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

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 • 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

Pucotenlimab Combined with MRG002 for HER2-positive Cancer of Unknown Primary (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Zhiguo Luo, MD, PhD

New P2 trial • Oncology

SCRIPBOT: 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 (clinicaltrials.gov) - P2 | N=33 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital

New P2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Pucotenlimab, nab-paclitaxel and carboplatin versus pucotenlimab monotherapy for resected stage III acral melanoma: A prospective phase 2 randomized controlled trial (ChiCTR) - P2 | N=86 | Recruiting | Sponsor: West China Hospital, Sichuan University; West China Hospital, Sichuan University

New P2 trial • Melanoma • Oncology • Solid Tumor

Intratumoral oncolytic virus OH2 injection in patients with locally advanced or metastatic sarcoma: a phase 1/2 trial. (PubMed, J Immunother Cancer) - "Intratumoral injection of oncolytic virus OH2 is well tolerable in patients with sarcoma. Further investigation of OH2 with HX008 in select sarcoma subtypes is warranted."

Journal • P1/2 data • Herpes Simplex • Oncology • Sarcoma • Solid Tumor • CSF2

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

New P2 trial • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

OH2 Oncolytic Viral Therapy in Solid Tumors (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Aug 2024 ➔ Aug 2025 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Oncolytic virus • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Gastrointestinal Disorder • Herpes Simplex • Oncology • Solid Tumor

Preliminary results of phase II study to evaluate safety and efficacy of combination pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC) (ESMO Asia 2024) - P1/2 | "It may provide an efficacious salvage treatment option for R/M-NPC pts who had failed anti-PD-(L)1 and platinum-based therapy. Further follow-up is ongoing."

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

Preclinical pharmacology characterization of HX009, a novel PD1 x CD47 Bi-specific antibody. (PubMed, Sci Rep) - "We report a new rationally-designed bispecific-antibody (BsAb), HX009, simultaneously targeting PD1 and CD47 to improve both the efficacy and safety over the respective single-targeting agents by grafting the extracellular domain of SIRPα onto the parental anti-PD1-monoclonal antibody, HX008. The IV single-dose toxicology study with a 14-day observation revealed a maximum tolerated dose of 150 mg/kg, while the repeated-dose (once weekly for 4 weeks, 5 doses in total) study showed a highest non-severely toxic dose (HNSTD) of 15 mg/kg. The desired preclinical PK and safety profiles, along with its antitumor activity, support HX009's candidacy for its clinical development."

IO biomarker • Journal • Preclinical • Acute Myelogenous Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • PD-1 • SIRPA • TNFRSF4

A prospective, single-arm, single-center clinical study of neoadjuvant doxorubicin liposome combined with pucotenlimab in the treatment of undifferentiated pleomorphic sarcoma and myxofibrosarcoma (ChiCTR) - P2 | N=22 | Not yet recruiting | Sponsor: Shanghai Changzheng hospital; Shanghai Changzheng hospital

New P2 trial • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

CHANGEABLE: Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=37 | Completed | Sponsor: Fudan University | Recruiting ➔ Completed

Metastases • Trial completion • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • BAP1 • BARD1 • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK1 • CHEK2 • FANCA • FANCC • FANCD2 • FANCE • FANCF • FANCM • HER-2 • NBN • PTEN • RAD50 • RAD51C • RAD51D • WRN

CCGLC-013: Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Tongji Hospital | Trial completion date: Jun 2026 ➔ Jun 2028 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Clinical predictive value of PD-1/PD-L1-induced electrocardiogram changes for cardiotoxicity (PubMed, Zhonghua Zhong Liu Za Zhi) - "Groups were divided according to immunotherapy regimen: Group A (drug code: 609A), 16 patients were given 1 mg/kg of the drug for 21 days; Group B (drug code: HX008), 23 patients were treated with 200mg for 21 days; Group C (drug code: GB226), 28 patients were treated with 3mg/kg for 14 days; Group D (drug code: LP002), 26 patients were treated with 900mg for 14 days. The high sensitivity of early ECG changes induced by immune checkpoint inhibitors enables early prediction of related cardiotoxicity. The presence or absence of comorbid underlying disease and drug dosage are correlated with the occurrence of adverse cardiac events, and these early changes provide a evidence for clinical treatment and prevention."

Journal • Cardiovascular • Oncology • Solid Tumor • PD-1 • PD-L1

MRG002-HER2 ADC combined with pucotenlimab (a PD-1 inhibitor), in patients with locally advanced or metastatic urothelial carcinoma (UC): Preliminary results of a phase I/II study (ESMO 2024) - "This phase I/II study was to evaluate the safety and activity of combination therapy in mUC patients who failed 1st line chemotherapy or not suitable for cisplatin as 1L therapy. IIn dose-escalation stage (Phase I), Eligible patients were assigned to MRG002 at cohort of 1.8mg/kg or 2.2mg/kg Q3W, combined with HX008 3mg/kg (cap with 200mg) Q3W. Compared with other combination of IO+ADCs, MRG002+HX008 results less incidence of grade 3/4 toxicities, and can bring durable progression-free survival benefit. Further evaluation of safety and efficacy is ongoing."

Clinical • IO biomarker • Metastases • P1/2 data • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Axitinib in Combination With anti–PD-1 ab(Pucotenlimab ) plus intra-hepatic injection of Oncolytic virus(OH2), in Mucosal Melanoma Patients With liver Metastasis: An Open-Label Phase I Trial (CSCO 2024) - "Study group: [CSCO Malignant Melanoma Expert Committee]"

Clinical • Combination therapy • Oncolytic virus • P1 data • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

Lepu Biotech’s ADC pipeline has made significant progress [Google translation] (iis.aastocks.com) - "In the first half of the year, the sales revenue of its core product Puyouheng (pucotenlimab Injection) reached 94.8 million yuan, doubling year-on-year, and was the main source of the company's revenue of 133 million yuan. contribute. In April 2023, pucotenlimab has been successfully included in the 2023 CSCO and CSGO guidelines for the treatment of melanoma and MSI-H/dMMR solid tumors, indicating high recognition by clinical KOLs."

Clinical guideline • Sales • Melanoma • Solid Tumor

Clinical Efficacy Study of Pucotenlimab Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer (clinicaltrials.gov) - P2 | N=39 | Not yet recruiting | Sponsor: Women's Hospital School Of Medicine Zhejiang University

Metastases • New P2 trial • Endometrial Cancer • Oncology • Solid Tumor

Neoadjuvant SBRT Combined With Lenvatinib and Pucotenlimab for Resectable Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor