JS207 / Shanghai Junshi Biosci - LARVOL DELTA

A phase I study of JS207, a PD-1/VEGF bispecific antibody, in patients with advanced malignancies (ESMO Asia 2025) - P1 | "JS207 is engineered on the backbone of toripalimab with a VEGFA-specific nanobody inserted between Fab and Fc domains. JS207 demonstrated acceptable safety and promising monotherapy efficacy in solid tumors. JS207 is being evaluated in multiple phase II studies as monotherapy or in combination with standard care."

Clinical • Metastases • P1 data • Colorectal Cancer • Hepatocellular Cancer • Kidney Cancer • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer • MSI • PD-1 • PD-L1

Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. FDA has approved its investigational new drug application for a phase II/III clinical study of JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, for the neoadjuvant treatment of non-small cell lung cancer (NSCLC) patients. (TipRanks)

IND • New P2/3 trial • Non Small Cell Lung Cancer

Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

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

JS207 Combination Therapy in Triple-negative Breast Cancer (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor (clinicaltrials.gov) - P1 | N=98 | Active, not recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Recruiting ➔ Active, not recruiting | N=192 ➔ 98

Enrollment change • Enrollment closed • Solid Tumor

Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | N=42 ➔ 72 | Trial completion date: Sep 2026 ➔ Jun 2026 | Trial primary completion date: Sep 2026 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

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

JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

JS207 Combination Therapy in Triple-negative Breast Cancer (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

A Study of JS207 (PD-1/VEGF Bispecific Antibody) in Combination With Chemotherapy in Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Shanghai Junshi Bioscience 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

A Study of JS207 (PD-1/​VEGF Bispecific Antibody) in Combination With Chemotherapy in Advanced Non-small Cell Lung Cancer (ChiCTR) - P2 | N=42 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

IO biomarker • New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • NTRK • PD-L1 • RET • ROS1

JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

JS207 Combined With Chemotherapy in Subjects With Stage II-III NSCLC (clinicaltrials.gov) - P2 | N=76 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of JS207 (PD-1/VEGF Bispecific Antibody) in Combination With Chemotherapy in Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=42 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

IO biomarker • New P2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor (clinicaltrials.gov) - P1 | N=192 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Trial completion date: Sep 2025 ➔ Jun 2026 | Trial primary completion date: Nov 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor (clinicaltrials.gov) - P1 | N=192 | Recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2026 ➔ Sep 2025 | Trial primary completion date: Sep 2025 ➔ Nov 2024

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Junshi Biosciences Announces 2023 Interim Financial Results and Provides Corporate Updates (GlobeNewswire) - "Shanghai Junshi Biosciences Co., Ltd...announced its 2023 interim financial results and provided corporate updates....In particular, the sales revenue of TUOYI® (toripalimab) was approximately RMB447 million, representing an increase of approximately 50% compared to the corresponding period in 2022....In June 2023, the IND application for JS207 (a recombinant humanized anti-PD-1/VEGF bispecific antibody) was accepted by the NMPA."

New trial • Sales • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Urothelial Cancer

China Approves Junshi Biosciences's Clinical Trial for Anti-Tumor Injection; Shares Fall 3% (Market Screener) - "China's medical products administrator approved Shanghai Junshi Biosciences'...clinical trial for the JS207 injection for advanced malignant tumor treatment, according to a Sunday filing....Shares fell 3% in Hong Kong during Monday's morning trading."

Commercial • New trial • Oncology

The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor (clinicaltrials.gov) - P1 | N=162 | Not yet recruiting | Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor