Puyouheng (pucotenlimab) / Taizhou Hanzhong Biopharma, Lepu Med, HanX Biopharma - LARVOL DELTA

MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Fudan University

New P2 trial • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

A Multicenter, Single-Arm, Open-Label Clinical Study of Cetuximab Beta in Combination with Pucotenlimab and Chemotherapy as Neoadjuvant Therapy for KRAS/NRAS Wild-Type Left-Sided Colon Cancer and Upper Rectal Cance (ChiCTR) - P2 | N=53 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Fujian Medical University; The First Affiliated Hospital of Fujian Medical University

New P2 trial • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • KRAS

A Prospective, Single-Arm, Multi-Center Exploratory Clinical Study of Neoadjuvant Pucotenlimab Combined with Cetuximab and Albumin-Bound Paclitaxel Followed by Sequential Radiotherapy for Locally Advanced Hypopharyngeal Cancer (ChiCTR) - P4 | N=26 | Not yet recruiting | Sponsor: The First Hospital of Jilin University; The First Hospital of Jilin University

New P4 trial • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Solid Tumor • PD-L1

Updated long term efficacy results of phase II study for becotatug vedotin combined with pucotenlimab in recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC) (ESMO 2025) - "It may provide an efficacious treatment option for R/M-NPC pts who had failed anti-PD-(L)1 and platinum-based therapy. The efficacy and safety of MRG003 combined with HX008 in NPC is currently undergoing further investigation in randomized controlled clinical trials."

Clinical • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • EGFR

Preliminary results of phase II study to evaluate safety and efficacy of becotatug vedotin in combination with pucotenlimab as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) (ESMO 2025) - P1/2 | "There is further improved ORR trend as observed at higher dose cohort with 2.3mg/kg. Further follow-up is ongoing to determine the optimal dose of becotatug vedotin."

Clinical • Combination therapy • Metastases • P2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed/Refractory Hepatoblastoma in Children (clinicaltrials.gov) - P=N/A | N=24 | Recruiting | Sponsor: Sun Yat-sen University

New trial • Hepatoblastoma • Oncology • Pediatrics • Solid Tumor

Exploring the safety and efficacy of sacituzumab tirumotecan combined with pucotenlimab in the treatment of advanced cholangiocarcinoma (ChiCTR) - P2 | N=53 | Recruiting | Sponsor: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma (clinicaltrials.gov) - P2 | N=59 | Recruiting | Sponsor: Sir Run Run Shaw Hospital

New P2 trial • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT) (clinicaltrials.gov) - P2 | N=68 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting ➔ Recruiting | Initiation date: Jan 2025 ➔ Aug 2024

Enrollment open • Trial initiation date • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

IDEAL: 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 (clinicaltrials.gov) - P2 | N=106 | Not yet recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete et Cou | Initiation date: Jun 2025 ➔ Oct 2025

Trial initiation date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

An Exploratory, Multicenter Clinical Study of Cetuximab in Combination with Pucotenlimab and Nab-Paclitaxel for the Treatment of Recurrent or Metastatic Hypopharyngeal Cancer (ChiCTR) - P4 | N=32 | Not yet recruiting | Sponsor: The First Hospital of Jilin University; The First Hospital of Jilin University

New P4 trial • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Solid Tumor • PD-L1

Preoperative short-term radiotherapy combined with Pucotenlimab for advanced soft tissue sarcoma of the limbs and trunk-a single cohort pilot study (ChiCTR) - P=N/A | N=10 | Recruiting | Sponsor: The First Affiliated Hospital, Air Force Medical University; The First Affiliated Hospital, Air Force Medical University

New trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Pucotenlimab Combined with Chemotherapy and Lenvatinib as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase II Clinical Trial (ChiCTR) - P2 | N=47 | Not yet recruiting | Sponsor: Department of oncology, Beijing Friendship Hospital, Capital Medical University; Department of oncology, Beijing Friendship Hospital, Capital Medical

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Pucotenlimab Combined With Chemotherapy as Perioperative Treatment for Locally Advanced Gastroesophageal Junction Carcinoma (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Tang-Du Hospital

New trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

OH2 Injection in Combination With HX008 for Melanoma. (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Nov 2023 ➔ Nov 2025 | Trial primary completion date: Nov 2023 ➔ Nov 2025

Trial completion date • Trial primary completion date • Herpes Simplex • Melanoma • Oncology • Solid Tumor

MH-Penile-001: MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Jiyan Liu

New P1 trial • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (clinicaltrials.gov) - P2 | N=116 | Recruiting | Sponsor: Shanghai Miracogen Inc. | Trial completion date: Sep 2023 ➔ Dec 2026 | Trial primary completion date: Jan 2023 ➔ Jun 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Safety and efficacy of pucotenlimab combined with standard chemotherapy regimens in the neoadjuvant treatment of pediatric patients with intermediate or high-risk rhabdomyosarcoma: A phase I/II study. (ASCO 2025) - P1/2 | "This study demonstrates the safety and potential efficacy of neoadjuvant pucotenlimab plus chemotherapy, with an acceptable safety profile, in patients with pediatric rhabdomyosarcoma. Summary of safety profile of 15 patients received pucotenlimab combined with the standard chemotherapy regimen."

Clinical • P1/2 data • Endocrine Disorders • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Pucotenlimab in high microsatellite instability/mismatch repair–defificient (MSI-H/ dMMR) solid tumors: Results update from a multicenter, phase II, open-label study. (ASCO 2025) - P2 | "Pucotenlimab as ≥2L therapy for advanced MSI-H/dMMR solid tumors demonstrates durable OS and PFS benefit. The updated, long-term follow-up data confirmed durable clinical benefit of pucotenlimab in this patient population, especially for CRC pts. Clinical trial information: NCT03704246."

Clinical • dMMR • Mismatch repair • MSI-H • P2 data • Anemia • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

The phase 1 clinical trial of anti–PD-1 ab plus intrahepatic injection of oncolytic virus (OH2) combined radiotherapy of liver metastasis in stage IV melanoma. (ASCO 2025) - P1 | "Pts received intravenous Pucotenlimab Q3W combined with ultrasound guided intrahepatic injection of OH2 Q2W (107CCID50/mL, 8ml per injection) after SBRT (24-30Gy/3Fx) of liver metastasis... The combination of systemic anti-PD-1 therapy with intralesional injection of an oncolytic virus and radiotherapy has demonstrated a remarkable ORR and excellent OS in patients with melanoma and liver metastases, with manageable toxicity."

Clinical • Metastases • Oncolytic virus • P1 data • Eye Cancer • Gastroenterology • Gastrointestinal Disorder • Hepatocellular Cancer • Herpes Simplex • Immunology • Infectious Disease • Melanoma • Ocular Melanoma • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor

HX016-9, a novel PD1xVEGF BsAb, as a new candidate treatment of solid tumors (AACR 2025) - "With the clinical confirmation of the superior efficacy of AK112, a first-in-class (FIC) PD1xVEGF bispecific antibody (BsAb), in the treatment of NSLCL cancers, over the PD1 monoclonal antibody (mAb), as shown in a head-to-head phase III trial, we set out to engineer a novel and potentially best-in-class (BIC) PD1xVEGF BsAb using a unique PD1 (HX008, an approved PD1-mAb) and a novel VEGF (HX006, a mAb with more favor activity over Avastin) mAb sequences. In a xenograft A549 NSCLC tumor in immunocompromised mice, HX016-9 also caused anti-tumor activity that can be attributed to anti-VEGF function. These activities are comparable or superior to those of the FIC molecule, warranting the HX016-9 candidacy to move into IND-enabling evaluation and further clinical development."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Magic-C002: A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=446 | Not yet recruiting | Sponsor: Shanghai Miracogen Inc.

New P3 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Safety and Efficacy of Pucotenlimab in pLECC (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Nasopharyngeal Carcinoma • Oncology

IDEAL: 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 (clinicaltrials.gov) - P2 | N=106 | Not yet recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital

New P2 trial • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck