SYS6090 / CSPC Pharma - LARVOL DELTA

JMT108, a novel anti-PD-1/IL-15 bifunctional fusion protein, in patients with advanced solid tumors: results from a first-in-human phase I/II study (ESMO 2026) - No abstract available

Clinical • First-in-human • Metastases • P1/2 data • Oncology • Solid Tumor • IL15

SYS6090 (JMT108) granted Fast Track Designation by U.S. FDA for treatment of patients with MSS/pMMR mCRC (CSPC Press Release) - "The data supporting this Fast Track designation include preclinical study results, and data from Phase 1 clinical studies underway in both China and the United States. The granting of Fast Track designation by the FDA recognizes that the Product has demonstrated the potential to treat a serious or lifethreatening disease, and will facilitate and expedite its development and approval in the United States as well as globally."

Fast track • pMMR • Colorectal Cancer

Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=288 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

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

CSPC Pharmaceutical Group Limited…is pleased to announce that the Phase Ib/II clinical trial (Study Protocol No.: SYS6090-007) of SYS6090 Injection (the 'Product') developed by the Group, for the treatment of hepatocellular carcinoma has been officially initiated at the first centre in China (HKEXnews) - "The approved clinical trial is an open-label, multi-centre Phase Ib/II clinical study aimed at evaluating the safety, tolerability, and efficacy of the combination therapy of the Product in participants with hepatocellular carcinoma."

Trial initiation date • Hepatocellular Cancer

JMT108-003: Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors (clinicaltrials.gov) - P1/2 | N=500 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | N=188 ➔ 500

Enrollment change • Melanoma • Oncology • Solid Tumor

A Phase Ib/II Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=260 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

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

SPC Pharmaceutical Group Limited…is pleased to announce that the Phase Ib/II clinical trial (SYS 6090-008) of the combination therapy of SYS6090 Injection (the 'Product') developed by the Group for the treatment of colorectal cancer has been officially initiated at the first research centre in China (HKEXnews) - "The approved clinical trial is an open-label, multi-centre Phase Ib/II clinical trial aimed at evaluating the safety, tolerability and efficacy of the combination therapy of the Product in participants with colorectal cancer....Based on the results of this study, the Group will subsequently continue to advance the Phase III confirmatory clinical trial of the combination therapy of the Product in participants with colorectal cancer..."

New P1/2 trial • Colorectal Cancer

A novel anti-PD-1/IL-15 fusion protein JMT108 (SYS6090) with highly selective PD-1⁺ immune cell activation and potent anti-tumor efficacy (AACR 2026) - P1/2 | "JMT108 showed markedly higher selectivity for PD-1⁺ T cell activation versus N-803, with >10,000 fold lower potency in naïve PBMCs. Notably, it reduced PD-1 expression on activated CD8⁺ T cells, in contrast to the upregulation observed with N-803. In hHSC-mice, JMT108 induced sustained expansion of CD8⁺ effector cells (PD-1⁺) without proliferation of naïve T cells."

Clinical • Immune cell • IO biomarker • Hepatocellular Cancer • Melanoma • Oncology • Solid Tumor • CD8 • IL15

SYS6090 Combination Therapy in Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=596 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

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

A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=270 | Recruiting | Sponsor: Conjupro Biotherapeutics, Inc.

New P1 trial • Cholangiocarcinoma • Colorectal Cancer • Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma (clinicaltrials.gov) - P1/2 | N=188 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma (clinicaltrials.gov) - P1/2 | N=188 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P1/2 trial • Melanoma • Oncology • Solid Tumor

JMT108-001: First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=400 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Phase classification: P1 ➔ P1/2 | N=270 ➔ 400

Enrollment change • First-in-human • Phase classification • Oncology • Solid Tumor

JMT108-001: First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=270 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

JMT108 (BI-FUNCTIONAL FUSION PROTEIN DRUG) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. (HKEXnews) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited (the 'Company', together with its subsidiaries, the 'Group') is pleased to announce that JMT108 (the 'Product'), a new Class I bi-functional fusion protein drug developed by the Group, has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the U.S....The indication for this approval is advanced malignant tumors."

IND • Oncology

First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=270 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P1 trial • Oncology • Solid Tumor

JMT108 (BI-FUNCTIONAL FUSION PROTEIN DRUG) OBTAINS CLINICAL TRIAL APPROVAL IN CHINA (HKEXnews) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited (the 'Company', together with its subsidiaries, the 'Group') is pleased to announce that JMT108 (the 'Product'), a new Class I bi-functional fusion protein drug developed by the Group, has been approved by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. The Product is a recombinant fully human anti-PD-1/IL-15 bi-functional fusion protein, which relieves immunosuppression on PD-1 positive tumor infiltrating immune cells caused by the interaction of PD-1 and PD-L1....The indication for this approval is advanced malignant tumors."

New trial • Oncology