nilvanstomig (ZG005) / Suzhou Zelgen - LARVOL DELTA

ZG005 in combination with etoposide and cisplatin for the first-line treatment of advanced neuroendocrine carcinoma (ESMO 2025) - P1/2 | "Background Advanced neuroendocrine carcinoma (NEC) has limited therapeutic options, with etoposide/cisplatin (EP) or etoposide/carboplatin (EC) remaining as the first-line standard. Serious adverse events occurred in 20.7% of pts in the ZG005+EP arms, with two cases (immune-mediated enterocolitis and subclinical myocarditis) deemed treatment-related. Conclusions The combination of ZG005 with standard EP based chemotherapy showed a favorable safety profile and encouraging anti-tumor activities in pts with NEC."

Clinical • Combination therapy • Metastases • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor • TIGIT

ZG005 combination hydrochloride gilteritinib tablets in patients with relapsed or refractory lymphoma: a multicentre, open-label, dose-exploration and dose-expansion phase I/II clinical study. (ChiCTR) - P1/2 | N=60 | Recruiting | Sponsor: The First Affiliated Hospital of Zhejiang University School of Medicine; The First Affiliated Hospital of Zhejiang University School of Medicine

New P1/2 trial • B Cell Lymphoma • Classical Hodgkin Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Large B Cell Lymphoma • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Suzhou Zelgen Biopharmaceuticals…announced that China’s National Medical Products Administration (NMPA) has approved clinical studies for ZGGS18 and ZG005 in combination with chemotherapy for advanced solid tumors, advancing two Category 1 biologics with novel mechanisms into human trials (flcube.com) - "Study Design: Phase I/II dose‑escalation and expansion;...Manufacturing: Zelgen’s Suzhou facility (capacity 10,000 L) will produce both assets for clinical trials; commercial scale‑up planned for 2028. Clinical Speed: NMPA’s Category 1 biologic fast‑track enables Phase I initiation in Q2 2026 and potential conditional approval by 2029."

China approval • Commercial • New P1/2 trial • Solid Tumor

Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Oncology

Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma (clinicaltrials.gov) - P1/2 | N=350 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer • Solid Tumor

Study of ZG005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Oncology • Solid Tumor

Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Cervical Cancer • Hepatocellular Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

…FDA…approved a clinical trial combining its novel bispecific antibody ZG005 with the bifunctional fusion protein ZGGS18 for the treatment of advanced solid tumors (flcube.com) - "Suzhou Zelgen plans to begin patient enrollment in late 2025, focusing on solid tumors with high PD‑L1 expression and angiogenic profiles."

IND • New trial • Solid Tumor

Suzhou Zelgen Biopharmaceuticals…announced that the…NMPA has approved its clinical trial for ZG005 in combination with gecacitinib hydrochloride tablets and chemotherapy for advanced solid tumors (flcube.com)

New trial • Solid Tumor

Study of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=153 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Solid Tumor

Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Cervical Cancer • Oncology • Solid Tumor

Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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

ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma (clinicaltrials.gov) - P1/2 | N=350 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Preliminary results of ZG005, a bispecific antibody targeting PD-1 and TIGIT, as monotherapy in patients with advanced cervical cancer. (ASCO 2025) - "ZG005 has demonstrated a tolerable safety profile and promising anti-tumor activity at the 20 mg/kg dose as monotherapy in patients with advanced cervical cancer."

Clinical • Metastases • Monotherapy • Anemia • Cervical Cancer • Endocrine Disorders • Hypertension • Immunology • Myositis • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-1 • TIGIT

Preliminary results of ZG005, a bispecific antibody targeting PD-1 and TIGIT, in combination with chemotherapy with or without bevacizumab as first-line treatment for advanced cervical cancer. (ASCO 2025) - P1/2 | "In the Part 2, pts were randomized at 1:1 ratio to receive ZG005 at 10 mg/kg or 20 mg/kg in combination with the standard chemotherapy (paclitaxel [175 mg/m2] plus carboplatin [AUC 5] or cisplatin [50 mg/m2]), with or without bevacizumab (15 mg/kg) every 3 weeks for six cycles, followed by the maintenance therapy of ZG005 with or without bevacizumab for up to 2 years. ZG005 in combination with the chemotherapy, with or without bevacizumab, demonstrated favorable safety and tolerability profiles at both 10 mg/kg and 20 mg/kg dosages. Additionally, this regimen exhibited a significant antitumor activity in first-line cervical cancer pts, with the 20 mg/kg dose group showing a notably better efficacy in comparison with the 10 mg/kg dose group."

Clinical • Combination therapy • Metastases • Cervical Cancer • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • PD-1 • TIGIT

Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Cervical Cancer • Endocrine Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Study of ZG005 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P2 trial • Solid Tumor

Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma (clinicaltrials.gov) - P1/2 | N=60 | Not yet recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

New P1/2 trial • Hematological Malignancies • Lymphoma • Oncology

Zelgen Pharmaceuticals' ZG005 for injection in combination with platinum-containing chemotherapy regimens has been approved for clinical trials [Google translation] (Sina Corp) - "According to public inquiries, ZG005 is one of the first drugs with the same target to enter clinical research in the world. Currently, no drug with the same mechanism has been approved for marketing worldwide. ZG005 has the dual-target blocking effect of PD-1 and TIGIT."

New trial • Oncology

Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Hepatocellular Cancer • Oncology • Solid Tumor

Preliminary results from a Phase I/II clinical trial of ZG005, a bispecific antibody targeting TIGIT/PD-1, in subjects with advanced solid tumors (CSCO 2024) - "Study Group: [CSCO Clinical Research Expert Committee]"

Clinical • Metastases • P1/2 data • Oncology • Solid Tumor • TIGIT

Zelgen Pharmaceuticals: Announcement on Voluntary Disclosure of Clinical Research Progress of ZG005 for Injection [Google translation] (Sina Corp) - P1/2 | N=484 | NCT06233292 | Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd | "As of August 6, 2024, the 'Phase I/II Clinical Trial of ZG005, a Bispecific Antibody Targeting TIGIT/PD-1, for Subjects with Advanced Solid Tumors' (Protocol No.: ZG005-001) has enrolled 46 patients with advanced cervical cancer, among whom most subjects (87%, 40/46) had previously received at least one line of systemic treatment with anti-tumor drugs, and some subjects (28%, 13/46) had previously used immune checkpoint inhibitors....In terms of efficacy, among the 36 cervical cancer subjects with evaluable efficacy (1 in the 3 mg/kg group, 20 in the 10 mg/kg group, and 15 in the 20 mg/kg group), 2 achieved complete remission (CR), 12 achieved partial remission (PR), and 15 achieved stable disease (SD), with an objective response rate (ORR) of 38.9% and a disease control rate (DCR) of 80.6%."

P1/2 data • Cervical Cancer • Solid Tumor