FIELDS AND PIPELINE

Fields & Pipeline

We focus on innovative research to develop cell therapy technology in order to defeat malignant tumors. At present, we are mainly engaged in the development and application of gene and cell drugs.

Relying on our original technology, we have mastered key technologies such as immune cell therapy (multi-target CAR-T, universal CAR-T, solid tumor CAR-T, and efficient method for preparing CAR-T cells), stem cell therapy, and gene therapy.

We have deployed more than ten product R&D pipelines for leukemia, lymphoma, myeloma, kidney cancer, colorectal cancer, lung cancer and breast cancer. We obtained 4 Class I biological CAR-T new drugs and 9 indications of implied license.


Product Candidates

Indications

IIT/IIS

Pre-Clinical

Phase I

Phase II

NDA

pCAR-19B

ALL(3-21 pediatric)

ALL(22-70 adult)

C-4-29

Multiple myeloma for adults

Renal cell carcinoma for adults

C-13-60

Colorectal cancer/Gastric cancer/Esophageal cancer

C-13-X

Pancreatic cancer/Lung cancer/Breast cancer

MC-1-50

ALL/NHL/Autoimmune diseases

UCAR-T

ALL/NHL/Autoimmune diseases

UCAR-NK

AML

Product Candidates

Indications

Approved Time

Product Features

pCAR-19B

ALL(3-21 pediatric)

2019.02

Filling the domestic gap: for the treatment of children and adolescents with relapsed/refractory B-cell acute lymphoblastic leukemia, the self-developed pCAR-19B autologous cell reinfusion preparation is the first CAR-T product in China to enter the phase II clinical stage for this indication. The overall response rate was 100%.

ALL(22-70 adult)

2020.05

Lymphoma

2020.05

C-4-29

Multiple myeloma for adults

2020.12

The first target in China: C-4-29 cell preparation with dual indications for both hematological tumors and solid tumors. It is the first CAR-T product targeting renal cell carcinoma solid tumors in China. Both indications have obtained the registered clinical implied license.

Renal cell carcinoma for adults

2021.09

C-13-60

advanced malignant solid tumors that progress or are intolerant after systematic standard treatment and have no effective treatment means

2022.12

The first CAR-T product targeting CEA approved by clinical trials in China. Its second indication :the unique intraperitoneal local medication can break through the limitations of traditional intravenous infusion, establish a long-lasting circulating immunity, enhance the killing of solid tumors and prevent recurrence, and may reduce the risk caused by off-target effect.

This candidate product is indicated for patients ≥ 18 years of age with CEA-positive advanced malignancies,including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, non-small cell lung cancer, breast cancer, bile duct cancer, etc.

2023.12

MC-1-50

For patients (≥ 18 years of age) with relapsed/refractory CD19-positive B-cell non-Hodgkin's lymphoma

2023.10

It is a CD19-targeted CAR-T cell product based on the company's innovative PRIMCAR ® platform, which implements a new faster and more efficient CAR-T preparation technology that results in lower doses, fewer side effects, and longer lasting effects.

For patients ≥ 18 years of age with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia

2023.12