Company Introduction
Company Introduction
Company Introduction
Company Introduction
Company Introduction

CARsgen® is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. The Company has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production.

 

CARsgen® has developed a competitive product pipeline with global rights, featuring nine CAR T-cell products. Among them, zevorcabtagene autoleucel (“zevor-cel” or “CT053”), an autologous B-cell maturation antigen (BCMA) CAR T-cell therapy, has been approved in China. Another key product candidate, satricabtagene autoleucel ("satri-cel" or "CT041"), is an autologous CAR T-cell therapy targeting Claudin18.2. Satricabtagene autoleucel is expected to be the first CAR T-cell therapy for solid tumors to file for a New Drug Application. In addition to its autologous products, CARsgen® is also advancing differentiated allogeneic CAR T-cell therapies.

To address major challenges of CAR T-cell therapies, CARsgen® has also developed novel technologies and platforms, including:

 

1) THANK-uCAR® (Target and Hinder the Attack of NK cells on Universal CAR) — differentiated allogeneic CAR-T platform, enhances proliferation and persistence of the allogeneic CAR T cells;

 

2) CARcelerate® — one-day culture, produces CAR T cells that are younger;

 

3) CycloCAR® (Cytokine and Chemokine Loaded CAR) — enhance efficacy in solid tumors;

 

4) LADAR® (Local Action Driven by Artificial Receptor) — a versatile platform for precise targeting.

CARsgen Image
CARsgen Image
CARsgen Image

CARsgen® has established in-house, vertically integrated manufacturing capabilities for the three key stages of CAR T manufacturing, including the production of plasmids, lentiviral vectors, and CAR T cells. The company has established commercial manufacturing facilities in China and the United States to support clinical trials and commercial manufacturing. With the commercial GMP manufacturing facility in Jinshan, Shanghai, we manufacture CAR T-cell products in-house to support clinical trials in China and manufacture the lentiviral vectors in-house to support clinical trials globally. Our GMP manufacturing facility in Durham, North Carolina (“RTP Manufacturing Facility”) will support clinical studies and early commercial launch in the United States, Canada and Europe.

 

The company's diverse team of experts collaborates across borders to advance the development of CAR T-cell therapies and ensure that they meet the needs of patients around the world.

CARsgen’s mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer curable.

Milestones

2014

CARsgen was established in Shanghai

2015

Initiated the world’s first Glypican-3 (GPC3) CAR T investigator-initiated trial for hepatocellular carcinoma (HCC)

2016

Registered a subsidiary in Delaware, U.S.

2017

Initiated the world’s first Claudin18.2 CAR T clinical trial for gastric cancer or gastroesophageal junction cancer (GC/GEJ)

IND filing: Glypican-3 (GPC3) CAR T

2018

IND filing: CD19 CAR T, BCMA CAR T

2019

6 INDs

Zevor-cel was granted Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) by the Food and Drug Administration (FDA), and was granted PRIority Medicine (PRIME) by the European Medicines Agency (EMA)

CARsgen’s Jinshan facility in Shanghai got China’s first Drug Production License for CAR T

2020

CT041 INDs (China/U.S.)

Zevor-cel pivotal phase II initiated in China

Zevor-cel was granted Breakthrough Therapy Drug by the National Medical Products Administration (NMPA), and was granted Orphan Drug by the European Medicines Agency (EMA)

CT041 was granted Orphan Drug by the FDA

2021

CARsgen was listed on Hong Kong Exchanges and Clearing Limited (HKEX) (Stock Code: 2171.HK)

Zevor-cel initiated phase 2 clinical trial in the U.S./Canada

CT041 was granted Orphan Drug and PRIority Medicine (PRIME) by the European Medicines Agency (EMA)

CT011 completed phase I enrollment in China

2022

Zevor-cel’s new drug application (NDA) accepted by the National Medical Products Administration (NMPA)

CT041 initiated a confirmatory phase II clinical trial in China

CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) by the Food and Drug Administration (FDA)

CARsgen’s current good manufacturing practices (CGMP) facility started operation in the RTP, U.S.

2023

Agreement with Huadong Medicine for the commercialization of the BCMA CAR T-cell product zevorcabtagene autoleucel (zevor-cel) in mainland China

CARsgen collaborates with Moderna to evaluate CT041 in combination with an mRNA cancer vaccine

CT041 initiated Phase 2 clinical trial in the U.S.

2024

CT011 achieved IND clearance from the NMPA for hepatocellular carcinoma (adjuvant)

NMPA approved the NDA for zevorcabtagene autoleucel

Completion of enrollment in the pivotal Phase II clinical trial of satricabtagene autoleucel (CT041)