R&D Pipelines - Shanghai Lishan Biopharmaceutical Co., Ltd

Live Biotherapeutic Products

LS-LBP-001

Crohn's disease (CD) is closely related not only to immune-mediated pathogenic factors, but also to the disorder of gut microbiota and the loss of control of the gut microenvironment.

The LS-LBP-001 pipeline of Lishan Biotech is based on the globally innovative biophysical Swarming technology, which has discovered significant Swarming bacterial enrichment in the intestinal contents of CD patients. From a biophysical perspective, it is committed to alleviating intestinal inflammation and oxidative stress, restoring the intestinal tract to a low oxygen state when healthy, improving symptoms related to intestinal inflammation, and solving the problem of intestinal microbiota colonization. Compared to molecular biologics and antibody drugs, the LS-LBP-001 pipeline has advantages such as higher safety, more comprehensive treatment, and more supportive policies.

Pipeline

LS-LBP-001

Indication

Pipeline

Indication

Discovery

Preclinical

IND

Phase 1

Phase 2

Phase 3

BLA

LS-LBP-001

At present, the LS-LBP-001 pipeline has completed the Ia clinical trial and is currently undergoing Ib/IIa clinical trials.

LS-LBP-002

Renal cell carcinoma (RCC) is a common malignant tumor, and its prevention and treatment still face severe challenges in the United States, with a mortality rate of up to 18%, and sharing the core commonality of targeted and immunotherapy in treatment.

The LS-LBP-002 pipeline of Lishan Biotech aims to synergize microbial therapy with anti-PD-1 therapy. Through its natural and safe mechanism, it is expected to reshape the patient's immune response, enhance anti-tumor efficacy, and provide new treatment hope for RCC patients.

Pipeline

LS-LBP-002

Indication

Tumor

Pipeline

Indication

Discovery

Preclinical

IND

Phase 1

Phase 2

Phase 3

BLA

LS-LBP-002

RCC

At present, the LS-LBP-002 pipeline has completed overseas Ib clinical trials and is advancing phase II clinical trials.

LS-LBP-003

In the course of tumor chemotherapy, high-dose Methotrexate Adverse Reaction (MTX-AR) compromises patient quality of life and diminishes chemotherapy efficacy. However, there remains a lack of comprehensive intervention strategies to prevent or mitigate the adverse effects induced by MTX.

The LS-LBP-003 pipeline of Lishan Biotech addresses this challenge through a metagenomic sequencing approach. This strategy identified a differential bacterial strain, DX-M01, distinguishing between MTX-AR response and remission groups. Subsequent validation in clinical samples has demonstrated its potential to alleviate MTX-induced intestinal damage and myelosuppression.

Pipeline

LS-LBP-003

Indication

MTX-AR

Pipeline

Indication

Discovery

Preclinical

IND

Phase 1

Phase 2

Phase 3

BLA

LS-LBP-003

MTX-AR

At present, the LS-LBP-003 pipeline is still in the preclinical research stage.

Small Molecule Drugs

LS-SM-001

Ulcerative Colitis (UC) has more than 5 million cases worldwide, and the incidence rate is rising.

The LS-SM-001 pipeline of Lishan Biotech has screened the small molecule pregnane X receptor (PXR) receptor with the best efficacy and least toxicity through a microbial mimetic platform. PXR activation can inhibit the NF - κ B pathway, regulate inflammation related gene expression, and restore intestinal homeostasis. The LS-SM-001 pipeline simultaneously utilizes lipid nanoparticle technology for drug delivery, achieving precise and stable release to achieve long-term relief of UC.

Pipeline

LS-SM-001

Indication

Pipeline

Indication

Discovery

Preclinical

IND

Phase 1

Phase 2

Phase 3

NDA

LS-SM-001

At present, the LS-SM-001 pipeline has completed preclinical research and is preparing for FDA IND application.

LS-SM-002

Autism Spectrum Disorder (ASD) affects approximately 2% of children worldwide. It primarily impacts brain development and neural connectivity, with core clinical manifestations including impairments in social interaction and communication. Currently, there is a lack of effective pharmacological treatments.

The LS-SM-002 pipeline of Lishan Biotech addresses this unmet need through a synbiotic combination therapy predominantly composed of 2'-FL and Bifidobacterium animalis. This therapeutic strategy is designed to alleviate symptoms of ASD and related psychiatric conditions by inhibiting harmful bacteria and their neuro-damaging metabolites.

Pipeline

LS-SM-002

Indication

ASD

Pipeline

Indication

Discovery

Preclinical

IND

Phase 1

Phase 2

Phase 3

NDA

LS-SM-002

ASD

At present, the LS-SM-002 pipeline is still in the preclinical research stage.

LS-SM-003

Liver Cancer (LC) is one of the most prevalent malignant tumors worldwide, ranking among the highest in both incidence and mortality. Hepatocellular Carcinoma (HCC), accounting for approximately 75%-85% of all cases, represents the predominant pathological type.

The LS-SM-003 pipeline of Lishan Biotech targets NSUN5. By modulating ribosome biogenesis and translation, it maintains the stemness of tumor cells and influences the tumor microenvironment. The optimal small molecule for this intervention was identified through our large-scale computational screening platform.

Pipeline

LS-SM-003

Indication

Pipeline

Indication

Discovery

Preclinical

IND

Phase 1

Phase 2

Phase 3

NDA

LS-SM-003

At present, the LS-SM-003 pipeline is still in the preclinical research stage.