Pucotenlimab

Overview

Pucotenlimab is a recombinant humanized anti-PD-1 monoclonal antibody. It received its first global approval in China in July 2022 for the treatment of solid tumours. It is being investigated in other cancers.

Indication

用于治疗微卫星高度不稳定╱错配修复缺陷(MSI-H/dMMR)实体瘤的患者，包括既往经过氟尿嘧啶类、奥沙利铂和伊立替康治疗后出现疾病进展的晚期结直肠癌患者；既往至少一线治疗后出现疾病进展且无满意替代治疗方案的其他晚期实体瘤患者。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma	2025/07/08	NCT07054307	Not Applicable	Not yet recruiting	Jiyan Liu
Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck	2025/05/06	NCT06959108	Phase 2	Not yet recruiting	Groupe Oncologie Radiotherapie Tete et Cou
The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC	2025/03/26	NCT06895369	Phase 2	Not yet recruiting	Sir Run Run Shaw Hospital
Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer	2025/03/12	NCT06872606	Phase 2	Not yet recruiting	Sir Run Run Shaw Hospital
Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)	2025/01/13	NCT06770270	Phase 2	Not yet recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
Clinical Efficacy Study of Pucotenlimab Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer	2024/08/20	NCT06561308	Phase 2	Not yet recruiting	Women's Hospital School Of Medicine Zhejiang University
Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen	2024/06/13	NCT06456892	Phase 1	Recruiting	Sun Yat-sen University
Pucotenlimab Combined With Lenvatinib as a Neodjuvant Therapy for Non Clear Cell Renal Cell Carcinoma	2023/11/13	NCT06129955	Phase 2	Not yet recruiting	Sun Yat-sen University
A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer	2022/12/15	NCT05652894	Phase 3	Not yet recruiting	Taizhou Hanzhong biomedical co. LTD
A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors	2021/04/01	NCT04825392	Phase 1	UNKNOWN	Taizhou Hanzhong biomedical co. LTD

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Pucotenlimab Injection	乐普生物科技股份有限公司	国药准字S20220022	生物制品	注射剂	7/19/2022

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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