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    DRUG:

    Puyouheng (pucotenlimab)

    i
    Other names: HX008, HX 008, HX-008, LP001, AK103
    Company:
    HanX Biopharma, Lepu Med, Taizhou Hanzhong Biopharma
    Drug class:
    PD1 inhibitor
    Related drugs:
    21h
    A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=190, Recruiting, Taizhou Hanzhong biomedical co. LTD | Not yet recruiting --> Recruiting | Trial primary completion date: Jan 2026 --> Jun 2026
    Enrollment open • Trial primary completion date • Mismatch repair • MSI-H • dMMR
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • capecitabine • oxaliplatin • irinotecan • Puyouheng (pucotenlimab)
    8d
    Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P3, N=556, Recruiting, Sun Yat-sen University
    New P3 trial
    |
    MSI (Microsatellite instability)
    |
    capecitabine • oxaliplatin • Puyouheng (pucotenlimab)
    9d
    Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=514, Not yet recruiting, Sun Yat-sen University
    New P3 trial
    |
    cisplatin • gemcitabine • Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    15d
    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, Recruiting, Groupe Oncologie Radiotherapie Tete et Cou | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    15d
    The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Sir Run Run Shaw Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin) • becotarug (JMT101)
    15d
    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, Recruiting, Jiyan Liu | Not yet recruiting --> Recruiting | Initiation date: Jul 2025 --> Feb 2026
    Enrollment open • Trial initiation date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    19d
    Results and Exploratory Biomarker Analyses of a Phase II Study CHANGEABLE: Combination of PD-1 Inhibitor and Niraparib in GErm-Line-mutAted Metastatic Breast Cancer. (PubMed, MedComm (2020))
    This phase II trial evaluated the efficacy and safety of combining niraparib with the PD-1 inhibitor HX008 in patients with metastatic breast cancer who had germline DNA damage response (DDR) mutations. Somatic TP53 mutations significantly correlated with shorter PFS, while ASXL1 mutations correlated with longer PFS. This chemotherapy-free regimen demonstrates promising efficacy and a tolerable safety profile in patients with metastatic breast cancer and germline DDR mutations, providing a novel therapeutic option for this patient population, even those with brain metastases.
    P2 data • Journal • BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ASXL1 (ASXL Transcriptional Regulator 1) • PALB2 (Partner and localizer of BRCA2) • XPO1 (Exportin 1)
    |
    HER-2 positive • TP53 mutation • HER-2 negative • PALB2 mutation • ASXL1 mutation
    |
    Zejula (niraparib) • Puyouheng (pucotenlimab)
    22d
    TRIUMPH-AM: Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Shanghai Zhongshan Hospital
    New P2 trial
    |
    temozolomide • Lenvima (lenvatinib) • Puyouheng (pucotenlimab)
    25d
    A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Fudan University
    New P2 trial • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin) • becotarug (JMT101)
    1m
    MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II) (clinicaltrials.gov)
    P1/2, N=160, Not yet recruiting, Lepu Biopharma Co., Ltd.
    New P1/2 trial • Checkpoint inhibition
    |
    GPC3 (Glypican 3)
    |
    Avastin (bevacizumab) • Puyouheng (pucotenlimab)
    2ms
    Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Sun Yat-sen University
    New P2 trial • pMMR
    |
    capecitabine • oxaliplatin • Puyouheng (pucotenlimab)
    2ms
    Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=38, Not yet recruiting, Fudan University
    New P2 trial
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin) • becotarug (JMT101)