCT06062563 Nov 2023 → Dec 2024 Peking Union Medical College Hospital Unknown No outcome recorded
NCT05784987 Apr 2023 → Jan 2024 diffuse large B-cell lymphoma The First Affiliated Hospital with Nanjing Medical University Unknown No outcome recorded
NCT05800080 Apr 2023 → Feb 2024 gastric cancer Xijing Hospital Unknown No outcome recorded
NCT05561699 Sep 2022 → Sep 2024 esophageal squamous cell carcinoma Shanghai Zhongshan Hospital Unknown No outcome recorded
NCT05385900 Jun 2022 → Jun 2023 gastric cancer Xijing Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 9 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/24 trials
Phase 1/2 NCT06943820 Comparator May 2025 → Dec 2026 expected colorectal adenocarcinoma, head and neck squamous cell carcinoma, non-small cell lung carcinoma Akeso Recruiting No outcome recorded
Phase 1/2 NCT06825494 Background Apr 2025 → Mar 2026 overdue neoplasm Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT05834543 Background May 2023 → Oct 2024 esophageal squamous cell carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Terminated No outcome recorded
Phase 1/2 NCT05783921 Background May 2023 → Aug 2024 head and neck squamous cell carcinoma, metastatic squamous cell carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 24 trials
Phase 2 NCT07387081 Background Dec 2025 → May 2028 expected LaNova Medicines Limited Recruiting No outcome recorded
Phase 2 NCT07086326 Comparator Jul 2025 → Dec 2026 expected non-small cell lung carcinoma Yang Fan, MD Not yet recruiting No outcome recorded
Phase 2 NCT06586242 Background Apr 2023 → Apr 2025 overdue esophageal cancer Xijing Hospital Recruiting No outcome recorded
Phase 2 NCT05193617 Comparator Jan 2022 → Jan 2025 overdue nasopharyngeal carcinoma Sun Yat-sen University Active not recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05809336 Background May 2019 → Oct 2022 neoplasm Beijing Friendship Hospital Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 85 sources stand behind the page.

FieldValueCited text
Known as penpulimab “We developed an IgG1 backbone anti-programmed cell death protein-1 (PD-1) antibody, penpulimab, which is designed to remove crystallizable fragment (Fc) gamma receptor (FcγR)...” PMID 35833116 Jun 2022
69

“We developed an IgG1 backbone anti-programmed cell death protein-1 (PD-1) antibody, penpulimab, which is designed to remove crystallizable fragment (Fc) gamma receptor (FcγR)...” PMID 35833116 Jun 2022

“TQB2252 injection is a compound preparation of TQB2223 monoclonal antibody (LAG-3) and penpulimab (PD-1), with a specification of 300mg TQB2223 monoclonal antibody and 100mg...” NCT06649656

“Immunotherapy drugs can be Pembrolizumab /Penpulimab/ Camrelizumab/ Tislelizumab / Sintilimab/ sulgarizumab and so on” NCT06032052

“Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer” NCT05313906

“AK105(penpulimab): 200mg, every 3 weeks, 21 days as a treatment cycle” NCT05137171

“Drug: Penpulimab Q2W Administered intravenously” NCT07387081

Penpulimab 200 mg every 3 weeks for 8 cycles” NCT07392320

“anti-PD-1 antibody Penpulimab (AK105)” NCT04736810

Penpulimab injection” NCT05809336

NCT07612098

NCT05244642

NCT05265962

NCT05001971

NCT05387109

NCT05229003

NCT05949931

NCT05193617

NCT07086326

NCT05488353

NCT05834543

NCT06821503

NCT05885399

NCT05784987

NCT05344924

NCT06297642

NCT05894421

NCT06114225

NCT07075419

NCT06586242

NCT04970914

NCT06081673

NCT05385900

NCT05783921

NCT05400876

NCT06010901

NCT05975645

NCT05460481

NCT06444009

NCT05186558

NCT04974398

NCT05347641

NCT05726175

NCT07381075

NCT05493995

NCT05800080

NCT06062563

NCT06320080

NCT05485350

NCT05519202

NCT06500091

NCT06853769

NCT06048315

NCT05862337

NCT04952493

NCT05563480

NCT05494060

NCT05028504

NCT05260671

NCT06943820

NCT05214222

NCT05576480

NCT06516978

NCT05561699

NCT06825494

NCT05807880

NCT04846634

NCT06767800

NCT06341530

NCT06051851

Known as AK105 “A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma” NCT04974398
21

“Penpulimab(AK105):200mg, iv, day1, q3weeks, 6 cycles in total;” NCT05726175

“Penpulimab (AK105) + platinum-based doublet chemotherapy” NCT07086326

“penpulimab(AK-105) 200 mg intravenously every 3 weeks” NCT05265962

“anti-PD-1 antibody Penpulimab (AK105)” NCT04736810

NCT05333276

NCT04291248

NCT05137171

NCT03866967

NCT03866980

NCT03866993

NCT04803851

NCT04203719

NCT05068206

NCT04207463

NCT05244993

NCT04344158

NCT04172506

NCT04385550

NCT05683704

NCT05033587

NCT04172571

Known as AK105 injection AK105 injection: intravenous drip on Day 1;” NCT05068206
Known as Penpulimab injection Penpulimab Injection 100mg per bottle, 200mg IV Day 1, cycled every 21 days” NCT05494060
1

Penpulimab injectionNCT05809336

Action Inhibit “anti-programmed cell death protein-1 (PD-1) antibody” PMID 35833116 Jun 2022
Modality Monoclonal antibody “Penpulimab, an Fc-Engineered IgG1 Anti-PD-1 Antibody, With Improved Efficacy and Low Incidence of Immune-Related Adverse Events.” PMID 35833116 Jun 2022
Route Intravenous intravenous (IV) infusion” NCT03866967
Target PDCD1 “We developed an IgG1 backbone anti-programmed cell death protein-1 (PD-1) antibody, penpulimab, which is designed to remove crystallizable fragment (Fc) gamma receptor (FcγR)...” PMID 35833116 Jun 2022